Why is this important? (Important Because)
From The Embassy of Good Science
A description to provide more focus to the theme/resource (max. 200 words)
- ⧼SA Foundation Data Type⧽: Text
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Those responsible for conducting clinical trials sometimes fail in their ethical obligations towards subjects, sponsors, the scientific community and the general public by not publishing study outcomes in a timely manner. Some do not make results available at all (see e.g. [https://www.bmj.com/content/344/bmj.d7292 Ross 2012], [https://www.bmj.com/content/352/bmj.i637 Chen 2016]). Problems surrounding the reporting of research outcomes could lead to an erosion of trust in clinical trials. Subjects feel their contribution is not respected, harms are not adequately managed, and taxpayers feel their money is misspent. A failure to report all of the outcomes of research also slows the pace of scientific development. The regulatory policies demanding clinical trials’ registration in advance of the purposed beginning of the study aim to address and mitigate these problems.
The registration of all interventional trials is considered to be a scientific and ethical responsibility. The Declaration of Helsinki states that "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject". The trials registration offers the following advantages: 1) ensure global access to scientific data;2) prevent unnecessary duplications, informing about similar or identical trials and therefore saving public resources;3) offer to patients the possibility of being recruited in an experimental study;4) facilitate the identification of publication bias and selective reporting;5) allow investigators to increase the quality of research design;6) support international scientific cooperation by enabling researchers and health care practitioners to identify trials in which they may have an interest;and 7) reduce the tendency to under-report negative findings.'"`UNIQ--ref-00000006-QINU`"'
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Exploratory and confirmatory parts of research are two different stages and it is important to clearly distinguish them. However, researchers very often don’t make that distinction;they generate or change their hypotheses after observing the data and yet they report their study as exploratory or hypothesis-generating (see HARKing thematic page)'"`UNIQ--ref-0000001F-QINU`"'. Observing the data before choosing which statistical tests to conduct can show statistical significance where there actually isn’t any'"`UNIQ--ref-00000020-QINU`"'. Subsequently, this leads to false positive results. Stopping these practices is important in every research area, but especially in medicine. Hypotheses regarding drug effects generated in exploratory research are tested in confirmatory research'"`UNIQ--ref-00000021-QINU`"'. Without careful hypotheses testing, patients are put at risk'"`UNIQ--ref-00000022-QINU`"'.
To avoid this kind of inappropriate research, and all the consequences that can arise from it, pre-registration of a study is essential. Pre-registration consists of specifying and recording your study plans before you even start observing the data'"`UNIQ--ref-00000023-QINU`"''"`UNIQ--ref-00000024-QINU`"'. It refers to recording hypotheses, subjects, statistical analysis and predictions'"`UNIQ--ref-00000025-QINU`"'. This will help clearly distinguish the exploratory and confirmatory data'"`UNIQ--ref-00000026-QINU`"''"`UNIQ--ref-00000027-QINU`"''"`UNIQ--ref-00000028-QINU`"', prevent bias'"`UNIQ--ref-00000029-QINU`"', avoid p-hacking'"`UNIQ--ref-0000002A-QINU`"', ensure transparency and openness of the analysis plans'"`UNIQ--ref-0000002B-QINU`"', and increase trustworthiness and reproducibility of study findings'"`UNIQ--ref-0000002C-QINU`"'.
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As a researcher, it is essential to distinguish your work from that of others, not just because publications are valuable for your career, but also because each contribution should be recognized appropriately, fairly and transparently. This is important as sometimes it can be quite challenging to identify authors’ contributions due to long authorship lists, inconsistencies in authorship credit practices, name ambiguities or because a surname has changed.'"`UNIQ--ref-0000000A-QINU`"' An ORCID identifier is a great way to make sure your contribution as an author is recognized and linked to your research profile. In addition, an ORCID identifier can be used to connect researchers with their data sets.'"`UNIQ--ref-0000000B-QINU`"'
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After almost six centuries of using print as the main way to produce and disseminate knowledge, humanities subjects have embraced digital tools'"`UNIQ--ref-00000002-QINU`"'. This new practice, first known as “humanities computing”, began in the second half of the 1940s with the pioneering project ''Index Thomisticus'' – a collaboration between the Italian Jesuit priest Roberto Busa and IBM '"`UNIQ--ref-00000003-QINU`"''"`UNIQ--ref-00000004-QINU`"'. The project resulted in an “index verborum” (i.e. the use of punch-cards to index every word in St Thomas Aquinas’ work as well as in the works of related authors, resulting in an index of 11 million words of medieval Latin) '"`UNIQ--ref-00000005-QINU`"''"`UNIQ--ref-00000006-QINU`"'. From then on, the ''Index'' was printed in 56 volumes, it appeared on a CD-ROM and later on the web '"`UNIQ--ref-00000007-QINU`"'. Finally, 2006 marked the start of a new project, the ''Index Thomisticus Treebank'', which aims to syntactically annotate the entire corpus '"`UNIQ--ref-00000008-QINU`"'. Suffice it to say that this project has had an immense impact on humanities computing.
New digital tools present a wide range of possibilities for research and publication outputs in the humanities. They enable remote reading, visualization and easier access to primary sources '"`UNIQ--ref-00000009-QINU`"' through the creation of archives and databases for texts and artworks, and the development of new methods such as computer-based statistical analysis '"`UNIQ--ref-0000000A-QINU`"'. Using digital tools has improved the humanities’ social impact and the accessibility and public visibility of individual disciplines '"`UNIQ--ref-0000000B-QINU`"'. For instance, through image processing techniques, the public can now view 3D reconstructions of the ancient city of Babylon '"`UNIQ--ref-0000000C-QINU`"' and read ancient documents such as the Vindolanda Tablets from Hadrian’s Wall '"`UNIQ--ref-0000000D-QINU`"'.
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Some research areas have domain-specific challenges or considerations when it comes to research integrity. These differences can be due to methodological, conceptual, historical or other differences between disciplines, and can also reflect priority issues that stem from the kind of research that is performed within a particular discipline. That is why it can be important to have more specific codes and guidelines that explicitly address these topics and put them into context.
In particular, research areas in which practitioners have a dual role and also offer services to clients - such as sociologists, psychologists, or statisticians - often have well-established domain-specific codes of conduct. It is also common for disciplines in which researchers collaborate with industry or media respresentatives, deal with sensitive data, or involve human and animal subjects in research, to provide more detailed guidance on these topics over and above that mentioned in domain-general codes and guidelines. +
A number of national and institutional guidelines, frameworks and codes for research integrity have been developed in many European countries, and the European Code of Conduct for Research Integrity sets out common principles for those documents. But the handling of cases of research misconduct is mostly under the responsibility of research institutions, which vary in their capacity and willingness to do that. The main obstacles in the handling of research misconduct at the level of institutional committees are conflicts of interest, fear of reputational damage, lack of time due to the voluntary nature of the task, and lack of expertise. Investigation committees in national bodies have the advantage that they are more distant from local researchers, so the risk of conflicts of interest is lower. However, they exist only in a couple of countries. The effect is that not all misconduct is addressed, and the level of thoroughness and objectivity of investigations is inconsistent across Europe. +
When clinicians apply or offer the treatment to their patients, they should be up to date with the most recent guidelines regarding the particular treatment. The recommendation in the guideline may arise from a well- conducted and large randomised controlled trial. In that case, clinician can provide the treatment while being aware of all the benefits and the risks. On the other hand, treatment recommendations may come from studies that are graded as evidence of lower quality. If so, the treatment should be applied bearing in mind possible undesirable effects or costs, so clinicians can help patients to decide according to their values and preferences. Since the recommendations in the guidelines affect patients' lives, guidelines and recommendations must therefore transparently indicate whether the evidence is one of high quality or there is an uncertain balance. +
Images often serve as primary data (e.g. cell biology). In other instances, they are key in making an article attractive to read or serve comprehensive purposes. Accordingly, images are often included in article abstracts. The information they carry is thus a vital part of research and should remain identical to what is observed in the experiment.'"`UNIQ--ref-00000005-QINU`"'
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As important as moral values and integrity are, it's also very important to regulate what a researcher's legal limitations are too. Malpractice and misconduct can effect not only the staff involved but the entire institution as well, later on reflecting on other researchers and their work as well. It can stain the institution as a whole in funders eyes as well as other institutions who could've been involved collaboratively. Not only does it have negative connotations towards the scientific community involved, but it can also change public opinions towards the entire academic community. Even if all that's put aside, as a researcher your goal should always primarily be to be a part of a mission towards a deeper understanding of the world around us. +
The person who makes an allegation of misconduct may be penalized if he or she is not protected by the institutional investigation. Also, the accused has a right to due process, as false accusations can be made. That is why it is important that institutional procedures respect the rights both of the accuser and accused. +
It is important that the principles of proportionality and due process are respected in investigations of misconduct. Otherwise this may lead to erroneous judgments of integrity commissions, or unfair punishments. Moreover, scientists, as citizens, have legal rights, and if these are not respected in self-regulatory investigations, then cases of alleged misconduct will increasingly be handled by the courts. +
Different research has shown that the prevalence of depression among doctoral students in the US is high '"`UNIQ--ref-00000000-QINU`"', along with an increased risk for other psychiatric disorders, when compared to other highly educated groups. One in two PhD students experiences psychological distress'"`UNIQ--ref-00000001-QINU`"'. These problems often result from organizational change, increased workload, the rise in short term contracts, budget cuts, increased competition, and academic culture of ‘publish or perish’'"`UNIQ--ref-00000002-QINU`"''"`UNIQ--ref-00000003-QINU`"'. Mental health problems include burnout, depression, anxiety and emotional exhaustion. This could impact the quality and number of published articles, influence the organizational climate of research teams, and lead to fewer students completing their PhDs '"`UNIQ--ref-00000004-QINU`"'.
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The promise of openness brings to mind a commitment to transparency and opportunities for greater engagement. By removing barriers to access research, the identification of errors and malpractice is facilitated, and the democratisation of knowledge production fostered.'"`UNIQ--ref-00000004-QINU`"' In the context of research integrity, open science is seen as an enabler of reproducibility because it allows wider evaluation and scrutiny of research results. Thus, also aligning itself closely with Mertonian ethos, especially, communism and organized skepticism.'"`UNIQ--ref-00000005-QINU`"'
Open access has also been subject to political review and discussion. For instance, beneficiaries of the European funding scheme called Horizon 2020, “must ensure open access (free of charge, online access for any user) to all peer-reviewed scientific publications relating to its results”. '"`UNIQ--ref-00000006-QINU`"'
It is clear that the first beneficiary of Open Science practices is, Science. If it’s true that the role of Science in society is to create knowledge, drive progress, and guarantee better human lives than it does not surprise that all of this can be achieved faster and more efficiently by following transparent, inclusive and participatory practices. Moreover, it has been shown that Open Science can help Early Career Researchers (ECRs) succeed,'"`UNIQ--ref-00000007-QINU`"' especially through the practice of preprints and open access publications (which promote visibility in the scientific community and therefore improve the chance to collect feedback and be cited'"`UNIQ--ref-00000008-QINU`"'). Lastly, it has been shown that with access to scholarly articles, entrepreneurs and small businesses can accelerate innovation and discovery, which is advantageous for advancing the entrepreneurial state of society.'"`UNIQ--ref-00000009-QINU`"'
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Plan S is a major scientific publishing initiative. Given the speed of scientific advances and the demand for relevant and quality information, there is an increased demand for quick and universal access to the most up-to-date findings. However, public access to scientific publications is still extremely limited, and is usually reserved for those who subscribe to specific journals or repositories.'"`UNIQ--ref-00000004-QINU`"' Many institutions, especially those in the developing world, cannot afford the subscription fees, which have been criticized for being disproportionately expensive.
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If the standards for career advancement are not reasonable, this can lead to considerable friction between individual researchers and the research institution. This is not fair to the individual researcher, and by creating resentment, can hamper potential collaboration within a research institution, and can constitute a structural cause for research misconduct. +
Research integrity advisors (RIAs) are responsible for providing advice on matters related to research integrity. Whether you are in the early stage of your research career, or you are senior researcher, it is good to know there is someone who can answer you the questions related to research integrity and research misconduct. They usually do not have investigative roles, but they can definitely be a good stop for advice on how to proceed in a specific case. +
Research integrity committees usually serve as a base of knowledge for questions regarding research integrity and research misconduct. The importance of the RI committee lies in its responsibility in promoting research integrity, i.e. providing advice for researchers on how to adhere to the responsible conduct of research. This is usually done by guidelines, checklists and other documents in which good research practices are presented. Moreover, RI committees are responsible for dealing with cases of research misconduct and they should be notified if an alleged case of research misconduct has occurred. By performing these actions, RI committees contribute to better science and the prevention of research misconduct. +
Nowadays, not only research projects on the biomedical sciences, but increasingly also research projects in various other disciplines, like psychology or education, require ethical review. For that reason, RECs will continue to play an important role in ethical research governance. Hence, an important question is which skills REC members should ideally have.
Conducting thorough ethical reviews of research projects not only presupposes sufficient disciplinary expertise to understand proposed research designs and methodologies, but also skills crucial for delivering practical recommendations that accord with prevalent social norms. Moreover, skills conducive to maintaining dialogical attitudes among all REC members certainly are beneficial as RECs modus operandi is deliberation. Consequently, systematizing these skills is helpful for setting up effective RECs and selecting members according to transparent criteria. +
Research ethics committees have been created with two main goals. First is to protect the rights, safety, dignity and well-being of research participants;and second is to facilitate and promote ethical research that is of potential benefit to participants, science and society. '"`UNIQ--ref-00000001-QINU`"'
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Research and innovation are often funded by society and even if they are not, it is reasonable to expect that they have implications for society. This is why there is a movement aimed towards aligning research with societal needs and values and tackling societal challenges. There are several definitions of RRI. Von Schomberg defined it as “a transparent, interactive process by which societal actors and innovators become mutually responsive to each other with a view to the (ethical) acceptability, sustainability and societal desirability of the innovation process and its marketable products (in order to allow a proper embedding of scientific and technological advances in our society)”'"`UNIQ--ref-00000009-QINU`"'. A broader definition is offered by Stilgoe et al., who refer to “taking care of the future through collective stewardship of science and innovation in the present”'"`UNIQ--ref-0000000A-QINU`"'. The UK Engineering and Physical Sciences Research Council defined RRI as “a process that seeks to promote creativity and opportunities for science and innovation that are socially desirableand undertaken in the public interest”'"`UNIQ--ref-0000000B-QINU`"'. According to the European Commission, RRI “means that societal actors work together during the whole research and innovation process in order to better align both the process and its outcomes, with the values, needs and expectations of European society”'"`UNIQ--ref-0000000C-QINU`"'.
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