What are the best practices? (Has Best Practice)
From The Embassy of Good Science
1
10 Things for Curating Reproducible and FAIR Research
Thing 1: Completeness
Thing 2: Organization
Thing 3: Economy
Thing 4: Transparency
Thing 5: Documentation
Thing 6: Access
Thing 7: Provenance
Thing 8: Metadata
Thing 9: Automation
Thing 10: Review +
A
Reproducing any part of an article or book (figure, table, etc) definitely requires permission from the copyright holder. The copyright holder is usually the publisher since authors tend to transfer the copyright to the publisher upon submission of their manuscripts. +
COPE recommends the retraction of articles that contain fabricated data and a reporting made to the appropriate institutional misconduct body. Universities and research centres should be very sensitive to this important issue by reprimanding or dismissing researchers involved in fabrication. +
For COPE in matters relating to the addition or omission of an author, a request should be sent to the publishing journal. The journal will ask for the permission of all authors with corrections made following their consent. +
According to COPE, this is a clear case of guest or gift authorship. It is not recommended to add a researcher to the authors list of an article if he/she do not fulfil the requirements for authorship. If an editor finds out about an instance of gift authorship, COPE recommends the removal of the suspected gift author from the authorship list. For article submissions, it is strongly recommended that they include a statement of contributions agreed by all contributors. +
This practice is discouraged by COPE. Authors should resist such requests as much as possible. +
On submission of an article, authors are usually asked to mention whether their submission is under review elsewhere. Duplicate submission is a form of research misconduct. However, if a journal does not review a manuscript in an appropriate amount of time, authors can withdraw their manuscript. However, the editor-in-chief should be informed beforehand and a record of all correspondence maintained by the corresponding author. Authors should never submit a manuscript to another journal before appropriate withdrawal of the manuscript or notice of a rejection. +
On submission of an article, authors are usually asked to mention whether their submission is under review elsewhere. Duplicate submission is a form of research misconduct. However, if a journal does not review a manuscript in an appropriate amount of time, authors can withdraw their manuscript. However, the editor-in-chief should be informed beforehand and a record of all correspondence maintained by the corresponding author. Authors should never submit a manuscript to another journal before appropriate withdrawal of the manuscript or notice of a rejection. +
This is a case of redundant publication. Authors are usually asked to provide a signed statement that the manuscript they are submitting has not been published elsewhere. Any violation of this statement is considered to be a case of misconduct and can result in retraction. If a translation of a previously published article is going to be submitted to another journal, prior permission should be sought from the publisher of the first article and the second manuscript should contain an appropriate reference to the first publication +
Regulatory compliance
Data archiving and management +
- Maintaining Privacy
-Confidentiality and Anonymity
-Protecting vulnerable groups
-Data sharing +
This workbook discusses how to put the principle of AI Fairness into practice across the AI project workflow through Bias Self-Assessment and Bias Risk Management as well as through the documentation of metric-based fairness criteria in a Fairness Position Statement. +
In this workbook, we introduce fundamental concepts of AI, responsible research and innovation, and AI ethics and governance, such as the SSAFE-D Principles – which stands for Sustainability, Safety, Accountability, Fairness, Explainability, and Data-Stewardship. The SSAFE-D Principles are a set of ethical principles that serve as starting points for reflection and deliberation about possible harms and benefits associated with data-driven technologies. +
This workbook introduces the SUM Values (Support, Underwrite, Motivate), a set of ethical values intended to help AI project teams to assess the potential societal impacts and ethical permissibility of their projects. It then presents a Stakeholder Engagement Process (SEP), which provides tools to facilitate proportionate engagement of and input from stakeholders with an emphasis on equitable and meaningful participation and positionality awareness. +
This workbook provides a template of the SIA and activities that allow a deeper dive into crucial parts of it. For example, it discusses methods for weighing values and considering trade-offs during the SIA process, and highlights the need to approach the SIA as an end-to-end process of responsive evaluation and re-assessment. The workbook also includes a series of activities related to AI in Urban Planning to assist public sector bodies in developing a shared vocabulary and practical skills to implement ethical AI projects. +
When a complaint is submitted to the Executive Board of a university, it is the Board's duty to forward the case to the university's research integrity office.
When researchers are commissioned to produced research in a personal capacity, the associated studies should explicitly state that the authors are working in a personal capacity. In addition, there should be no mention of their academic affiliations. +
- Preservation and access
- Developing infrastructure
- Addressing interdisciplinary differences
- Recognition of good data practices
- Using standards +
The cases reveal practices to avoid:
<br />
*Plagiarism
*Undeserved authorship
*Duplicate submission
*Unprofessional conduct
*Lack of ethical approval
*Redundant or duplicate publication
Other experienced misconduct to avoid were:
<br />
*"‘salami‐slicing’– dividing up a piece of research as thinly as possible to get the maximum number of papers out of it; this naturally involves a great deal of repeated information, especially in the ‘methods’ section;"
*"cutting and pasting whole sections from 1 manuscript to another – another unfortunate temptation of the electronic age;"'"`UNIQ--ref-0000018F-QINU`"'
*"publishing a paper in a small national journal, then having it translated into English and submitting it to a larger journal without revealing its previous publication;"
*"publishing a paper in a minor journal or in some other format such as an e‐journal and then submitting it to a larger journal without revealing its previous publication, and"
*"attempting to have a paper published in 2 journals simultaneously; some authors even go so far as to give identical papers different titles and list the authors in a different order in an attempt to disguise this type of misconduct." '"`UNIQ--ref-00000190-QINU`"'
'"`UNIQ--references-00000191-QINU`"' +
Following [http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html International Committee of Medical Journal Editors' (ICMJE) recommendations] +
B
There are six tenets or principles: indigenous identity development, indigenous paradigmatic lens, reflexivity and power sharing, critical immersion, participation and accountability, and methodological flexibility.
See more at: [https://journals.sagepub.com/doi/10.1177/1476750315622542 Guidance in the article published in Action Research.] +
C
COPE provides collection of [https://publicationethics.org/guidance/Guidelines guidelines] on publication ethics. +
As an author, assuming responsibility and being accountable for one's work requires the disclosure of one's identity. +
Case-based ethics instruction: the influence of contextual and individual factors in case content on ethical decision-making +
Cases must include a rich and realistic description of the social context. +
This teaching material was developed by the NRIN. In the first session in which this material was used, case 1 was not entirely clear to the participants. Some information was therefore added to this material. A session with discussions on all dilemma’s would take about 60-90 minutes.
Cases 2 and 3 were slightly simplified for a meet-the-keynote-speaker session with Prof. Lex Bouter. He used one only case 2 (Case A in the ppt) in this session, because it already yielded a lively discussion with the participants who also discussed related dilemma’s they encountered in their work.
The material then was further developed for the course on research integrity for PhD-candidates at VUmc. New materials to be uploaded. +
- General Scientific Integrity
- Collegiality
-Responsibility to research participants
- Protection of animals in research
- Obligations to students
-Social Responsibility +
- Publication ethics
- Supervision and mentoring
- Institutional policy +
In their virtue-based model of ethical decision-making, Crossan et al. outline how a virtue-based orientation may be a means of resilience for individuals who are trying to navigate between high situational pressures and demands for ethical behavior.'"`UNIQ--ref-00000009-QINU`"'
Medeiros et al. give an overview of cognitive biases prevalent among university staff.'"`UNIQ--ref-0000000A-QINU`"' Mecca et al. give valuable insights on the efficacy of a training intervention based on the finding of Medeiros et al.'"`UNIQ--ref-0000000B-QINU`"'
Cassam recently introduced an account on how epistemic vices may influence unethical decision-making.'"`UNIQ--ref-0000000C-QINU`"' Moreover, he gives an overview on how these vices may be corrected (see chapter 8 “Self-improvement“, p. 167-187).'"`UNIQ--ref-0000000D-QINU`"'
'"`UNIQ--references-0000000E-QINU`"' +
Collaborative Working Between Academia and Industry: An Educational Scenario by the EnTIRE project +
The aim of all eight scenarios is to allow researchers, research ethics committees ('RECs'), research integrity offices ('RIOs') and research administrators to focus their reflection on core principles and research contexts that enshrine good research practice as well as their local rules and practices. +
The European Code of Conduct'"`UNIQ--ref-00000052-QINU`"' states that good research practice with regard to collaborations are based on the following principles:
*"All partners in research collaborations take responsibility for the integrity of the research.
*All partners in research collaborations agree at the outset on the goals of the research and on the process for communicating their research as transparently and openly as possible.
* All partners formally agree at the start of their collaboration on expectations and standards concerning research integrity, on the laws and regulations that will apply, on protection of the intellectual property of collaborators, and on procedures for handling conflicts and possible cases of misconduct.
*All partners in research collaborations are properly informed and consulted about submissions for publication of the research results. "(ECC 2017, section 2.6)
Vicens and Bourne (2007) suggest the following rules'"`UNIQ--ref-00000053-QINU`"':
#Do Not Be Lured into Just Any Collaboration
#Decide at the Beginning Who Will Work on What Tasks
#Stick to Your Tasks
#Be Open and Honest
#Feel Respect, Get Respect
#Communicate, Communicate, and Communicate
#Protect Yourself from a Collaboration That Turns Sour
#Always Acknowledge and Cite Your Collaborators
#Seek Advice from Experienced Scientists
#If Your Collaboration Satisfies You, Keep It Going
'"`UNIQ--references-00000054-QINU`"' +
While some COIs might be inevitable (e.g. in case of scientists who move between academia, industry, and government), disclosure and providing extra information is believed to empower readers to place credence on presented data. '"`UNIQ--ref-000002A5-QINU`"'
Conflict of interests is explained in numerous guidelines . For example, Committee on Publication Ethics (COPE) has issued several guidelines for dealing with conflict of interest, from both reviewers’ and readers’ point of view. COPE guidelines for reviewers can be found [https://www.embassy.science/theme/A%20lot%20has%20been%20said%20about%20conflict%20of%20interest.%20For%20example,%20Committee%20on%20Publication%20Ethics%20(COPE)%20has%20issued%20several%20guidelines%20for%20dealing%20with%20conflict%20of%20interest,%20from%20both%20reviewers%E2%80%99%20and%20readers%E2%80%99%20point%20of%20view.%20COPE%20guidelines%20for%20reviewers%20can%20be%20found%20here here], and guidelines for readers can be accessed [https://www.embassy.science/theme/A%20lot%20has%20been%20said%20about%20conflict%20of%20interest.%20For%20example,%20Committee%20on%20Publication%20Ethics%20(COPE)%20has%20issued%20several%20guidelines%20for%20dealing%20with%20conflict%20of%20interest,%20from%20both%20reviewers%E2%80%99%20and%20readers%E2%80%99%20point%20of%20view.%20COPE%20guidelines%20for%20reviewers%20can%20be%20found%20here here].
International Committee of Medical Journal Editors (ICMJE) also addressed the issue of conflict of interest, and defined purposeful failure to disclose conflicts of interest as a form of misconduct. They categorize conflict of interest as following: financial relationships (such as consultancies, stock ownership or options, honorary payments, patents…), personal relationships or rivalries, academic competition, and intellectual beliefs. A more detailed ICMJE explanation and guide can be found [https://www.embassy.science/theme/International%20Committee%20of%20Medical%20Journal%20Editors%20(ICMJE)%20also%20addressed%20the%20issue%20of%20conflict%20of%20interest,%20and%20defined%20purposeful%20failure%20to%20disclose%20conflicts%20of%20interest%20as%20a%20form%20of%20misconduct.%20They%20categorize%20conflict%20of%20interest%20as%20following%3A%20financial%20relationships%20(such%20as%20consultancies,%20stock%20ownership%20or%20options,%20honorary%20payments,%20patents%E2%80%A6),%20personal%20relationships%20or%20rivalries,%20academic%20competition,%20and%20intellectual%20beliefs.%20A%20more%20detailed%20ICMJE%20explanation%20and%20guide%20can%20be%20found%20here here].
A separate ICMJE declaration of conflict of interest form can be accessed [http://www.icmje.org/conflicts-of-interest/ here]. Completed ICMJE COI declaration is often a requirement for submitting an article to a scientific journal.
'"`UNIQ--references-000002A6-QINU`"'
- Awareness of potential conflicts of interest
- Institutional oversight +
Researchers can consult the following guidelines on collaboration with communities:
* Kate Chatfield et al. (2018) Research with, not about, communities - Ethical guidance towards empowerment in collaborative research, a report for the TRUST project. http://trust-project.eu/
* Figueiredo Nascimento, S., Cuccillato, E., Schade, S., Guimarães Pereira, A. (2016) Citizen Engagement in Science and Policy-Making. doi:10.2788/40563 https://ec.europa.eu/jrc/communities/sites/jrccties/files/mc10_rio_sio-lopez_mobility_reading.pdf +
D
- Green Open Access
- Golden Open Access
- Collaboration between partners
- Creation of a national Open Access Platform
- Quality assurance and monitoring +
Data Practices, Data Management and FAIR Principles: An Educational Scenario by the EnTIRE project +
The aim of all eight scenarios is to allow researchers, research ethics committees ('RECs'), research integrity offices ('RIOs') and research administrators to focus their reflection on core principles and research contexts that enshrine good research practice as well as their local rules and practices. +
Resnik et al (2015) list four measures researchers can take to address deception by research subjects. '"`UNIQ--ref-00000197-QINU`"'
# Researchers can verify information by letting participants undergo physical exams and laboratory tests.
# Research subjects can be excluded from the study when deception is uncovered.
# Studies can consider rewarding research subjects when they provide accurate self-reported information.
# Researchers can require subjects to be registered in a clinical trial particpant registry. +
<br />
'"`UNIQ--references-0000020A-QINU`"' +
The case provides some ideas of best practices in order to avoid such plagiarism allegations:
a) Create your own review model after you have read a number of different review examples, rather heavily relying on one single example
b) Acknowledge that the book review model used relies heavily on XX’s review by referencing appropriately +
The Irish national statement for research integrity <sup>7</sup> is developed in line with the ECoC.
- Principles of Research Integrity
- Research Misconduct
- Collaboratiosns +
The philosophical importance of dialogue has been elaborated in philosophical hermeneutics. '"`UNIQ--ref-0000002B-QINU`"''"`UNIQ--ref-0000002C-QINU`"'
Moral Case Deliberation is an example of group reflection on moral issues through dialogue.'"`UNIQ--ref-0000002D-QINU`"' In MCD, a morally troublesome situation is investigated by a group, guided by a facilitator. During the investigation, the conflicting values in the situation are examined in dialogue.
'"`UNIQ--references-0000002E-QINU`"' +
Failures to disclose conflicts of interests should be investigated on the basis of institutional codes of conduct for research integrity. +
E
Core parts of the learning pathways are based on case studies because experience has shown that they are particularly suitable to promote knowledge and foster skills conducive to acting ethically and with integrity in research. More specifically, the case studies allow learners to reflect on what they have learned and to apply newly acquired skills to concrete examples. Moreover, learners can assess their knowledge by answering a set of questions and obtaining feedback on their responses via email. Thus, the ENERI Classroom is an interactive and responsive learning platform.
The cases in the resources section on the Embassy as well as the educational scenarios developed by the EnTIRE project that are available in the educational resources section can complement the ENERI Classroom by adding further issues of interest and/or elaborating existing ones. +
The ENERI Decision Tree summarizes and links to many important laws, regulations, codes and other documents that can help researchers to work ethically and with integrity and that can support RECs and RIOs in performing their roles adequately and fulfilling their responsibilities. More detailed information on all topics covered in the Decision Tree is available in the ENERI Manual on Research Ethics and Research Integrity. Besides, the [[Resource:C386dbba-2f69-4257-89c2-903898cf1f12|ENERI Classroom]] as well as the [[Guide:Bbe860a3-56a9-45f7-b787-031689729e52|VIRT2UE Training Guide]] provide access to educational materials on research ethics and research integrity that help fostering skills conducive to ethical reflection.
Furthermore, the [https://embassy.science/wiki-wiki/index.php/Special:BrowseData/Resource?_search_Resource_Type%5B0%5D=Cases cases] in the resources section of the Embassy as well as the educational scenarios developed by EnTIRE that are available in the [https://embassy.science/wiki-wiki/index.php/Special:BrowseData/Resource?_search_Resource_Type%5B0%5D=Education educational resources] section can be used for further reflections and deliberations on specific research ethics and research integrity problems. +
All European Academies (ALLEA) published a revised and updated European Code of Conduct for Research Integrity (ECoC), in which it emphasized the importance of addressing ethics and research integrity. The ECoC defines principles and practices of good research, and includes the virtues of reliability, honesty, respect and accountability. Usually philosophers consider honesty and the following characteristics to be epistemic virtues: attentiveness, benevolence (principle of charity), creativity, curiosity, discernment, humility, objectivity, parsimony, studiousness, understanding, warranty, and wisdom. '"`UNIQ--ref-00000004-QINU`"'
'"`UNIQ--references-00000005-QINU`"' +
- Exercising necessary care and competence, even in the face of pressure
- Exercise social responsibility
- Data management and publication practices
- Ensure that research is free from vested interests +
The ASA Ethical Guidelines present the responsibilities that researchers have with research participants, funders, sponsors, employers, host governments and the discipline of anthropology in general. +
Recent advances in research allow for a more defined view of the ethical issues surrounding the treatment of aging. Today we know that the senescence of the organism is a pathological process with a great variety of pathological consequences in old age (which causes or aggravates cardiovascular disease, cancer, neurodegenerative diseases and many others). It has also been shown that in laboratory animals it is possible to slow down aging, prolong healthy adulthood and reduce the age incidence of a broad spectrum of aging-related diseases. This is accompanied by an overall extension of the life span, sometimes to a great extent. Ethics discussions in this area argue how the treatment of aging can have detrimental consequences on society as a whole.
Anyway, given the developments in research in the treatment of diseases linked to aging, it would be useful to define how these interventions must be applied without ethically compromising the meaning of existence as a society, devaluing life by extending its duration'"`UNIQ--ref-000004CE-QINU`"' . In conclusion, decelerated aging leads to conflicting decisions. The health benefits force us to pursue it, despite the change in some ethical aspects of human society will be inevitable. +
F
The movies included in the final selection are:
*And the band played on (1993)
*Awakenings (1990)
*Creation (2009)
*Dallas Buyers Club (2013)
*Extreme measures (1996)
*Kinsey (2004)
*Lorenzo's oil (1992)
*On being a scientist (2016)
*Silkwood (1983)
*Star Trek 'Nothing human' (1998)
*The boys from Brazil (1978)
*The China syndrome (1979)
*The Fly (1986)
*The Insider (1999)
*The Island (2005)
*The Lawnmower man (1992)
*Wit (2001) +
Part Three (pages 161-224): Fostering Integrity in Research
Chapter 9 (page 163): [https://www.nap.edu/read/21896/chapter/1#content-toc_pz15-2 Identifying and Promoting Best Practices for Research Integrity]
Chapter 10 (page 195): [https://www.nap.edu/read/21896/chapter/1#content-toc_pz15-3 Education for the Responsible Conduct of Research] +
This Framework sets out the elements of a collaborative agreement that can be enhanced with regards to good research practices. +
==Funders and research ethics==
Reporting standards and ethics regulations vary between funding organizations. The European Commission has developed an elaborate procedure for ensuring that funded projects satisfy ethical requirements. In order to complete one´s application for funding within Horizon 2020, one must fill out an extensive ethics self-assessment. All projects that qualify for funding are subject to an ethics review procedure. The outcome of the ethical committee can influence the requirements funders have for the study. If ethical issues are judged to be particularly severe or complex, certain monitoring procedures may be required, such as engaging an ethics advisor or an ethics board within the project.
The Missenden Code of Practice for Ethics and Accountability'"`UNIQ--ref-0000005B-QINU`"' was drawn up to promote ethical research in British universities in the face of growing pressure from industry and private funders. The Missenden code identifies eight difficulties that some universities have encountered through their collaborations with industry: i) Safeguarding Academic Freedom; ii) Tasking an ‘Ethics Committee’; iii) Defending the Academic’s Right to Publish; iv) Protecting Intellectual Property Rights; v) Meeting the Student Expectation; vi) Preparing for Controversy; vii) Managing the New Model University; viii) Sourcing Alternative Funding. The code addresses each one of the difficulties using case studies, and makes 14 suggestions to help universities respond to the development of commercial funding of university research.
==Funders and research integrity==
The current climate for research funding is highly competitive. Many high-quality grant applications are rejected. Research shows that ‘high ranked’ institutions in the US were 65% more likely to succesfully receive grants, and received 50% more awards.'"`UNIQ--ref-0000005C-QINU`"' At the same time, lower ranked institutions had a higher impact with the research they performed.'"`UNIQ--ref-0000005D-QINU`"''"`UNIQ--ref-0000005E-QINU`"' This finding may be indicative of funding bias. Moreoever, a highly competitive funding climate can feed perverse incentives. On the one hand, funders rely on assessment criteria, which include publication records and journal impact factors. As a result, researchers may strive to get as many papers published as possible without due care for the integrity of their research. On the other hand, researchers may feel the need to exagarate the expected impact of the proposed research or exagarate their skills and qualitifications.
Nontheless, RFO’s can implement policies fostering research integrity. For example, the Wellcome Trust in the UK provides a ‘transition support fund’ for PhD students. '"`UNIQ--ref-0000005F-QINU`"' The fund can be used after the completion of a PhD project, and the student can decide how they want to further their career by using the fund as they see fit. The fund can be used, for instance, to write another paper or to do an internship.
RFOs can also develop initiatives to combat perverse incentives. For instance, many funders have signed the San Francisco Declaration on Research Assessment, or DORA.'"`UNIQ--ref-00000060-QINU`"' The declaration’s aim is to reduce the use of journal impact factors in funding evaluations. Instead, other indicators, such as altmetrics, should be used. Implementing DORA in reviewing grant proposals can mean evaluating a researcher by asking about their most important publication, the impact of their previous research, and their other qualifications besides publications. '"`UNIQ--ref-00000061-QINU`"'
'"`UNIQ--references-00000062-QINU`"'
G
General Code of Ethics in Scientific Research (Romanian Ministry of Education, Research and Youth) +
- Responding to misconduct +
The BRIDGE guidelines are the proposed best practices +
Apart from its work on concrete inquiries, the Commission states that its aim is to play a critical role in further developing the guidelines governing good scientific practice. It sees the alignment of legal requirements with the principles of research integrity as a key task for the future. To that end, the Commission states that it will initiate a regular forum on "Good Scientific Practice and the Law". +
TENK launched the Research Integrity Adviser system in order to raise awareness of the responsible conduct of research in Finland, to increase personal guidance on research integrity, and to offer expert training on responsible conduct of research and procedures.
TENK advised various parties on mechanisms to resolve allegations of research misconduct as well the guidelines for handling alleged violations.
TENK coordinates the ethical review of research in the field of human sciences and promotes cooperation between regional and institutional research ethics committees. The Board annually monitors the state of ethical review in universities and research institutions by gathering information on the cases handled by research ethics committees.
TENK established a working group to update the guidelines for the ethical review of research in the field of human sciences in order to meet the requirements of the new General Data Protection Regulations ('GDPR'). +
The Plagiarism Control Group checks the research proposals submitted to the SNSF both at random (5% of all submissions) and when it is alerted to potential research integrity cases by persons outside the SNSF.
The SNSF uses the ''iThenticate'' software, produced by Turnitin, in order to compare research proposals with texts on the internet and scientific databases. Only results with a similarity index of ≥ 10% and/or the largest possible degree of correspondence of >200 words are followed up. +
- Authorship acknowledgements
-Journal reviewing practices
<br /> +
This guide was developed during the COVID pandemic by the department of Experimental Immunology of Amsterdam UMC and is implemented by this department to talk about stress with their PhD-candidates. +
- Procedures for misconduct investigation +
- Obligation to society
-Protection of research participants
- Citation and publication
-Protection of animals in research
-Whistleblowing +
Guidelines for Research Ethics in the Social Sciences, Humanities, Law and Theology (NESH, Norway) +
Detailed best practices relating to:
- Respect for individuals
-Respect for groups and institutions
- Interacting with the research community
-Performing commissioned research
-Good dissemination practices +
Given the broad diversity that exists among research institutions, it is possible that some recommendations are not applicable in all research settings. For this reason, the guidelines should not be seen as a ‘one-size-fits-all’, but rather as tools that can be used flexibly and adapted to meet institutions’ specific needs. +
Given the broad diversity that exists among research institutions, it is possible that some recommendations are not applicable in all research settings. For this reason, the guidelines should not be seen as a ‘one-size-fits-all’, but rather as tools that can be used flexibly and adapted to meet institutions’ specific needs. +
H
Based on the provided information in the case, this can be seen as examplary conduct that shows how a virtuous researcher deals with problematic situations. +
Hungarian Decree on the system of integrity management at public administration bodies and the procedural rules of receiving lobbyists +
- Appointment of integrity officers
- Internal and external oversight mechanisms +
I
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[[Resource:Dd4e2cd2-c665-43a6-86ec-8e75a43eef3a]] +
Following should be disclosed:
*Funding received from government, commercial, private foundation, etc. for conducting the research
*Relevant financial activities outside the submitted work.
*Intellectual Property
<br /> +
Irish National Forum on Research Integrity's Guidelines for the Investigation of Misconduct in Research +
- Initial review
- Panel composition
- Formal investigation
-Maintaining Confidentiality +
Irish National Forum on Research Integrity's Report on Fostering a Climate of Excellence for Irish Research +
- Collaboration to ensure adherence to RI standards
- RI dilemmas +
L
-General Principles of Research Integrity: Respect, Honesty, Protecting Research Subjects, Publication and dissemination
- Integrity in different aspects of research such as teaching, mentoring, reviewing, providing expertise and contributing to society +
- Adherence to ethics guidelines
-Interdisciplinary and inter-institutional collaboration +
- General good practice guidelines, including data management practices, dissemination of results and research process;
- Misconduct, including misrepresentation of data, plagiarism, and intellectual property fraud;
- Misconduct handling and duties of the ombudsperson;
- Principles for handling industry partnerships such as academic independence and transparency +
M
- Excellence
-Honesty
- Openness
- Rigour
- Safety
- Ethical Responsibility
-Responsible Management
- Regulatory Compliance
- Professional Standards
- Reporting Research Misconduct +
- Check University RDM Policy and funder requirements
- Create and maintain a data management plan
- Address data protection and ethics
- Consider intellectual property and licensing
- Gather together all eligible costs +
- Data Protection by design
- Privacy notices +
- Confidentiality, data protection and information sharing
- IP Ownership
- Rights in IP Creation
-General Rights +
- General principles of conducting research , teamwork and publication
- Collaborations and Leadership
- Guiding early career scientists
- Data storage and retrieval
- Scientific publications
- Conflicts of Interest
- Ombudspersons and their duties
- Whistleblower protection
<br /> +
According to Merton:
*''Communism'' (sometimes referred to as communalism) addresses common ownership of scientific discoveries and the need for scientists to publicly share their discoveries. This could be seen as a precursor to modern initiatives such as open science;
*''Universalism'' is the idea that everyone can do science, regardless of race, nationality, gender or any other differences, and that everyone’s scientific claims should be scrutinized equally. In science, it’s all about your arguments, line of evidence and methodology, regardless of who you are;
*''Disinterestedness'' expresses the idea that scientists should work only for the benefit of science;
*''Organized scepticism'' expresses the idea that the acceptance of all scientific work should be conditional on assessments of its scientific contribution, objectivity and rigor. '"`UNIQ--ref-00000325-QINU`"'
These norms describe the ideal scientific community. In reality, however, the research climate falls short of this ideal. Scientific discoveries can often be found behind paywalls or remain unpublished. Research can sometimes be appraised and published on the basis of the authority and status of its authors. The culture of ‘publish or perish’ and the increased dependence on grants for success can sometimes obfuscate the value of scientific research.
These phenomena are described as counter-norms: secrecy, particularism, interestedness, dogmatism. '"`UNIQ--ref-00000326-QINU`"' Some have suggested employing originality and replication as additional norms. '"`UNIQ--ref-00000327-QINU`"'
'"`UNIQ--references-00000328-QINU`"' +
The European Code of Conduct states that good research practice with regard to collaborations are based on the following principles:
*All partners in research collaborations take responsibility for the integrity of the research.
*All partners in research collaborations agree at the outset on the goals of the research and on the process for communicating their research as transparently and openly as possible.
*All partners formally agree at the start of their collaboration on expectations and standards concerning research integrity, on the laws and regulations that will apply, on protection of the intellectual property of collaborators, and on procedures for handling conflicts and possible cases of misconduct.
*All partners in research collaborations are properly informed and consulted about submissions for publication of the research results. (ECC 2017, section 2.6)
Vicens and Bourne (2007) suggest the following rules: '"`UNIQ--ref-00000208-QINU`"'
#Do Not Be Lured into Just Any Collaboration
#Decide at the Beginning Who Will Work on What Tasks
#Stick to Your Tasks
#Be Open and Honest
#Feel Respect, Get Respect
#Communicate, Communicate, and Communicate
#Protect Yourself from a Collaboration That Turns Sour
#Always Acknowledge and Cite Your Collaborators
#Seek Advice from Experienced Scientists
#If Your Collaboration Satisfies You, Keep It Going
'"`UNIQ--references-00000209-QINU`"' +
Reflection on moral conflicts, and especially on moral dilemmas, is an important element of responsible research practice. Take for example Phase I trials that involve novel therapies for patients (so-called First-In-Human (FIH) Trials). '"`UNIQ--ref-00000038-QINU`"' These trials involve a high degree of uncertainty in intervention development and possible outcomes. Although this step, hopefully, in turn, will make a Phase-III clinical trial in compliance with the basic epistemological and ethical requirement of therapeutic trials possible, it is a fact that so far no widely accepted standards for judgments of uncertainty, safety, and value of FIH trials have yet been formulated. Consequently, no selection of patients to be included in such trials can be said to be fully satisfactory, i.e. without the possibility of moral failure. Through acknowledging the possible existence of irresolvable moral conflicts in research, researchers will learn modesty, and thereby also protect themselves from being infected by the vice of ''hybris''.
Reflection on moral dilemmas can be fostered by organizing Moral Case Deliberation (MCD). '"`UNIQ--ref-00000039-QINU`"' In MCD, a morally troublesome situation is investigated by a group, guided by a facilitator. During the investigation, the conflicting values in the situation are examined in dialogue. This enables participants to become aware of, and reflect on the moral conflict involved. MCD specifically focuses on moral conflicts that cannot be restlessly solved, that is on moral dilemmas. The aim is to investigate different values of stakeholders in practice, and become aware that in making a choice, certain values will be harmed. This may result in the awareness that, although a choice is unavoidable, one should be open to the negative consequences of and take responsibility for them.
'"`UNIQ--references-0000003A-QINU`"' +
N
Avoid the following pitfalls (behavioral aspect with an example): (a) Temptation - “Getting my name on this article would look really good on my CV”, (b) Rationalization - “It’s only a few data points, and those runs were flawed anyway”, (c) Ambition - “The better the story we can tell, the better a journal we can go for”, (d) Group and authority pressure - “The PI’s instructions don’t exactly match the protocol approved by the ethics review board, but she is the senior researcher”, (e) Entitlement - “I’ve worked so hard on this, and I know this works, and I need to get this publication”, (f) Deception - “I’m sure it would have turned out this way (if I had done it)”, (g) Incrementalism - “It’s only a single data point I’m excluding, and just this once”, (h) Embarrassment - “I don’t want to look foolish for not knowing how to do this”, (i) Stupid systems, “It counts more if we divide this manuscript into three submissions instead of just one”. +
O
TENK believes that it is important to keep the threshold low for initiating a preliminary inquiry into such cases. +
- Open access publishing +
P
Different publishers have a different set of rules for reporting research and conducting peer review so it is always recommended to familiarize yourself with any specific guidelines which are available on each journal’s webpage. Before you can accept an invitation to review, it is necessary to consider does your area of expertise match the topic of the proposed article as well as your potential conflict of interest. A successful peer review usually contains a clear answer on the question should the proposed article be accepted, rejected, or revised. It also contains a list of any major and/or minor issues, their location within the article as well as explanations and suggestions to the author(s). There are some freely available resources which can help with peer review process such as COPE's ethical guidelines for peer reviewers '"`UNIQ--ref-000000FF-QINU`"', Peer review golden rules and good practice checklist '"`UNIQ--ref-00000100-QINU`"' and the Handbook on Best Practices for Peer Review '"`UNIQ--ref-00000101-QINU`"', published by the Association of American University Presses.
'"`UNIQ--references-00000102-QINU`"' +
The researcher entered into a Voluntary Settlement Agreement with the ORI. They voluntarily agreed to exclude themselves from serving in any advisory capacity to the PHS and to certify in every PHS research application or report that all contributions to the application or report are properly cited or otherwise acknowledged. +
Polish Ministry of Science and Information Society Technologies' Good Scientific Research Practice Recommendations +
- Observing basic good conduct such as honesty
- Proper management and cooperation in research teams
- . Special consideration of the needs of young researchers
- Securing and maintaining research results
- Observance of copyrights of the scientific publications.
- Avoiding conflicts of interest +
[https://www.allea.org/wp-content/uploads/2017/05/ALLEA-European-Code-of-Conduct-for-Research-Integrity-2017.pdf The European Code of Conduct for Research Integrity] defines good practices for training, supervision and mentoring:
"Senior researchers, research leaders and supervisors mentor their team members and offer specific guidance and training to properly develop, design and structure their research activity and to foster a culture of research integrity" +
- Tips to ensure public engagement
- Promoting gender equality in research
- Policy recommendations
- Open access
- Science education at schools +
- The pros and cons of self-regulation and statutory regulation
- Who oversees self-regulation? +
In areas such as physics, mathematics and economy, preprint servers have been in use for almost 30 years.'"`UNIQ--ref-000005F2-QINU`"' In 1991 a centralized automated repository, the arXiv preprint server, was the pioneer in this method of dissemination of research results. It played an important role in physics, astronomy and mathematics, and later was implemented into other research areas.'"`UNIQ--ref-000005F3-QINU`"' Significant number of journals has adopted this practice of posting their manuscripts on preprint servers. About 46% of the 2,566 publishers indexed in SHERPA RoMEO support preprint servers.'"`UNIQ--ref-000005F4-QINU`"' The Lancet, for example, posts articles to preprint severs from Social Science Research Network (SSRN).'"`UNIQ--ref-000005F5-QINU`"'
Preprint servers can be journal (Netprints), non-journal (arXiv), mixed (ResearchGate), subject repositories (Social Sciences Research Network) as well as national and regional servers (Chinese Preprint Server Online).'"`UNIQ--ref-000005F6-QINU`"' They can be supported by con-commercial and non-editorial organizations as well. For example, the Welcome Trust in UK has its own preprint server.'"`UNIQ--ref-000005F7-QINU`"' Research institutions and funding organizations also can have preprint servers. One of the examples is UK’s Medical Research Council (MRC) that includes the manuscripts posted on preprint servers in biomedical research grant applications.'"`UNIQ--ref-000005F8-QINU`"'
Some of the most popular preprint servers are:
-[https://www.biorxiv.org/ BioRxiv] (a preprint repository for the biological sciences);
-[https://arxiv.org/ arXiv] (an open access archive operated by Cornell University, containing 1,774,607 articles in the fields of physics, mathematics, computer science, quantitative biology, quantitative finance, statistics, electrical engineering and systems science and economics);
-[https://thewinnower.com/ the Winnower] (an open access online publishing platform that offers an open post-publication peer review);
-[https://psyarxiv.com/ PsyArXiv] (a preprint server for the field of psychology, launched in 2016 by Cornell University);
-[http://www.prepubmed.org/ PrePubMed] (a platform that indexes preprints from PeerJ Preprints, Figshare, bioRxiv, and F1000Research)'"`UNIQ--ref-000005F9-QINU`"';
-[https://www.medrxiv.org/ medRxiv] (the first preprint server for medicine, launched in 2019 by Yale and BMJ).'"`UNIQ--ref-000005FA-QINU`"'
Longer list of preprint repositories can be found [https://docs.google.com/spreadsheets/d/1zYOy6bcydDZ9G56FKmDzg_pexTarVsJR5hH0KiQGt_I/edit#gid=1494155948 here] and [https://asapbio.org/preprint-servers here].
Although there are some preprint servers for medicine, shortcomings of this practice have to be considered. Medical research findings are often discussed by the media and public, so the media release of an unreviewed work can be harmful.'"`UNIQ--ref-000005FB-QINU`"''"`UNIQ--ref-000005FC-QINU`"' Preprints in medicine also raise ethical questions regarding research with humans, therefore the confidentiality of participants should be protected.'"`UNIQ--ref-000005FD-QINU`"'
Nevertheless, in this time of COVID-19 pandemic preprint servers showed to be a useful tool because of the accelerated dissemination of research results. This is important especially regarding treatments and vaccines.'"`UNIQ--ref-000005FE-QINU`"' From the early stages of the pandemic to the mid October, more than 19,000 preprints were produced.'"`UNIQ--ref-000005FF-QINU`"' We also have to consider that peer reviewed articles published in journals can present low-quality work. One of the examples is article about a Russian vaccine, published in the Lancet,'"`UNIQ--ref-00000600-QINU`"' which instigated objections and an open letter to the authors and the Lancet editor. The objections addressed data presented in the article and called for full availability of the original data in order to evaluate the study and enable reproduction of the research findings.'"`UNIQ--ref-00000601-QINU`"''"`UNIQ--ref-00000602-QINU`"'
'"`UNIQ--references-00000603-QINU`"'
- Ensuring academic independence
- Enabling integrity in research
- Misconduct handling +
According to the Belmont[https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html]'"`UNIQ--ref-000004A7-QINU`"' report:
· Respect
· Beneficence
· Justice
<br />
'"`UNIQ--references-000004A8-QINU`"' +
*Nowadays, ‘good publication’ is considered to be peer reviewed publication. Since 1830 peer review became systematic and operational and is considered essential for academic publishing in present times.
*Journal editors are responsible for the publication process. Their standards are defined in guidelines of the Committee on Publication Ethics (COPE) which were founded in 1997.
+
The aim of all eight scenarios is to allow researchers, research ethics committees ('RECs'), research integrity offices ('RIOs') and research administrators to focus their reflection on core principles and research contexts that enshrine good research practice as well as their local rules and practices. +
Q
When qualitative research is intended to generate hypotheses for future research or to test the feasibility and acceptability of interventions, then applying the results is relatively straightforward.
Can the results of qualitative research be applied directly to daily clinical practice? If the study population seems similar enough to one’s own, then the clinician can justifiably consider the usage of the study results to reflect on his or her practice (2). +
Pre-registration of study protocols enhances the transparency of the research process and lends credibility to results. +
R
Recommendations of the Finnish National Board on Research Integrity TENK for Research Integrity Advisers and related background organisations1 +
Advisors' range of activities include:
- Supporting the responsible conduct of research
- Providing guidance on the handling of misconduct
- Conducting preliminary ethical reviews +
Some of the most common examples of replication failures come from drug discovery and development. Usually drugs are developed in several stages, beginning with cells and animal studies and ultimately advancing to human trials. Failures in both conceptual and direct replication are frequent in this branch of science. Conceptual failure, for example, can occur when testing a drug that has promising action in animals for the first time in humans'"`UNIQ--ref-0000039B-QINU`"''"`UNIQ--ref-0000039C-QINU`"', whereas a direct replication failure might occur when testing the same drug on a similar group of people'"`UNIQ--ref-0000039D-QINU`"'. Since successful replications enhance public trust in science and medicine, the increasing number of non-replicable studies in various disciplines, mainly psychology, have resulted in what has been described as a “replication crisis” and raised serious concerns'"`UNIQ--ref-0000039E-QINU`"'. A study conducted by a team of 270 scientists at the University of Virginia in Charlottesville showed that only 35 of 100 studies published in one of the prominent psychology journals in 2008 could be replicated'"`UNIQ--ref-0000039F-QINU`"'. Some argue however that there is no such thing as a “replication crisis”; moreover, sometimes the “non-replicability” could be helpful to science'"`UNIQ--ref-000003A0-QINU`"'.
If replication fails, it does not necessarily mean that the original result of the experiment which is being replicated is false. It indicates some unknown factors are different in the replication experiment vs. the original experiment and an attempt should be made to investigate these '"`UNIQ--ref-000003A1-QINU`"''"`UNIQ--ref-000003A2-QINU`"'. If such factors are found (either of a technical or knowledge domain specific nature) they can substantially improve the understanding of the phenomena being studied.
In the last few years, leading scientific institutions in the United States have taken some steps to improve replicability. In 2014, the National Institutes of Health (NIH) provided training modules for postdoctoral fellows and a list of publications regarding replicability on their website, and emphasized addressing transparency in grant applications'"`UNIQ--ref-000003A3-QINU`"'. The National Science Foundation (NSF) and the Institute for Education Sciences (IES) have published Companion Guidelines on Replication and Reproducibility in Education Research in 2018. The guidelines suggest several actions to enhance replicability. For example, proposals for replication studies should guarantee objectivity, pre-registration of the research design and methods should ensure transparency, research should be described in detail, and all research data should be publically available'"`UNIQ--ref-000003A4-QINU`"'. Taking these important steps calls for a significant culture shift so that accuracy in research would be valued more than swiftness'"`UNIQ--ref-000003A5-QINU`"'.
'"`UNIQ--references-000003A6-QINU`"'
There have been some cases of successful study replication. One of the most known cases is deciphering the Rosetta Stone. The Stone which was discovered during the Napoleonic Egyptian Campaign in 1799 contains texts both in Ancient Egyptian (hieroglyphic and Demotic script) and in Ancient Greek. By comparing the Demotic, hieroglyphic and ancient Greek texts, British scholar Thomas Young and French scholar Jean-François Champollion managed to decipher Egyptian hieroglyphic.'"`UNIQ--ref-000005BC-QINU`"' Numerous scholars have studied the stone later and the main results have been replicated multiple times.'"`UNIQ--ref-000005BD-QINU`"' '"`UNIQ--ref-000005BE-QINU`"'
Although there is no consensus in the research community, some research organisations, academic journals and platforms have been encouraging replication in the humanities. One of them is the [https://www.nwo.nl/en/about-nwo Netherlands Organisation for Scientific Research] (NWO). The NWO recognizes that while not all humanities research is suitable for replication, this practice is possible in the empirical humanities and this is what it aims to “encourage and facilitate”.'"`UNIQ--ref-000005BF-QINU`"'
Cambridge University based journal [https://www.cambridge.org/core/journals/language-teaching Language Teaching] is also fostering original research articles which replicate previous experimental studies in the field of language learning and teaching.'"`UNIQ--ref-000005C0-QINU`"' It emphasizes that replication studies can improve the way we interpret empirical research because they provide a second opinion regarding the hypotheses, methods and results of the original paper.'"`UNIQ--ref-000005C1-QINU`"'
Publishing platform [https://opencontext.org/ Open context], founded by archaeologists, also supports and encourages replication in the humanities.'"`UNIQ--ref-000005C2-QINU`"'
'"`UNIQ--references-000005C3-QINU`"' +
The aim of all eight scenarios is to allow researchers, research ethics committees ('RECs'), research integrity offices ('RIOs') and research administrators to focus their reflection on core principles and research contexts that enshrine good research practice as well as their local rules and practices. +
Good scientific practices (general)
- Good practices in grant applications
- Ethics in research involving animals +
The aim of all eight scenarios is to allow researchers, research ethics committees ('RECs'), research integrity offices ('RIOs') and research administrators to focus their reflection on core principles and research contexts that enshrine good research practice as well as their local rules and practices. +
The Concordat to Support Research Integrity lists eight aspects which are important for a good research environment to promote best practices and research integrity.'"`UNIQ--ref-000004ED-QINU`"' They state a good research culture should include, as a minimum, the following: <br>
*Have clear policies, practices and procedures to support researchers
*Have research ethics and integrity training, including mentoring opportunities
*Have robust management systems ensuring implementation of policies related to research, its integrity and researchers behaviour
*Create awareness among the standards of behaviour of researchers
*Ensure a system is in place that can identify concerns at an early stage
*Provide support mechanisms for those that need assistance
*Have policies in place ensuring no stigma is attached to those that find they need assistance from their emplyees
*Communicate and implement processes to raise concerns about research integrity
'"`UNIQ--references-000004EE-QINU`"' +
On an individual level, the most important research metrics are the H-index and the i-10 index. The H-index, also known as Hirsch index, is an author level metric that shows how many articles have been cited a certain number of times. For example, a h-index of 10 shows that the author has 10 articles, each cited at least 10 times.'"`UNIQ--ref-0000011F-QINU`"' The i-10 index shows the number of articles an author has published with at least 10 citations.
On a journal level, the impact factor shows an average number of citations per article in two consecutive years.'"`UNIQ--ref-00000120-QINU`"' Other famous journal metric systems are Eigenfactor and the SCImago Journal Rankings.
It is important to note that every metric system has its flaws. As a result, they should not be the only criterion when determining the quality and performance of a particular researcher, article, journal or research project.
'"`UNIQ--references-00000121-QINU`"' +
Various practices are related to research misconduct, ranging from building an environment conducive to good research conduct to the policies and procedures for reporting misconduct. Below, some initiatives to improve the reporting of misconduct are detailed.
The European Code of Conduct for Research Integrity focuses on the adherence to Integrity and Fairness in misconduct procedures. Find the code [https://www.embassy.science/resources/the-european-code-of-conduct-for-research-integrity here.]
The Committee on Publishing Ethics (COPE) outline the responsibilities of journal editors and publishers in their ‘core practices’ [https://publicationethics.org/resources/elearning/introduction-publication-ethics/publication-ethics-and-misconduct here]. Recommendations include:
*"Journals must take seriously allegations of misconduct pre-publication and post-publication"
*"Journals should have a clearly described process for handling allegations, however they are brought to the journal's or publisher's attention"
*"COPE expects members to have robust and well-described, publicly documented practices in all these areas for their journals and organisations" +
- Following the OeAWI guidelines on Good Scientific Practice
- Scientific record-keeping +
The European Code of Conduct for Research Integrity (ECoC RI) defines a good practice in mentorship:'"`UNIQ--ref-0000054F-QINU`"'
“Senior researchers, research leaders and supervisors mentor their team members and offer specific guidance and training to properly develop, design and structure their research activity and to foster a culture of research integrity.” The ECoC RI also defines the misuse of seniority to encourage violations of research integrity as an unacceptable practice.
The Office for Research Integrity of the US Department of Health and Human Services defines the expectations of trainees and mentors in the research process.'"`UNIQ--ref-00000550-QINU`"'
“Trainees need to know:
· how much time they will be expected to spend on their mentor’s research;
· the criteria that will be used for judging performance and form the basis of letters of recommendation;
· how responsibilities are shared or divided in the research setting;
· standard operating procedures, such as the way data are recorded and interpreted; and, most importantly,
· how credit is assigned, that is, how authorship and ownership are established.
Mentors need to know that a trainee will:
· do assigned work in a conscientious way,
· respect the authority of others working in the research setting,
· follow research regulations and research protocols, and
· live by agreements established for authorship and ownership.”
'"`UNIQ--references-00000551-QINU`"' +
Good scientific practice involves researchers providing explicit information on the origin of their test material in a way that is clear to readers of the paper.
All authors of a scientific article have responsibility for its overall content, including reading the final manuscript carefully before submitting it to a journal. +
Reviewing, Evaluating, Editing and Research Integrity: An Educational Scenario by the EnTIRE project +
The aim of all eight scenarios is to allow researchers, research ethics committees ('RECs'), research integrity offices ('RIOs') and research administrators to focus their reflection on core principles and research contexts that enshrine good research practice as well as their local rules and practices. +
S
SOPs4RI - Guidelines for research institutions on community building for a positive research culture +
Given the broad diversity that exists among research institutions, it is possible that some recommendations are not applicable in all research settings. For this reason, the guidelines should not be seen as a ‘one-size-fits-all’, but rather as tools that can be used flexibly and adapted to meet institutions’ specific needs. +
Given the broad diversity that exists among research institutions, it is possi- ble that some recommendations are not applicable in all research settings. For this reason, the guideline should not be seen as a ‘one- size-fits-all’, but rather as a tool that can be used flexibly and adapted to meet institutions’ specific needs. +
Given the broad diversity that exists among research institutions, it is possible that some recommendations are not applicable in all research settings. For this reason, the guidelines should not be seen as a ‘one-size-fits-all’, but rather as a tool that can be used flexibly and adapted to meet institutions’ specific needs.
Furthermore, several best practices are highlighted in the guidelines itself. +
Given the broad diversity that exists among research institutions, it is possible that some recommendations are not applicable in all research settings. For this reason, the guidelines should not be seen as a ‘one-size-fits-all’, but rather as a tool that can be used flexibly and adapted to meet institutions’ specific needs.
Furthermore, several best practices are highlighted in the guidelines itself. +
SOPs4RI Guidelines for research institutions on Responsible Supervision and Leadership - Supervision requirements & guidelines +
Given the broad diversity that exists among research institutions, it is possible that some recommendations are not applicable in all research settings. For this reason, the guidelines should not be seen as a ‘one-size-fits-all’, but rather as a tool that can be used flexibly and adapted to meet institutions’ specific needs.
Furthermore, several best practices are highlighted in the guidelines itself. +
Given the broad diversity that exists among research institutions, it is possible that some recommendations are not applicable in all research settings. For this reason, the guidelines should not be seen as a ‘one-size-fits-all’, but rather as a tool that can be used flexibly and adapted to meet institutions’ specific needs. +
SOPs4RI Guidelines for research institutions on the research integrity education of bachelor, master and PhD students +
Given the broad diversity that exists among research institutions, it is possible that some recommendations are not applicable in all research settings. For this reason, the guidelines should not be seen as a ‘one-size-fits-all’, but rather as a tool that can be used flexibly and adapted to meet institutions’ specific needs. +
SOPs4RI Guidelines for research institutions on the research integrity education of institutional research integrity stakeholders +
Given the broad diversity that exists among research institutions, it is possible that some recommendations are not applicable in all research settings. For this reason, the guidelines should not be seen as a ‘one-size-fits-all’, but rather as a tool that can be used flexibly and adapted to meet institutions’ specific needs. +
SOPs4RI Guidelines for research institutions on the research integrity education of post-doctorate and senior researchers +
Given the broad diversity that exists among research institutions, it is possible that some recommendations are not applicable in all research settings. For this reason, the guidelines should not be seen as a ‘one-size-fits-all’, but rather as a tool that can be used flexibly and adapted to meet institutions’ specific needs. +
Given the broad diversity that exists among research institutions, it is possible that some recommendations are not applicable in all research settings. For this reason, the guidelines should not be seen as a ‘one-size-fits-all’, but rather as a tool that can be used flexibly and adapted to meet institutions’ specific needs.
Furthermore, several best practices are highlighted in the guidelines itself +
Safeguards, Data-sharing and the Disclosure of Sensitive Results: An Educational Scenario by the EnTIRE project +
The aim of all eight scenarios is to allow researchers, research ethics committees ('RECs'), research integrity offices ('RIOs') and research administrators to focus their reflection on core principles and research contexts that enshrine good research practice as well as their local rules and practices. +
Authors highlight the role that organisations such as the US Office of Research Integrity or the Danish Committees on Scientific Dishonesty can play in streamlining the process of dealing with cases of misconduct. +
It shows that researchers' responsibilities towards their projects and collected data extends beyond the duration of their employement in a particular research institute. +
Specific advice for authors: "Do not put your name on a manuscript written by someone else. • Do not insert someone else’s text as a place-holder in a draft manuscript. The original might not be replaced later. • Do not copy verbatim the background section of someone else’s paper. Copying an amount beyond fair use might violate copyright law. The background section could be incomplete or erroneous. A subsequent inquiry or investigation would consume a lot of time from faculty and administrators, and it could embarrass the institution. • Include references to all sources, with appropriate citations, in all manuscripts and grant proposals. • Take allegations of plagiarism to a research integrity officer. If there is no research integrity officer, then consult a knowledgeable administrator"'"`UNIQ--ref-000002CA-QINU`"'
'"`UNIQ--references-000002CB-QINU`"' +
- Establishing research networks
- Quality assessment of scientific training +
- Maintaining an equal gender distribution in evaluation panels
- Ensuring that the gender ratio among grant awardees is representative of that of the applicants
- Ensuring that men and women have equal success rates in grant applications
- Incorporate gender equality into analysis, evaluation and communication +
- Early identification of potential conflicts of interest
- Preventing conflicts of interest: by notifying council members or colleagues in the evaluation panel, avoiding handling applications which could be potentially conflicting +
- Planning research
-Collaboration
-Publication
-Avoiding misconduct +
- Obligations to list authors
- Authorship requirements
- Procedure for determining authorship
- Order of authorship
- Authors' responsibility
- Acknowledgements +
This guideline has best practice recommendations with respect to
- Institutional structures
- Collaborations
- Publication and dissemination
- Authorship
- Data management
- Assessment and evaluation
- Research process
- Private funding +
T
The Croatian Ministry of Science, Education and Sports' Law on Scientific Activity and Higher Education' +
- Regulation and quality assurance in higher education
- General provisions of scientific work
- Academic freedom and responsibilities
- Academic collaborations +
- Management of the research process
- Research results and idssemination +
- Policy measures to prevent undue influence
- Emphasis on personal scientific integrity +
There are hundreds of different reporting guidelines which an author can choose from. Selecting the right guideline seems difficult, but has been made easier with the use of a few tools. [http://www.equator-network.org/wp-content/uploads/2013/11/20160226-RG-decision-tree-for-Wizard-CC-BY-26-February-2016.pdf This flowchart] depicts in several easy steps which of the most common research methods (i.e. systematic review, randomized trials, observational studies) match a reporting guideline. If you have a more specific study, [https://www.penelope.ai/equator-wizard this reporting guideline wizard] was developed to reveal which guideline you can use. Please visit the [http://www.equator-network.org/ EQUATOR Network] for more information on reporting medical research. +
- Transparency regarding proposal authorship and collaborations
- Cautious use of authorship information by RFOs
- Transparency regarding misconduct procedures
- Avoiding duplicate funding +
The German Association of University Professors and Lecturers' (DHV) Position Paper on Scientific Self-regulation and Scientific Misconduct +
- Honesty in all scientific endeavors
- Supervision and guidance of students
- Dealing with misconduct +
- Awareness of legal basis
- Ethical principles of authorship +
The document offers a rationale and examples of each of the five principles. +
For department leaders: ask your coworkers to read the executive summary, and organize a meeting to talk about it and what role the department and the individuals in that department could play to address the issue. +
Leiden university also made a MOOC with this movie: https://www.coursera.org/learn/scientist. Read more on the university website https://www.universiteitleiden.nl/en/news/2018/01/mooc-on-the-dilemmas-of-science
This movie is also included in the collection of fiction movies for RCR education (NRIN). See www.nrin.nl/ri-collection/library/videos/on-being-a-scientist-movie-2016/ +
The Manchester University's Code of Practice for Investigating Concerns about the Conduct of Research +
- Identifying what constitutes Research Misconduct
- Initial Screening
- Investigative procedures and possible outcomes
-Maintaining fairness, confidentiality and integrity +
Six principles: Honesty and scrupulousness, Reliability, Verifiability, Impartiality, Independence and Responsibility +
- Integrity
- Openness
- Legal requirements
- Supervision and training
- Maintaining data records
- Publication practices
- Ethical principles in human and animal research +
The Swiss National Science Foundation and National Research Council's Regulations on scientific misconduct +
- Responsibilities regarding misconduct proceedings and appeals +
Although adequeate checks and balances seem to have not been in place at the time when the experiment was being conducted, Dr. Green should have informed his patients about the unorthodox method he was using. +
- Standards of Professionalism and trust
- Equality
- Academic freedom
- Teamwork and mutual respect
- Social responsibility
- Integrity and loyalty
- Response to misconduct allegations +
- Honesty
- Respecting the dignity of human subjects
- Non-maleficence
- Proportionality
- Social responsibility
- Respect for the environment +
- Abiding by the Law of Academic Freedom
- Honesty in scientific work
- Following ethical guidelines of specific area of research
- Acknowledging colleagues and sources
- Ensuring good collaboration
- Being accountable for resources
- Ensure validity of results
- Adhering to publication norms
- Unbiased reporting of results
- Maintaining and improving scientific competence +
- Impartiality
-Students' and Supervisors' Obligations +
Worldwide, governmentally regulated limitations for maintaining embryos in cryostorage vary from 24 months to an infinite duration'"`UNIQ--ref-00000971-QINU`"'. Although consensus regarding the ethics of thawing and discarding does not exist, in the absence of explicit, contemporaneous consent, approaches to the issue of unclaimed embryos have been proposed by other advisory bodies. The European Society of Human Reproduction and Embryology (ESHRE) Task Force on Ethics and Law has advocated standard time limits that can be renewed a limited number of times on a couple’s demand'"`UNIQ--ref-00000972-QINU`"', while the ASRM committee concluded that a clinic can consider embryos abandoned and discard them if 5 years has passed since the last contact with the couple and if significant efforts have been made to contact that couple'"`UNIQ--ref-00000973-QINU`"'. Spanish regulations mandate that embryos should only be used for reproductive purposes, which makes embryo donation the only legal solution when couples do not want the embryos for their own transfer'"`UNIQ--ref-00000974-QINU`"'. Meanwhile, Malta is one of the countries whose legislation does not permit embryo discarding and allows to inseminate up to three oocytes while all resulting embryos are required to be transferred'"`UNIQ--ref-00000975-QINU`"'. Although this immensely complicated issue is substantially discussed in the bioethical and philosophical literature, it is still one of the most significant ethical dilemmas in the world of Assisted Reproduction Technology (ART)'"`UNIQ--ref-00000976-QINU`"' +
See also: http://www.nature.com/news/fewer-numbers-better-science-1.20858 +
As Anne Pybern (a member of the Committee on Ethics) notes, such scenario requires carefully considered and flexible responses so that we do not end up serving the various existing rules instead of using these rules to service the ethical needs of humanity accordingly. +
*A set of guidelines to develop mentorship training designed to take into account ethical ambiguities from a cultural perspective and identifying beliefs, attitudes, values and behaviors that could impact interpretation or acceptance of institutional standards and guidelines (Children's Hospital of Philadelphia guidebook).
*A set of online modules designed to offer the user an open-ended learning environment. This is to say that there is no set path that all users must follow, while there will be a strongly suggested path, the module will not force each user into an area. Users are free to decide how to use the materials presented to suit their individual needs and interests. Of course, our wish is that the user will review all sections of the module in depth along our suggested path (Columbia University training module)
*A set of online modules on RCR topics developed with the support of RCR Education Grants awarded by the Office of Research Integrity to the Faculty Development and Instructional Design Center at Northern Illinois University (Northern Illinois University training module).
*A series of video vignettes and discussion guide to provoke discussion, facilitate problem-solving and identify alternate courses of action (Children's Hospital of Philadelphia training module).
+
The aim of all eight scenarios is to allow researchers, research ethics committees ('RECs'), research integrity offices ('RIOs') and research administrators to focus their reflection on core principles and research contexts that enshrine good research practice as well as their local rules and practices. +
Editors need to publish a retraction notice and specifically clarify the unreliability of results, without making a reference to the mental state of the author. +
U
The concordat targets four main areas:
*Maintaining the highest standards of research integrity
*Embedding a culture of research integrity
*Dealing with allegations of research misconduct
*A commitment to strengthening research integrity
<br /> +
- Institutions' role in promoting good authorship practices
- Handling authorship disputes
- Deciding when faulty authorship practices constitute misconduct +
- Preparatoty steps
-Steps of investigative procedure: pre-screening, screening, formal investigation +
- Maintaining RI standards
- Ethical and other frameworks
- Fostering a culture of research integrity
- Handling and preventing research misconduct
- Practices to strengthen integrity +
Understanding artificial intelligence ethics and safety: A guide for the responsible design and implementation of AI systems in the public sector +
This document provides end-to-end guidance on how to apply principles of AI ethics and safety to the design and implementation of algorithmic systems in the public sector. The guidance has set the foundation for The AI Ethics and Governance in Practice Programme curriculum which is composed of a series of eight workbooks, the first four published in 2023 and the second four to be published in 2024.
Each of the workbooks in the series covers how to implement a key component of the PBG Framework. These include sustainability, fairness, technical safety, accountability, explainability, and data stewardship. Each of the workbooks also focuses on a specific domain, so that case studies can be used to promote ethical reflection and animate the key concepts. +
The Belmont report '"`UNIQ--ref-0000020E-QINU`"' , the Declaration of Helsinki '"`UNIQ--ref-0000020F-QINU`"' and similar ethical and legal documents were enacted by governing bodies and professional associations.
'"`UNIQ--references-00000210-QINU`"' +
V
Values and norms are core concepts in moral reflection about research integrity. For instance in Moral Case Deliberation (MCD), a method used to reflect on morally troublesome situations, investigation of values and norms is used to deepen the understanding of the situation at stake.'"`UNIQ--ref-0000003E-QINU`"' A core element in this investigation, guided by a facilitator, is analysing the case by looking at the values and norms of all relevant perspectives (persons involved in the case and/or participants in the MCD meeting). Which values motivate each person? How can these values be specified into norms? For example, a moral issue might concern supervision. Should one, as a supervisor of a PhD student, in preparing a response to a reviewer, give guidance and correct mistakes, or at some point take over the writing? A relevant value for the supervisor in the case might be: autonomy. The corresponding norm in the case could be: I should give the opportunity to the PhD student to try this herself. Another value might be: effectiveness. The norm related to this value in the concrete situation could be: the article should be accepted and published. In analysing the case from the perspective of the supervisor, the group becomes aware of these conflicting values. This may then give rise to a dialogue on what value is most important in this situation. This can lead to a conclusion on the most desirable norm and related course of action. Also, the dialogue might provide insights in how to deal with the conflicting value which turns out less important. How can one do justice to the value which will not be realized? In the example, efficiency might turn out to be the most important for the supervisor, meaning that, at a certain point, she will take over the writing. In order to do justice to the value of autonomy, the supervisor might, for instance, propose that the PhD student will get more responsibility for writing the response after submission of the next article. MCD can thus foster decision making, not by prescribing a rule, but by encouraging reflection and dialogue, enabling participants to achieve a new and richer view of the situation.
It is useful to differentiate between three different types of scientific values and norms: ''internal'' values and norms, ''external'' values and norms, and ''linkage'' values and norms.'"`UNIQ--ref-0000003F-QINU`"' Internal values and norms of science justify and guide the practice of science itself. Examples of scientific values of the internal kind are: truth, honesty, simplicity, consistency, coherence, economy, exactitude and completeness, openness, open-mindedness, confidence, originality and ‘interestingness’. External values and norms comprise general ideals and rules for action, which are relevant for science, but are not constitutive of the practice of science itself. Examples of external values are human (and animal) welfare notions, which are related to the wider social and cultural context in which scientists operate. Finally, we have a different set of values and norms guiding scientific research, which represent normative points of contact - linkage - between the research community and the community at large, between internal and external values and norms. Examples are requirements of fruitfulness and relevance.
'"`UNIQ--references-00000040-QINU`"'
Values and norms are core concepts in moral reflection about research integrity. For instance in Moral Case Deliberation (MCD), a method used to reflect on morally troublesome situations investigation of values and norms is used to deepen the understanding of the situation at stake. '"`UNIQ--ref-00000049-QINU`"' A core element in this investigation, guided by a facilitator, is analysing the case by looking at the values and norms of all relevant perspectives (persons involved in the case and/or participants in the MCD meeting). Which values motivate each of the persons? How can these values be specified into norms for the person? For example, a moral issue might concern supervision. Should one, as a supervisor of a PhD student, in preparing a response to a reviewer, give guidance and correct mistakes, or at some point take over the writing? A relevant value for the supervisor in the case might be: autonomy. The corresponding norm in the case could be: I should give the opportunity to the PhD student to try this herself. Another value might be: effectiveness. The norm related to this value in the concrete situation could be: the article should be accepted and published. In analysing the case from the perspective of the supervisor, the group becomes aware of these conflicting values. This may then give rise to a dialogue on what value is most important in this situation. This can lead to a conclusion on the most desirable norm and related course of action. Also, the dialogue might provide insights in how to deal with the conflicting value which turns out less important. How can one do justice to the value which will not be realized? In the example, efficiency might turn out to be most important for the supervisor, meaning that at a certain point she will take over the writing. In order to do justice to the value of autonomy, the supervisor might, for instance, propose that the PhD student will get more responsibilty for writing the response after submission of the next article. MCD can thus foster decision making, not by prescribing a rule, but by fostering reflection and dialogue, enabling participants to achieve an new and richer view on the situation.
It is useful to differentiate between three different types of scientific values and norms: ''internal'' values and norms, ''external'' values and norms, and ''linkage'' values and norms . '"`UNIQ--ref-0000004A-QINU`"' ''Internal'' values and norms of science justify and guide the practice of science itself. Examples of scientific values of the internal kind are: ''truth, honesty, simplicity, consistency, coherence, economy, exactitude and completeness, openness, open-mindedness, confidence, originality and ‘interestingness’.'' External values and norms comprise general ideals and rules for action which are relevant for science, but are not constitutive of the practice of science itself. Examples of external values are human (and animal) welfare notions which are related to the wider social and cultural context in which scientists operate. Finally, we have a different set of values and norms guiding scientific research which represent normative points of contact - linkage - between the research community and the community at large, between internal and external values and norms. Examples are requirements of fruitfulness and relevance.
'"`UNIQ--references-0000004B-QINU`"'
[
Before the research commences, all researchers must be in agreement on a number of components. First of all, they should agree on what they are aiming for and the goals of their research as well as what is expected from them and their part of the research. Moreover, they should also plan for ways of meeting and communicating and how they will handle any cases of conflict. Also, all researchers should put forward any virtues that they wish to be followed, in order to ensure that everyone is respected and protected.
Researchers should be aware of differences in research practice and should try to reach consensus in the design of their research and how they will be implementing it. All researchers should take responsibility for their part of the work and hold themselves accountable for it. Also, one must communicate and seek advice in case of any difficulties in their work as after all, the purpose of a collaboration is to work together and help each other. It could also be beneficial for researchers to review one another’s work besides their own.
Finally, before any work is submitted, all researchers should give their consent and make sure that there was no breach of research integrity. Also, all collaborators should be given credit for all the parts that they contributed towards. +
The [https://wcrif.org/documents/354-montreal-statement-english/file Montreal Statement on Research Integrity] in Cross-Boundary Research Collaborations was developed at the 3rd World Conference on Research Integrity, 2013. '"`UNIQ--ref-00000055-QINU`"' The statement details twenty separate responsibilities of individuals and institutions concerning general collaborations, management of collaborations, collaborative relationships, and outcomes of research.
'"`UNIQ--references-00000056-QINU`"' +
'''Montreal Statement'''
[https://wcrif.org/documents/354-montreal-statement-english/file The Montreal Statement on Research Integrity] in Cross-Boundary Research Collaborations was developed at the 3rd World Conference on Research Integrity, 2013.'"`UNIQ--ref-00000024-QINU`"' The statement details twenty separate responsibilities of individuals and institutions concerning general collaborations, management of collaborations, collaborative relationships, and outcomes of research.
'''TRUST'''
TRUST is an EU funded project which aims to foster high ethical standards in research globally and to counteract the practice of “Ethics dumping” or double standards in research.
The TRUST project have developed a [http://www.globalcodeofconduct.org/ global code of conduct for research in research poor settings].
For the project website, click [http://trust-project.eu/ here].
'''Bridge Guidelines'''
The BRIDGE guidelines for good epidemiological practice in (global health) research foster high-quality epidemiological studies with impact where it is needed the most: in the local communities and local research systems where the research is conducted.
For more information see [[Resource:Edb02e27-f2e5-4b75-a78c-ec42e76011f6|here]].
'''Cape Town Preamble Statement on fostering Research Integrity through Fairness and Equity'''
This statement was drafted at the 7th World Conference in Research Integrity, held in Cape Town in 2022. The statement offers recommendations and principles for conducting research in a fairer and more equitable way, especially when the research in question involves collaborations between high and low- or middle-income countries.
The WCRI have developed [https://www.wcrif.org/downloads/main-website/cape-town-statement/580-cts-poster/file a poster summarising and explaining the preamble to the statement].
You can read the Cape Town Statement in full [https://www.wcrif.org/guidance/cape-town-statement here].
'''Lancet Global Health Initiative'''
In 2023, the Global Health team at the ''Lancet'' published a statement in support of the decolonising agenda in global health, and against "helicopter research" in particular. This statement outlines measures that can be taken to counter helicopter research, including a new Equitable Partnership Declaration that will be published alongside future articles where at least one author is from a high-income country, but in which the research itself was conducted in a low- or middle-income country.
You can find the statement [https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(23)00278-4/fulltext here].
'''International Ethical Guidelines for Health-related Research Involving Humans'''
The 2016 guidelines published by the Council for International Organizations of Medical Sciences (CIOMS) offer guidelines for different aspects of research involving humans, to ensure it is conducted in an ethical manner.
Guidelines two and three concentrate explicitly on guideliens for the ethical conduct of research in low-resource settings and for the equitable distribution of benefits and burdens among partners in the conduct of research respectively.
You can find the full guidelines [https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf here].
<br />
'"`UNIQ--references-00000025-QINU`"'
Knowledge produced by the SSH does not receive enough attention from policy-makers and other research communities.'"`UNIQ--ref-00000650-QINU`"' These disciplines are often not involved in formulating the research questions that identify the interdisciplinary projects from the beginning; they are only included in specific work packages and activities.'"`UNIQ--ref-00000651-QINU`"' Some argue that one of the reasons for that is that research programs do not consider differences between STEM and SSH disciplines which reflects negatively on efficiency, since SSH “have a more complex relationship to truth, power and knowledge than their siblings from the sciences”.'"`UNIQ--ref-00000652-QINU`"' Also, SSH are still concentrated on disciplinary research'"`UNIQ--ref-00000653-QINU`"' and their objectives are mainly local.'"`UNIQ--ref-00000654-QINU`"' With regards to that, there have been ongoing discussions that try to come up with a solution for successful integration of SSH in interdisciplinary research.'"`UNIQ--ref-00000655-QINU`"'
Representatives of some European SSH institutions presented a strategy to embed SSH in interdisciplinary research.'"`UNIQ--ref-00000656-QINU`"' This resulted in publication of the [http://horizons.mruni.eu/vilnius-declaration-horizons-for-social-sciences-and-humanities/ Vilnius Declaration] which articulated main principles for integration of SSH in one of the major funding programs, the European Framework Programme for Research and Innovation, Horizon 2020.'"`UNIQ--ref-00000657-QINU`"' The Declaration stated that the SSH knowledge and methodologies can lead to new ways of dealing with societal problems. It also presented conditions for the successful integration of the SSH into H2020, for example, through recognising the knowledge diversity, encouraging interdisciplinary training and research as well as connecting social values and research evaluation.'"`UNIQ--ref-00000658-QINU`"'
Although SSH have been part of Horizon 2020 through some programs, their impact has been inconsistent.'"`UNIQ--ref-00000659-QINU`"' Social sciences are not included in almost 75% of interdisciplinary projects, while humanities are engaged in about one third of the SSH-flagged topics, which shows that humanities are not included in 90% of Horizon 2020.'"`UNIQ--ref-0000065A-QINU`"' This led to a new [https://www.h2020.cz/files/svobodova/SSH-position-FP9.pdf declaration] in 2018, adopted by several European universities, which suggested five concrete actions: creating an SSH Platform to facilitate the collaboration, encouraging researchers to consider academic and societal impact when drafting proposals, recognising that all disciplines can contribute to an “inclusive and prosperous Europe”, investing in SSH research and innovation and also introducing target budget for SSH spending, which is set at 10% of the civil research budget for 9th EU Framework Programme for Research & Innovation.'"`UNIQ--ref-0000065B-QINU`"' Regardless of the efforts, the integration of the SSH in interdisciplinary and multidisciplinary research has been moving at a slow pace. There is still a lot of work to do for the SSH to be recognized as important as other disciplines'"`UNIQ--ref-0000065C-QINU`"' and to reach their potential. It has been argued that maximizing their participation in interdisciplinary and multidisciplinary projects will require new platforms and tools.'"`UNIQ--ref-0000065D-QINU`"'
In its guidelines for editors, Elsevier states a number of possible situations which are considered to be a conflict of interest. Some of these are: co-authoring or working in the same department with some of the authors in the last three years, being a supervisor or supervisee of the author, having a personal relationship with the author, and having a direct financial interest or other professional benefit from the review. Another example is when you are asked to review a research submitted from a competing research team (Elsevier guidelines for conflict of interest in peer review provided in the tools section). Your own research experience and ambition may influence the way you see other teams’ work.
To handle this issue, not much can be done. If we would prevent everyone with potential conflict of interest to do a peer review, the quality of peer review would drop. Many researchers with knowledge and expertise can have a personal or professional connection with the authors, especially in a small and niche research area. Another option is blinding the reviewers, so that they do not know the names of the authors. Research has shown that reviewers often recognize the authors even when blinded, and blinding doesn’t mask the products or medicines used in research.'"`UNIQ--ref-0000023F-QINU`"' However, any researcher asked to do a review should decline to do so if they have a COI. Clearly defined journal policies on this matter should also be put in place.
'"`UNIQ--references-00000240-QINU`"' +
The [[Resource:C386dbba-2f69-4257-89c2-903898cf1f12|ENERI Classroom]] as well as the ENERI [[Resource:F47b9bc7-c5a5-4b92-918b-438101bd9434|Research Ethics and Research Integrity Manual]] describe in more detail what COIs are and how they can be avoided and managed responsibly.
[[Theme:1fc5c5b6-6c30-4400-a79b-8838b5a041cc|Path2Integrity]] has developed a [[Resource:C13f2fea-2e63-4da9-8b9a-e4039c3dfde1|learning card]] (instruction for a learning unit) on COIs (card Y7).
The Research Ethics Program of the University of California, San Diego has developed an [http://research-ethics.org/topics/conflicts-of-interest/#summary educational resource on COIs].
The Office of Research Integrity (ORI) has collected [https://ori.hhs.gov/conflicts-interest-and-commitment resources on COIs and commitment].
The Committee on Publication Ethics (COPE) has developed [https://publicationethics.org/competinginterests guidelines] for addressing COIs in the realm of publication ethics.
The International Committee of Medical Journal Editors (ICMJE) has [http://www.icmje.org/disclosure-of-interest/ disclosure of interest form]. +
Different journals have different rules concerning editorial conflicts of interest. Some journals have no requirements, while others have strict rules (3). The International Committee of Medical Journal Editors (ICMJE) states that journal editors cannot participate in editorial decisions regarding submitted articles if they have a COI. The same rules apply to editorial staff and guest editors. Editorial staff must not use information gained through working with manuscripts for private gain. Editors should also regularly publish disclosure statements about potential conflicts of interests related to their own commitments and those of their journal staff. For more information, click [http://www.icmje.org/recommendations/browse/roles-and-responsibilities/author-responsibilities--conflicts-of-interest.html <u>here</u>].
The Committee on Publication Ethics (COPE) provided a case of an editor who submitted a manuscript to their own journal. This can often happen when the choice of journals is limited due to the highly specialised nature of the particular subject matter. In such cases, a well-documented and transparent process is necessary to minimise potential bias in the review process. This is usually done by requiring another associate editor to guide the peer review process. One could also have the manuscript anonymized (which is often impossible in a very narrow fields) and publish supplemental material to ensure transparent reporting of the peer review process. +
Good organization between the pharmaceutical companies, CRO and clinics where the research takes place. +
The use of DMPs in aeronautical and engineering projects in the 1960s expanded into other engineering and scientific fields in the late 1970 and 1980s. Their purpose was to help complex projects cope with their data management requirements during data collection or analysis stages.'"`UNIQ--ref-000006CE-QINU`"' In the early 2000s the Organisation Economic Co-operation and Development (OECD) has recommended that “responsibility for the various aspects of data access and management should be established in relevant documents”, such as grant applications, and six major UK research funding bodies recommended that all funding bodies should mandate submission of DMPs with grant applications.'"`UNIQ--ref-000006CF-QINU`"' Some of them have implemented the recommendation, among them Medical Research Council and the Wellcome Trust.'"`UNIQ--ref-000006D0-QINU`"' Today, 86% of UK Research Councils and 63% of US funding bodies requires submission of DMPs with funding applications.'"`UNIQ--ref-000006D1-QINU`"' DMPs have been created and promoted mostly by University libraries which have become “institutional centres of data management practice”.'"`UNIQ--ref-000006D2-QINU`"' Two most known are the Digital Curation Centre and California Digital Library.
The Digital Curation Centre (DCC), a leading centre in digital information curation that gives advice and help on how to store, manage, protect and share digital research data, provides resources, such as online tools, guidance and training. One of them is DMP online, a free web-based tool that supports researchers in developing DMPs by providing them with templates and guidelines.'"`UNIQ--ref-000006D3-QINU`"'
California Digital Library has also developed DMPTool, an open and international source project, that helps researchers, institutions, and funders in the USA in creating DMPs.'"`UNIQ--ref-000006D4-QINU`"'
Science Europe, an association of Research Funding Organisations and Research Performing Organisations, has developed Practical Guide to the International Alignment or Research Data Management. This Guide, which provides a basis for development of data practices and management, has identified six main requirements for DMPs:
1. Data description and collection or re-use of existing data
2. Documentation and data quality
3. Storage and backup during the research process
4. Legal and ethical requirements, codes of conduct
5. Data sharing and long-term preservation
6. Data management responsibilities and resources.'"`UNIQ--ref-000006D5-QINU`"'
'"`UNIQ--references-000006D6-QINU`"'
Data Protection Authorities in the EU and the EDPB have emphasized that data protection rules cannot override the measures implemented to fight against the pandemic.'"`UNIQ--ref-000004FC-QINU`"' According to the European Union General Data Protection Regulation (GDPR), “the processing of special categories of personal data may be necessary for reasons of public interest in the areas of public health without consent of the data subject” and “such processing should be subject to suitable and specific measures so as to protect the rights and freedoms of natural persons”.'"`UNIQ--ref-000004FD-QINU`"' However, “such processing of data concerning health for reasons of public interest should not result in personal data being processed for other purposes by third parties such as employers or insurance and banking companies”.'"`UNIQ--ref-000004FE-QINU`"'
In April 2020 the EDPB has released [https://edpb.europa.eu/sites/edpb/files/files/file1/edpb_guidelines_202003_healthdatascientificresearchcovid19_en.pdf Guidelines 03/2020 on the processing of data concerning health for the purpose of scientific research in the context of the COVID-19 outbreak]. The guidelines stated that both consent of the data subject and GDPR can provide legal basis for data processing concerning health in the COVID-19 pandemic.'"`UNIQ--ref-000004FF-QINU`"' Apart from that, the EU and the national legislator of each Member State can enact specific laws with regard to that.'"`UNIQ--ref-00000500-QINU`"' Sensitive data such as health data (i.e. data related to the physical or mental health of a person) must have higher protection because processing them could have negative impacts for data subjects.'"`UNIQ--ref-00000501-QINU`"' The guidelines emphasized that principles of transparency, data minimization and storage limitation as well as integrity and confidentiality should be respected.'"`UNIQ--ref-00000502-QINU`"'
These guidelines, however, will keep developing further and in more detail as guidance for the processing of health data for the purpose of scientific research is part of the annual work plan of the EDPB.'"`UNIQ--ref-00000503-QINU`"'
'"`UNIQ--references-00000504-QINU`"'
The European Commission decided to run a pilot under Horizon 2020 the [http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/oa-pilot/h2020-hi-erc-oa-guide_en.pdf Open Research Data Pilot] (ORD pilot). Which aims to improve and maximise access to and re-use of research data generated by Horizon 2020 projects. This initiative supports and requires the application of FAIR principles within the H2020 research projects, and therefore it strives to maximise the output and outreach of publicly funded research. +
Feeding back results from genomic studies is complicated because GWA is a research tool and is not designed for clinical diagnosis. In addition, most of the discoveries of whole genome methods identify genetic variants that explain very little in disease risk or quantitative trait variance. Feeding back raw data, would however, be completely misleading and not widely understandable. Providing participants with information about the general findings of research, such as publications based on the research, is an uncontroversial and welcome practice. +
Digital Curation Centre (DCC) has issued a checklist containing relevant questions for researchers concerning criteria for their selection of repositories. However, it has emphasised that while it provides “a shortcut through relevant policies and standards”, it does not guarantee that these repositories comply with specific standards or funders’ policies. Therefore, this guide provides a framework to help researchers with what can be a somewhat difficult decision. By going through these questions, researchers should be able to make a well informed decision on whether their repositories are suited for their data. They should also always check funder and journal policies for compliance.
The checklist contains five questions to consider when looking for repositories:
-Is a repository of your choice reputed?
-Will it take the data you want to deposit?
-Will it be safe legally?
-Will it sustain the data value?
-Will it support analysis and tract data usage?'"`UNIQ--ref-00000921-QINU`"'
This guide also contains information on where researchers can find repository registries, such as Re3data and Biosharing.'"`UNIQ--ref-00000922-QINU`"'
'"`UNIQ--references-00000923-QINU`"' +
'''Planning stage of the clinical trial'''
To reduce the risks of missing data in the panning of the clinical trial, statistical analyses should be specified, key data items should be identified, and the procedures to prevent missing data '"`UNIQ--ref-0000056C-QINU`"'.
'''Analysis stage'''
There are different strategies to deal with missing data that will depend on the specific clinical trial and type of missing data:
1. Complete cases analysis could be used when the proportions of missing data are below 5%and the potential impact of the missing data is negligible '"`UNIQ--ref-0000056D-QINU`"'.
2. Single imputation replaces missing values by a value defined by a certain rule. However, this method ignores the data variation and can potentially introduce bias and should be used with great caution '"`UNIQ--ref-0000056E-QINU`"'.
3. When the missing data accomplish certain characteristics, multiple imputation may be used to minimize bias . Missing values are replaced by a random sample of plausible values imputations. There are several multiple imputation methodologies that must be chosen according to the variable with missing values '"`UNIQ--ref-0000056F-QINU`"'.
To conclude, handling missing data validly is an important, yet difficult and complex, task. This theme showed different strategies to handle missing data but always statistical expertise’s advice is needed.
'"`UNIQ--references-00000570-QINU`"' +
To support wide data availability, authors should publish their data so it could provide inputs to new hypotheses, and innovation (5,6). Journals could increase awareness on data availability and request mandatory data deposition. Modern manuscript checklists should routinely include data availability part which should additionally emphasize its importance to the authors. Finally, all of this could improve the verification of result, and reduce the misconduction related to data fabrication and falsification, and could serve as training tools for junior researchers (6). +
Some journals, such as Nature, require depositing data to data repositories as part of the manuscript submission process. This is one of the prerequisites for publication.'"`UNIQ--ref-00000917-QINU`"' Nature has set out certain criteria for data repositories. They should:
-provide long-term preservation of data (at least 5 years after publication)
-be supported by a research community or institution
-provide deposited datasets with stable and persistent identifiers
-allow open access
-provide terms of data use
-facilitate for anonymous reviewers to access data under embargo.'"`UNIQ--ref-00000918-QINU`"'
The journal also offers a list of repositories across research areas for researchers who are not certain where to deposit their data:
-[https://www.nature.com/sdata/policies/repositories#:~:text=Generalist%20repositories-,Biological%20sciences,-%E2%A4%B4 Biological sciences]
-[https://www.nature.com/sdata/policies/repositories#:~:text=Generalist%20repositories-,Biological%20sciences,-%E2%A4%B4 Health sciences]
-[https://www.nature.com/sdata/policies/repositories#:~:text=view%20FAIRshaing%20entry-,Chemistry%20and%20Chemical%20biology,-%E2%A4%B4 Chemistry and Chemical biology]
-[https://www.nature.com/sdata/policies/repositories#:~:text=view%20FAIRsharing%20entry-,Earth%2C%20Environmental%20and%20Space%20sciences,-%E2%A4%B4 Earth, Environmental and Space sciences]
-[https://www.nature.com/sdata/policies/repositories#:~:text=view%20FAIRsharing%20entry-,Physics,-%E2%A4%B4 Physics]
-[https://www.nature.com/sdata/policies/repositories#:~:text=view%20re3data%20entry-,Materials%20science,-%E2%A4%B4 Material science]
-[https://www.nature.com/sdata/policies/repositories#:~:text=view%20FAIRsharing%20entry-,Social%20sciences,-%E2%A4%B4 Social sciences]
-[https://www.nature.com/sdata/policies/repositories#:~:text=view%20re3data%20entry-,Generalist%20repositories,-%E2%A4%B4 Generalist repositories].'"`UNIQ--ref-00000919-QINU`"'
'"`UNIQ--references-0000091A-QINU`"'
The purpose of “Five steps to decide what data to keep” checklist for appraising research data, developed by the Digital Curation Centre (DCC) is to guide researchers and help them choose what data to keep in order to meet their objectives and comply with the institutional and external funders demands.'"`UNIQ--ref-0000090C-QINU`"' These are five steps proposed by the Guide:
Step 1. Identify purposes that the data could fulfil
Before deciding what data to keep, researchers should be able to identify goals and objectives of these data: verification, further analysis, building academic reputation, community resource development, further publications, learning and teaching, or private use. Identifying one of more of these purposes will make the selection process go smoother and faster.
Step 2. Identify data that must be kept
This concerns legal principles that should be respected. With regard to this issue, researchers should answer following questions: Are there Research Data Policy reasons to keep it? Do regulations require the availability of the data? Are there other legal or contractual reasons? Does it contain personal data relevant to the reuse purpose?
Step 3. Identify data that should be kept
This step concerns researchers’ expertise and knowledge on research data. Before making a decision regarding this aspect, they should consider following questions: Is it good enough? Is there likely to be a demand? How difficult is it to replicate? Do any barriers to further use exist? Is it the only copy?
Step 4. Weigh up the costs
Considering this step will help researchers in economic aspects of data keeping, i.e. potential costs of all the stages of data keeping - creation, collection & cleaning, short-term storage & backup, short-term access & security, team communication & development, preservation & long term access, and staff time.
Step 5. Complete the data appraisal
This final step includes filling out the table on data collection, reuse purposes, value, risk of budget shortfall and whether you plan to keep your data.'"`UNIQ--ref-0000090D-QINU`"'
The Dutch funding agencies ZonMw and NWO have set up guidelines for dealing with COIs in the reviewing process. COI citeria include:
*personal interests
*professional interests
*interests arising out of other positions
*business (financial or economic) interests
The following personal interests always exclude participation in the process:
*being the applicant or joint applicant
*having written any part of an application without being an applicant or joint applicant
*having any of the following relations with the applicant or joint applicant
*actual or anticipated project manager or sub-project manager
*direct manager
*blood relation or affinity (up to and including the third degree
*contract of cohabitation (other than a civil partnership
*dean of the applicant’s institute'"`UNIQ--ref-00000220-QINU`"'
Both ZonMw and NWO ask reviewers to declare their COIs. Next, the head of the committee assesses the impact of the declared COIs. He or she can decide if the reviewer cannot assess a particular application, or if he or she should not partake in the review process at all. Subsequently, the committee states whether they agree or disagree with this decision. Moreover, to ensure impartiality, individual reviewers do not get to see each other’s scores. After the review process has concluded, the reviewers assess whether the process has raised new insights into COIs. In the worst case scenario, if the process has been influenced by a reviewer’s COI, the whole review process is redone.
'"`UNIQ--references-00000221-QINU`"' +
When research is sponsored by industry stakeholders this should be declared as a conflict of interest. Moreover, in a systematic scoping review Cullerton, Adams, Forouhi, Francis & White identified themes for good collaboration with industry stakeholders (specifically in the food industry).'"`UNIQ--ref-00000307-QINU`"' In [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6767600/figure/obr12851-fig-0003/ this flowchart] the auhtors describe several steps and actions sthat can be taken to ensure good collaboration between researchers and industry stakeholders.
'"`UNIQ--references-00000308-QINU`"' +
According to their policy on IP rights, the Dutch funder ZonMw states that when a contract is written, the IP rights derived from a project belong to the research performing institution. However, when the IP rights are not exploited adequately, ZonMw can interfere, in order to increase the impact of the research. Moreover, when considering public-private partnerships in funding, the research performing organization needs to have a strong judicial position. Therefore, research institutes are encouraged to seek legal expertise or request advice from ZonMw. This is to ensure that the IP is not exploited by other private, commericial and industrial institutions, as has happened in the past.
The European IPR Helpdesk has developed a fact sheet on IP management for Horizon 2020 projects.'"`UNIQ--ref-0000022F-QINU`"' The factsheet includes guidance on IP rights in a research proposal. It suggests the following:
*Proposals should describe how results will be protected from commercial and industrial exploitations
*Within multi-center research, the involved institutes need to organise ownership and access of rights and include the economic conditions of dividing the rights
*Proposals should state how joint ownership for expected jointly-owned results will be organized. For example, third-party licensing needs to be considered
*Proposals should consider the exploitation of research results (see Figure 1)
*Proposals should indicate the confidentiality measures that need to be put in place
*“When defining the management structure, applicants should consider the management of intellectual property rights. A committee for exploitation and intellectual property or a manager could be considered and even a consulting body of external experts from industry.”
'"`UNIQ--references-00000230-QINU`"' +
==Bullying and harassment policies==
Bullying and harassment policies allow RFOs to stimulate positive research cultures. Such policies can improve research culture, and their existence “sends a signal that certain ethical standards must be met by researchers and organizations in exchange for funding”.'"`UNIQ--ref-00000226-QINU`"' The US based funder National Science Foundation (NSF) requires RPOs receiving funding to inform the NSF about sexual harassment.'"`UNIQ--ref-00000227-QINU`"' In addition, the Wellcome Trust has elaborate rules on what they expect from the organizations they fund (7):'"`UNIQ--ref-00000228-QINU`"'
1. The funded organization requires policies that set out:
*standards of behavior from staff
*the procedure for responding to complaints
2. The funded organization should have an equivalent policy in place at sub-levels, where relevant.
3. The funded organization should investigate allegations of bullying and harassment in an impartial, fair and timely manner. It must:
*protect the rights of all employees involves
*take appropriate action.
4. The funded organization should contact the Wellcome Trust when an investigation has been opened.
5. The funded organization should contact the Wellcome Trust when the investigation has been completed.'"`UNIQ--references-00000229-QINU`"' +
Managing people, projects, and budgets, as well as setting workplace procedures that foster efficiency, safety ethics, and high staff morale, are all issues that come with running a laboratory. Lab safety and ethics are two of the most important components of running a lab, yet they are often overlooked in favor of more fundamental lab management skills. It is critical to work hard to build a laboratory culture that prioritizes safety. +
To manage conflict of interests, which is inevitable and must always be declared, it is important to maximize transparency in industry-funded research. Some of the proposed approaches include a carefully constructed advisory board with specific responsibilities as well as strict guidelines to protect research quality.'"`UNIQ--ref-00000956-QINU`"' It is important to fully disclose financial, personal, and professional interests. Oversight by an independent third party is recommended as well as pre-registration of the study. The role of commercial partners must be defined and the relationship has to be continuously monitored. '"`UNIQ--ref-00000957-QINU`"' The scientific community has improved recently in regards to some of the key indicators of research reproducibility and transparency. This includes information on funding, conflict of interests statements, and an increase in protocol and data sharing. There is also a growing number of fully available texts, although the majority of texts are still not fully available. Nevertheless, confusion about research transparency still exists, and even though there has been some improvement, the scientific community is far from perfect in terms of research transparency and reproducibility.'"`UNIQ--ref-00000958-QINU`"'
'"`UNIQ--references-00000959-QINU`"' +
The best practices is the first step in the targeting the right population of the patients that will be included in research. Also, it is important to give them the informed consent at the beginning of the research, before any procedure. +
'''How it works''' The session takes place annually in Alzheimer Center Amsterdam. All researchers are obliged to attend. Some preparation from the senior researchers in advance of the session is expected: they are asked to share an example of ‘sloppy science’ or a research integrity dilemma drawn from their personal experience. The session starts with a short introduction and is opened by the head of research. Senior researchers share their stories first, to show that issues happen to everybody, and it’s okay to talk about it. This is key to create an environment where it feels safe to speak about issues. Hearing about the issues and mistakes from the seniors stimulates junior researchers to talk more openly about the obstacles they have encountered in their research projects. The goal is not to discuss all issues during these particular sessions, but rather to keep researchers from feeling afraid or embarrassed to discuss issues during everyday research practice all year round. The session ends with educating the junior researchers about who they can talk to during the year if issues arise, as well as sharing the contact info of the hospital ombudsman.
'''Evaluation''' Whereas there has not yet been an empirical evaluation of the initiative, so far, the responses from researchers are very positive. The experience is that issues within the center are discussed timely. Researchers tend to speak first to people in their close working environment, whom they trust. Since the ‘Billen Bloot’ meetings are embedded in weekly scientific sessions, are costless, take place in the center itself and are mandatory to attend, the feasibility of the ‘Billen Bloot’ sessions is very high. This feasibility allows for a smooth implementation and therefore, it makes it a very attractive initiative.
The success of the formula in Alzheimer Center Amsterdam can partly be explained by the already open environment. It is possible that if this initiative is implemented in a less open work environment, it may be harder to make it a success.
'''What’s next?''' The ‘Billen Bloot’ sessions were initiated within the scope of the Alzheimer Center Amsterdam. However, in the last two years the initiative has been copied by other departments and institutions. Finally, researchers of Alzheimer Center Amsterdam have given presentations on the initiative to share the idea with others.
A number of frameworks exist that can be used to advance sharing, (re)using and valuing software. A guideline originally created for data management, the FAIR principles (Findable, Accessible, Interoperable and Reusable), can similarly provide an infrastructure for software reproducibility.'"`UNIQ--ref-000002D9-QINU`"' To specify, ''interoperability'' means the ability of non-collaborating researchers to integrate and work with each other’s resources with minimal effort. A recent collaboration between the Netherlands eScience Center and DANS (Data Archiving and Networked Services), launched a website with a step-by-step route to create FAIR software: https://fair-software.nl/.
The TOP (Transparency and Openness Promotion) guidelines seek to establish a new shared standard of openness and citation, applying to both data and software.'"`UNIQ--ref-000002DA-QINU`"' In summary, the TOP guidelines consist of eight principles (citation standards, code -and material transparency amongst others) and provide ‘levels’ that reflect how strictly might be adopted by journals. Of course, this boils down to the efforts by the researchers. The Reproducibility Enhancement Principles (REP), part of TOP, addresses software specifically. For one, they highlight that software needs not ‘merely’ be shared, but also the workflow and details regarding the computational environment should be communicated. The guidelines are available at: https://cos.io/top/. In their discussion, Alnoamany and Borghi (2018) add that education should give researchers a basic understanding of software, to later guide them in this process. '"`UNIQ--ref-000002DB-QINU`"'(p18)
Lastly, mention-worthy is the Software Preservation Network (SPN), although not purely specific for research software. They seek to ensure long-term access to software .'"`UNIQ--ref-000002DC-QINU`"' Their five core activities are law & policy, training & education, metadata & standards, technological infrastructure and research-in-Practice. Furthermore, they have a number of running projects and a database of resources regarding the theme, all available at their website: https://www.softwarepreservationnetwork.org/.
'"`UNIQ--references-000002DD-QINU`"'
'''The data stewards'''
All the data stewards at TU Delft have a different background. They are either familiar with the faculty by having a research background as a PHD-candidate/Postdoc or by using similar methodologies. A coordinator assures good communication and oversight between data stewards and research teams at the TU Delft. In this way, data stewards function as a ‘gear’ amongst different research support service teams.
The task of data stewardship has extended from only consultation for data management plans to a wide scale of diverse tasks. These tasks include, for instance, implementation of research data policy, training (workshops), information sessions, creating pilots and course education materials. All these things rely on the data stewards’ ability to translate data management literature studies into concrete actions. Sometimes, a ten minutes talk is enough and other times it requires continuous support during a research project. When more assistance is necessary, data stewards support each other via meetings or chat platforms.
'''Evaluation'''
According to Yan Wang, the current data steward at the architecture and building faculty, Data Stewardship has become popular at the university. The role of data steward has proven to be very diffuse. For instance, the data stewards realized that everything about data management is also connected to research ethics. Yan Wang believes that during the pilot, a relationship started to develop in which researchers came to the data stewards for all sorts of things.
Of course, every faculty has a different work environment. Yan Wang believes that data stewardship in the science and engineering faculties is slightly more formal than in the social faculties, possibly due to the faculties’ different extent. There are annual surveys on the awareness of data management per faculties, perhaps indicating how the role of data stewards differs amongst the faculties. These findings are to be found in a [https://openworking.wordpress.com/data-stewardship/ blog] post, which is regularly updated by the university.
In the United States, the Office for Research Integrity (ORI) is developing policies, procedures, and regulations related to the responsible conduct of research and research misconduct. Moreover, ORI develops activities and programs aimed to promote research integrity and foster good research practices.
In Europe, the [https://lari.lu/ Luxembourg Agency for Research Integrity] and [https://oeawi.at/en/ Austrian Agency for Research Integrity] are good examples of institutions providing all kind of resources for the promotion of research integrity. These organizations have developed guidelines and recommendations that are implemented by research institutions in their countries. Moreover, they offer training and workshops for researchers in different stages of their career and deal with cases of research misconduct. +
This kind of semiformal meeting is very supportive, not only for PhD candidates, but for all members of research teams.
Sometimes, team members are coming from different institutions and this is the best way for them to get to know each other better. In this way they would improve their communication which will become much easier and of better quality. +
The aim of all eight scenarios is to allow researchers, research ethics committees ('RECs'), research integrity offices ('RIOs') and research administrators to focus their reflection on core principles and research contexts that enshrine good research practice as well as their local rules and practices. +
The European Commission funded VIRT2UE project has designed a set of practical tools for recognizing and dealing with RI dilemmas in practice. One of these tools is the so called ‘Virtues, Values and Norms in Perspective’ exercise. In this exercise, inspired by a [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5236068/ virtue ethics approach to RI education], '"`UNIQ--ref-0000009C-QINU`"' participants are asked to reflect on a concrete dilemma experienced by one of the participants. By engaging in a dialogue, trainees are asked to put themselves in the shoes of the people involved in the case at stake and reflect on which values would be important for each of them. Then they are asked to reflect on which virtues are required to deal with the dilemma at stake: are they in conflict with each other? How are they related to salient norms? Which virtue is the most important in this situation? What is needed (concretely) to act in accordance with that virtue?
This exercise aims at fostering reflection in oneself by means of understanding the concepts of virtues/values and norms and their relationship with practice.
Another initiative is the [https://www.eur.nl/sites/corporate/files/24708_integriteitsspel_interactief_2016.pdf Rotterdam Dilemma Game], '"`UNIQ--ref-0000009D-QINU`"' which focuses less on virtue ethics but nonetheless provides structure to discuss RI dilemmas.
'"`UNIQ--references-0000009E-QINU`"' +
To address the issues stated above, the REWARD campaign offers five set of recommendations. First, research priorities need to be selected. This means that prior to engaging in any experimentation or observation, a systematic review of literature should be done, funders should make their criteria for funding transparent, and research funders should develop sources of information about ongoing research.
Second, the REWARD campaign supports rigor in research design, conduct and analysis. This includes improving protocols and making them public, engaging professional staff and non-conflicted stakeholders, as well as rewarding quality and reproducibility of the research, rather than novelty.
Third, research waste can be reduced through research regulation and management. It emphasizes the important role and influence of research regulators who, along with policy makers, should collaborate with researchers, patients and health professionals. Their cooperation should simplify and coordinate laws and regulations that control or guide research. Furthermore, researchers should be able to improve the efficiency of their research using high quality designs that reduce inefficiencies of recruitment, retention, data monitoring, and data sharing. Finally, the integration of research findings in daily clinical practice should be promoted.
Fourth, all information on research methods and findings should be accessible. Academic institutions and funders should reward research that is publicly available and disseminated. REWARD recommends the standardization of protocols and data sharing, as well as the release of complete study reports. Finally, journals, funders, sponsors, research ethics committees, regulators and legislators should support and enforce study registration and availability of complete information regarding research.
Fifth, research reports should be complete and usable. With that aim, the REWARD campaign suggests that the focus of research regulations and rewards should be to encourage complete research reporting. To facilitate this, there is a need for good reporting infrastructure. Authors, editors and reviewers should be trained about reporting guidelines, publication ethics, and research integrity. Funders should support and monitor training.
Researchers should be up-to-date in their field of interest and, when they notice a retraction of an article that they have previously cited, correct the article. The easiest way to be regularly updated on retractions is by following Retraction Watch and their database '"`UNIQ--ref-000004CB-QINU`"'. Zotero citation manager has established a partnership with Retraction Watch and has implemented retraction notifications that pop-up when an article from the users’ database has been retracted. Hopefully other citation managers will follow this practice.
An initiative to stimulate this kind of behavior could result in more corrected articles. In practice, taking into account the number of articles that are published every day, it is hard to expect an individual to notice everything. The ideal practice would be that the journal which has retracted the article, notifies authors which have cited the retracted article. However, that is hard to be expected, especially for older articles. Alternately, authors of the retracted article could inform all the authors who have cited their article. This may be expected from authors whose article is retracted due to unintentional mistake and have initiated the retraction, but it might be illusory to expect this from authors who have committed fabrication, plagiarism, or similar misconduct.
'"`UNIQ--references-000004CC-QINU`"' +
According to the newest WHO (World Health Organization) research [https://www.euro.who.int/en/media-centre/sections/press-releases/2012/05/who-report-reveals-teenagers-do-not-get-a-fair-deal-on-health], teenagers do not get a fair deal when it comes to health. The survey gathered information from young students about their health and well-being, as well as their social situations and behavior. Adolescent health inequalities can lead to long-term inequalities in adulthood. Adolescence is unquestionably a critical period for mental health, particularly for girls. Predictably, family support is linked to a healthier lifestyle, including improved communication with parents, increased support from classmates, and a larger number of close friends. This has been found to lead to improved mental health. The report shows that addressing the social determinants of health inequalities in childhood and adolescence can enable young people to maximize their health and well-being, ensuring that these inequalities do not extend into adulthood, with all of the potential negative consequences for individuals and society. +
What should we do, then, if we experience imposter syndrome? There might not be a single -effective strategy to minimize it. Yet, new evidence indicates that reframing might be effective. One option is to introduce the idea of imposter syndrome to graduate students. By doing this, you might highlight the idea that imposter syndrome is a natural emotion and let go of the shame that goes along with it. Students may be able to adopt a growth mindset toward their sense of belonging by reframing their experience and using guided reflection exercises to facilitate discussion and support of this experience [5].
References:
# Villwock JA, Sobin LB, Koester LA, Harris TM. Impostor syndrome and burnout among American medical students: a pilot study. Int J Med Educ. 2016; 7: 364-9.
# Sakulku J, Alexander J. The impostor phenomenon. J Behav Sci. 2011; 6 (1): 75-97.
# Sverdlik A, CHall N, McAlpine L. PhD imposter syndrome: Exploring antecedents, consequences, and implications for doctoral well-being. Int J Dr Stud. 2020; 15: 737-58.
# Kernan W, Bogart J, Wheat ME. Health-related barriers to learning among graduate students. Health Educ. 2011; 111 (5): 425-45.
# Morgenstern BZ, Beck Dallaghan G. Should medical educators help learners reframe imposterism? Teach Learn Med. 2021; 33 (4): 445-52.
Lauren A. Mason. +
The presence of a dilemma’s indicates that there is no universal hierarchy of values. A guideline or algorithm cannot simply resolve the dilemma'"`UNIQ--ref-000006B7-QINU`"'. But, a dilemma (‘tragedy’) can be the start of reflection and improvement. Depending on the severity of the situation and the impact of your choice, consider the following:
*Informal discussion with peers
*Consult your supervisor or mentor
*Check a code of conduct or guideline
*Consult a confidentiality advisor
*Discuss it with ‘neutral outsiders’, friends or family
*Analyse the dilemma in more detail, e.g. by [[Instruction:C0cf8cfb-6090-49e3-94f5-20f530f83ffd|moral case deliberation]]
*Is there a rearrangement of practices that can remove the tragedy (Hegel’s question)?
'"`UNIQ--references-000006B8-QINU`"' +
The COMET initiative focuses on developing standardised sets of outcomes that represent a minimum that should be measured and reported in studies with different study designs. Core outcomes included in sets must be relevant for patients and healthcare providers.
The COMET Initiative has a database open to all researchers planning to conduct a study with an 'advanced search' option to find core outcome sets appropriate for their studies'"`UNIQ--ref-0000095C-QINU`"'. +
The EQIPD quality system is currently applied at research labs within the IMI consortium and a group of interested labs. EQIPD made all the developed resources available to the public. Currently, this includes a preprint publication describing the EQIPD system in greater detail on the Open Science Framework [https://osf.io/ng32b/ here]. Additionally, a wiki page, [https://eqipd-toolbox.paasp.net/wiki/EQIPD_Quality_System the EQIPD toolbox], is available providing information developed by the consortium and a broader stakeholder group. +
To support cooperation between national RECs associations and address novel research ethical challenges, EUREC organizes regular conferences of members, sets up working parties, monitors legal developments, collects and evaluates training materials, and participates in various research projects. Among other things, EUREC currently supports initiatives connecting the hitherto rather disparate communities of research ethics and research integrity specialists (like the Embassy, ENERI, and Path2Integrity) and projects addressing novel ethical challenges emanating from technological transformations (like PANELFIT, SHERPA, and SIENNA).
Besides further information about EUREC and the projects EUREC participates in, the network’s website ([http://www.eurecnet.org/ www.eurecnet.org]) provides information on and links to:
*RECs in Europe
*national legislation governing RECs
*EU legislation governing RECs
*literature on RECs
*training materials
==Other information==
EUREC is a pan-European network registered in Germany. +
Drawing on existing networks like the European Network of Research Ethics Committees (EUREC)(2)'"`UNIQ--ref-00000085-QINU`"' and the European Network of Research Integrity Offices (ENRIO),'"`UNIQ--ref-00000086-QINU`"' ENERI has established an operable platform connecting RE and RI experts. The platform complements The Embassy by focusing mainly on interlinking experts and institutional representatives, whereas The Embassy addresses the entire community of researchers.
In order to facilitate the building of a vibrant community, ENERI has created an expert database'"`UNIQ--ref-00000087-QINU`"' that, along with the ENERI Handbook,'"`UNIQ--ref-00000088-QINU`"' forms the main building block of the network. While the database simplifies building strong network ties among community members, the handbook serves as a basis for discussing novel challenges and disseminating best practices. In contrast to most other manuals, the ENERI handbook has been construed as a living document seeking to constantly evolve by incorporating network members' expertise. As the database seeks to facilitate network growth, the handbook aims to expand the stock of expert knowledge.
Both the database and the handbook not only transcend the boundary between RE and RI, but also bridge divides between different academic disciplines. Whereas ethical review relies on an elaborate infrastructure in the medical sciences in most countries, similar infrastructures are often still lacking in other disciplines. ENERI is based on the premise that research ethics and integrity concern all academic disciplines, including the humanities and social sciences. Many of the challenges researchers in various disciplines typically face as well as examples of good practice are outlined in the handbook.
==Other information==
ENERI is a pan-European network receiving funding receiving funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 710184
'"`UNIQ--references-00000089-QINU`"'
'''Networks'''
*[https://allea.org/ ALLEA] (All European Academies)
*[https://amsterdamresearchclimate.nl/ ARCA] (Amsterdam Research Climate)
*[https://publicationethics.org/ COPE] (The Committee on Publication Ethics )
*[https://ease.org.uk/about-us/ EASE] (The European Association of Science Editors)
*[http://www.academicintegrity.eu/wp/ ENAI] (European Network for Academic Integrity)
*[http://eneri.eu/ ENERI] (European Network of Research Ethics and Research Integrity)
*[http://www.enohe.net/ ENOHE] (European Network of Ombuds in Higher Education)
*[http://www.enrio.eu/ ENRIO] (European Network for Research Integrity Officers)
*[https://www.eosc-portal.eu/ EOSC] (European Open Science Cloud)
*[https://www.equator-network.org/ EQUATOR Network] (Enhancing the QUAlity and Transparency Of health Research)
*[http://www.eurecnet.org/index.html EUREC] (European Network of Research Ethics Committees )
*[https://irafpa.org/en/ IRAFPA] (Institute of Research and Action on Fraud and Plagiarism in Academia)
*[https://lari.lu/ LARI] (the Luxembourg Agency for Research Integrity)
*[https://www.scienceeurope.org/our-priorities/research-integrity-and-ethics/ Science Europe]
*[https://www.wcrif.org/ WCRIF] (World Conference on Research Integrity Foundation)
'''Projects'''
*[http://entireconsortium.eu/ EnTIRE] (Mapping Normative Frameworks for EThics and Integrity of REsearch)
*[https://www.fosteropenscience.eu/ FOSTER] (Fostering the practical implementation of Open Science)
*[http://h2020integrity.eu/ INTEGRITY]
*[https://www.nrin.nl/about/inspire-project/ INSPIRE] (Inventory in the Netherlands of Stakeholders' Practices and Initiatives on Research Integrity to set an Example)
*[https://on-merrit.eu/ ON-MERRIT] (Observing and Negating Matthew Effects in Responsible Research & Innovation Transition)
*[https://www.openaire.eu/ OpenAIRE]
*[https://www.path2integrity.eu/ Path2Integrity]
*[https://printeger.eu/ Printeger] (Promoting Integrity as an Integral Dimension of Excellence in Research)
*[https://satoriproject.eu/ SATORI]
*[https://www.sops4ri.eu/ SOPs4RI] (Standard Operating Procedures for Research Integrity)
*[http://trust-project.eu/ TRUST]
*[http://virt2ueconsortium.eu/ VIRT2UE] (Virtue-based ethics and Integrity of Research: Train-the-Trainer program for Upholding the principles and practices of the European Code of Conduct for Research Integrity)
*The [https://prores-project.eu/ PRO-RES] Framework for Ethical Evidence
<u>The INSPIRE Checklist</u>
Part of the INSPIRE project was to develop a checklist to assess and classify initiatives that foster responsible research practices. Following a Delphi method including two online surveys and a workshop, a checklist was drafted, piloted and revised until consensus among the INSPIRE team was achieved. The result is an extensive yet practical checklist that can be used by many stakeholders and for multiple purposes. It is used for the taxonomy of the spectrum of initiatives on The Embassy of Good Science. The checklist can also be used by stakeholders to assess and improve their initiatives themselves, or by others who plan to implement an existing initiative, for example which they found in the spectrum on The Embassy!
<u>The Webcrawler</u>
To support and inspire stakeholders in research to implement initiatives to foster responsible research practices, one of the goals of the INSPIRE project was to make an inventory of such initiatives. A web crawler was one of the strategies used for the inventory. A list of keywords was compiled in both Dutch and English. These were used to search multiple search engines. The unique, safe and scannable URL’s were scanned for specific words or combinations of words on the web pages to indicate the potential relevance of the URL. The words and word combinations were originally based on the primary key words and words found in the INSPIRE checklist, and further improved by ‘learning on the job’. Based on the search words, their combinations, and the number of results on a URL, a prioritisation was made. The results were processed by manually checking the URL’s with the highest prioritisation.
<u>Highlighted initiatives</u>
So far we highlighted the following initiatives:
*"Met de billen bloot" (airing your dirty laundry) ([[Theme:A12b4bab-b331-46d1-93e0-dc9e9c5453cd]])
*Data stewardship at TU Delft ([[Theme:D44f7704-4e28-484c-a137-fbb2bb44836b]])
*Superb Supervision: integrity training for supervisors ([[Theme:73bfb9ec-b7f5-4a0a-a0b0-e460990b59cb]])
*A couple of initiatives on 'Computational reproducibility: safeguarding the backbone of science' ([[Theme:46e89570-c93b-41ca-9ac7-d78826bdfad8]]) including FAIR-software, TOP guidelines and the Software Preservation Network.
*A couple of initiatives contributing to 'Image Integrity' ([[Theme:20f32f16-72a1-46f0-b9a6-24fac05b0937]]) including guidelines, educational materials, InspectJ and an action set in Photoshop.<br />
Asking permission and consent for acknowledging persons and for the wording of the acknowledgement. +
One example of adaption of open peer review policies in seen in BMC series journals. BMC begun with open peer review in 1999, and since then has promoted the benefits of peer review and developed different variations and options in peer review system. On top of that, they have decided to move beyond “prescription” of peer review patterns and instructions, and have started publishing a journal called Research Integrity and Peer Review, whose main focus is on research on peer review. Recently, the very same journal has published an article on guidelines for the implementation of open peer review, with a checklist aimed at making the implementation of peer review easier. This was developed mostly for editors, but for those who are still unfamiliar with open peer review, there are plenty of long (e.g. FOSTER course on open peer review) and short'"`UNIQ--ref-000000F7-QINU`"' educational materials.
'"`UNIQ--references-000000F8-QINU`"' +
Shortcomings in the current system have led to discussions in the SSH community with the aim of addressing the challenges and implementing some changes. In February 2020, the European Network for Research Evaluation in the Social Sciences and the Humanities (ENRESSH) provided a report, an “[https://enressh.eu/wp-content/uploads/2017/09/Hoffman-Holowiecki-Holm-Ochsner-Overview-of-Peer-Review-Practices-in-the-SSH.pdf Overview of Peer Review Practices in the SSH]” '"`UNIQ--ref-000003F3-QINU`"'. The report stressed that, in contrast to STEM, SSH disciplines are more heterogeneous in their publication outputs. This makes it difficult to define and evaluate research methodologies, which, subsequently, leads to a lack of consensus when it comes to the criteria for assessing the quality of research outputs '"`UNIQ--ref-000003F4-QINU`"'. The report states that copying the evaluation models that exist for STEM disciplines is not the best response '"`UNIQ--ref-000003F5-QINU`"'. However, some argue that certain practices, such as open peer review, could apply to SSH. The advantages of open peer review are that it would speed up the publication process and enable dialogue between authors and readers '"`UNIQ--ref-000003F6-QINU`"'.
In order to speed up the review process, the report offers other suggestions, including, limiting the length of manuscripts, limiting the number of publications per researcher or institution and recruiting more reviewers '"`UNIQ--ref-000003F7-QINU`"'. In addition, the SSH community could learn from new peer review models in STEM subjects, and seek to apply them if possible '"`UNIQ--ref-000003F8-QINU`"'. Although SSH disciplines are heterogeneous, there is a call for general standards and principles for peer review '"`UNIQ--ref-000003F9-QINU`"', in order to ensure “timeliness, transparency and verifiability” '"`UNIQ--ref-000003FA-QINU`"'.
Even though the SSH tend to be slower to respond to calls for change when compared with STEM disciplines, some journals and platforms have been adapting to recent developments in peer review systems, including 1) Kairos, which adopted a three-stage review process '"`UNIQ--ref-000003FB-QINU`"', 2) Palgrave Macmillian, which has trialed open peer review trial '"`UNIQ--ref-000003FC-QINU`"' and open publishing '"`UNIQ--ref-000003FD-QINU`"', and 3) Wellcome Open Research, which provides post-publication peer review '"`UNIQ--ref-000003FE-QINU`"'.
'"`UNIQ--references-000003FF-QINU`"'
The most famous practice example of post publication peer review system is [https://f1000.com/ F1000], which is not a traditional journal, but more of an open science platform where published articles can be modified. New versions are uploaded online, with references to previous versions and changes. Moreover, the entire peer review process is transparent from the beginning to the end of the procedure. In that way, the manuscripts can be changed and adapted to include new insights. However, there are some critics who point out that it is a problem that previous versions of the article are still available online to anyone, even if they contain flawed reporting. Recent research has been discouraging for PPPR. It showed that online comments in PLOS and BMC journals decline in frequency and that existing comments rarely contain anything related to the content of the article.
In addition, PubPeer is considered as one of the major platforms designed for post-publication peer review and also conversations about publications. Users can leave comments with their ORCID username or anonymously.'"`UNIQ--ref-0000010A-QINU`"'
'"`UNIQ--references-0000010B-QINU`"' +
The Belmont report, '"`UNIQ--ref-000000B1-QINU`"' the Declaration of Helsinki '"`UNIQ--ref-000000B2-QINU`"' and similar ethical and legal documents were enacted by governing bodies and professional associations.
'"`UNIQ--references-000000B3-QINU`"' +
Asking participants questions about the study and what they expect from it can reveal gaps in knowledge that need to be addressed. Taking time to ensure a realistic understanding of the study aims and outcomes is essential for the informed consent process and helps prevent participants dropping out. +
There have been discussions regarding potential risks for research in sites such as Central Asian region that includes Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, and Uzbekistan – countries with authoritarian regimes.'"`UNIQ--ref-0000060D-QINU`"' One of the examples that can adequately present what type of risk researchers can encounter is the arrest and accusation for espionage of Alexander Sodiqov, a Tajik citizen and political science PhD student at the University of Toronto, in Tajikistan in 2014 during his fieldwork on conflict resolution.'"`UNIQ--ref-0000060E-QINU`"' Sodiqov was arrested while interviewing Tajik civil society leaders and he spent five weeks in jail.'"`UNIQ--ref-0000060F-QINU`"' His colleagues in Canada maintained that this event implied that research in Tajikistan is “under threat”.'"`UNIQ--ref-00000610-QINU`"' This case shows that researchers must be aware of potential risks that await them at their fieldwork. In order to handle them adequately, they need to plan a strategy before embarking upon a field research. This is where advice and recommendations from the research community can be very useful. However, there is a lack of uniform guidelines that would cover all the categories of fieldwork in dangerous zones and that would specify all potential risks.'"`UNIQ--ref-00000611-QINU`"'
Some researchers with experience in fieldwork offer their advice and recommendations individually. The most important part is pre-departure planning.'"`UNIQ--ref-00000612-QINU`"' Before the actual fieldwork, researchers should be able to understand the local context well'"`UNIQ--ref-00000613-QINU`"' and know their legal rights as foreign scholars conducting research.'"`UNIQ--ref-00000614-QINU`"' Engaging local contacts for some insights regarding potential risks can also be helpful.'"`UNIQ--ref-00000615-QINU`"''"`UNIQ--ref-00000616-QINU`"' One of the most important things while conducting research is to protect confidentiality and anonymity of the participants at any cost, even to the detriment of other research objectives.'"`UNIQ--ref-00000617-QINU`"'
The European Commission (EC) has also offered a list of recommendations for research in regions or countries of high risks for researchers and participants. The EC also emphasizes the importance of making a clear strategy for keeping their research participants and themselves safe.'"`UNIQ--ref-00000618-QINU`"' With regards to that, a risk assessment has to be made and it should include details of safety measures the researchers are planning to take, for example training for staff and insurance cover.'"`UNIQ--ref-00000619-QINU`"' It is also important for researchers to provide justification in their ethics self-assessment for choosing an approach or site of research that involves higher risk, explain why alternative approaches are not possible, identify the potential risks and show how they intend to mitigate these risks.'"`UNIQ--ref-0000061A-QINU`"'
The necessity of conducting research in sites that pose risk to researchers and research participants compels policy-makers, universities and funding agencies, in collaboration with researchers experienced in fieldwork in risk zones, to formulate clear and precise guidelines and recommendations on the topic.
'"`UNIQ--references-0000061B-QINU`"'
Informed consent is an explicit agreement between the researcher and the subject, where the researcher promises not to reveal the identity or the personal data of the subject. +
The training of forensic anthropologists is usually associated with archaeology, with little or no contact with human remains that are not skeletonized. Education is important for the proper implementation of ethical principles. So, it is necessary to educate forensic anthropologists in practical skills, and moral and legal responsibilities brought about by their work.
Moreover, when talking about forensic anthropology there are few international or national associations with formal codes of ethics like the American Board of Forensic Anthropology, the British Association for Forensic Anthropology, and the International Forensic Center of Excellence for the Investigation of Genocide. These associations provide broad guidelines about behavior but little attention to practice '"`UNIQ--ref-00000987-QINU`"' .
'"`UNIQ--references-00000988-QINU`"' +
Clear protocols should be followed from planning through reporting. Standards for Reporting Qualitative Research (SRQR) aims to improve the transparency of all aspects of qualitative research by providing clear standards for reporting qualitative research [https://journals.lww.com/academicmedicine/fulltext/2014/09000/Standards_for_Reporting_Qualitative_Research__A.21.aspx]. These standards assist authors during manuscript preparation, editors and reviewers in evaluating a manuscript for potential publication, and readers when critically appraising, applying, and synthesizing study findings. +
Researchers must always consider mitigation strategies to overcome challenges that occur when it comes to involving children with disabilities in research and to do it in an ethical and respectful way. For meaningful participation, the individual capacities of each child involved must be considered at all stages of the research cycle, to ensure that processes are suitable for the diverse competencies, knowledge, interests, access, needs and contexts of all children involved. +
There are some guidelines and recommendations available on how to handle incidental findings in the social sciences and the humanities. The APA Committee on Human Research, for example, suggests including potential incidental findings in a researcher’s study plan or project proposal, with details about the threshold for reporting them '"`UNIQ--ref-0000040A-QINU`"'. The European Commission’s “[https://ec.europa.eu/research/participants/data/ref/h2020/other/hi/h2020_ethics-soc-science-humanities_en.pdf Ethics in Social Sciences and Humanities]” also suggests that researchers should consider potential incidental findings in their research '"`UNIQ--ref-0000040B-QINU`"'. They should draft a policy for coping with these findings and discuss them with their consortium, taking into account the legal context in which they are conducting their research, and, if appropriate, liaising with the legal department of their host institution. Furthermore, researchers should also inform the participants about the limits of confidentiality '"`UNIQ--ref-0000040C-QINU`"'. The European Commission also released their “[https://ec.europa.eu/research/participants/data/ref/h2020/other/hi/guide_research-refugees-migrants_en.pdf Guidance note — Research on refugees, asylum seekers & migrants]”, intended to help researchers in the social sciences and the humanities deal with incidental research findings when they relate to specific vulnerable populations '"`UNIQ--ref-0000040D-QINU`"'. When human research subjects are refugees, asylum seekers and migrants, the European Commission recommends that researchers contact the relevant NGOs rather than the authorities '"`UNIQ--ref-0000040E-QINU`"'. In order to mitigate the potential power differences between researchers and participants, the European Commission advises that projects involving these specific vulnerable populations should look to include researchers with a refugee or migrant background or, at least, researchers from the same culture. When the participants are unaccompanied minors, researchers should also contact National Refugee Councils for legal advice, psychological and interpretive support, and legally assigned supervision '"`UNIQ--ref-0000040F-QINU`"'.
Researchers in the biomedical and health sciences also require guidance regarding the management and communication of incidental findings '"`UNIQ--ref-00000410-QINU`"'. The Presidential Commission for the Study of Bioethical Issues in 2013 issued a report, stating that researchers should communicate potential incidental findings as part of the informed consent process '"`UNIQ--ref-00000411-QINU`"'. In addition, researchers should make a plan to evaluate and manage anticipatable and un-anticipatable incidental findings and seek the approval of the relevant institutional review board '"`UNIQ--ref-00000412-QINU`"'. It is important that researchers inform the participants about the potential un-anticipatable incidental findings. If such findings occur, researchers should assess their importance and consult with experts on the matter '"`UNIQ--ref-00000413-QINU`"'.
'"`UNIQ--references-00000414-QINU`"'
Throughout the world, different practices have been developed to protect the interest of children participating in clinical trials. In the United States, researchers have to ask permission from both minors and their parents or legal guardians. Permission from minors has to be definitive and the lack of objections cannot be defined as assent. When asking for assent, researchers should present all relevant information in a simple and understandable language, according to the child’s level of understanding (1). In the European Union, different practices exist, and some countries provide different legal and mandatory or recommended ages for assent (review of practices provided in tools section). In some situations, giving informed consent is not necessary. For example, when the only treatment for a disease is only available through clinical trials.'"`UNIQ--ref-000000C1-QINU`"' +
The idea of written informed consent is not new. It first appeared in the early 20<sup>th</sup> century in Walter Reed’s research of yellow fever.'"`UNIQ--ref-000000C4-QINU`"' The development of human rights after the second World War brought to life numerous declarations and rules (e.g., the Nuremberg Code) regarding human experimentation.'"`UNIQ--ref-000000C5-QINU`"'
In order for informed consent to be valid, four conditions need to be met'"`UNIQ--ref-000000C6-QINU`"':
*Voluntariness: subjects should not be coerced. This could be a tricky condition sometimes, especially when subjects have no alternative choice (e.g., when a terminally ill patient is offered to join an experiment that might save their life)
*Capacity: subjects should have the capacity to understand and judge provided information. This could become a thorny issue when dealin with vulnerable subjects (e.g., children) or patients with mental problems (e.g., those suffering from illnesses such as dimensia)
*Information: subjects should be provided with adequate amount of information. These may include methodology, process, duration of the experiment, but also research goals, beneficiaries, data retention schedule, others uses of extracted data (e.g., publication of research articles, use of material in tangent projects, etc.).
*Comprehension: subjects should understand the provided information. Relevant considerations include using straightforward language that is understandable for the least advantaged members of the target group, and avoding the use of scientific jargon.
Before accepting a manuscript for publication, editors should make sure authors have all the necessary research ethics permissions and signed informed consent forms from all participants.
'"`UNIQ--references-000000C7-QINU`"' +
From the end of the 1990s some research institutions and journals began to establish and develop rules and guidelines for research in online setting. In 1999 the American Association for the Advancement of Science (AAAS) issued a report [https://www.aaas.org/sites/default/files/report2.pdf Ethical and Legal Aspects of Human Subjects Research on the Internet] which emphasized the importance of using informed consent with disclosure of the risks and benefits of the research to the human subject. To this day, the AAAS report is considered “a benchmark” reference for the Internet research ethics .'"`UNIQ--ref-0000059A-QINU`"'
In the past few years, organizations such as [https://aoir.org/ethics/ The Association of Internet Researchers], [https://www.bera.ac.uk/publication/ethical-guidelines-for-educational-research-2018-online The British Educational Research Association], [https://www.bps.org.uk/sites/www.bps.org.uk/files/Policy/Policy%20-%20Files/Ethics%20Guidelines%20for%20Internet-mediated%20Research%20(2017).pdf The British Psychological Society] and [https://www.forskningsetikk.no/en/guidelines/social-sciences-humanities-law-and-theology/a-guide-to-internet-research-ethics/ The Norwegian National Research Ethics Committees], have also released guidelines with aim of providing frameworks for researchers facing ethical challenges in online research. While most of them stress the necessity of informed consent, some highlight obstacles and difficulties in obtaining it. For example, when children and other vulnerable groups are involved in research, the consent must be obtained from their parent or guardian. Also, children might pretend to be their parents, which would make the consent invalid.'"`UNIQ--ref-0000059B-QINU`"' Researchers working with children online must respect also the [https://www.ftc.gov/enforcement/rules/rulemaking-regulatory-reform-proceedings/childrens-online-privacy-protection-rule Children’s Online Privacy Protection Act (COPPA)] and when collecting children’s personal data, they must clarify how they intend to use the information.
Another important issue is securing participants’ anonymity. Although complete anonymity may be difficult to ensure, guidelines recommend removal of all identifying data prior to publication and, where an individual is identifiable, require explicit consent before publication.'"`UNIQ--ref-0000059C-QINU`"' The British Sociological Association in [https://www.britsoc.co.uk/media/24834/j000208_researching_online_forums_-cs1-_v3.pdf Researching Online Forums] case-study recommends that when collecting data from online forums, all names and any identifying information should be removed, which includes URLs or “links” to forum websites.
Social media data might contain copyrighted material. In such cases researcher should obtain the copyright holder’s consent.'"`UNIQ--ref-0000059D-QINU`"' If researcher is planning to publish the materials, they should request consent from all people who appear in photographs, audio or video. Same applies to publication of direct quotes that have not previously been published.'"`UNIQ--ref-0000059E-QINU`"'
'"`UNIQ--references-0000059F-QINU`"'
Starting in the 18th century, more and more arguments against research with animals have been voiced. Today, guidance for ethical use of animals in research is represented by so called 3R principles. 3R stands for replacement, reduction and refinement.'"`UNIQ--ref-000000D6-QINU`"''"`UNIQ--ref-000000D7-QINU`"' Replacement implies that animals as an experimental system should be replaced with a system from which the identical conclusion could be made if it is available. Reduction means that minimal numbers of animals should be used to prove something in experiments. Refinement means that if suffering of animals is present in the experiment it should be refined with pain killing medications and other support measures. In 2013, European Union formally applied EU Directive 2010/63/EU on the protection of animals used for scientific purposes.'"`UNIQ--ref-000000D8-QINU`"'This directive refers to 3R principles, and its ultimate goal is to replace animals in research altogether.
'"`UNIQ--references-000000D9-QINU`"'The application of the 3R principles is considered to be of crucial importance for the ethical use of animals in medicine testing across the European Union. Therefore, the European Medicines Agency (EMA) in collaboration with a dedicated 3Rs Working Party (3RsWP) develops scientific guidelines to help medicine developers comply with EU Directive 2010/63/EU. In order to ensure that there are no references to animal tests that are no longer considered appropriate, the EMA reviews and updates EMA guidelines to implement best practice with regard to 3Rs. Additionally, in accordance with Regulatory Science Strategy to 2025, the Agency is promoting 3Rs through a multidisciplinary group - the Innovation Task Force (ITF). This approach is expected to encourage prioritising of alternative methods and facilitate their integration into the development and evaluation of medicinal products. +
In a 2007 study, Einarsdóttir collected data in several ways:
'''''Group and individual interviews combined with observation'''''
Interviews were primarily used, which together with observations are the most common method used in research with children. They can be group or individual. The emphasis here is on talking to the child, that is providing an opportunity to be heard. Group interviews involve mostly preschool children who are used to being together in groups, and through interacting with other children they learn and form their attitudes towards the environment.
'''''Using props'''''
Some researchers suggest the use of props such as toys, paper and crayons, clay, or sand. Children’s drawings can also provide insight into the view and experience of young children. The advantage is providing non-verbal expression, and children are active and creative as they draw. The disadvantages are the possible imitation of other children's drawings or simply the child does not like to draw. Many authors recommend the use of photographs taken by children as a method of data collection. Photographing combined with touring increases the power of children because data collection is directly in their hands. Photography gives children the opportunity to express their views in different ways, inviting them to combine visual and verbal language. In addition, in the above-mentioned study, disposable cameras were given to the children. They were told that they could take photos of what they want and what they consider important in kindergarten, and after developing the photos, the teachers sat down with the children individually and talked to them about what was in the photos and why they were taken.
'''''Modified surveys'''''
Surveys are not a common method for research with children primarily because of their age. However, there is the possibility of constructing a questionnaire in the form of a child-friendly game. This may include paper forms of different colors that contain questions that the children in the game answer. This allows data to be collected during everyday children’s activities rather than in a fictional context.
Throughout history, multiple violations of ethical principles in human research have occurred. The most widely known are perhaps the inhumane experiments conducted by the Nazis and Japanese during the WW2. In the aftermath of the WW2, the Nuremberg Code was published to provide basic guidelines in human research. To further improve the ethics of human research, the World Medical Association developed the Declaration of Helsinki in 1964. While providing some guidance, instances of unethical research persisted. In the United States, a large study was conducted to assess the impact of syphilis, and hundreds of participants were barred from seeking treatment in what was known as the Tuskegee experiment. Following the public outcry, the Belmont report was published in 1978. These documents set important standards in human research and provide the foundations of medical ethics. Some of the important points are respect for the person, personal autonomy (and informed consent), justice, and beneficence. Nowadays, different countries have national laws, informed by the aforementioned international guidance, regarding clinical research and oversight by research ethics committees.
'''Related guidelines'''
<br />
*[https://history.nih.gov/research/downloads/nuremberg.pdf Nuremberg code]
*[https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ Declaration of Helsinki]
*[https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html Belmont report]
'''Related cases'''
<br />
*[https://www.cdc.gov/tuskegee/timeline.htm Tuskegee syphilis experiment]
*[https://encyclopedia.ushmm.org/content/en/article/nazi-medical-experiments Nazi human experiments] +
Since World War II, a lot has been said about human experimentation, and vulnerable groups in particular. Many different reports and guidelines have been developed and should be consulted when thinking about involving vulnerable and non-competent individuals. Start with the Declaration of Helsinki and don’t forget to check the appropriate regulations of your own country and institution. +
Each institution should have its official, long and shortened affiliations for the institution in general, as well as its departments in specific.
Every author should list affiliations for all institutions they're connected to, regardless of which institution funds the research. +
Practice guidelines are diverse and vary according to the scientific field. Rather than rules, professional bodies provide guidelines or recommendations and most guidelines leave some room for interpretation.
===='''Medicine'''====
The best-known authorship guideline comes from the International Committee of Medical Journal Editors. The ICMJE recommends that an author should meet all four of the following criteria: '"`UNIQ--ref-000000E5-QINU`"'‘‘Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work,’’'"`UNIQ--ref-000000E6-QINU`"'’’Drafting the work or revising it critically for important intellectual content,’’ '"`UNIQ--ref-000000E7-QINU`"' ‘‘Final approval of the version to be published,’’ and '"`UNIQ--ref-000000E8-QINU`"'‘‘Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved’’. The committee further designates that in addition to excluding a scholar who has not met all four criteria, any scholar who meets all four should be included as an author. Following the authorship criteria, the ICMJE expressly describes contributions that should be included as an acknowledgment, and not authorship (i.e., funding, supervision, writing assistance, technical or language editing, proofreading). '"`UNIQ--ref-000000E9-QINU`"'
===='''Science'''====
The Council of Science Editors describes authors as “individuals identified by the research group to have made substantial contributions to the reported work and agree to be accountable for these contributions. In addition to being accountable for the parts of the work he or she has done, an author should be able to identify which of their co-authors are responsible for specific other parts of the work. In addition, an author should have confidence in the integrity of the contributions of their co-authors. All authors should review and approve the final manuscript.”'"`UNIQ--ref-000000EA-QINU`"'
===='''Chemistry, Physics, and Mathematics'''====
Guidelines in the physical and mathematical sciences offer somewhat less precise definitions, such as this from the American Physical Society: “Authorship should be limited to those who have made a significant contribution to the concept, design, execution or interpretation of the research study. All those who have made significant contributions should be offered the opportunity to be listed as authors. Other individuals who have contributed to the study should be acknowledged, but not identified as authors.”'"`UNIQ--ref-000000EB-QINU`"'
===='''Sociology'''====
The American Sociological Association includes the following in its Code of Ethics: “(a) Sociologists take responsibility and credit, including authorship credit, only for work they have actually performed or to which they have contributed. (b) Sociologists ensure that principal authorship and other publication credits are based on the relative scientific or professional contributions of the individuals involved, regardless of their status. In claiming or determining the ordering of authorship, sociologists seek to reflect accurately the contributions of main participants in the research and writing process. (c) A student is usually listed as principal author on any multiple-authored publication that substantially derives from the student’s dissertation or thesis.” '"`UNIQ--ref-000000EC-QINU`"'
'"`UNIQ--references-000000ED-QINU`"'
There are numerous cases of violation of publication ethics with regards to authors’ rights. For instance, when journals publish articles without the authors’ consent. One of the representative examples is an article on the quality of therapeutic trials in perinatal medicine, written by Dr Jon Tyson and his colleagues and published in the Journal of Pediatrics in 1983.'"`UNIQ--ref-00000668-QINU`"' Six months after that, the paper was published in full in the journal of Obstetrics and Gynecology without the authors’ consent only to be described “as a poor study” in a hostile accompanying editorial.'"`UNIQ--ref-00000669-QINU`"''"`UNIQ--ref-0000066A-QINU`"'
Another case regards dispute between the authors. An article was submitted to a journal by corresponding author (CA), at the time a PhD student, and published online. Later, co-author A (head of the research group) informed the publisher that the paper was submitted to a journal by CA during her absence (maternity leave) and that she as well as other 7 co-authors were not informed about the publication. Additionally, she requested the retraction of the article. She also mentioned that she had recently submitted an updated version of the same paper to another journal and that all authors, including CA, had agreed to the publication. When journal contacted CA, he stated that he had asked co-author A for permission to submit the article but that the had not received an answer for one year.'"`UNIQ--ref-0000066B-QINU`"' The CA replied that he had signed contract at the research institution where co-author A worked and where the research had been conducted. He agreed to retract the article. One of the co-authors also contacted the publisher asserting that CA had published the paper without his approval and he also suggested retraction of the paper. '"`UNIQ--ref-0000066C-QINU`"'In the end, the authors submitted an updated version of the same paper to another journal.'"`UNIQ--ref-0000066D-QINU`"'
This case was discussed at the COPE Forum. The Forum suggested for future notice that when a journal receives a manuscript, it must send an acknowledgement to all of the authors, not just the corresponding author.'"`UNIQ--ref-0000066E-QINU`"' Most Forum members agreed that there was no ground for retraction of the article, because there was no issue concerning the scientific content of the article. However, since the editor did not have authors’ consent for publication, some members of the Forum concluded that the authors did have some ground for retraction.'"`UNIQ--ref-0000066F-QINU`"'
'"`UNIQ--references-00000670-QINU`"'
There is no single uniform consent form for all journals, only general principles and guidance provided by committees for publication ethics. The British Medical Journal (BMJ) Ethics Committee, for example, offers recommendations on how to obtain the participant’s consent. The consent is necessary even if identifying details are removed. Participant’s personal information will not be published if he or she refuses to give consent, with the exception of high importance to public health.'"`UNIQ--ref-0000067A-QINU`"' Some recommendations to publish research findings without participant’s consent include these conditions:
-the participant cannot be found in order to give his consent or it is impossible or unreasonable to expect to gain consent from the patient or his next-of-kin
-the article contains data which importance for public health overrides the importance of participant’s consent
-it is expected that a participant would not object to the publication of the case. This requires an assessment of the intrusiveness of the disclosure and potential embarrassment or distress
-the case is anonymized so that the participant’s identity will not be revealed.'"`UNIQ--ref-0000067B-QINU`"'
The committee has also stated that giving absolute priority to confidentiality would hold back medical research and education, so there must be a balance between confidentiality and the need for data sharing.'"`UNIQ--ref-0000067C-QINU`"'
Committee on Publication Ethics (COPE) has released a [https://publicationethics.org/files/u7140/Discussion_document_on_Best_Practice_for_Consent_for_Publishing_Medical_Case_Reports.pdf Discussion document on Best Practice for Consent for Publishing Medical Case Reports]. The document stated that authors are obliged to collect the signed consent forms, not journals, and that forms should be used for cases where an individual or a group of individuals could be identified.'"`UNIQ--ref-0000067D-QINU`"' It concluded that no single form would be adequate for all journals, so it presented some specific points that a consent form should include:
-a place for the name of the patient and the name of the individual signing the form
-a place for the name of the person who has explained the form to the patient or family member
-indication that the patient has seen the case report and pictures regarding it and that they agree to it
-information that the journal cannot guarantee confidentiality after publishing the case report
-information under what license the report is published
-information that form does not remove the patient’s rights to privacy
-information that the patient has been informed of his right to revoke consent at any time before publication
-information that patients cannot expect any financial benefit from the publication of the case.
The document also provided links to examples of cases report forms and relevant guidance.'"`UNIQ--ref-0000067E-QINU`"' Example of participant’s consent for publication in a PLos One journal can be found [https://journals.plos.org/plosone/s/file?id=8ce6/plos-consent-form-english.pdf here].
<br />
HIRMEOS integrates five publishing platforms:
-[https://books.openedition.org/ OpenEdition Books], the OpenEdition platform dedicated to open access books. It is run by the Center for Open Electronic Publishing (Cléo) in France. The platform disseminates more than 2700 open access books from 51 publishers from the SSH fields.
-[https://www.oapen.org/ OAPEN Library], a service run by OAPEN Foundation in Netherlands. It contains 2600 freely accessible academic books, mostly in the SSH disciplines. The platform collaborates with 120 publishers and provides services for publishers, libraries and research funders for deposit, quality assurance, dissemination as well as digital preservation.
-[https://epublishing.ekt.gr/ ΕΚΤ ePublishing], the ePublishing platform of the National Documentation Centre in Greece. It offers advanced e-infrastructures and related services to institutional publishers in Greece such as universities, research centers, scholarly societies and memory institutions, with aim of publishing peer-reviewed journals, proceedings and monographs in the SSH disciplines.
-[https://www.sub.uni-goettingen.de/en/publishing-open-access/goettingen-university-press/ Göttingen University Press], the publishing house of Göttingen University in Germany which has published scholarly texts by researchers affiliated with the university since 2003. It supports the principles of open access, meaning it provides online content for users free of costs and limitations. All digital publications of Göttingen University Press are available for the public use permanently.
-[https://www.ubiquitypress.com/ Ubiquity Press], an open access publisher of peer-reviewed academic journals, books and data affordable for everyone. This publisher collaborates with RUA - an open source application developed by Ubiquity Press and designed to assist with the stages of the publishing monographs process: optional proposal, submission, internal review, peer review, copy editing, production and publication.'"`UNIQ--ref-0000052B-QINU`"'
One of the HIRMEOS objectives is to enrich these five digital publishing infrastructures with more functionalities and features to facilitate their further integration into the European Science Open Cloud.'"`UNIQ--ref-0000052C-QINU`"'
'"`UNIQ--references-0000052D-QINU`"'
Around 13 000 scholarly publishers, those with both open access and subscription requirement, have already been submitting their bibliographic metadata and references to Crossref.'"`UNIQ--ref-000006AB-QINU`"' At the launch of I4OA in September 2020, 8.3% of journal articles with a Crossref DOI had their abstracts available in the repository.'"`UNIQ--ref-000006AC-QINU`"' Publishers such as [https://www.bmj.com/ BMJ], [https://www.thebritishacademy.ac.uk/ The British Academy], [https://www.life-science-alliance.org/ Life Science Alliance], [https://academic.oup.com/journals/pages/open-abstracts-i4oa Oxford University Press], [https://us.sagepub.com/en-us/nam/home SAGE], [https://f1000research.com/ F1000], [https://www.mdpi.com/ MDPI], and many others have already joined I40A or have accepted to join. Longer list of these publishers is available [https://i4oa.org/#:~:text=Publishers%20supporting%20I4OA here]. +
The Initiative has asked scholarly publishers, who were already depositing the reference lists of their publications at Crossref, to make them open and available to everyone. Before this Initiative, only 1% of all references deposited at Crossref were open. As of August 2021, the percentage of publications with open references has grown from 1% to 88% out of 56.1 million articles with references submitted to Crossref.'"`UNIQ--ref-00000544-QINU`"'
Among significant publishers there are [https://www.crossref.org/members/prep/239 BMJ], [https://www.crossref.org/members/prep/56 Cambridge University Press], [https://www.crossref.org/members/prep/281 MIT Press], [https://www.crossref.org/members/prep/286 Oxford University Press], [https://www.crossref.org/members/prep/292 The Royal Society of Chemistry], [https://www.crossref.org/members/prep/179 SAGE Publications], and [https://www.crossref.org/members/prep/311 Wiley].'"`UNIQ--ref-00000545-QINU`"' You can see the full list [https://i4oc.org/#:~:text=Participating%20publishers here].
'"`UNIQ--references-00000546-QINU`"' +
OPERAS offers several services that are currently at different stages of development:
-[https://www.operas-eu.org/services/certification-service-doab/ Certification service], based on the Directory of Open Access Books ([https://www.doabooks.org/ DOAB]). It provides an international list of SSH open access publications that meet minimal quality criteria regarding peer-reviewing and licensing.'"`UNIQ--ref-000005DD-QINU`"'
-[https://www.operas-eu.org/services/metrics-service/ Metrics service], developed by one of the OPERAS projects HIRMEOS. This service aims to collect the usage and impact metrics related to Open Access monographs from different sources and enable their access, display and analysis.
-[https://www.operas-eu.org/services/publishing-service-portal-psp/ Publishing service portal], designed to provide users with a single access to the publishing and scholarly communication services of OPERAS members.
-[https://www.operas-eu.org/services/discovery-service-triple/ Discovery service], based on the existing French ISIDORE platform which will enable European researchers in SSH to discover open resources such as data, publications and other materials important to their research that are currently dispersed across local repositories. This service will also enable discovery of these sources in different languages.
-[https://www.operas-eu.org/services/research-for-society/ Research for Society], designed to be an interactive platform that would link SSH researchers with society on the [https://hypotheses.org/ hypotheses.org], the largest academic platform in the world with more than 2000 blogs. This service will facilitate collaboration between researchers and socioeconomic actors on research projects.'"`UNIQ--ref-000005DE-QINU`"'
OPERAS will offer also some [https://www.operas-eu.org/services/future-services/ Future Services], such as a platform to support translation, a single access point to book reviews, a support service to publishing tools, etc.
'"`UNIQ--references-000005DF-QINU`"'
There are different ways to make research open access. The two main routes that authors can take towards publishing open access are self-archiving, the so-called green route, and open access publishing, the gold route. '"`UNIQ--ref-000000F1-QINU`"' When taking the green route, the article is published behind a paywall, but a free copy is published in an online repository. In the gold route, articles are published immediately in open access mode.
'"`UNIQ--references-000000F2-QINU`"' +
COPE has guidelines on many different topics, for different target stakeholders, including those for [https://publicationethics.org/resources/code-conduc editors] and [https://publicationethics.org/system/files/Code_of_conduct_for_publishers_Mar11.pdf publishers]. In addition, there are ten core practices formulated by cope, ranging from allegations of misconduct to ethical oversight to data and reproducibility. For all ten practices and explanations, see the [https://publicationethics.org/core-practices COPE core practices]. +
For example, the U.S. National Library of Medicine, which produces PubMed, the largest bibliographical database in health research, describes different types of procedures for amendments to the [http://wayback.archive-it.org/org-350/20180312141525/https://www.nlm.nih.gov/pubs/factsheets/errata.html published scientific record]. Retraction of an article involves publishing a retraction notice that explains the reasons for retraction and who is making the retraction. This notice links to the retracted article, which is clearly marked in the indexing database.
The current list of all retractions in PubMed, regardless of the cause (error or misconduct) is available [https://www.ncbi.nlm.nih.gov/pubmed?term=retracted+publication+%5Bpt%5D here].
Some journals want to differentiate between retractions due to misconduct and those that are due to an error that makes a research conclusion wrong, but can be corrected. Such corrections have been termed “retraction with republication” or “retraction with replacement” by the International Committee of Medical Journal Editors (ICMJE). This type of retraction is used when a serious error makes published results unreliable, but it was judged that the error was not intentional and the corrections are possible. Such retraction and replacement should be accompanied by full explanation, including a clear presentation of the extent of changes that were made.
The problem may occur when the retracted and replaced articles keep the same pagination and bibliographic identifiers (such as DOI – digital object identifier). Some bibliographical databases may not recognize this as a proper correction of literature. Databases usually require that the original and corrected/replaced publication are kept as separated publication items, with added notice that links them. Different understanding of how a retracted publication can be replaced with a corrected publication has caused differences in indexing of such publications in bibliographical databases, creating confusion for the users of published research articles.
A relevant tool to detect retracted papers and keep up to date on retraction scandals is Retraction Watch. Retraction watch is both a blog and a database of an estimated 17,000 retracted papers. The blog regularly updates on papers and authors that are retracted/about to be retracted. The database, found [http://retractiondatabase.org/ here], is a tool to find out whether a paper has been retracted. Journals, authors and reasons for retractions are given in the search results.
===Difficulties===
Common practises on standards of authorship vary between scientific disciplines, and between countries, making standardizing difficult. They also change over time. As the Swiss Academies of Arts and Sciences note:
''“Customs have changed over the past few decades; for example, the practice of granting “honorary” authorship to an eminent researcher – formerly not unusual – is no longer considered acceptable.”'''"`UNIQ--ref-00000118-QINU`"'
==='''European Code of Conduct '''===
''The European Code of Conduct for Research Integrity (2017)'' states the following:'"`UNIQ--ref-00000119-QINU`"'
*All authors are fully responsible for the content of a publication, unless otherwise specified
*All authors agree on the sequence of authorship, acknowledging that authorship itself is based on a significant contribution to the design of the research, relevant data collection, or the analysis or interpretation of the results
*Authors acknowledge important work and intellectual contributions of others, including collaborators, assistants, and funders, who have influenced the reported research in appropriate form, and cite related work correctly
*All authors disclose any conflicts of interest and financial or other types of support for the research or for the publication of its results
==='''COPE'''===
*Guideline: [https://publicationethics.org/files/2003pdf12_0.pdf How to handle authorship disputes: a guide for new researchers]
*Guideline: [https://publicationethics.org/files/International%20standard_editors_for%20website_11_Nov_2011.pdf Responsible research publication: international standards for editors]
'"`UNIQ--references-0000011A-QINU`"' +
Although it is evident that non-peer-reviewed information has its pros and cons, it is not evident what the obligations of researchers are with regard to the dissemination of their research. The European Code of Conduct in Research Integrity, for instance, states that authors should be “…. honest in their communication to the general public and in traditional and social media.” <sup>13</sup> Thus, it does not explicitly forbid the pre-publication dissemination of results. In a public health emergency such as the ongoing pandemic, the situation is even more complex. The WHO Working Group on Ethics and COVID-19 states that “researchers generating information that has the potential to aid response efforts have an ethical obligation to share that information as soon as it is quality-controlled for release (e.g., peer-reviewed),” and that they should “…share this information without waiting for publication in scientific journals.” <sup>14</sup> These statements seem confusing, as it is unclear whether authors should wait until the manuscript is peer reviewed (which could be a long period) or circumvent this step. Here, the benefits of timely communication should be balanced against the potential risk of spreading inaccurate information, which can have lasting consequences.
When unreviewed information is communicated, however, it should be clearly labelled as such. In line with the principles of honesty, accuracy and transparency recommended by the ECCRI, neither the findings nor the relevance of the research should be exaggerated or misrepresented. +
The most prominent examples in practice are diagnostic studies and hypothesis generating studies. When developing new diagnostic models authors tend to combine multiple prognostic factors and then test such models using the ROC analysis on whole sample without validating the model on a separate sample. However, sometimes the need for validation of model is not disclosed in discussion section. Hypothesis generating studies are usually done on “big data” from databases such as The Cancer Genome Atlas. The primary goal of such studies is to build models based on large data sets and “get the feeling for the data”, or in more technical language to do exploratory data analysis, sometimes such studies do not disclose need for model validation (i.e. confirmatory data analysis). Sometimes after ANOVA, correction for multiple comparison testing also known as post hoc testing is done, these post hoc tests have more stringent statistical significance criteria with the purpose of somewhat replacing model validation. However, replacing model validation with more stringent statistical significance criteria is highly debated topics in a world of statistics.
Another case which is usually confused with HARKing are planned multiple comparisons after ANOVA. In this case the fact that comparisons are planned means that model was built before the experiment and based on it, comparisons are done after gathering data.'"`UNIQ--ref-0000024C-QINU`"'
'"`UNIQ--references-0000024D-QINU`"' +
This is the definition of duplicate publication by the Committee on Publication Ethics (COPE):
“When a published work (or substantial sections from a published work) is/are published more than once (in the same or another language) without adequate acknowledgment of the source/cross-referencing/justification”.'"`UNIQ--ref-0000019A-QINU`"'
The International Committee of Medical Journal Editors (ICMJE) differentiates between '''duplicate submission''' – when authors submit the same work (possibly in different languages) to two or more journals at the same time; and '''duplicate publication''' – when the same work is already published more than once.
Duplicate publications must be retracted, and duplicate submissions, if discovered by journal editors, are usually rejected. COPE provides guidance on how to handle duplicate publications. Some indexing databases, such as PubMed, automatically tag duplicate publications when they identify them during indexation. '"`UNIQ--ref-0000019B-QINU`"'
Acceptable '''secondary publication''' is publication of the same work but with clear reference to its first publication and is usually intended for a different audience. In addition, authors must have approval from the journal that first published the article. The secondary publication must be a faithful reflection of the original publication and it must clearly reference the primary publication – as a note in the article and in the title of the secondary article.
What is not a duplicate publication? The ICMJE considers that a structured abstract under 500 words and registration of trial results in public trial registries are not redundant publications. This means that publishing a conference abstract is not considered a publication. Presentations at a meeting (poster or a talk) are also not considered to be proper publications, because they are usually not peer reviewed. Increasingly, authors post their work first in a preprint server (online research repositories) and many journals do not consider this to be duplicate publication. Journals expect the authors to inform them about where the work was posted on a preprint server.
'"`UNIQ--references-0000019C-QINU`"'
To prevent funding bias, the International Committee of Medical Journal Editors (ICMJE) requires that research articles have Disclosure Form containing:
“-sources of support for the work, including sponsor names along with explanations of the role of those sources if any in study design;
-collecting, analysis, and interpretation of data;
-writing of the report;
-any restrictions regarding submission of the report for publication;
-or a statement declaring that the supporting source had no such involvement or restrictions regarding publication.”'"`UNIQ--ref-00000559-QINU`"'
In addition to that, editors may request that authors also sign a statement, such as: “I had full access to all of the data in this study and I take complete responsibility for the integrity of the data and the accuracy of the data analysis”.'"`UNIQ--ref-0000055A-QINU`"'
Some investigators have even proposed that academic studies funded by industry should continue only if academic medical centres would be solely responsible for the design, conduct, analysis, and reporting of clinical trials. Others have recommended that conflict-of-interest committees should be created at academic institutions to monitor the finances.'"`UNIQ--ref-0000055B-QINU`"'
'"`UNIQ--references-0000055C-QINU`"' +
On the systemic level, HARKing can be prevented by changing researcher assessment and promoting the preregistration of studies, ideally in a form involving reviewed preregistration with guaranteed publication if the accepted protocol is followed.
Individual researchers should make post hoc hypotheses transparent and thereby avoid deceiving readers to reap the benefits from exploratory studies without misrepresenting them as following a hypothetico-deductive model. +
===Related tools===
By Jensen (2000) '"`UNIQ--ref-00000258-QINU`"'
*New data and cross-validation
*Sidak, Bonferroni, and other adjustments
*Resampling and randomization techniques
By Glenn & Cormier (2015) '"`UNIQ--ref-00000259-QINU`"'
*Performing own reviews of the sources of data,
*Checking for retractions and corrections,
*Requiring full disclosure of methods,
*Acquiring original data and reanalyzing it,
*Avoiding secondary sources,
*Avoiding unreplicated studies or studies that are not concordant with related studies, and
*Checking for funding or investigator biases.
===Related cases===
Convenience, dichotomization, stratification, regression to the mean, impact of sample size, competing risks, immortal time and survivor bias, management of missing values . '"`UNIQ--ref-0000025A-QINU`"' '"`UNIQ--ref-0000025B-QINU`"'
'"`UNIQ--references-0000025C-QINU`"' +
A prominent example of the distortion of research findings by the media relates to an article published in ''PLoS One'' in 2009 '"`UNIQ--ref-0000044F-QINU`"'. It presented a study that examined whether NHS hospitals in England have a higher mortality rate in the first week of August than in the last week of July, due to the fact that newly qualified doctors begin working in hospitals on the first Wednesday of August. The study used hospital admissions data from 2000 to 2008 for all emergency patients in the last week of July and the first week of August. Taking into account the year, patient gender, socio-economic deprivations and co-morbidity, the study showed that for patients admitted on the first Wednesday of August the odds of death were 6% higher in comparison to those admitted on the last Wednesday in July. Also, clinical patients on the first Wednesday of August had 8% higher odds of death than surgical patients. Even though the confidence intervals for these odds ratios included a value of 1, and researchers suggested that further studies were needed, the media distorted the study findings. Under a sensationalist headline, “Killing Season”, ''The Daily Mail'' reported that death rates are 8% higher in the said period because newly qualified doctors had started their jobs '"`UNIQ--ref-00000450-QINU`"'. It reported that the “number of mistakes are so notoriously high that day of the week” that this day should be called “Black Wednesday” '"`UNIQ--ref-00000451-QINU`"'. Other media outlets reprised the phrases “Killing season” '"`UNIQ--ref-00000452-QINU`"'. Some even said that it was “the worst day of the year to go to hospital” '"`UNIQ--ref-00000453-QINU`"'.
Sometimes researchers and reporters can, together, contribute to sensationalism and the exaggeration of research findings. One of the studies that caused a lot of uproar in 2015 was written by Tomasetti and Vogelstein, and published in ''Science'' '"`UNIQ--ref-00000454-QINU`"'. The media, along with some experts, including the authors, oversimplified the interpretation of the results, claiming that the vast majority of cancers are caused by random mutations or “bad luck” '"`UNIQ--ref-00000455-QINU`"'. However, experts and the media paid insufficient attention to the study design. It was an observational study, so no definitive or reliable inferences could be made regarding the cause and effect relationship; conclusions could only be based on the associations between different cancer-occurrence factors, which do not reliably support conclusions regarding direct causation.
'"`UNIQ--references-00000456-QINU`"'
The ASA statement on P-values gives instructions on the correct use of P-values, with the goal of improving interpretation in quantitative science. The overall conclusion of the ASA is that scientific inferences should not be based exclusively on P-value threshold, because that, in itself, does not provide substantial evidence regarding a model or hypothesis, nor does it measure the size of a certain effect or determine the importance of the results. Researchers should use P-values within a proper context, because otherwise it can lead to selective reporting '"`UNIQ--ref-0000041F-QINU`"'. Good scientific inference requires the full and transparent reporting of data and methods '"`UNIQ--ref-00000420-QINU`"'. There are other methods that researchers can use with or instead of P-values, which mostly focus on estimations as opposed to testing. These include confidence, credibility or prediction intervals, Bayesian methods, decision-theoretic modeling and false discovery rates '"`UNIQ--ref-00000421-QINU`"'.
Since its release in 2016, the ASA statement has been cited about 1,700 times and downloaded nearly 300,000 times. In 2017, the ASA organized a symposium on statistical methods, which resulted in 43 articles on the topic of the responsible use of P-values'"`UNIQ--ref-00000422-QINU`"' . Statisticians and scientists are currently considering “a world beyond p<0.05” ('"`UNIQ--ref-00000423-QINU`"'), suggesting a wide spectrum of solutions and possibilities. One solution involves changing the P-value threshold for statistical significance from 0.05 to 0.005 ('"`UNIQ--ref-00000424-QINU`"''"`UNIQ--ref-00000425-QINU`"'). By contrast, others argue that reproducibility of results and pre-registration are the best means for preventing selection bias '"`UNIQ--ref-00000426-QINU`"'. Others still recommend including more information when reporting P-values, such as the researcher’s confidence in the P-value or their assessment of the likelihood that a statistically significant finding is, in fact, a false positive result '"`UNIQ--ref-00000427-QINU`"'.
Critiques, initiatives and recommendations require not only further academic discussion, but also significant educational reforms in statistics '"`UNIQ--ref-00000428-QINU`"'.
'"`UNIQ--references-00000429-QINU`"'
Regardless of the importance and necessity to fully report study limitations, in practice researchers still need to be encouraged to report their limitations and to describe them properly and thoroughly. The following example demonstrates that scientists in medicine do not fully discuss and present limitations of their research '"`UNIQ--ref-00000463-QINU`"'. A study was conducted on 400 articles published in 2005 in journals with the highest number of citations, among them two open-access journals. Full-texts of these articles were electronically searched, looking for words ‘limitation’, ‘caveat’ or ‘caution’. The results showed that only 67 articles (17%) used at least one of the mentioned words when presenting their own research. Furthermore, only four articles (1%) used the word ‘limitation’ in their abstract, while not one article mentioned limitations of their research that had impact on the conclusions '"`UNIQ--ref-00000464-QINU`"'.
Researchers do not present their study limitations because perhaps they do not fully understand the significance, outcomes and implications of these limitations to the study results. Maybe they think that probability for publication of their work would be higher by not addressing them '"`UNIQ--ref-00000465-QINU`"'. Journals also bear great responsibility in this matter because of the word limits that prevent authors from reporting and thoroughly describing their limitations '"`UNIQ--ref-00000466-QINU`"'. When researchers do mention their study limitations, they usually provide only a list, they do not fully describe them '"`UNIQ--ref-00000467-QINU`"'.
There are several things researchers and journals can do to responsibly report study flaws and limitations. When describing them, researchers should clearly classify the type of limitation so that readers could interpret the research findings correctly '"`UNIQ--ref-00000468-QINU`"'. They should not only describe the limitations, but also explain their implications. Assessing impact of limitations on conclusions of the research and its validity is also very important and can help to avoid bias. Researchers should explain why they did not take some alternative approaches or maybe provide some alternative explanations of their findings. Finally, researchers should describe efforts taken to mitigate the implications of study limitations '"`UNIQ--ref-00000469-QINU`"'. Journals, on the other hand, should encourage authors to present their study limitations and provide them with some guidelines '"`UNIQ--ref-0000046A-QINU`"'.
Reporting study flaws and limitations should enter the everyday research practice. The only way to deal with such uncertainties is to present data, methodology, limitations and study deficiencies transparently so that decision makers can be fully aware of quality and potential errors in inference.
'"`UNIQ--references-0000046B-QINU`"'
If a study’s methodology is valid, it is important to publish all of the results, including negative ones. The International Committee of Medical Journal Editors stated that researchers should publish negative data in order to prevent publication bias and potential waste of time and money because of duplication. World Health Organization, in 2005, called for publication of previous non-reported negative findings. The Committee on Publication Ethics, in their guidelines, state that journals should not refuse to publish negative findings. Some journals are dedicated to publication of null results only, such as the Journal of Negative Results, in the field of ecology and evolutionary biology. BioMed Central’s Journal of Negative results in BioMedicine ceased to publish in 2017.
In order to assess publication bias when conducting a meta-analysis, researchers use a funnel plot. A funnel-plot is a type of scatter-plot, in which both treatment effect and study precision are shown. If the data is not symmetrical, there is a high chance of either publication bias or small-study effect. '"`UNIQ--ref-00000266-QINU`"' This is especially important when doing a meta-analysis of clinical trials, as such results often end up being used as the strongest evidence in making of clinical practice guidelines.'"`UNIQ--ref-00000267-QINU`"'
'"`UNIQ--references-00000268-QINU`"' +
The use of appropriate statistical analyses and the full publication of results (whether approving or rejecting the study’s hypothesis) are among the best practices. Preregistering research is another way of communicating research plans and improve the credibility of results.'"`UNIQ--ref-00000269-QINU`"'
In the case of clinical trials, ICMJE advises groups to register clinical trials and link the analysis of clinical trials to the same registration. They are also advised to make sure that there is no discrepancy between the registered methodology in the registries and what is published in the journals, and publish the registration number at the end of the abstract. Since July 2018, groups are also asked to include their data sharing plan and data sharing statement.'"`UNIQ--ref-0000026A-QINU`"'
Furthermore, in order to encourage impartial and clear use of statistical methods, ICMJE asks groups to:
“Describe statistical methods with enough detail to enable a knowledgeable reader with access to the original data to judge its appropriateness for the study and to verify the reported results. When possible, quantify findings and present them with appropriate indicators of measurement error or uncertainty (such as confidence intervals). Avoid relying solely on statistical hypothesis testing, such as P values, which fail to convey important information about effect size and precision of estimates. References for the design of the study and statistical methods should be to standard works when possible (with pages stated). Define statistical terms, abbreviations, and most symbols. Specify the statistical software package(s) and versions used. Distinguish pre-specified from exploratory analyses, including subgroup analyses” (p.16-17). '"`UNIQ--ref-0000026B-QINU`"'
'"`UNIQ--references-0000026C-QINU`"' +
It’s difficult to address the issue of P-value hacking, especially since there aren’t many incentives to replicate research. However, some steps can be taken in order to prevent it. Cross-validation, or out-of-sample testing is a statistical method used to create two sets of data. The first set of data is then used for statistical analysis, to develop new models or hypotheses, and the other, independent set is then used to verify them.'"`UNIQ--ref-00000275-QINU`"' A number of statistical analyses is also available to check for p-value hacking, such as Bonferonni correction, Scheffé's method and false discovery rate. A lot of journals will now ask for raw data to be published, or shift their way of work to registered report format. That is a publication process in which journals accept the publications based on theoretical justification and methodology only, without looking at results. '"`UNIQ--ref-00000276-QINU`"'
'"`UNIQ--references-00000277-QINU`"' +
Everybody who ever performed research probably experienced the sadness of getting a p value bigger than 0.05. Instead of critically looking at the data and results in the light of present knowledge and trying to figure out the impact of results, the hypothesis usually gets abandoned and another set of experiments gets initiated. There is some effort to change the existing practice. A new course in editorial policy for publication, which is considering only the methodological rigor, and not the direction of results, was set by PLOS some 20 years ago. Another praise worthy initiative is Journal of Negative Results which also considers methodological rigor as the only criteria for the publication of a manuscript. +
<br />
'"`UNIQ--references-00000288-QINU`"' +
The correct use of previously published material does not involve selective citation to enhance one’s own findings or to please editors, reviewers or colleagues.'"`UNIQ--ref-0000028C-QINU`"' References to published material should not be used to promote self-interests.'"`UNIQ--ref-0000028D-QINU`"' Nuanced use of previously published material involves using resources in a neutral and unbiased way.
'''Examples of citation in the scientific and popular literature'''
Journal articles:
*[https://bmjopen.bmj.com/content/9/2/e026518 Selective citation in the literature on the hygiene hypothesis: a citation analysis on the association between infections and rhinitis]
*[https://jamanetwork.com/journals/jamaophthalmology/fullarticle/267954 Selective Citation of Evidence Regarding Photoreceptor Loss in Glaucoma]
*[https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-017-0041-z Selective citation in the literature on swimming in chlorinated water and childhood asthma: a network analysis]
Blog sphere:
*[https://www.embassy.science/theme/Citation%20bias%20favoring%20positive%20clinical%20trials Citation bias favoring positive clinical trials]
News outlets:
*[https://theconversation.com/how-time-poor-scientists-inadvertently-made-it-seem-like-the-world-was-overrun-with-jellyfish-61564 How time-poor scientists inadvertently made it seem like the world was overrun with jellyfish]
*[http://www.israelnationalnews.com/News/News.aspx/167812 'Stunningly Offensive' Paper 'Negates Judaism]'
'"`UNIQ--references-0000028E-QINU`"' +
Open data practices can help increase transparency, allowing other researchers and interested parties to undertake their own analyses.
A technique to identify and classify spin in RCT reports has been developed by Boutron et al,'"`UNIQ--ref-0000029A-QINU`"''"`UNIQ--ref-0000029B-QINU`"' focusing on RCTs reporting statistically nonsignificant primary outcomes because the interpretation of these results is more likely to be subject to prior beliefs of effectiveness, leading to potential bias in reporting. Similar approaches are available to systematically assess the explicit presentation of nonsignificant results in trial reports in various subspecialties, such as described by Lockyer et al, and Turrentine. '"`UNIQ--ref-0000029C-QINU`"''"`UNIQ--ref-0000029D-QINU`"'
'"`UNIQ--references-0000029E-QINU`"' +
Institutions and journals need to have clear guidelines on publication and authorship in place. Guidelines should involve a section about gaining consent from all authors before submitting a manuscript or grant proposal. The Forum from COPE suggests that journals should send acknowledgements to all listed authors, not just the corresponding author, upon receiving a manuscript.'"`UNIQ--ref-0000038A-QINU`"'
'"`UNIQ--references-0000038B-QINU`"' +
Concern for research collaborators and those involved in research forms an important tenet of the ECoC. <sup>4</sup> In the spirit of respect and collegiality, it is essential that decisions regarding benefits and burdens be made after sufficient deliberation with the different teams.
According to the ECoC, all involved partners should agree in advance on important aspects of the research, such as the goals and outcomes. <sup>4</sup> The attribution of credits (such as authorships) also form important benefits, and should be decided in consultation with all collaborators. The Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations <sup>5</sup> states that all involved partners should reach an agreement at the outset, and later as needed, as to how the outcomes of the research, research data and authorship and publication responsibilities will be handled. The Committee on Publication Ethics (COPE) also offers best practice guidelines on how to handle authorship disputes, should they arise. <sup>6</sup> +
Considering fake review, there are several strategies journals can implement to overcome the challenges. A first strategy is not accepting the requests of peer reviewers from the authors. The reviewers are chosen by the journal editors, and ensure there are no ‘fake reviewers’. However, many journals cannot find (enough) peer reviewers, and granting the request can be time saving for journals.'"`UNIQ--ref-00000381-QINU`"' At times, journals need to rely on the requests of authors to find peer reviewers at all.
A second strategy is implementing an easy system that verifies reviewers. One online platform created to facilitate verification is Publons.'"`UNIQ--ref-00000382-QINU`"''"`UNIQ--ref-00000383-QINU`"' Here, journal editors can do background checks on the reviewers, and easily check their contributions in the field. In addition, reviewers get recognition for their reviews, even if these are anonymous. '"`UNIQ--ref-00000384-QINU`"'
<br />
'"`UNIQ--references-00000385-QINU`"' +
A working paper by [https://www.leru.org/files/LERU-PPT_Bias-paper_Jadranka_Gvozdanovic_January_19_18.pdf LERU] sets out the following recommendations:'"`UNIQ--ref-000001A4-QINU`"'
#"Universities and other research institutions need to have regular '''monitoring''' in place to examine whether their organisational structures and processes are susceptible to a potentially biased access to resources that cannot be justified by the meritocratic principle. If so, they should develop and implement a plan to mitigate any identified bias. It is crucial that the university’s leadership commits to this plan, sees it through with appropriate encouragement, support and initiatives, throughout the organisation. Clear '''accountability''' should be assigned, with final responsibility for action resting with the President/Rector and the governing body.
#Universities and other research institutions should examine crucial areas of potential bias and define '''measures''' for countering bias. Progress needs to be monitored and, if necessary, measures re-examined and adjusted.
#Universities and other research institutions should gather expertise and organise '''gender bias training''' in various formats, including the possibility of anonymous training. There is no shortage of national and international resources which organisations can use.
#'''Recruitment''' and/or '''funding processes''' should be as open and transparent as possible and be genuinely merit-based. This includes measures such as briefing selection committees about bias pitfalls, deciding on clear selection criteria at the outset, letting '''external observers''' monitor the selection process and involving external evaluators.
#There should be close monitoring of potential '''bias in language''' used in recruitment processes.
#Universities should undertake action towards eliminating the '''pay gap''' and monitor progress, examining bias as a contributing factor to pay gap.
#Employees should be compensated for '''parental leave''', making sure the process is bias-free, for example by extending fixed-term positions or calculating the leave administratively as active service, yet exempt from publication expectations.
#Universities and other research institutions should monitor '''precarious contracts''' and '''part-time positions''' for any gender-based differences and correct any inequalities. Universities should examine conditions for part- time positions for professors and their gendered division.
#Universities and other research institutions should undertake '''positive action''' towards a proper representation of women in all leading positions, making sure that leadership and processes around leadership are free from bias."
'"`UNIQ--references-000001A5-QINU`"'
The International Committee of Medical Journal Editors (ICMJE) provides recommendations for defining the roles of authors and contributors. The ICMJE recommends the four main criteria that should be taken into account for authorship. These criteria include a) substantial contribution related to the study design, data collection, data analysis, and data interpretation, and b) drafting and critically revising the work, and c) approval for the final version for publication, and d) accountability for all aspects of the work, including its integrity '"`UNIQ--ref-000006BF-QINU`"'. The ICMJE emphasizes that those who meet all four criteria should be assigned as authors and provides guidance for acknowledging those who do not meet all of the above-mentioned criteria but still contributed to the study and whose contribution should be acknowledged. The Contributor Roles Taxonomy (CRediT) is another example of guidance for avoiding authorship malpractices and disputes '"`UNIQ--ref-000006C0-QINU`"'. CRediT statement contains 14 items related to the authors’ contributions. For example, some of the items included in the statement are the authors’ contributions in conceptualization, methodology, analysis, writing and editing the manuscript, visualization, supervision, etc. Many publishers have already adopted the CRediT taxonomy and encourage authors to use it when providing authors contributions during the manuscript submission process '"`UNIQ--ref-000006C1-QINU`"'. +
It is difficult to cope with negative criticism, especially when it’s hostile in nature. Always keep in mind that any reviewer is a person, just like you.'"`UNIQ--ref-00000251-QINU`"' Maybe they were burdened with work, maybe they had a bad day at the office. It is nothing personal, and can happen to anybody. Think of anything useful that you can take from such a review. Maybe there is advice hidden under that unnecessary criticism? Speak with your superior, talk to your mentor. If you both consider that the review is insulting, consider raising that topic with the editor.
'"`UNIQ--references-00000252-QINU`"' +
A lot has been said about authorship. One of the milestones in tackling authorship are the famous four criteria of the International Committee of Medical Journal Editors. That means that those who fulfil the ICMJE criteria should be listed as authors (to avoid not giving credit when credit is due and to avoid ghost-writers), and authors should fulfil all of those criteria (to avoid guest and honorary authorship). Researchers who fulfil some, but not all four criteria should be acknowledged in the manuscript.
When submitting research manuscript, journals will often ask for the statement of authorship, signed by authors. That way, journals’ editors want to make sure all authors have been informed, and they can be held accountable if any problem arises. +
Variety of journals, such as [https://journals.plos.org/plosone/s/submission-guidelines PLOS ONE], [https://thelancet.com/pb/assets/raw/Lancet/authors/tlrm-info-for-authors.pdf The Lancet] or [https://www.nature.com/nature/for-authors/supp-info Nature], request complete disclosure and transparency from authors, so by not acknowledging your contributors you are disregarding the principle of transparency. This also means that you are not being completely honest because you do not acknowledge that someone has done a certain amount of work for you.
Some authors even use the help of professional writers who, for example, may substantially contribute to drafting or write a full first draft of the manuscript'"`UNIQ--ref-000006A2-QINU`"'. In such a case, authors should also acknowledge the contribution and obtain a written permission from those named in acknowledgments.'"`UNIQ--ref-000006A3-QINU`"'
'"`UNIQ--references-000006A4-QINU`"' +
For successful collaboration it is necessary to '"`UNIQ--ref-00000565-QINU`"':
*''Address mutual expectations''. Each team member may have different expectations about their contribution and the recognition they will receive. If you discuss these expectations openly, it will be easier for each team member to contribute effectively to the project.
*''Clearly divide and define who is responsible for what task.'' Similar to expectations, a clear division of labor makes each team member's role in the project clear. This facilitates conversations about authorship.
*''Determine authorship.'' In a collaborative effort, it may appear that each person has a clear role. However, this assumption can lead to confusion and disagreement about initial authorship. Agree on authorship at the beginning of the project.
*''Communicate frequently.'' Ensure open communication with the team. If you do not have a clear timeline or research goals, it can be easy to lose sight of each other.
*''Access to data''. Not all parties may have access to all data. A clear conversation at the beginning of the project is necessary to determine who will have access to what information.
*Collaboration in research also means ''a shared responsibility for the integrity of the research.''
'"`UNIQ--references-00000566-QINU`"' +
Different fields take different stances in regard to self-plagiarism. For example, legal research has a lot more tolerance for reuse of one's work than biomedical science. In 1969, the scientific journal the “New England Journal of Medicine” announced they would no longer publish already published work. This is called Ingelfinger rule and became a norm for high quality scientific journals. '"`UNIQ--ref-00000291-QINU`"'Because of the rise of preprint servers (such as arXiv), journals now tend to loosen that policy. Secondary publications are a different issue, as they clearly state that work has been previously published. They are produced with a goal of reaching a bigger (and sometimes different) audience, often through translations to different languages.
Keep in mind that a lot of scientific journals use computer software to check if your text is similar to anything already published. The majority of software works through screening available online databases for similarities. '"`UNIQ--ref-00000292-QINU`"'
'"`UNIQ--references-00000293-QINU`"' +
The ECoC states that all partners involved in research take full responsibility for the overall integrity of the project. All partners are also expected to have agreed at the outset on the standards of research integrity that will be maintained. <sup>1</sup> This can include all aspects of the research, from conception to publication, in order to prevent ambiguity at a later stage. The Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations <sup>4</sup> states that all involved partners openly discuss their customary practices and expectations, including those of research integrity. While every individual is responsible fully for their own contribution, there should also be a collective responsibility for the integrity of the project. <sup>4</sup> +
*A zero-tolerance culture towards putative breaches of research integrity. When institutions or individuals turn a blind eye to misbehaviour, they fail to foster a culture of research integrity. A zero-tolerance culture encourages people to report suspicions of malpractice.
*A clear reporting system, including clear procedures and access to guidance and help (e.g. ombudspersons). A scheme has to be in place to handle expressions of concern and actual allegations of potential errors.
*Protection of whistleblowers, clarity about the rights of both whistleblowers and persons who are accused.
+
Being a reviewer comes with the responsibility of fairly reviewing others. One way to promote fair processes is ''transparent ''peer review. For example, Nature, BMC and EMBO now publish peer review and editorial comments after a manuscript has been accepted for publishing, when both reviewers and authors agree on this.'"`UNIQ--ref-00000372-QINU`"' In the words of Nature: “in adopting transparent peer review, we are taking a step towards supporting increased openness, accountability and trust in the publishing process.”.'"`UNIQ--ref-00000373-QINU`"' Transparent peer reviewing is an example initiative to encourage fair reviewing and to appreciate the contribution of reviewers. Moreover, having a bullying and harassment policy in place sends a signal that bullying, including unfair reviewing, is inappropriate,'"`UNIQ--ref-00000374-QINU`"' thereby promoting good behaviour of scientists. Lastly, conflicts of interest should always be disclosed when professional or personal interests collide with the review process
'"`UNIQ--references-00000375-QINU`"' +
'''Data organization'''
Data should be organized in a logical and structured way. Within research groups, consensus on naming and organizing data and files can help in structuring data. The University of Cambridge has provided [https://www.data.cam.ac.uk/data-management-guide/organising-your-data this resource] which provides a good oversight of what you should keep in mind for naming files, organizing folders and more. In addition, they collected various resources [https://www.data.cam.ac.uk/support/external that can support in data management].
'''Pseudonymization'''
When performing research involving human subjects, participants should be pseudonymized or anonymized. Pseudonymization removes the information that would allow for identification of individuals from a dataset. The main researchers have access to an encryption key. When John Smith, aged 31 and Jane Doe, aged 25 are in your data set, you should not pseudonymize with ‘JS31’ and ‘JD25’. Correct pseudonymization is naming them, for example, participants 001 and 002.
According to the GDPR, “‘personal data’ means any information relating to an identified or identifiable natural person (‘data subject’); an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person”. '"`UNIQ--ref-0000036F-QINU`"'
<br />
'"`UNIQ--references-00000370-QINU`"' +
'''Laboratory notes'''
When performing experiments, researchers should carefully and comprehensively report their experimental design, materials and techniques used, and all of their outcomes. Here, reproducibility and transparency are paramount. This is important within the biomedical sciences, physics, chemistry, computer science, etc. Laboratory notebooks are important to use when performing experiments of any kind.
The ten rules, as adapted below, can help in organizing and providing complete information in your notebook.'"`UNIQ--ref-00000390-QINU`"'
#'''Learn your institution’s or laboratory’s notebook policy o'''r create one in your research team
#'''Select the right medium for your lab notebook''' either electronically or a hardcopy.
#'''Make the habit of keeping the lab notebook in your desk''' to keep your notebook at hand while working.
#'''Record all scientific activities in your lab notebook''' including thoughts during meeting, theorizing about problems etc.
#'''Every entry should be recorded with a date, subject and protocol''' to organize your lab journal or notebook.
#'''Keep a record of how every result was produced''' to ensure reproducibility of your experiments.
#'''Keep an overview of the different study protocols you use''' including adaptations from standard (laboratory) protocols
#'''Keep a lab notebook that can serve as a legal record of your work''' to ensure you can take ownership of ideas, show you deserve authorship or protect intellectual property rights.
#'''Create a table of contents in your lab notebook''' to eEnsure your notebook is organized and easily searchable.
#'''Protect your lab notebook.''' Your lab notebook belongs to your institution since you are funded through your institution. “Your lab notebook is part of the scientific legacy of your laboratory. Therefore, you need to protect your lab notebook."'"`UNIQ--ref-00000391-QINU`"'
'''Fieldnotes'''
For qualitative researchers it is important to record: 1) descriptive information related to the data generation; and 2) to reflect on the process of data generation and interpretation. Both types of notes help in the interpretation and contextualization of findings. Descriptive information should focus on observations related to the research problem. For the reflective content, the importance of note taking is to place into observations in the perspective of the researcher’s “personal, cultural and situational experiences”. Here, a critical attitude is important, with notes focusing on initial impressions, assumptions, concerns, and surprises. '"`UNIQ--ref-00000392-QINU`"'
<br />
'"`UNIQ--references-00000393-QINU`"'
VIGOR (Vioxx Gastrointestinal Outcomes Research) study is one of the most known cases where researchers ignored safety risks. The study aimed to examine if a new drug Vioxx, produced by drug maker Merck, would cause fewer gastrointestinal side effects for the treatment of the rheumatoid arthritis than naproxen. Over 8,000 patients participated in the study, half of them taking Vioxx, and the other half naproxen. As it turned out, the risk of serious heart problems and death was twice as higher for patients using Vioxx, than for those using naproxen, however, the study decided to ignore the risks and obscure the results.'"`UNIQ--ref-00000535-QINU`"''"`UNIQ--ref-00000536-QINU`"' Five years after Vioxx’s launch, Merck withdrew the drug from the market, but by that time it had already sold billions of dollars of the drug'"`UNIQ--ref-00000537-QINU`"'. Another study published in the medical journal Lancet estimates that 88,000 Americans had heart attacks from taking Vioxx, and 38,000 of them died.'"`UNIQ--ref-00000538-QINU`"'
'"`UNIQ--references-00000539-QINU`"' +
Observational studies, such as cohort or case – control studies, are sometimes overinterpreted in terms of cause-effect relationship. Correlation between a factor and an outcome does not necessarily mean causation. When it comes to experimental studies, sometimes randomization is not possible due to ethical reasons which should be taken in account when interpreting results of such studies. '"`UNIQ--ref-0000025F-QINU`"' Sometimes outcome measures do not correspond completely to questions asked in the study i.e. they are only indirectly connected.
All of this is usually addressed in research methodology classes. When planning, doing and reporting research, you can always rely on appropriate EQUATOR reporting guidelines to make sure you have everything accounted for.
'"`UNIQ--references-00000260-QINU`"' +
There are several ways to deal with this questionable research practice. The first is disclosing the changes made to the research design. The second is preregistration of studies.
'''Disclosing changes'''
Deviating from the research design is allowed under certain instances. For instance, new sub-questions can surface when further progressing with the project. These can only be answered by performing extra analyses or different tests. In those cases, disclosing changes to the research design is considered a good practice. These analyses or changes should be presented as explorative, rather than final.
'''Preregistration'''
Preregistration is the process of submitting the research design before performing the study. Preregistration can be seen as an effective way to address researchers from not ‘luring’ them into changing methods to present results more spectacularly.
Some journals also publish protocols and/or accept studies based in their design, proposed methods and relevance – and make a commitment to publish results. The outcome of the study is made of lesser importance, and the relevance of the study and rigor of the study design more important. +
In a series of the Lancet on research waste, '"`UNIQ--ref-00000310-QINU`"' the following steps were suggested for setting research priorities and diminishing research waste (as cited from pg. 158):
#Include objectives in research groups’ strategic plans and define the stakeholders whose opinions and priorities will be considered
#Draw on an existing summary of previous priority-setting exercises in the specialty before undertaking own exercise
#Use available methodological reviews of research priority setting as guidance about how to meet priority-setting objectives
#Ensure that the priority-setting team has the necessary data, information about context, and skill set for their exercise
#Pilot, assess, revise, and update the priority-setting exercise at intervals
#Participate in discussions within the community of interest to share findings and experiences”
'"`UNIQ--references-00000311-QINU`"' +
CRISPR technology is supposed to be used to help individuals with major life-threatening diseases.'"`UNIQ--ref-00000962-QINU`"' Recently, a new device was developed and introduced in the Phase I study in patients with Type 1 diabetes mellitus, which contains a medium of beta cells developed from pluripotent stem cells.'"`UNIQ--ref-00000963-QINU`"' Other potential areas of use of this technology would be gene therapy in cancer treatment or personalized genetic medicine. +
How to reform the incentive structure of science is a subject of ongoing research and debate. See, e.g.,
*Bornmann, L., & Williams, R. (2017). Can the journal impact factor be used as a criterion for the selection of junior researchers? A large-scale empirical study based on ResearcherID data. Journal of Informetrics, 11(3), 788–799. doi:[https://doi.org/10.1016/j.joi.2017.06.001 10.1016/j.joi.2017.06.001]
*Krimsky, S. (2004). Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research? Rowman & Littlefield.
*Sandström, U., & Van den Besselaar, P. (2018). Funding, evaluation, and the performance of national research systems. Journal of Informetrics, 12(1), 365–384. doi:[https://doi.org/10.1016/j.joi.2018.01.007 10.1016/j.joi.2018.01.007] +
Holm and Ploug suggest that researchers should address the following two questions:
#If the results of your current (well planned and well conducted) project point in the opposite direction of the results of your previous research on this topic, would your first reaction be to reanalyse the data and reconsider your methods, or to reconsider your previous conclusions?
#If your findings were the exact same as the opposing researchers in this field of research, would your policy recommendations be any different from the recommendations of the opposing group? '"`UNIQ--ref-0000027B-QINU`"'
Four questions about polarized research:
*'''Why does polarized research exist?''' Because researchers have different perspectives and interests.
*'''Is polarized research fraud?''' No, because it is based on valid scientific methods.
*'''How does polarized research occur?''' Researchers may use different definitions, indexes, end-points, models, statistical methods, interpretations etc making their results come out very differently.
*'''How can we avoid polarized research?''' One suggestion is to force authors to declare “polarized conflict of interest” when submitting papers. Another is to make editors and publishers check for polarized conflicts of interest.
'"`UNIQ--references-0000027C-QINU`"' +
Lists of predatory publishers (blacklists) as well as lists of high quality open access publishers (whitelists) are of great value to researchers and decision makers.
===Blacklists===
The University of Colorado librarian Jeffrey Beall developed a list of potential predatory journals in 2008, which has been since taken offline because of certain flaws in the methodology.
*[https://beallslist.weebly.com/ Beall's list]
*[https://www2.cabells.com/blacklist Cabells' lists]
*[https://predatoryjournals.com/ Stop Predatory Journals]
===Whitelists===
*[https://doaj.org/ Directory of Open Access Journals (DOAJ)]
===Choosing a journal===
Stefan Eriksson and Gert Helgesson have identified 25 signs of predatory publishing, '"`UNIQ--ref-000001F6-QINU`"' and argue that more points on the list that apply to the journal at hand, the more skeptical you should be."
#The publisher is not a member of any recognized professional organization committed to best publishing practices (like COPE or EASE)
#The journal is not indexed in well-established electronic databases (like MEDLINE or Web of Science)
#The publisher claims to be a "leading publisher" even though it just got started
#The journal and the publisher are unfamiliar to you and all your colleagues
#The papers of the journal are of poor research quality, and may not be academic at all (for instance allowing for obvious pseudo-science)
#There are fundamental errors in the titles and abstracts, or frequent and repeated typographical or factual errors throughout the published papers
#The journal website is not professional
#The journal website does not present an editorial board or gives insufficient detail on names and affiliations
#The journal website does not reveal the journal's editorial office location or uses an incorrect address
#The publishing schedule is not clearly stated
#The journal title claims a national affiliation that does not match its location (such as "American Journal of ..." while being located on another continent) or includes "International" in its title while having a single-country editorial board
#The journal mimics another journal title or the website of said journal
#The journal provides an impact factor in spite of the fact that the journal is new (which means that the impact cannot yet be calculated)
#The journal claims an unrealistically high impact based on spurious alternative impact factors (such as 7 for a bioethics journal, which is far beyond the top notation)
#The journal website posts non-related or non-academic advertisements
#The publisher of the journal has released an overwhelmingly large suite of new journals at one occasion or during a very short period of time
#The editor in chief of the journal is editor in chief also for other journals with widely different focus
#The journal includes articles (very far) outside its stated scope
#The journal sends you an unsolicited invitation to submit an article for publication, while making it blatantly clear that the editor has absolutely no idea about your field of expertise
#Emails from the journal editor are written in poor language, include exaggerated flattering (everyone is a leading profile in the field), and make contradictory claims (such as "You have to respond within 48 h" while later on saying "You may submit your manuscript whenever you find convenient")
#The journal charges a submission or handling fee, instead of a publication fee (which means that you have to pay even if the paper is not accepted for publication)
#The types of submission/publication fees and what they amount to are not clearly stated on the journal's website
#The journal gives unrealistic promises regarding the speed of the peer review process (hinting that the journal's peer review process is minimal or non-existent)—or boasts an equally unrealistic track-record
#The journal does not describe copyright agreements clearly or demands the copyright of the paper while claiming to be an open access journal
#The journal displays no strategies for how to handle misconduct, conflicts of interest, or secure the archiving of articles when no longer in operation
A number of other initiatives have also put together criteria for journal selection:
*[https://thinkchecksubmit.org/ Guideline to choose the right journal for research] -
*[https://guides.mclibrary.duke.edu/beinformed Be iNFORMEd: Checklist] - A checklist to assess the quality of a journal or publisher
==Other information==
[http://www.wame.org/identifying-predatory-or-pseudo-journals The World Association of Medical Editors (WAME) statement on predatory publishing]
[https://www.tandfonline.com/doi/full/10.1080/03007995.2019.1646535 The American Medical Writers Association (AMWA), European Medical Writers Association (EMWA), and International Society for Medical Publication Professionals (ISMPP) Joint Position Statement on Predatory Publishing]
[http://www.icmje.org/news-and-editorials/fake_predatory_pseudo_journals_dec17.html ICMJE document on predatory publishing]<br />
'"`UNIQ--references-000001F7-QINU`"'
==QRPs==
According to research integrity experts who participated in a survey, '"`UNIQ--ref-00000239-QINU`"' there are a number of QRPs that occur frequently and have a high impact on science. In relation to study design, for instance, QRPs include presenting misleading information in a grant application or ignoring risks of unexpected findings or safety risks to study participants, workers or environment. Under data collection falls behaviour such as collecting more data when noticing that statistical significance is almost reached or keeping inadequate notes of the research process. in relation to reporting, examples of QRPs are hypothesizing after the results are known (HARKing), concealing results that contradict earlier findings, or not publishing a study with negative results. Moreover, selective citing to enhance your own findings or pleasing editors and colleagues is reported to often occur. QRPs that fall under collaboration are demanding or accepting authorship for which you do not qualify and reviewing your own papers. In addition, the misbehaviour that is estimated to occur the most and have a high impact on truth is insufficiently supervising junior coworkers. The misbehaviour that occurs the most and has the highest impact on trust is using published ideas of others without referencing.
=='''Prevention'''==
A way to counter QRPs could be to create awareness about research integrity issues and alter the current reward system. Instead of rewarding the number of publications, alternative aspects that could be rewarded include a researcher's commitment to pre-registration, data sharing and open science.
'"`UNIQ--references-0000023A-QINU`"' +
Since 2008, the American Food and Drug Administration (FDA) has required that results of all trials have to be posted within one year of their completion. This legislation, like others, does not work retroactively, which means that every treatment tested before 2008 does not have to have published results. Also, since the legislation came into action, no studies have been fined for noncompliance, and research has shown that 80% of clinical trials do not comply.'"`UNIQ--ref-00000082-QINU`"''"`UNIQ--ref-00000083-QINU`"' Major clinical trial registries (clinicaltrials.gov, eudraCT), have independent trials trackers, led by Data Lab from Oxford University. They collect a list of trials that have ended and whether or not they published their results. The Data Lab also collaborated with Goldacre on Open Trials. Its aim is to collect everything related to clinical trials in one place, including their registration, data, reports, publications and researchers.
'"`UNIQ--references-00000084-QINU`"' +
One of the techniques for detecting the fabrication of numbers is to check the “rightmost digits” of the collected data. The “rightmost digit” is the digit that a number ends in. It is considered to be “the most random digit of a number,” which means that that the numbers that make up a data set should be uniformly distributed as in a lottery '"`UNIQ--ref-00000430-QINU`"''"`UNIQ--ref-00000431-QINU`"'. Since the rightmost digits in each study should be unpredictable, the appearance of any patterns is a reason to suspect data fabrication'"`UNIQ--ref-00000432-QINU`"' '"`UNIQ--ref-00000433-QINU`"''"`UNIQ--ref-00000434-QINU`"''"`UNIQ--ref-00000435-QINU`"'.
Research conducted by Mosimann et al. in 1995 showed that most people cannot generate random numbers when fabricating data, which makes it possible to detect potentially fabricated data '"`UNIQ--ref-00000436-QINU`"'. They also developed a program called the “chi-square test for uniformity of the digit distributions”, which measures the production of random digits '"`UNIQ--ref-00000437-QINU`"'. If the distribution of numbers is not uniform, the numbers are falsified '"`UNIQ--ref-00000438-QINU`"''"`UNIQ--ref-00000439-QINU`"''"`UNIQ--ref-0000043A-QINU`"'.
There are other methods that can be used to detect the fabrication of rightmost digits. For example, some journals have adopted a policy of statistical review for all papers containing numerical data '"`UNIQ--ref-0000043B-QINU`"' '"`UNIQ--ref-0000043C-QINU`"'. In addition, published graph data can be compared with “raw” notebook or computer data to determine whether the numbers have been reported correctly '"`UNIQ--ref-0000043D-QINU`"''"`UNIQ--ref-0000043E-QINU`"'. Authors should present the raw data that supports their findings, while journals, universities and granting agencies should promote this practice '"`UNIQ--ref-0000043F-QINU`"' '"`UNIQ--ref-00000440-QINU`"'. Some argue that the use of statistical methods will significantly reduce fabrication of numerical data '"`UNIQ--ref-00000441-QINU`"'.
'"`UNIQ--references-00000442-QINU`"'
The best practice is to preregister study protocols online in a registry. When describing their study designs, researchers should be as transparent and complete as possible.
To date, only two reliable animal registries are available:[https://preclinicaltrials.eu/ Preclinicaltrials.eu] and the [https://www.animalstudyregistry.org/asr_web/index.action Animal Study Registry].
It is also possible to use general registries, e.g. the Open Science Framework, however the registration forms will not be tailored to animal studies specifically.
If a study could not be preregistered, it is still worthwhile to register its protocol at a later stage; especially if the study could not be published. Although, prospective registration (i.e., registration before the experiments) should be encouraged. +
In 2004, the International Committee of Medical Journal Editors (ICMJE) announced that clinical trials beginning after July 1, 2005, would be under a new trial registration policy. '"`UNIQ--ref-00000093-QINU`"' To be published in member journals, the trials would have to be registered in an approved trial registry prior to the enrollment of the first participant. Since 2005, ICMJE has reiterated that registering a prospective study should be a condition of publication and after the announcement, several journals endorsed this policy. The registration must occur prior to enrollment of the first study participant in a trial registry that meets the quality criteria developed by WHO. '"`UNIQ--ref-00000094-QINU`"' However, the adherence for this requirement remains low by both researchers and journal editors and, unfortunately, not all clinical trials are registered before they start.
Recent findings suggest that among the reasons that lead to the low adherence to the new requirement by the researchers are: lack of awareness of the criteria; misunderstandings regarding the definition of clinical trial by ICMJE; and difficulties for registration. '"`UNIQ--ref-00000095-QINU`"' On the part of journal editors, the main reason is that not all journals are equally committed to meeting the registration requirements, strengths, and limitations of the study. The Committee on Publication Ethics suggested that “it is probably best to judge each paper on a case by case basis.”
'"`UNIQ--references-00000096-QINU`"' +
The most relevant examples are studies needed for drug approval. The approval procedure usually requires a series of clinical trials divided into three phases. Phase I and II can involve model building according to European Medicines Agency (EMA), however phase III trial is always designed as a confirmatory trial'"`UNIQ--ref-000003C7-QINU`"'. Both the EMA and the Food and Drug Administration (FDA) require statistical pre-registration before the beginning of a trial. Exploratory trials aim to produce evidence of effectiveness of new drugs. These results then lead to confirmatory trials'"`UNIQ--ref-000003C8-QINU`"'. The need for pre-registrations of trials is demonstrated by the following case. In 2004, the New York attorney general’s office filed a lawsuit against pharmaceutical company GlaxoSmithKline. Four unpublished clinical trials showed evidence that use of the antidepressant Paxil increases the risk of suicidal tendencies amongst young people. This lawsuit helped raise awareness that studies need to be pre-registered'"`UNIQ--ref-000003C9-QINU`"'. That year the International Committee of Medical Journal Editors required pre-registration of clinical trials'"`UNIQ--ref-000003CA-QINU`"'.
US laws also require clinical trials to be pre-registered'"`UNIQ--ref-000003CB-QINU`"'. Journals and research funders support pre-registration and some organizations promote it as an important step towards openness and transparency in research'"`UNIQ--ref-000003CC-QINU`"'. There have been some other interesting efforts that promote pre-registration, such as the Preregistration Challenge, sponsored by the Center for Open Science. This campaign offered $1,000 awards to researchers who pre-register their studies and publish their results within a deadline'"`UNIQ--ref-000003CD-QINU`"''"`UNIQ--ref-000003CE-QINU`"''"`UNIQ--ref-000003CF-QINU`"'. These initiatives have led to a certain “cultural shift” - there are now more than 8,000 pre-registrations on Open Science Framework for research in different disciplines'"`UNIQ--ref-000003D0-QINU`"'. APS journals also began to practice pre-registration in 2014. From 2014 to 2019, 43 of 154 articles published in Psychological Science earned “Preregistered badge” due to pre-registration of design and analysis plan of their studies'"`UNIQ--ref-000003D1-QINU`"'.
Although pre-registration has demonstrated benefits for the trustworthiness of research, the practice still needs to be widely adopted across the scientific community.
'"`UNIQ--references-000003D2-QINU`"'
In 2012, ORCID launched their Registry as a result of which researchers could be assigned unique identifiers, a 16-character code compiled of numbers 0-9, and thus distinguish themselves from other researchers. In 2019, there are more than 7 million ORCID accounts'"`UNIQ--ref-0000032E-QINU`"' registered to individual researchers, universities, scientific publishers and commercial companies. '"`UNIQ--ref-0000032F-QINU`"' Increasingly, funding organisations are requiring that their applicants provide their ORCID identifier.
'"`UNIQ--references-00000330-QINU`"' +
One of the best examples of the application of digital tools within the humanities is the collaborative, interdisciplinary research project [http://republicofletters.stanford.edu/index.html Mapping the Republic of Letters], developed by Stanford University in 2010 and funded by the National Endowment for the Humanities (NEH). The aim of the project is to map the 17<sup>th</sup> and 18<sup>th</sup> century correspondence of prominent and influential intellectuals in the Age of Enlightenment '"`UNIQ--ref-000003E2-QINU`"'. The “Republic of Letters” was a self-proclaimed community of scholars that exchanged their ideas via handwritten letters across Europe and the Americas. The researchers on the project used metadata to produce maps, charts and other visual tools '"`UNIQ--ref-000003E3-QINU`"'. These modern visualization tools provide a greater understanding of distribution of the letters over hundreds of years and help identify geographic “hot-spots” in the archive '"`UNIQ--ref-000003E4-QINU`"'. They shed light on, for example, Voltaire’s correspondence, which consists of about 15.000 letters. The visualization of the letter exchanges on a map shows the places where Voltaire traveled and reveals patterns in his writing at specific times and in specific places '"`UNIQ--ref-000003E5-QINU`"'. These maps of correspondence raise new questions and facilitate new interpretations of the letters and related documents '"`UNIQ--ref-000003E6-QINU`"'. The project also provides a basis for further research not only concerning the Republic of letters, but also in related topics.
The use of digital tools in the humanities has seen the formation of organizations that foster research in the digital humanities. One of them is the European Association for Digital Humanities (EADH), established in 1973 under the name of the Association for Literary and Linguistic Computing '"`UNIQ--ref-000003E7-QINU`"'. This organization is one of the constituent organizations in the Alliance of Digital Humanities (ADHO), formed in 2005, which supports and promotes digital research and education in all the arts and humanities disciplines '"`UNIQ--ref-000003E8-QINU`"'. In addition, numerous universities now offer undergraduate and graduate courses and programs in the digital humanities '"`UNIQ--ref-000003E9-QINU`"'.
'"`UNIQ--references-000003EA-QINU`"'
The main options analysed are the establishment of permanent European bodies to support institutions in investigating, overviewing or advising on research misconduct investigations. A European body to carry out investigations on behalf of institutions would ensure that investigations are carried consistently, reduce the risk of conflicts of interest, allow expertise to develop, and professionalize the handling of cases. It would be particularly helpful for institutions that still do not have any structures or experience in handling research misconduct allegations. Some obstacles would have to be overcome for such a body to be effective. Institutions might be reluctant to expose internal problems for fear of damaging their reputation and losing their autonomy; national regulations might limit access to data; and some counties might not recognize its legitimacy.
A further option would be to set up an oversight body that would not conduct investigations but only review investigations carried out by institutions to make sure that they have followed appropriate procedures, previously agreed on internationally. This might motivate institutions to follow those procedures, and so it would bring more homogeneity in the handling of allegations across Europe. As well, an external check would help control and lower risks of conflict of interest. On the other hand, depending on its status, it might not be able to require an institution to redo a poorly conducted investigation, and if it did, this would require more resources for each investigation.
Another role that a European body could have is advisory. It could advise institutions on how to create structures and policies to prevent research misconduct and protect integrity, and it could even set up a database of experts to assist investigations committees. The main concern about such a body is that it might be appear redundant or in conflict with existing national advisory bodies. +
Experts in their respective fields and organizations who are in charge of creating clinical practice guidelines should be aware of discrepancies that may arise if the grading system is not well defined. Ratings of quality of evidence should be transparent and based on detailed and clear criteria, so it can be used by clinicians and patients. However, it can't be expected of clinicians or patients to comprehend a variety of grading systems. A simple, transparent grading of the recommendation, such as the GRADE system, is an example of a good solution. It's the system that provides their users to assess the judgments behind recommendations regarding health care. +
The Catholic University of Leuven (KU Leuven) has a dedicated webpage on image integrity. They identified some of the most important sources and tools on the subject (available [https://www.kuleuven.be/english/research/integrity/practices/image-processing here], accessed on 24-04-2020). As their page is brief, a more elaborate description of what it contains, and additional sources, follows below.
Rossner & Yamada (2004)'"`UNIQ--ref-000002E1-QINU`"' wrote a prominent article arguing for a standard for image integrity. Working as Editors for The Journals of Cell Biology, they noticed the discrepancies between guidelines on image integrity journals gave to their authors (if any). To have a comprehensive overview, they developed their own guidelines for the Journal of Cell biology. They write that, for every aspect of the guideline, the main question is: “Is the image that results from this adjustment still an accurate representation of the original data?”'"`UNIQ--ref-000002E2-QINU`"' (p. 5). Whenever the answer is ‘no’, researchers should provide a detailed description of the adjustments, its purpose and the original image on request. If not, their actions might be regarded as misconduct.
A step-by-step translation of the guideline is available on the website of American Journal Experts (access [https://www.aje.com/en/arc/avoiding-image-fraud-7-rules-editing-images/, here], accessed on 24-04-2020) and on the KU Leuven webpage. A similar guideline, and additional editorials on the subject, are given by the journal Nature on their editorial policies page (available [https://www.nature.com/nature-research/editorial-policies/image-integrity here], accessed on 24-04-2020).
The Center for Ethics and Values in the Sciences, of the University of Alabama in Birmingham, created a website for both students and researchers with much material regarding image integrity (available [https://ori.hhs.gov/education/products/RIandImages/default.html here], accessed on 24-04-2020). They provide guidelines with more in depth explanations and illustration videos, but also educational material such as case studies, discussion hand outs and a quiz.
The Office of Research Integrity provides a tutorial on how to use ‘action sets’ in photoshop (available [https://ori.hhs.gov/actions here], accessed on 24-04-2020). These actions sets allow you to document the changes you make to an image and ‘slide’ (i.e. going back and forward) between all the steps you made. The process of the image you manipulated will hereby be completely transparent if you provide the ‘action set’ combine with a copy of the original image.
For those reviewing papers, a free open source program, called InspectJ, is available on GitHub to identify cloning, stitching, patching and erased objects within an image. An advanced version also provides histogram equalization and gamma correction for improved image inspections (both available [https://github.com/ZMBH-Imaging-Facility/InspectJ here], accessed on 24-04-2020)
'"`UNIQ--references-000002E3-QINU`"'
There should be an open dialogue about research practices between all levels of staff at an institution. The guidelines themselves, as a written set of rules should be easily accessible. All procedures should have a level of transparency and there should be secure channels of contact in case of concern about certain practices being planned out or implemented. +
The [https://www.embassy.science/resources/the-european-code-of-conduct-for-research-integrity European Code of Conduct] states that fairness and integrity are most important for procedures for investigating misconduct, principles to be followed are also stated.'"`UNIQ--ref-00000073-QINU`"'
'"`UNIQ--references-00000074-QINU`"' +
This is still a novel area of research. Official advice and policies regarding the prevention of mental health problems in academia is lacking. However, previous research has established connections between organizational climate and health '"`UNIQ--ref-0000031F-QINU`"'. Suggested actions to combat the rise of mental health problems in academia include raising awareness, creating more dialogue, providing training on mental health and emotional wellness, effective mentoring practices, monitoring mental health via anonymous surveys, and providing free counseling sessions for those marked as symptomatic or at high-risk. What should also be considered is the need to establish official policies that reward researchers not just for their scientific output and ability to obtain funding, but also for their educational, mentoring and “wellness” practices. '"`UNIQ--ref-00000320-QINU`"'
[https://embassy.science/wiki-wiki/index.php/Resource:D3784352-c18f-4c40-b862-d9ee2afabb0a This guide] was developed during the COVID pandemic by the department of Experimental Immunology of Amsterdam UMC and is implemented by this department to talk about stress with their PhD-candidates.
'"`UNIQ--references-00000321-QINU`"' +
When submitting the final, written output of their research, researchers can publish it in an Open Access Journal. The [https://doaj.org/ DOAJ] indexes more than 13k of open access, high quality and peer-reviewed journals. Given that only a small portion of these open access journals require payment of an Article Processing Charge (APC),'"`UNIQ--ref-0000034D-QINU`"' researchers can choose from a variety of journals. At the same time, researchers can post a preprint of their article to a preprint server (a list of preprint servers, organised by discipline is available [https://osf.io/preprints/ here]).
Research data can also be stored online in a research data repository. For an extensive list of repositories researchers can check [https://www.re3data.org/ Registry of Research Data Repositories] and [http://databib.org/ Databib]. [https://zenodo.org Zenodo] is among the well-known repositories that allows researchers to archive various digital artefacts such as data sets, research software, reports, posters.
'"`UNIQ--references-0000034E-QINU`"' +
The main principle of Plan S states that all research funded from public or private grants must be openly accessible when published. There are, in addition, ten sub-principals:
#Authors should have copyright of their publications, which should be made available under a Creative Commons Attribution license;
#Robust criteria for evaluation in high-quality open access journals, platforms and repositories should be developed;
#Funders should provide incentives to establish and support open access journals where there aren’t any;
#Funders should cover the cost of publication fees;
#Funders should support the diversity of business models for open access journals and platforms;
#Funders should ensure transparency by supporting alignment of strategies, policies and practices;
#Monographs and book chapters should have a longer process of achieving open access;
#Hybrid models of publishing should be only be a means of transforming to full open access;
#Funders should monitor compliance;
#Research outputs should be assessed on the basis of their internal value, and not their scientometric characteristics. '"`UNIQ--ref-00000333-QINU`"'
In September 2018, 11 national research funding organizations (from Austria, France, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Slovenia, Sweden and United Kingdom) signed a commitment to implement all that is necessary for the Plan S mission by 1<sup>st</sup> January 2020.
'"`UNIQ--references-00000334-QINU`"' +
The Qualification portfolio, implemented by Utrecht UMC. To be described in further detail elsewhere on The Embassy. +
Research integrity advisors are experienced researchers with in-depth knowledge of research integrity and research ethics. They are appointed by the university to serve the complex role of dealing with all sort of questions related to research integrity practices, procedures, and issues.
For example, in Australia, universities have established research integrity advisors’ teams to assist researchers and research students in conducting research with integrity and advise them on questions that may arise during the research process. If you are not sure who to talk with, the universities web pages contain lists of RIAs and guidance on when to approach to an advisor. '"`UNIQ--ref-00000097-QINU`"' At Melbourne University, RIAs also have a responsibility to report alleged cases of research misconduct to authorized bodies. '"`UNIQ--ref-00000098-QINU`"'
In Europe, for example, in Denmark, some Danish research institutions (e.g., Aarhus University) have special advisors for supporting the good scientific practice. '"`UNIQ--ref-00000099-QINU`"' Moreover, LARI (Luxembourg Agency for Research Integrity) provides research ethics consultations to researchers of all levels. While LARI advisors are not officially called RI advisors, they still have a similar role. '"`UNIQ--ref-0000009A-QINU`"'
'"`UNIQ--references-0000009B-QINU`"' +
The organizational structures of RI committees and their responsibilities regarding cases of research misconduct may vary. In some countries, RI committees (or commissions) are established at the national level, hence their responsibility is to handle cases of research misconduct, or serve as an advisory body, for all research institutions within state borders (e.g. National Commission for Research Integrity-Luxembourg, Finnish National Board on Research Integrity, Danish Committee on Research Misconduct (DCRM), Commission for Research Integrity-Austria, French Office for Scientific Integrity, Netherlands Board on Research Integrity). For example, the Danish law on research misconduct stipulates the responsibility of the DCRM to handle the cases of research misconduct, while each institution has a responsibility to process cases of questionable research practices.
Some RI committees are established as a part of research integrity organisations, providing training and other educational activities for researchers (e.g. the Luxembourg Agency for Research Integrity, the Austrian Agency for Research Integrity).
In some countries, dealing with cases of research misconduct is the responsibility of research institutions and institution-based committees as there is no national body to handle investigations and process cases of misconduct. An example of the latter is Sweden, where each research institution is responsible for conducting an investigation of research misconduct and to impose a sanction.
All these RI bodies, both at the national and institutional level, are doing important work in the field of research integrity promotion and guiding researchers with the principles of good scientific practices. There are numerous documents, issued by RI bodies and committees in the form of guidelines and checklist, as well as documents describing committees’ procedures when dealing with misconduct allegations. Some European examples are: Guidelines for Good Scientific Practice by the Austrian Agency for Research Integrity, FNR Research Integrity Guidelines, Guidelines for the Investigation of Misconduct (by the Irish National Forum), Roadmap for Scientific Integrity 2020 (OFIS), Integrity and responsibility in research practices (CNRS-CPU), Scientific integrity guideline(CNRS), TENK Guidelines.
ENERI has recently published an insightful policy brief on what makes a research ethics and research integrity expert. Based on a participatory research design culminating in a series of consensus conferences with 50 stakeholders from various positions within or close to academia, ENERI has found the following skills to be particularly useful for REC members:
'''Hard skills'''
*comprehensive knowledge of relevant guidelines, regulations, and laws
*experience with ethical assessments or academic qualifications in relevant disciplines, like philosophy or law
*research experience
*legal expertise
*analytical skills
*the ability to think critically
'''Soft skills'''
*Communicative skills
*interpersonal skills
*attention to detail
*the ability to manage and resolve conflicts
*the ability to work collaboratively
'''Process skills'''
*administrative and management skills
*decision-making skills
*the ability to transform abstract theoretical ideas into practical recommendations
'''Emotional skills'''
*open mindedness
*independence
*awareness of social norms and the likely consequences of breaching them
*personal commitment
According to ENERI, RE experts individually inevitably need hard skills, but do not necessarily have to possess all soft skills, process skills, and emotional skills. However, all soft skills, process skills, and emotional skills should be present on the institutional level in RECs which, therefore, should have a diverse membership with complementary skills.
The role of the chair role is particularly crucial. The chair needs to have broad soft skills, process skills, and emotional skills to guarantee that all represented perspectives are included in assessment, review, and advice procedures. Hence, chairpersons need more skills than ordinary board members due to the pivotal position they occupy in organizing inclusive deliberations. +
Several documents and declarations have been developed in relation to ethical research committees. The European Network of Research Ethics Committees - EUREC is a network that brings together existing national Research Ethics Committees, networks or comparable initiatives on the level of European Union. RECs can be established for each academic institution and/or universities. In the United States, Institutional Review boards (IRBs) exist in both academic and state institutions. +
The details of an RIO's job vary from country to country, but the position is mandatory in many.
In the United States, any institution that receives Public Health Service funding reports to the Office of Research Integrity (ORI) at the Department of Health and Human Services. A RIO serves as the liaison between the ORI and their institution. By law, they ensure that the institution has policies and procedures for investigations and reports these to the ORI.'"`UNIQ--ref-000000A1-QINU`"' They also contribute to investigations that lead to retractions, expulsions, and (sometimes) arrests.
In the European Union, each country has slightly different requirements and roles for their RIOs, but their task is essentially the same. The European Network of Research Integrity Officers serves as the expert agency in the EU, assisting RIOs with advice and guidance.
With the increasing pace of scientific publications, an RIO's job is more important than ever. They serve an essential role in the scientific community. They protect individual researchers from accidental missteps. They protect the public from poor, fraudulent, and fabricated science. They protect the whole scientific community by building public trust. An RIO serves on the front lines of scientific integrity. They're present to guide researchers and foster trust in institutions. RIOs exist to protect science and are a resource for researchers who need guidance or help with misconduct questions.
'"`UNIQ--references-000000A2-QINU`"' +
The ‘Research; Increasing value, reducing waste’ project, led by The Lancet medical journal, provides an excellent example of an RRI approach. This project aims to address deficiencies in the medical research system that reduce the value of research and often result in significant financial loss caused by inadequate research agendas, flawed research designs, not publishing negative results, and poorly reporting findings.
In order to increase the value of research and reduce waste, the project adopted four RRI process requirements: diversity and inclusiveness, transparency and openness, anticipation and reflection, as well as responsiveness and adaptation to change. Inclusion of patients and medical caregivers in setting the right research agenda is recommended to increase diversity in the research process. The project proposes that research should be more transparent and open, and supports a full and public documentation of the research process. The project also highlights a need to discuss current practices that lead to wasted effort. Finally, a series of five papers published in The Lancet offers 17 recommendations that outline the changes that should be made to current structures and systems'"`UNIQ--ref-000003B2-QINU`"'.
RRI is not just about better science from a scientist’s point of view; it is a continuous effort to talk to diverse societal actors and involve them in the research process, through meaningful conversations and contributions beyond “just” being a participant'"`UNIQ--ref-000003B3-QINU`"'. Various activities for bringing more awareness to research processes, such as science cafés or open lab days, are just a part of the framework'"`UNIQ--ref-000003B4-QINU`"'. Collaboration with small enterprises and social innovators, as well as citizen scientists, is also a crucial part of RRI. It involves the improvement of science and society through mutual sharing of expertise and experiences.
'"`UNIQ--references-000003B5-QINU`"' +
Different types of scientific policy may be adopted. Sometimes investment in basic research is preferred. In these cases the expectation is that some kind of breakthrough will result in a vast array of new technologies which will then be commercialized and pay back the investments. Other times the focus may be on technology development, and more support for engineering than basic science. The most extreme examples of such science policies are the Manhattan project'"`UNIQ--ref-00000137-QINU`"' and the Space projects pursued by the US and the Soviet Union in the second half of the 20th century.
'"`UNIQ--references-00000138-QINU`"' +
In these situations, history teachers are mediators between different and sometimes conflicting collective memories.'"`UNIQ--ref-000005AC-QINU`"' Teaching topics such as the civil war in Northern Ireland, where everyday life reminds its population about their divisions due to past and present conflicts is particularly difficult for history teachers who teach in that area.'"`UNIQ--ref-000005AD-QINU`"' According to recent findings, many teachers feel uncertain and underprepared when teaching controversial and sensitive issues because of the fear of the emotional reaction in the classroom, perception of pressures from school, parents, local community or state or even because of their own beliefs and identities.'"`UNIQ--ref-000005AE-QINU`"''"`UNIQ--ref-000005AF-QINU`"' '"`UNIQ--ref-000005B0-QINU`"'This is why some European universities offer courses on teaching controversial and sensitive issues in history education with aim of preparing future teachers for these challenges.'"`UNIQ--ref-000005B1-QINU`"'
Providing students with balanced academic approach of these issues'"`UNIQ--ref-000005B2-QINU`"' is necessary to help them understand that almost every historical topic is open to different interpretations,'"`UNIQ--ref-000005B3-QINU`"' particularly when teaching these issues in societies with opposite narratives. That is an opportunity for a multi-perspective approach,'"`UNIQ--ref-000005B4-QINU`"' but also for developing students’ ability to deal with controversial issues and debating with people who do not share their opinion.
Main strategies teachers can use when dealing with these issues in the classroom are:
-distancing strategy (when an issue is highly sensitive in the community where the teacher is teaching or when the class is polarized. This strategy proposes examining analogies and parallels or going back further in time to trail the history of the issue that is being discussed).
-compensatory strategy (when students are expressing attitudes based on ignorance, when the minority is being bullied or discriminated against by the majority or when there is consensus in the class in favor of one particular interpretation. In these cases, teachers can play the devil’s advocate, highlight contradictions in students’ responses or demythologize popular beliefs).
-empathetic strategy (when the issue involves a group or nation which is unpopular with the students, when the issue involves latent discrimination against some group or where the issue is distant from the students’ own lives. Teachers can use several methods, such as role reversals, for-and-against lists, role play and simulations and also vicarious experience through examining films, novels or documentaries).
-exploratory strategies (when the issue is not clearly defined or where the teacher’s aim is also to use the issue as a tool to develop analytical skills. In such conditions, students can explore people’s diaries and memoirs or conduct oral history).'"`UNIQ--ref-000005B5-QINU`"'
'"`UNIQ--references-000005B6-QINU`"'
Researchers that work with personal data can consult the GDPR online [https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0679 here]. In 2020 the European Data Protection Supervisor issued [https://edps.europa.eu/sites/edp/files/publication/20-01-06_opinion_research_en.pdf A Preliminary Opinion on data protection and scientific research].
You should also be able to contact your local Data Protection Officer or study supervisor for more information on handling personal data. +
Whistleblower protections are an important element in an institution's ethics code, describing procedures to deal with allegations and violations of misconduct. There is general agreement within the scientific community that reporting misconduct is essential in the prevention and management of misconduct and that whistleblowers should be provided adequate safeguards. Whistleblower protections also support a culture of scientific integrity within an institution. However, policies on researchers’ duties to report and the consequent protections differ significantly by institution and country.
[https://www.embassy.science/resources/the-european-code-of-conduct-for-research-integrity The European Code of Conduct for Research Integrity] '"`UNIQ--ref-00000077-QINU`"'contains the following guidance in the section “Dealing with Violations and Allegations of Misconduct”:
"National or institutional guidelines differ as to how violations of good research practice or allegations of misconduct are handled in different countries. However, it always is in the interest of society and the research community that violations are handled in a consistent and transparent fashion. The following principles need to be incorporated into any investigation process.[…] Procedures are conducted confidentially in order to protect those involved in the investigation. Institutions protect the rights of ‘whistleblowers’ during investigations and ensure that their career prospects are not endangered."
In the UK it seems that universities develop a specific whistleblowing policy for different misbehaviours (grievance, bullying and harassment, discipline, research misconduct). As an example, we refer to the [https://le.ac.uk/~/media/uol/docs/about-us/policies/whistleblowing-policy-updated-may-2017.pdf document of the University of Leicester],'"`UNIQ--ref-00000078-QINU`"' which guarantees confidentiality for whistleblowers:
"The University will treat disclosures of information made under this Policy in a confidential and sensitive manner. The identity of individuals making allegations may be kept confidential, if requested by the individual(s) concerned, so long as it does not hinder or frustrate any investigation. In this event, the University will consult the individual before it takes any further action which might break the initial confidentiality. It should be recognised, however, that the investigation process may, of necessity, reveal the source of the information and, as part of the investigation, an individual making a disclosure may need to provide a statement as part of the evidence required."
In the USA, whistleblowers have well established legal protection. The Whistleblower Protection Enhancement Act of 2012 strengthened protection for federal employees who blow the whistle on waste, fraud, and abuse in government operations.
'"`UNIQ--references-00000079-QINU`"'
There are different online companies offering altmetrics services. Some of them are Altmetric, Impactstory, and Plum Analytics.'"`UNIQ--ref-00000124-QINU`"' They can track HTML views and PDF downloads, shared articles on social media platforms, saved and cited items. Altmetrics scores are often indicators of how popular an article is online with the general public. Unlike typical research metrics, Altmetrics software enables the user to track the dissemination of publications in real time. Some publishers have started offering their readers this information (BioMed Central, PLOS, Nature, Elsevier). Some argue that this form of metric is not a good indicator of popularity or quality, as social media activity and time of publication can have a big influence on the metric. '"`UNIQ--ref-00000125-QINU`"' There seems to be no correlation between citations and altmetrics.
'"`UNIQ--references-00000126-QINU`"' +
The website [http://www.eigenfactor.org/ www.eigenfactor.org] reports measures for publications indexed by JCR as well as journals, books, newspapers, and other reference items that are referred to by these publications.'"`UNIQ--ref-00000519-QINU`"' The number of journals has increased each year. In 1997 the website listed 6,439 journals, whereas in 2014 it measured influence of 11,200 journals.'"`UNIQ--ref-0000051A-QINU`"'
Two principle scores are calculated: Eigenfactor score and Article Influence score. Eigenfactor scores are scaled so that the scores of all journals listed in JCR sum up to 100. If a journal has an Eigenfactor score of 1.0, it has 1% of the total influence of all indexed publications. In 2014, the journal PLoS One had the highest Eigenfactor score, with a value of 1.533.'"`UNIQ--ref-0000051B-QINU`"' Since larger journals will have more citations, they will subsequently have larger Eigenfactor scores.'"`UNIQ--ref-0000051C-QINU`"''"`UNIQ--ref-0000051D-QINU`"''"`UNIQ--ref-0000051E-QINU`"' However, the most prestigious journals are not necessarily the largest, but the ones that receive the most citations per article. With regards to that, the Article Influence score measures the influence of a journal per article. It is calculated as a journal’s Eigenfactor Score divided by the number of articles in that journal and normalized so that the average article in the JCR has an Article Influence score of 1.'"`UNIQ--ref-0000051F-QINU`"' Therefore, if an Article Influence score of a journal is 3.0, then the articles of that journals are on average three times as influential as the average article in JCR.'"`UNIQ--ref-00000520-QINU`"' In 2014, the journal CA-A Cancer Journal for Clinicians had the highest Article Influence score, with value of 3.95.'"`UNIQ--ref-00000521-QINU`"'
'"`UNIQ--references-00000522-QINU`"' +
Advance data mining techniques can help identify impact factor manipulation. See [https://link.springer.com/article/10.1007%2Fs11192-016-2144-6 this article]. +
A study analyzed 61 neuroscience journals from 2003 to 2011. The aim was to find out whether there was an increase in publication delay over one decade and whether this phenomenon can increase IFs. The study showed that while for most journals in 2003 the phenomenon of online-to-print lag did not exist, about 50% of the studied journals from 2011 had online-to-print lag greater than 3 months. The lag varied between journals ranging from 0 to 19 months.'"`UNIQ--ref-00000688-QINU`"' There was an increase of lags over one decade, which subsequently raised the journals IF. Moreover, the larger the online-to-print lag, the higher the increase of IF.'"`UNIQ--ref-00000689-QINU`"'
This is why some researchers suggested that the date of the online publication should be used to calculate the IF and not the date of the print publication.'"`UNIQ--ref-0000068A-QINU`"''"`UNIQ--ref-0000068B-QINU`"' In the fall of 2020 Clarivate Analytics announced that it would make this shift.'"`UNIQ--ref-0000068C-QINU`"' This change will help reduce ambiguity and contribute to more transparent calculation of citation metrics.'"`UNIQ--ref-0000068D-QINU`"' The 2021 release using 2020 data is planned to be the transition year and the full switch will begin in 2022 using 2021 publication data.'"`UNIQ--ref-0000068E-QINU`"' +
An article analyzed bibliometric indicators for nuclear medicine journal. By comparison of Scopus and ISI scientists realised that seven nucelar medicine journals were indexed only on Scopus. By analysing these journals as they were part of ISI database potential IF of those journals was calculated and it put them in 11<sup>th</sup>, 14<sup>th</sup> i 15<sup>th</sup> place of nuclear medicine journal list. This result leads to conclusion that Scopus indexed journals shouldn't be overlooked when conducting quality assesment '"`UNIQ--ref-0000097F-QINU`"'. Another research among ISI and Scopus based on pediatric neurology journals showed that 3 journals were Scopus indexed only. Once again potential IF of three jorunals was calculated and it ranked them 12<sup>th</sup>, 13<sup>th</sup> and 14<sup>th</sup> among pediatric neurology journals. Self-citation doesn't affect SJR, but when it comes to IF self-citation has a great effect on it. When it comes to quality assesment of journal one should be aware of potential errors of IF and get familiar with new bibliometric indicators (such as ES, SJR) for best results '"`UNIQ--ref-00000980-QINU`"'.
'"`UNIQ--references-00000981-QINU`"' +
'''Detection'''
Educators are increasingly checking student essays and theses using plagiarism check software.
Publishers can also use similar software to undertake similarity checks on submitted manuscripts against published work and archived submissions. Springer has dedicated a [https://www.springer.com/gp/authors-editors/editors/plagiarism-prevention-with-crosscheck/4238 page] on the prevention of plagiarism.
There are, however, currently no known initiatives for funders to check plagiarism in funding applications. +
The use of card exchange games is an approach used in teaching the philosophy of science. It was developed by Bergquist and Phillips in 1975 and later popularized by Cobern. '"`UNIQ--ref-0000008F-QINU`"' The idea of card games is to foster dialogue between participants about statements written on cards, and such games have been effective in improving students’ knowledge.
In the peer review card exchange game, six different domains of peer review are explored by different statements written on cards. Participants can agree or disagree with the statements, but they are asked to discuss them and reach a consensus as a group. The explored domains are: responsiveness, competence, impartiality, confidentiality, constructive criticism and responsibility to science. Participants have to find which cards they all agree on. After that, they participate in a moderated discussion.
'"`UNIQ--references-00000090-QINU`"' +
The regulation of research integrity training for PhD students varies among countries. Some countries oblige RI training at postgraduate level in their national codes, like Denmark in the Danish code of conduct for research integrity. '"`UNIQ--ref-000000A7-QINU`"' This code states that research integrity training must be provided by higher education institutions. Similarly, in France the Ministry of Education declared that all PhD students must be trained in research integrity and research ethics before defending their thesis. In some countries, training is provided by both universities and independent research integrity institutions. An example of the latter is Luxembourg where training for PhD students on research ethics and principles of good research practice, is conducted by the University of Luxembourg while the LARI (Luxembourg Agency for Research Integrity), an independent body, offers training for researchers from all career stages. How the training is conducted also differs. LARI offers highly interactive, face to face training, combining traditional and creative methods while the Finnish National Board on Research Integrity (TENK), for example, provides online courses.
'"`UNIQ--references-000000A8-QINU`"' +
The best practices include the supervisor creating a relaxed atmosphere, being open to communication and making themselves approachable for students. In that sense, it is useful when supervisors respect the ideas of open science, and share their knowledge and experience with the researcher/student they are supervising. A relaxed, yet professional communication could also be helpful in achieving these goals. If any issues occur, or if a supervised researcher/student makes mistakes, this should be resolved through suggestions and recommendations for improvement, rather than harsh criticism or stressing the student's failures.
Students/early career researchers should be honest in communication and respecftul, while taking the supervisor's comments seriously and accepting criticism as a tool for improvement. +
There is increased recognition that lecturing supervisors about responsible supervision may not be the most useful approach. Below are some innovative examples that integrate responsible research with responsible supervision. This list is far from comprehensive, but should serve as a starting point for exploration of the topic.
First, Whitbeck described a group mentoring approach that was intended to support the discussion of research integrity in supervision. '"`UNIQ--ref-00000000-QINU`"'Besides, the research group was assisted in grasping the complexity of situations they may encounter that challenge the integrity of their research.
Second, Kalichman & Plemmons have developed a workshop curriculum for supervisors.'"`UNIQ--ref-00000001-QINU`"' This workshop curriculum is explicitly designed to convey responsible research in the actual research environment, as opposed to a classroom environment that is separated from the lab.
Thirdly, Anne Walsh and Mark Hooper from Queensland University of Technology office of Research Ethics and Integrity are developing a fully online training module that challenges supervisors to reflect on their own supervision and formulate concrete goals to improve their supervision skills, explicitly connected to responsible research.'"`UNIQ--ref-00000002-QINU`"' Their full training will be released late 2019.
Finally, as part of the Academic Research Climate in Amsterdam project, an interactive training called ''Superb Supervision'' was developed. The training continuously alternates responsible research and soft skill development and participants meet in between to discuss their own dilemmas, see [http://www.amsterdamresearchclimate.nl/superb-supervision/ here].
The [https://www.eur.nl/en/about-eur/strategy-and-policy/integrity/scientific-integrity/dilemma-game Erasmus Dilemma game] lists a variety of example dilemmas from the perspective of the junior researcher as well as from the senior researcher. These example dilemmas may serve as useful conversation starters when discussing responsible supervision.
'"`UNIQ--references-00000003-QINU`"'
The field of gaming in RCR education is growing. A few examples include ‘‘Grants and Researchers’’, a card game designed to simulate the experience of ethical decision making within the context of academic research. Rules of the game are available [http://youtu.be/L4Jk84HlLN8 here] . Gaming Against Plagiarism (GAP) project developed three games that put the player in the central role of various issues in authorship, misconduct and intellectual property. More information on the games can be found [https://digitalworlds.ufl.edu/research-production/projects/gaming-against-plagiarism-gap/ here]. +
A review from 2010 defines three models of supervision'"`UNIQ--ref-0000006E-QINU`"':
*a traditional model, a dyadic relationship between a supervisor and a student;
*a group supervision, in which there is a relationship between a student and a supervisor, as well as a student and other students, and
*a mixed model, which incorporates the two models and adds new technologies, such as online courses and teleconferences.
There is a guide for supervision of doctoral students in healthcare that defines the roles and requirements for a supervisor.'"`UNIQ--ref-0000006F-QINU`"' Some of those include clarifying the students’ purpose, understanding the student and their context, guiding them methodologically, intellectually and administratively, facilitating their communication and later on, introducing them to the scholarly community.
'"`UNIQ--references-00000070-QINU`"' +
The European Code of Conduct (2017) specifies that training is necessary for researchers to improve supervision and mentoring. '"`UNIQ--ref-00000071-QINU`"' Please click [https://www.embassy.science/resources/the-european-code-of-conduct-for-research-integrity#entry:29:url here] for the European Code of Conduct.
'"`UNIQ--references-00000072-QINU`"' +
The Taskforce Scientific Integrity from the Erasmus University Rotterdam has made a number of recommendations for use of the game in their institution. One of the recommendations is that the game is used as a part of PhD training, as well as a faculty training session on research integrity.'"`UNIQ--ref-00000002-QINU`"' The dilemma game has also proved useful beyond its home institution, for example it is used as an exercise in [https://www.ucl.ac.uk/research/integrity/training-accordion/integrity-seminars research integrity seminars] provided by University College London and the PRINTEGER project has listed the dilemma game as one of the [https://printeger.eu/upright/toc/ learning modules] on their platform. As an interactive and educational exercise, the dilemma game is used in training sessions for research integrity trainers by the Horizon 2020 VIRT2UE project.
'''Dilemma game app'''
The developers have been adapting the card game into an app, in order to make the dilemmas not only more accessible, but also more relevant to a rapidly changing research environment and available for different purposes. With this app, researchers and teachers can use it individually, in a classroom game-mode and in a lecture mode, by connecting in a group. Moreover, users are now more regularly confronted with integrity dilemmas through notifications, with new dilemma’s added each month and the invitation to share own research integrity dilemma’s. This app is a great example of an inspiring initiative, since it serves different objectives: it is a usable tool for training purposes, creates ongoing awareness and supports research culture by facilitating discussion.
The dilemma game can be downloaded as an application on [https://play.google.com/store/apps/details?id=nl.eur.dilemmagame&gl=NL Android devices] and [https://apps.apple.com/nl/app/dilemma-game/id1494087665 iOS]. The app has three modes: individual, group and lecture mode, allowing users to interact with the dilemma's in a variety of ways. You can also open the lecture mode in your [https://dilemmagame.eur.nl/ui/ browser], so you can show students the dilemma and their answers.
'"`UNIQ--references-00000003-QINU`"'
In the late 1990s, a large cross-national survey was conducted with aim of exploring young people’s opinions of their history education in Europe. They had to put themselves into the shoes of a young man or woman from the 15<sup>th</sup> century being forced into marriage and were given six options:
-Refuse because it is inhuman, immoral and illegitimate to force someone to marry without real love;
-Obey because good economy is more important for a family than passionate love between wife and husband;
-Run away to a nunnery or a monastery because religious life is worth more than worldly life;
-Consent because nearly all young people have married in accordance with their parents’ decisions;
-Resist because it is the natural right of any individual to marry for love;
-Obey because rebellion against the parents’ will is a rebellion against the law of God.'"`UNIQ--ref-000004DD-QINU`"'
Respondents’ answers mostly showed their preference for rebellion “in the name of love and natural rights” and difficulties in accepting reasons for obedience (tradition, paternal power, economic reasons) common for 15<sup>th</sup> century mentality.'"`UNIQ--ref-000004DE-QINU`"' Most students were not able to put themselves in the shoes of young people that lived in the 15<sup>th</sup> century because the question presented to them was out of their time and context. If we expect from students to apply empathy, they should have more knowledge about the 15<sup>th</sup> century society and some insights into mentality of the people living in that time. Many students projected their own contemporary opinions, feelings and stereotypes to the 15<sup>th</sup> century young people.'"`UNIQ--ref-000004DF-QINU`"'
Since empathy is something that can be learned and exercised,'"`UNIQ--ref-000004E0-QINU`"' contemporary history curriculums use it as one of the tools for “historical understanding”.'"`UNIQ--ref-000004E1-QINU`"' Several strategies that can be applied in history classroom to develop empathy among students are role-playing, structured debate, narrative-writing concerning issues historical figures confront,'"`UNIQ--ref-000004E2-QINU`"' history simulations, pro-and-con lists, examining films, novels and documentaries that provide “vicarious experiences”'"`UNIQ--ref-000004E3-QINU`"' and visits to historical sites.'"`UNIQ--ref-000004E4-QINU`"' These strategies can be applied particularly when some issue concerns a group or a nation unpopular with some or all students, or when an issue involves discrimination against a certain group.'"`UNIQ--ref-000004E5-QINU`"' It can also help understanding different cultures and improve communication and relations in multicultural societies.'"`UNIQ--ref-000004E6-QINU`"'
