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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Data are both factual information (e.g. statistical information, cell counts) and materials, means and products of scientific inquiry (e.g. tissue samples, written notes).'"`UNIQ--ref-00000000-QINU`"' Handling data refers to how data are “maintained, analysed, interpreted, and shared, transmitted or reported to others.” (pg. 95).'"`UNIQ--ref-00000001-QINU`"' When talking about handling data, The Office for Research Integrity (ORI) states that the following needs to be considered'"`UNIQ--ref-00000002-QINU`"':
· ''Data storage'' refers to how the data should be stored in such a way in order for (project) results can be reconstructed (by others).
· ''Data protection'' concerns the protection of written and electronic data and research materials from possible physical and electronic damage and from theft or tampering.
· ''Data retention'' refers to the length of time data needs to be stored after the end of a project. Per country, institution and funder this differs. Secure destruction of data also needs to be guaranteed.
· ''Data sharing'' is the act of sharing research results with other researchers and the public. How and if results should be shared is an important point to consider here.
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Researchers have a responsibility to keep notes, or up-to-date laboratory journals, of their research process. Between different disciplines, the content and structure of notes may differ. In addition, new ideas should be written down as comprehensively as possible and dated. This ensures researchers are given appropriate credit within a research team for generating ideas. '"`UNIQ--ref-00000002-QINU`"'
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Whether you carry out research in an academic setting or in the field, there is a variety of safety risks that could affect researchers and research participants. Depending on research areas, different kinds of safety risks may occur, ranging from physical (experiencing pain or other side effects from medication) to psychological harm (stress).'"`UNIQ--ref-0000000A-QINU`"' Furthermore, faculties at academic sites, such as chemical and microbiological laboratories, may pose hazardous risks.'"`UNIQ--ref-0000000B-QINU`"' Potential risks that can occur in social research are related to data or perspectives that impact on feelings, values and viewpoints of people involved in research.'"`UNIQ--ref-0000000C-QINU`"' Fieldwork particularly poses some risks, for example conducting interviews in high-risk locations, such as in war zones or in countries with authoritarian regimes.'"`UNIQ--ref-0000000D-QINU`"' Not considering safety risks in research can result in tragic events including death.
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Addressing any question in empirical sciences implies that there will be some kind of study, which needs to be designed in such fashion that it answers the question in the most unambiguous way. Scientific questions can usually fall into one of these categories: identification of influencing factors (etiology and risk factors), predicting power of those factors (prognosis and prediction), effects of interventions into those factors. To answer these questions, factors that are measured or manipulated must correspond to questions that are asked. Meaning, your outcome measure has to be relevant for your question. Preferably, it should answer your question directly. The design of your study also has to fit the outcome measure. Furthermore, if there are some factors that we are unaware of or others that are known to us but we cannot measure them, then we have to use randomization to reduce their possible influence on things that we want to measure. If you do not address things that are listed above when planning research, you can simply get wrong answers to your questions . '"`UNIQ--ref-00000004-QINU`"'
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Not disclosing changes creates a biased view of the research performed. Some of the changes that researchers perform after the first analyses include P-hacking, HARK-ing, cherry picking results, or performing explorative subgroup analyses. In qualitative research the methods can also be changed, for instance, changing the research question after data collection.
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Within the scientific community, posing irrelevant research questions is considered a problem because it leads to research waste. Funding in the scientific community is limited, and research waste uses valuable resources which could have been used elsewhere. Science, fundamentally, involves posing questions and forming hypotheses that might turn out to be wrong, but the questions asked should always be relevant. Within health research it is estimated 50% of questions are not relevant .'"`UNIQ--ref-0000000B-QINU`"' These include:
#Questions that have low priority of being researched. Assessing the risk of getting malaria is a relevant question in sub-Saharan Africa – but not when asking the same question in Northern Siberia – where the mosquito does not live.
#Questions which ignore the outcome of previous research, which results in duplicate research and wastes valuable resources. This is not the same as explicit replication of previous research, which is vital for the trustworthiness of science.
#Questions which do not involve those affected by the research in setting the research agenda. For example, most research on rheumatoid arthritis focused on pain relief. '"`UNIQ--ref-0000000C-QINU`"''"`UNIQ--ref-0000000D-QINU`"' However, a novel study found that fatigue was one of most prevalent, and ignored, problems among patients .'"`UNIQ--ref-0000000E-QINU`"' This shows that asking the right question is also concerned with societal relevance, and interacting with patients and clinicians is of great importance.
Formulating relevant research questions is not easy, and is a challenge for individual researchers and the scientific community as a whole.
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It is important that scientists are incentivized to do good science and be good scientists. This means that, as much as possible, good science should be rewarded. If not, then it may not be realistic to expect a culture that fosters research integrity, nor to expect a lasting solution to problems of reproducibility. Moreover, should institutions and journals keep perverse incentives in place, it may not be fair to individual scientists to hold them only responsible for undesirable scientific outcomes. +
Polarized research is a type of bias that with basis in (covert) conflict of interest. Therefore it may misguide or distort the production of knowledge. Being aware of polarized research is tremendously important for readers of scientific papers, for researchers, for editors, for information specialists (synthesizing knowledge), and for users of scientific evidence, such as policy makers.
Results on climate change have, for example, been polarized. Moreover, there are many examples from health care, where studies of effects of various procedures vary greatly – even when based on the same data. One of the most familiar cases from health care involves studies on [https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-018-0243-z mammography screening] of women for breast cancer, where results on breast cancer mortality reduction and overdiagnosis vary greatly.
While professional disagreement is what drives scientific progress, polarized research hampers it, as it frequently becomes static and entrenched. Or it can be related to "choice-supportive bias." It is an interesting issue whether polarized research borders on misconduct, as it involves strong and often covert conflict of interest. However, the interest is not directly related to money or profit. Alternatively, scientific conferences and consensus conferences can be one constructive manner to address the problem. +
The pay to publish model has introduced a perverse conflict of interest into academic publishing. Rejecting papers does not yield any income and conflicts with the publisher’s financial interest. Because predatory journals do not usually apply rigorous peer review, the average quality of the published research is lower than that of adequately peer reviewed papers.
Avoiding, bypassing, or diminishing the quality assurance step of peer review can result in poor knowledge production. This results in bad research being freely accessible to the public, which is harmful to those who read it, corrupts the record of published scientific results, undermines evidence-based practice, misguides decision and policy makers, and risks erosion of public trust in academic science.
A number of studies have exposed predatory journal practices. For example, a writer for the journal Science submitted a very flawed manuscript to a number of open-access journals and experienced that 57% of the journals accepted the paper. He then published his results in a paper called, "Who's Afraid of Peer Review?". '"`UNIQ--ref-0000000A-QINU`"' A fictitious scientist named Anna O. Szust applied for an editor position to 360 scholarly journals without relevant qualifications and with a made-up CV. 40 of 120 predatory journals accepted Szust as editor without any background check and often very quickly. '"`UNIQ--ref-0000000B-QINU`"'
Researchers, particularly those with less experience, are sometimes unaware of the predatory nature of a journal and can be tricked into submitting a manuscript. Publishing in a predatory journal means that the article is no longer original and cannot be published in a high quality, peer-reviewed journal. Another problem is, when a researcher learns of the predatory nature of the journal and requests a retraction, the journal will often either refuse to retract the article, or request another fee to take it down. To avoid reputational damage and wasting a good article in a worthless publication, it is important to be able to recognize and avoid predatory journals.
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QRPs are actions that concern trespassing "methodological principles that threathen the relevance, valdity, trustworthiness, or efficiency of the study at issue".'"`UNIQ--ref-00000019-QINU`"' QRPs can be divided over four main areas of the research process: the study design, data collection, reporting and collaboration. QRPs are estimated to occur far more frequently then serious misconduct, and therefore pose a threat to trust and truth in science. Under the current system QRPs are rewarded in the form of a higher number and more prestigious publications. Indeed, sloppy science as described above appears to have a strong 'fitness to survive'. '"`UNIQ--ref-0000001A-QINU`"'
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Data fabrication is a form of research misconduct that affects the credibility of research and decreases public trust in science. In addition, the misrepresentation of data in biomedical research can be a serious threat to public health and safety '"`UNIQ--ref-00000019-QINU`"'. Furthermore, because biomedical research is largely funded by the public – the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services invests more than $32 billion a year to improve public health '"`UNIQ--ref-0000001A-QINU`"' – data fabrication can lead to the loss of public funds.
When there is a suspicion of research misconduct, an investigation is conducted by the Division of Investigative Oversight (DIO) within the U.S.’s Office of Research Integrity (ORI) '"`UNIQ--ref-0000001B-QINU`"'. In recent years, numerous scientific papers have been retracted and about two-thirds of them were due to scientific misconduct '"`UNIQ--ref-0000001C-QINU`"'. While the ORI and the U.S. Department of Health and Human Services support and encourage the use of methods for detecting image manipulation, some argue that statistical methods, which can detect numerical data fabrication, “get much less attention,” even though this form of fabrication occurs regularly '"`UNIQ--ref-0000001D-QINU`"'.
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Preregistration prevents several biases often occurring in preclinical experiments and promote responsible & robust animal research. By reducing these biases, researchers increase the value and reliability of their studies and contribute to better science.
*The overview created by preregistration enables to '''counter publication bias''' by making these studies available regardless of their results.
*Preregistration enables to compare final publications and (pre)registered protocols, which '''increase transparency''' and '''reduce reporting bias''', such as <u>selective outcomes reporting</u>.
*By stating in advance hypotheses and statistical plans, preregistration '''reduces misconducts''' like <u>HARKing</u> (Hypothesis After Results are Known) and <u>p-hacking</u>.
*The free access of study protocols enables to verify which studies are or were conducted and hence permits to '''avoid unnecessary duplication''' of animal studies.
*Most preregistration forms request information linked to <u>internal validity</u> (e.g., randomisation, blinding, sample size calculation), which may impact '''study design robustness and reporting'''. +
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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