_The International Committee of Medical Journal Editors (ICMJE) is a working group of editors of selected medical journals that meets annually. Founded in Vancouver, Canada, in 1978, it currently consists of 11 member journals and a representative of the US National Library of Medicine. The major purpose of the Committee is to address and provide guidance for the conduct and publishing of biomedical research and the ethical tenets underpinning these activities. This advice is detailed in the Committee's _ Uniform (...) Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication (URM)._ Recently, the ICMJE has adopted an interventionist role to ensure transparency of conflict of interest revelations in the conduct and publication of industry supported research. It also pursues a policy for the lodgement with trial registries of specified details of Phase III clinical trials. Failure to comply would jeopardise publication of trial outcomes in ICMJE member journals. This policy has resulted in the coming on stream of trial registries, international agreement on trial minimal datasets and compliance with trial registration requirements._. (shrink)

BackgroundThe International Committee of Medical Journal Editors Recommendations set ethical and editorial standards for article publication in most leading medical journals. Here, I examine the strengths and weaknesses of the Recommendations in the prevention of commercial bias in industry-financed journal literature, on three levels – scholarly discourse, article content, and article attribution.DiscussionWith respect to overall discourse, the most important measures in the ICMJE Recommendations are for enforcing clinical trial registration and controlling duplicate publication. With respect to article content, the (...) ICMJE promotes stringent author accountability and adherence to established reporting standards. However, the ICMJE accepts the use of commercial editorial teams to produce manuscripts, which is a potential source of bias, and accepts private company ownership and analysis of clinical trial data. New ICMJE guidance on data sharing will address but not eliminate problems of commercial data access. With respect to attribution, the Recommendations oppose guest authorship and encourage clear documentation of author contributions. However, they exclude writers from coauthorship; provide no specific advice on the attribution of commercial literature, for instance with respect to company authorship, author sequence or prominent commercial labeling; and endorse the use of fine print and euphemism. The ICMJE requires detailed author interest disclosures, but overlooks the interests of non-authors and companies, and does not recommend that interests most salient to the publication are highlighted. Together, these weaknesses facilitate “advocacy”-based marketing, in which literature planned, financed and produced by companies is fronted by academics, enabling commercial messages to be presented to customers by their respected clinical peers rather than companies themselves.ConclusionsThe ICMJE Recommendations set important research and reporting standards, without which commercial bias would likely be a significantly greater problem than it is today. However, they also support practices of commercial data control, content development and attribution that run counter to science’s values of openness, objectivity and truthfulness. These weaknesses could be addressed with appropriate modifications to the Recommendations. The ICMJE should also disclose its own commercial interests and funding – not least because publishing organizations that finance it and pay the salaries of some member editors derive substantial revenues from industry. (shrink)

The International Committee of Medical Journal Editors is a working group of editors of selected medical journals that meets annually. Founded in Vancouver, Canada, in 1978, it currently consists of 11 member journals and a representative of the US National Library of Medicine. The major purpose of the Committee is to address and provide guidance for the conduct and publishing of biomedical research and the ethical tenets underpinning these activities. This advice is detailed in the Committee's Uniform Requirements for Manuscripts (...) Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication . Recently, the ICMJE has adopted an interventionist role to ensure transparency of conflict of interest revelations in the conduct and publication of industry supported research. It also pursues a policy for the lodgement with trial registries of specified details of Phase III clinical trials. Failure to comply would jeopardise publication of trial outcomes in ICMJE member journals. This policy has resulted in the coming on stream of trial registries, international agreement on trial minimal datasets and compliance with trial registration requirements. (shrink)

BackgroundThe International Committee of Medical Journal Editors Recommendations set ethical and editorial standards for article publication in most leading medical journals. Here, I examine the strengths and weaknesses of the Recommendations in the prevention of commercial bias in industry-financed journal literature, on three levels – scholarly discourse, article content, and article attribution.DiscussionWith respect to overall discourse, the most important measures in the ICMJE Recommendations are for enforcing clinical trial registration and controlling duplicate publication. With respect to article content, the (...) ICMJE promotes stringent author accountability and adherence to established reporting standards. However, the ICMJE accepts the use of commercial editorial teams to produce manuscripts, which is a potential source of bias, and accepts private company ownership and analysis of clinical trial data. New ICMJE guidance on data sharing will address but not eliminate problems of commercial data access. With respect to attribution, the Recommendations oppose guest authorship and encourage clear documentation of author contributions. However, they exclude writers from coauthorship; provide no specific advice on the attribution of commercial literature, for instance with respect to company authorship, author sequence or prominent commercial labeling; and endorse the use of fine print and euphemism. The ICMJE requires detailed author interest disclosures, but overlooks the interests of non-authors and companies, and does not recommend that interests most salient to the publication are highlighted. Together, these weaknesses facilitate “advocacy”-based marketing, in which literature planned, financed and produced by companies is fronted by academics, enabling commercial messages to be presented to customers by their respected clinical peers rather than companies themselves.ConclusionsThe ICMJE Recommendations set important research and reporting standards, without which commercial bias would likely be a significantly greater problem than it is today. However, they also support practices of commercial data control, content development and attribution that run counter to science’s values of openness, objectivity and truthfulness. These weaknesses could be addressed with appropriate modifications to the Recommendations. The ICMJE should also disclose its own commercial interests and funding – not least because publishing organizations that finance it and pay the salaries of some member editors derive substantial revenues from industry. (shrink)

In recent years there have been many revelations about ghost authors, who contribute to publications but are not credited, and guest authors, who do not contribute but are credited. Most medical and many other journals adhere to the authorship standards set by the International Committee of Medical Journal Editors (ICMJE), which were designed in part to combat the phenomena of ghost and guest authorship. However, the current criteria set for authorship by the ICMJE have their own problems. This (...) brief paper illustrates these problems with an example, and concludes that the current ICMJE definition of authorship is both illogical and unethical. (shrink)

Although popular, I argue that the International Committee of Medical Journal Editors (ICMJE) account of authorship is flawed. It inadvertently allows for practices that it was designed to prevent. In addition, it creates a new category of authorless papers—orphan papers. The original World Association of Medical Editors (WAME) criterion is preferable.

In this article, I describe and analyse the proposed new International Committee of Medical Journal Editors form for disclosing conflicts of interest and conclude that it has many flaws. The form does not mention ‘conflicts of interest’ even once in either its body or its title, it introduces a conceptually confused categorisation of different potential conflicts and it ignores future conflicts and intellectual biases. Finally, many of the authors of the new form have themselves failed to declare relevant potential conflicts (...) of interest. (shrink)

The authorship criteria of the International Committee of Medical Journal Editors (ICMJE) are widely accepted in biomedical journals, but many studies in large and prestigious journals show that a considerable proportion of authors do not fulfill these criteria. We investigated authorship contributions in a small medical journal outside the scientific mainstream, to see if poor adherence to authorship criteria is common in biomedical journals. We analyzed statements on research contribution, as checked by the corresponding author, for individual authors of (...) 114 research articles, representing 475 authors, submitted to the Croatian Medical Journal (CMJ) from 1999 to 2000. Only 40% of authors fulfilled the ICMJE authorship criteria. The authors listed first on the by-line were more likely to fulfill the authorship criteria than all other authors on the by-line. The percentage of authors fulfilling the ICMJE criteria of authorship decreased with the increase in the number of authors listed on the by-line. These results indicate that poor adherence to ICMJE authorship criteria is poor across biomedical journals, regardless of the size of the scientific community. Authorship and contributorship in biomedical journals, as well as editorial ethical responsibilities towards authorship criteria need critical redefinition and education of both editors and authors. (shrink)

Multiple authorship is the universal solution to multi-tasking in the sciences. Without a team, each with their own set of expertise, and each involved mostly in complementary ways, a research project will likely not advance quickly, or effectively. Consequently, there is a risk that research goals will not be met within a desired timeframe. Research teams that strictly scrutinize their modus operandi select and include a set of authors that have participated substantially in the physical undertaking of the research, in (...) its planning, or who have contributed intellectually to the ideas or the development of the manuscript. Authorship is not an issue that is taken lightly, and save for dishonest authors, it is an issue that is decided collectively by the authors, usually in sync with codes of conduct established by their research institutes or national ministries of education. Science, technology and medicine publishers have, through independent, or sometimes coordinated efforts, also established their own sets of guidelines regarding what constitutes valid authorship. However, these are, for the greater part, merely guidelines. A previous and recent analysis of authorship definitions indicates that the definitions in place regarding authorship and its validity by many leading STM publishers is neither uniform, nor standard, despite several of them claiming to follow the guidelines as set forward by the International Committee of Medical Journal Editors or ICMJE. This disparity extends itself to ghost and guest authorship, two key authorship-related issues that are examined in this paper to assess the extent of discrepancies among the same set of STM publishers and what possible influence they might have on publishing ethics. (shrink)

Examination of a limited number of publisher’s Instructions for Authors, guidelines from two scientific societies, and the widely accepted policy document of the International Committee of Medical Journal Editors (ICMJE) provided useful information on authorship practices. Three of five journals examined (Nature, Science, and the Proceedings of the National Academy of Sciences) publish papers across a variety of disciplines. One is broadly focused on topics in medical research (New England Journal of Medicine) and one publishes research reports in a (...) single discipline (Journal of Bacteriology). Similar elements of publication policy and accepted practices were found across the policies of these journals articulated in their Instructions for Authors. A number of these same elements were found in the professional society guidelines of the Society for Neuroscience and the American Chemical Society, as well as the ICMJE Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Taken together, these sources provide the basis for articulating best practices in authorship in scientific research. Emerging from this material is a definition of authorship, as well as policy statements on duplicative publication, conflict of interest disclosure, electronic access, data sharing, digital image integrity, and research requiring subjects’ protection, including prior registration of clinical trials. These common elements provide a foundation for teaching about scientific authorship and publication practices across biomedical and life sciences disciplines. (shrink)

Background Although most biomedical journals have adopted the authorship criteria established by the International Committee of Medical Journal Editors (ICMJE) in 1985, little is known about the extent Iranian researchers are familiar with these criteria. Objectives The study seeks to evaluate the number of authors fulfilling ICMJE authorship criteria (considering the names mentioned in the byline of 12 issues of the Archives of Iranian Medicine (AIM) journal), and to determine the type of contribution made by each author. Materials (...) and Methods The fulfilment of authorship criteria and contribution percentage of each researcher were evaluated according to their position in the bylines of 12 issues of the Archives of Iranian Medicine (AIM) journal published from January 2005 to October 2007. We asked corresponding authors to answer our questionnaire which was designed to assess authorship criteria and contribution. Results A total of 576 researchers' names were in the studied article bylines. The ratio of authors to articles was 3.48 in 2005, 4.06 in 2006, and 5.59 in 2007. Sixty three out of 128 corresponding authors (49.21%) responded to our questionnaire, so we evaluated 296 researchers' names, from which 186 authors (62.83%) met the authorship criteria; 110 authors (37.17%) were identified as guest authors, 97 of which deserved to be mentioned in the acknowledgement section. The major criteria used for authors order was their participation in research projects in addition to article writing, mostly determined by the corresponding author. Two authors (0.67%) whose names were not mentioned in the articles were considered to be ghost writers as the articles were based on the results of their thesis. Conclusion It is essential to make Iranian researchers familiar with ICMJE authorship criteria and to encourage applying the criteria in scientific writing. (shrink)

BackgroundAlthough most biomedical journals have adopted the authorship criteria established by the International Committee of Medical Journal Editors (ICMJE) in 1985, little is known about the extent Iranian researchers are familiar with these criteria.ObjectivesThe study seeks to evaluate the number of authors fulfilling ICMJE authorship criteria (considering the names mentioned in the byline of 12 issues of the Archives of Iranian Medicine (AIM) journal), and to determine the type of contribution made by each author.Materials and MethodsThe fulfilment of (...) authorship criteria and contribution percentage of each researcher were evaluated according to their position in the bylines of 12 issues of the Archives of Iranian Medicine (AIM) journal published from January 2005 to October 2007. We asked corresponding authors to answer our questionnaire which was designed to assess authorship criteria and contribution.ResultsA total of 576 researchers' names were in the studied article bylines. The ratio of authors to articles was 3.48 in 2005, 4.06 in 2006, and 5.59 in 2007. Sixty three out of 128 corresponding authors (49.21%) responded to our questionnaire, so we evaluated 296 researchers' names, from which 186 authors (62.83%) met the authorship criteria; 110 authors (37.17%) were identified as guest authors, 97 of which deserved to be mentioned in the acknowledgement section. The major criteria used for authors order was their participation in research projects in addition to article writing, mostly determined by the corresponding author.Two authors (0.67%) whose names were not mentioned in the articles were considered to be ghost writers as the articles were based on the results of their thesis.ConclusionIt is essential to make Iranian researchers familiar with ICMJE authorship criteria and to encourage applying the criteria in scientific writing. (shrink)

In a recent opinion paper, it was argued that individuals with multiple retractions or a record of academic misconduct should not serve as editors, including as editors-in-chief, on the editorial boards of scholarly or academic journals. As a first step towards appreciating how such a policy could be applied in practice, the presence of 30 individuals listed on the Retraction Watch Leaderboard on editorial boards was screened. Six cases are highlighted to gain an appreciation of the potential reputational risks that (...) journals and publishers might incur by including individuals with a tainted academic record on editorial boards. Given the reputational, legal and other risks associated with this type of assessment and decision, more formal positioning and guidance are needed by global ethics policy-related bodies such as COPE, the ICMJE, and the CSE, even more so in journals that claim to follow these organizations’ ethical guidelines. (shrink)

We propose a rational method for addressing an important question—who deserves to be an author of a scientific article? We review various contentious issues associated with this question and recommend that the scientific community should view authorship in terms of contributions and responsibilities, rather than credits. We propose a new paradigm that conceptually divides a scientific article into four basic elements: ideas, work, writing, and stewardship. We employ these four fundamental elements to modify the well-known International Committee of Medical Journal (...) Editors (ICMJE) authorship guidelines. The modified ICMJE guidelines are then used as the basis to develop an approach to quantify individual contributions and responsibilities in multi-author articles. The outcome of the approach is an authorship matrix, which can be used to answer several nagging questions related to authorship. (shrink)

Multiple authorship is the universal solution to multi-tasking in the sciences. Without a team, each with their own set of expertise, and each involved mostly in complementary ways, a research project will likely not advance quickly, or effectively. Consequently, there is a risk that research goals will not be met within a desired timeframe. Research teams that strictly scrutinize their modus operandi select and include a set of authors that have participated substantially in the physical undertaking of the research, in (...) its planning, or who have contributed intellectually to the ideas or the development of the manuscript. Authorship is not an issue that is taken lightly, and save for dishonest authors, it is an issue that is decided collectively by the authors, usually in sync with codes of conduct established by their research institutes or national ministries of education. Science, technology and medicine publishers have, through independent, or sometimes coordinated efforts, also established their own sets of guidelines regarding what constitutes valid authorship. However, these are, for the greater part, merely guidelines. A previous and recent analysis of authorship definitions indicates that the definitions in place regarding authorship and its validity by many leading STM publishers is neither uniform, nor standard, despite several of them claiming to follow the guidelines as set forward by the International Committee of Medical Journal Editors or ICMJE. This disparity extends itself to ghost and guest authorship, two key authorship-related issues that are examined in this paper to assess the extent of discrepancies among the same set of STM publishers and what possible influence they might have on publishing ethics. (shrink)

Objectives: To assess the knowledge and behaviour of researchers regarding criteria for authorship, and the practices of ghost and gift authorship. Design: Semidirective interviews of senior clinical researchers. Setting: University hospital. Participants: Thirty-nine main investigators of clinical research programmes. Main measurements: Awareness and use of International Committee of Medical Journal Editors (ICMJE) criteria for authorship, and perceptions about ghost and gift authorship. Results: A total of 48 protocols submitted by 42 principal investigators between 1994 and 1996 were identified. Thirty-nine (...) investigators were contacted; 37 (one of whom delegated a co-author) were interviewed between May 2002 and March 2003. Two co-authors of two principal investigators were also interviewed. In all, 42 studies were represented. The interviews lasted for 40–90 minutes and were conducted with openness and respect for confidentiality. The choice of names of co-authors did not follow the ICMJE recommendations. Half of the respondents stated they were aware of criteria for authorship and knew of ICMJE, but most of them did not cite any of the ICMJE criteria among those they applied in deciding authorship. Most of them disagreed with the obligation to meet the three criteria justifying co-authorship because they found these too rigid and inapplicable. Gift authorship was a common practice; 59% of the respondents had been a recipient of gift authorship. Twenty-five (64%) were aware of ghost authorship and the majority considered it questionable and blameworthy. Conclusions: The ICMJE criteria were ignored by clinicians at a university hospital. Ghost and gift authorship were frequent among them. There is a need for French guidelines for authorship to be prepared and implemented. (shrink)

The practice of assigning authorship for a scientific publication tends to raise two normative questions: 1) ‘who should be credited as an author?’; 2) ‘who should not be credited as an author but should still be acknowledged?’. With the publication of the revised version of The European Code of Conduct for Research Integrity (ECCRI), standard answers to these questions have been called into question. This article examines the ways in which the ECCRI approaches these two questions and compares these approaches (...) to standard definitions of ‘authorship’ and ‘acknowledgment’ in guidelines issued by the International Committee of Medical Journal Editors (ICMJE) and the World Association of Medical Editors (WAME). In light of two scenarios and the problems posed by these kinds of ‘real-world’ examples, we recommend specific revisions to the content of the ECCRI in order not only to provide a more detailed account of the tasks deserving of acknowledgment, but to improve the Code’s current definition of authorship. (shrink)

More than 800 (co-)authors participated in a large-scale cross-sectional survey on inappropriate attribution of authorship and the use of explicit authorship guidelines in psychological science (response rate 29.6%, predominantly from Europe and North America). Almost half of the respondents had been involved in a study where someone was added as an author who did not contribute substantially (gift authorship) at least a few times. Being involved in a study where someone was not listed as an author when they contributed substantially (...) (ghost authorship) was experienced considerably less frequently. In approximately half of the respondents’ research settings, the use of explicit authorship guidelines is actively encouraged, leading to more frequent discussion of authorship in earlier stages, as well as to the perception of authorship decisions as fairer. Encouraging the use of explicit authorship guidelines is a simple yet effective intervention. Importantly, the American Psychological Association’s (APA) authorship guidelines are considerably more lenient than the widely used criteria of the Committee on Publication Ethics and the International Committee of Medical Journal Editors. (shrink)

Objective: To analyse medical students’, graduate students’ and doctors’ and medical teachers’ perceptions of research contributions as criteria for authorship in relation to the authorship criteria defined by the International Committee of Medical Journal Editors .Design: Medical students with or without prior instruction on ICMJE criteria, graduate students/doctors and medical teachers rated the importance of 11 contributions as authorship qualifications. They also reported single contributions eligible for authorship, as well as acceptable combinations of two or three qualifying contributions.Results: Conception (...) and design, Analysis and interpretation and Drafting of article formed the most important cluster in all four groups. Students without prior instruction rated Critical revision and Final approval lower than the other three groups. “Final approval” was a part of the least important cluster in all groups except among students with instruction.Conclusions: Conception and design, Analysis and interpretation and Drafting of article were recognised as the most important of the ICMJE criteria by all participants. They can be considered independent of previous instruction or experience. Final approval and Critical revision should be actively taught as important authorship criteria to future scientists. (shrink)

This article explores the impact of an Increase in the average Number of Authors per Publication on known ethical issues of authorship. For this purpose, the ten most common ethical issues associated with scholarly authorship are used to set up a taxonomy of existing issues and raise awareness among the community to take precautionary measures and adopt best practices to minimize the negative impact of INAP. We confirm that intense international, interdisciplinary and complex collaborations are necessary, and INAP is an (...) expression of this trend. However, perverse incentives aimed to increase institutional and personal publication counts and egregious instances of guest or honorary authorship are problematic. We argue that whether INAP is due to increased complexity and scale of science, perverse incentives or undeserved authorship, it could negatively affect known ethical issues of authorship at some level. In the long run, INAP depreciates the value of authorship status and may disproportionately impact junior researchers and those who contribute to technical and routine tasks. We provide two suggestions that could reduce the long-term impact of INAP on the reward system of science. First, we suggest further refinement of the CRediT taxonomy including better integration into current systems of attribution and acknowledgement, and better harmony with major authorship guidelines such as those suggested by the ICMJE. Second, we propose adjustments to the academic recognition and promotion systems at an institutional level as well as the introduction of best practices. (shrink)

Background Several studies suggest that deviations from proper authorship practices are commonplace in medicine. The aim of this study was to explore experiences of and attitudes towards the handling of authorship in PhD theses at medical faculties in Denmark, Norway, and Sweden. Methods Those who defended their PhD thesis at a medical faculty in Scandinavia during the second half of 2020 were offered, by e-mail, to participate in an online survey. Survey questions dealt with experiences of violations of the first (...) three of the ICMJE authorship criteria and misuse of authorship order in the thesis articles, as well as respondents’ attitudes to these matters. Both questions with fixed response alternatives and questions with free-text responses were used. Quantitative data were analysed statistically using the Table functions in SPSS 25 and Chi-2 tests. Free-text responses were analysed qualitatively using manifest content analysis. Results 287 valid questionnaires were returned (response rate: 34.1%). Almost half (46.0%) of the respondents reported that the ICMJE authorship criteria were not fully respected in at least one of the papers in their thesis, while a vast majority (96.7%) found it important that authorship is handled according to the ICMJE authorship criteria. 24.4% reported inadequate handling of authorship order in at least one paper. The qualitative results provide a wide spectrum of examples of how the ICMJE authorship criteria are circumvented. Conclusion Despite increasing educational efforts to reduce deviations from good research practice at Scandinavian universities, the handling of authorship in medical papers remains problematic. (shrink)

This article argues that some reviewers contribute more to research than many authors, and suggests that reviewers meet the ICMJE criteria for authorship in many cases.

While much of the scholarly work on ethics relating to academic authorship examines the fair distribution of authorship credit, none has yet examined situations where a researcher contributes significantly to the project, but whose contributions do not make it into the final manuscript. Such a scenario is commonplace in collaborative research settings in many disciplines and may occur for a number of reasons, such as excluding research in order to provide the paper with a clearer focus, tell a particular story, (...) or exclude negative results that do not fit the hypothesis. Our concern in this paper is less about the reasons for including or excluding data from a paper and more about distributing credit in this type of scenario. In particular, we argue that the notion ‘substantial contribution’, which is part of the International Committee of Medical Journal Editors (ICMJE) authorship criteria, is ambiguous and that we should ask whether it concerns what ends up in the paper or what is a substantial contribution to the research process leading up to the paper. We then argue, based on the principles of fairness, due credit, and ensuring transparency and accountability in research, that the latter interpretation is more plausible from a research ethics point of view. We conclude that the ICMJE and other organizations interested in authorship and publication ethics should consider including guidance on authorship attribution in situations where researchers contribute significantly to the research process leading up to a specific paper, but where their contribution is finally omitted. (shrink)

Objectives Disclosures of funding sources and conflicts of interests (COI) in published peer-reviewed journal articles have recently begun to receive some attention, but many critical questions remain, for example, how often such reporting occurs concerning research conducted in the developing world and what factors may be involved. Design Of all articles indexed in Medline reporting on human subject HIV research in 2007 conducted in four countries (India, Thailand, Nigeria and Uganda), this study explored how many disclosed a funding source and (...) COI, and what factors are involved. Results Of 221 articles that met the criteria, 67.9% (150) disclosed the presence or absence of a funding source, but only 20% (44) disclosed COI. Studies from Uganda were more likely, and those from Nigeria were less likely to mention a funding source (p<0.001). Of articles in journals that had adopted International Committee of Medical Journal Editors (ICMJE) guidelines, 56% did not disclose COI. Disclosure of funding was more likely when: ≥50% of the authors and the corresponding author were from the sponsoring country, the sponsor country was the USA, and the articles were published in journals in which more of the editors were from the sponsoring countries. Conclusions Of the published studies examined, over a third did not disclose funding source (ie, whether or not there was a funding source) and 80% did not disclose whether COI existed. Most articles in ICMJE-affiliated journals did not disclose COI. These data suggest the need to consider alteration of policies to require that published articles include funding and COI information, to allow readers to assess articles as fully as possible. (shrink)

The consent process for publication of clinical images in medical journals varies widely. The extent of this variation is not known. It is also not known whether journals follow their own stated best practices or the guidance of the International Committee of Medical Journal Editors. We assessed consent requirements in a sample of 10 top impact factor general medicine journals that publish clinical images, examining variability in consent requirements for clinical image publication and congruence of requirements with the recommendations of (...) the ICMJE. Clinical image consent requirements varied widely from journal to journal. None of the studied journals, even amongst n = 4 ICMJE members or n = 8 journals who self-report adherence to ICMJE guidelines, comply with all of the recommendations of the ICMJE. Half of studied journals require a journal-specific consent form. Among top medical journals there is significant heterogeneity in consent requirements for clinical images. Variability of consent requirements is neither practical nor rational; inconsistent requirements create uncertainty for authors, present impediments to dissemination of scholarship, and undermine a shared professional understanding of how best to protect patient privacy. We propose adopting a standardized consent form and process for publication of identifiable images in medical journals, with uniform elements and explicit definitions. (shrink)

In medicine, professional behavior and ethics are often rule-based. We assessed whether instruction on formal criteria of authorship affected the decision of students about authorship dilemmas and whether they perceive authorship as a conventional or moral concept. A prospective non-randomized intervention study involved 203s year medical students who did (n = 107) or did not (n = 96) received a lecture on International Committee of Medical Journal editors (ICMJE) authorship criteria. Both groups had to read 3 vignettes and answer (...) 4 questions related to the distinction between conventional and moral domains. Written justification of student’ choices whether the authorship in a vignette was right or wrong was rated by 4 independent raters as based on justice or a rule. Formal instruction had no effect on students’ decisions on authorship in the vignettes (44, 34 and 39% ICMJE-consistent answers for 3 vignettes, respectively, by students receiving instruction vs. 38, 42 and 30% for those without instruction; P > 0.161 for all vignettes). For all dilemmas, more students decided contrary to ICMJE criteria and considered their decisions to be a matter of obligation and not a choice and to be general across situations and sciences. They were willing to change their decision if a rule was different only for peer situations but not for mentor–mentee situations. The number of students who used rule-based justification of their ICMJE criteria-consistent decisions was significantly higher in the instructed than in the uninstructed group. Instruction about formal authorship criteria had no effect on student’s decisions about authorship dilemmas and their decisions were related to the moral rather than a conventional domain. Teaching about authorship and other professionalism and integrity issues may benefit from interventions that bring intuitive processes into awareness instead of those fostering rule-based reasoning. (shrink)

To avoid the necessity of relying on trust in the matter of scientific authorship, most biomedical journals have adopted the uniform requirements for manuscripts submitted to biomedical journals, which are produced by the International Committee of Medical Journal Editors .1 The scientific journals that are members of the ICMJE routinely ask contributors to sign a statement that they accept full responsibility for the conduct of the study, had access to the data, and controlled the decision to publish. They even (...) request and publish information about the contributions of each person named as having participated.2,3 It turns out, however, that these requirements do …. (shrink)

BackgroundPatients with COVID-19 may feel under pressure to participate in research during the pandemic. Safeguards to protect research participants include ethical guidelines [e.g. Declaration of Helsinki and good clinical practice (GCP)], legislation to protect participants’ privacy, research ethics committees (RECs) and informed consent. The International Committee of Medical Journal Editors (ICMJE) advises researchers to document compliance with these safeguards. Adherence to publication guidelines has been suboptimal in other specialty fields. The aim of this rapid review was to determine whether (...) COVID-19 human research publications report compliance with these ethical safeguards.MethodsA rapid systematic literature review was conducted in MEDLINE using the search term ‘COVID-19’. The search was performed in April 2020 with no start date and repeated to include articles published in November 2020. Filters were ‘Full free text available’ and ‘English Language’. Two reviewers assessed article title, abstracts and full texts. Non-COVID-19 articles and non-clinical studies were excluded. Independent reviewers conducted a second assessment of a random 20% of articles. The outcomes included reporting of compliance with the Declaration of Helsinki and GCP, REC approval, informed consent and participant privacy.ResultsThe searches yielded 1275 and 1942 articles of which 247 and 717 were deemed eligible, from the April search and November respectively. The majority of journals had editorial policies which purported to comply with ICMJE ethical standards. Reporting of compliance with ethical guidelines was low across all study types but was higher in the November search for case series and observational studies. Reporting of informed consent for case studies and observational studies was higher in the November search, but similar for case series. Overall, participant confidentiality was maintained but some case studies included a combination of details which would have enabled participant identification. Reporting of REC approval was higher in the November search for observational studies.ConclusionsWhile the majority of journal’s editorial policies purported to support the ethical safeguards, many COVID-19 clinical research publications identified in this rapid review lacked documentation of these important safeguards for research participants. In order to promote public trust, ethical declarations should be included consistently. (shrink)

ObjectiveA high prevalence of authorship problems can have a severe impact on the integrity of the research process. We evaluated the authorship practices of clinicians from the same university hospital in 2019 to compare them with our 2003 data and to find out if the practices had changed.MethodsPractitioners were randomly selected from the hospital database. The telephone interviews were conducted by a single researcher using a simplified interview guide compared with the one used in 2003. The doctors were informed that (...) their answers would be aggregated without the possibility of identifying the respondents. During the interviews, the researcher ticked the boxes with the answers on a paper file.ResultsWe interviewed 26 clinicians from various medical specialties. They were unfamiliar with the ICMJE criteria for writing medical articles and felt that these criteria were not well met in general. With regard to ways of reducing the practice of honorary authors, the participants clearly felt that asking for a signature was hypocritical and of little use. The ghost authors were well known; this practice was considered as rather rare. The ‘publish or perish’ has always been cited as being responsible for bad practices. We compared these results with those observed in 2003 and no improvement has been observed in the past 15 years.ConclusionFor the second time in France, within a 15-year interval, we have shown that the ICMJE criteria were ignored and that honorary authorship was frequent. (shrink)

Numerous recommendations and guidelines aim to improve the quality, timeliness and transparency of medical publications. However, these guidelines use ambiguous language that can be challenging to interpret, particularly for speakers of English as a second language. Cultural expectations within the Asia-Pacific region raise additional challenges and several studies have suggested that awareness and application of ethical publication practices in the Asia-Pacific region is relatively low compared with other regions. However, guidance on applying ethical publication practice guidelines in the Asia-Pacific region (...) is lacking. This commentary aims to improve publication practices in the Asia-Pacific region by providing guidance on applying the 10 principles of the Good Publication Practice 3 (GPP3) guidelines and the International Committee of Medical Journal Editors (ICMJE) criteria for authorship. Recommendations are provided for encore presentations, applying the ICMJE authorship criteria in the context of regional cultural expectations, and the role of study sponsors and professional medical writers. Ongoing barriers to compliance with guidelines are also highlighted, and additional guidance is provided to support authors submitting manuscripts for publication. The roles of regional journals, regulatory authorities and professional bodies in improving practices are also discussed. (shrink)

An update of the widely acknowledged recommendations on how to handle authorship in research, issued by the International Committee of Medical Journal Editors, was issued in August, 2013. While the revised recommendations contain several clarifications compared to earlier versions, one arguably important aspect is still not addressed: the relationship between authorship and intellectual involvement in research. In this paper, it is argued that the ICMJE authorship criteria are flawed in this respect: they do not explicitly require of authors of (...) scientific papers that they do research. It is further suggested that unless academic authorship clearly reflects to what extent individual researchers have been intellectually involved in the research and to what extent they have merely contributed with research-related work, they will, in many cases, be misleading about research merits. (shrink)

One of the core problems of scientific research authorship is honorary authorship. It violates the ethical principle of clear and appropriate assignment of scientific research contributions. The prevalence of honorary authorship worldwide is alarmingly high across various research disciplines. As a result, many academic institutions and publishers were trying to explore ways to overcome this unethical research practice. The International Committee of Medical Journal Editors (ICMJE) recommended criteria for authorship as guidance for researchers submitting manuscripts to biomedical Journals. However, (...) despite the ICMJE guidelines, honorary authorship is still significantly present across various health research disciplines. The aim of this study was to explore the perceptions and knowledge of health care researchers towards honorary authorship according to the ICMJE guidelines across different health care fields in Jordan, which to our knowledge was never explored before. Data from an electronic survey that was distributed among researchers working in different healthcare fields across several major universities in Jordan, revealed that most of the respondents were assistant professors working mainly in the schools of Medicine and Pharmacy. The majority of the respondents (65.5%) were not aware of the ICMJE authorship guidelines. And, around 37% reported the inclusion of an honorary author, in which the most common non-authorship task reported by 73% of the respondents was reviewing the manuscript. Our findings emphasize the need for national academic and research institutions to address the issue of authorship in their educational programs and internal policies. (shrink)

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) research (P = (...) 0.001), more sponsor-country authors (P = 0.003), sponsor-country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host-country involved (P = 0.002), journals having sponsor-country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor-country editors and research being biomedical.Conclusions: One-third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) research (P = (...) 0.001), more sponsor‐country authors (P = 0.003), sponsor‐country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host‐country involved (P = 0.002), journals having sponsor‐country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor‐country editors and research being biomedical.Conclusions: One‐third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)

_This is a personal account based on many years experience as a medical writer. It considers aspects of medical writing with particular focus on the intellectual and ethical dilemmas it can raise. What makes medical writing both so interesting and so challenging is the fact that it often takes place at the border between different disciplines. For example, it straddles both science and art. Ethical issues also arise at the boundaries between academia and commerce. Until recently there have been few (...) guidelines to help navigate such potentially dangerous territory. I have been privileged to be involved in developing two such guidelines and I describe how I hope the Good Publication Practice guidelines for pharmaceutical companies and the European Medical Writers Association guidelines may improve the practice of this fascinating profession, Medical Writing._. (shrink)