Publication ethics glossary
Academic institutions increasingly have relationships with industries, such as pharmaceutical and biotechnology companies, for various purposes, including research funding, drug development, and technology transfer.(1) These relationships are common and can create conflicts of interest for faculty members; such conflicts need to be disclosed to the journals to which they submit papers. Disclosure is important, in part because research has shown that authors with ties to industry are more likely than those without such relationships to report results that favour the sponsor.(2) Research conducted by authors with ties to the sponsor is less likely to be published (i.e., negative results may be suppressed), and such studies, when published, may be of lower quality than studies conducted by authors without such ties.(3) To uncover these potential effects, and to increase accountability and transparency, journals should have clear and accessible policies on conflicts of interest.
In some disciplines, in particular the humanities, in which sole authorship is common, being the author of a paper simply means having written it. In science and medicine, however, authorship can be much more complex. The meaning of authorship may be very different and have little to do with writing. Instead, authorship credit may be given for: having had an idea for a project, being part of a research team, contributing patients, records, or materials to a study, running experiments, analysing data, or interpreting results.
Various definitions of authorship, usually combining the concepts of credit and responsibility, exist. The most extensive discussion of authorship has probably been in biomedicine, where explicit criteria have been developed over the past two decades.
An important early requirement was that each named author on a paper had to be able to take public responsibility for its content, and to be able to explain and defend the work. In 1985, the International Committee of Medical Journal Editors (ICMJE) established criteria for authorship. These have been revised and refined since, with the current version as follows:
“Authorship credit should be based on; 1) substantial contributions to conception and design, acquisition of data or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3. . . . Acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify authorship. . . . All persons designated as authors should qualify for authorship, and all those who qualify should be listed.” (4)
The order in which authors are listed may also reflect specific responsibilities, roles, or status. Sometimes authors’ names are listed alphabetically, or various explanations may be given for the order in which names appear (selected by a coin toss, etc.). Journals may elect to publish authors’ explanations for the order of names given on the byline.
Non-medical disciplines may have substantially different definitions, traditions, and practices of authorship. Because of this variability, journals should publish the criteria they use for authorship.
Clinical trials registration
To prevent selective reporting of results of clinical trials (see section: Data suppression), and the subsequent distortion of the totality of evidence related to a specific medical intervention, the International Committee of Medical Journal Editors (ICMJE) announced in 2004 that its member journals would require the registration of all clinical trials on submitted reports.(5) In this way, the existence and important features of all trials become part of a searchable public record. For ICMJE journals, registration is a precondition of considering a clinical trial report for publication.
Conflicts of interest
The potential for a conflicts of interest exists when an author, reviewer, editor, or institution has a relationship with another interest that could be seen to bias or influence the work. These relationships are often, though not exclusively, financial. The most common relationships that journals might consider as constituting conflicts of interest include: employment, stock ownership, consultancies, or membership on a board or speakers’ bureau. Journals may request disclosure of these relationships in order to evaluate whether they may have a bearing on the work in question. In some cases, journals may wish not to consider work from authors who have certain types of conflicts.
Reviewers and editors may also have conflicts of interest. Reviewers should be asked to declare any potential conflicts with papers they are asked to review. If these conflicts are so severe as to make an impartial review of the work impossible, the reviewer should recuse himself from reviewing the paper, and return the manuscript, without further consideration of it, to the journal.
Editors’ conflicts of interest are rarely discussed, but journals should have policies in place to address this issue. Some journals or publishers may have rules governing editors’ conflicts of interest. Conflicts may be reported privately to a governing, editorial, or advisory board and/or published in the journal.
The Council of Science Editors recently issued a guidance document for journals to use as a resource when formulating conflict of interest policies.(6)
Contributorship has been proposed as an alternative to authorship.(7) Anyone who contributed to a study or a paper can be listed, along with a brief description of that person’s role. This system removes the responsibility for any single author to be able to defend a paper in its entirety, a significant development in an era of large, extremely specialised, multi-centre collaborations. In addition, detailing authors’ specific roles can facilitate exchanges of information and expertise.
The major advantage of the contributorship system is its transparency: readers (and editors) can see for themselves exactly what all those involved with a study actually did. Listing contributors does not usually, however, do away with the author byline, the problems inherent to which remain. And, since there is no requirement for any one author to be able to defend the entire work, it is conceivable that a problem could be found with a study for which no one would ultimately be held accountable. This prospect led to the development of the idea of a guarantor, a contributor who takes responsibility for the integrity of the work as a whole.
Copyright, copyright infringement, intellectual property
Copyright is a form of legal protection for intellectual property. Copyright laws vary by country and can be exceedingly complex. In the United States, laws of copyright protect the original expression (in words, sounds, or images) of a work that is “fixed in any medium” (i.e., a work does not have to be published to be covered by copyright). Many publishers require authors to transfer all or some rights to the publisher. Authors are not then free to use these copyrighted works without permission from the publisher; to do so may infringe the copyright.
Data generated as part of research activities generally belong to the institution where the work was conducted, and should remain at that institution, even when researchers leave the institution. Therefore, institutions often have rules prohibiting researchers from entering into research projects in which another party (e.g., a sponsor, funding agency, or industry) would claim ownership or control of data. In addition, institutions may have policies about data retention, archiving, and destruction of research records. Likewise, some journals require authors to be able to produce a paper’s raw data for a specified period of time (The Lancet, for example, requires data to be retained for 5 years).
Access to data is a critical issue for researchers. Because of several highly contentious cases in which sponsors have prevented researchers from having unfettered access to their data(8) some journals require that authors attest that the sponsor placed no restrictions on access to data.
Sponsors (industry, government, etc.) are sometimes reluctant to submit for publication results that are unfavourable to them, and occasionally try to exercise veto power over submitting results for publication. Such suppression of data (underreporting, selective reporting) can have serious consequences—for the literature, for public health, and for the integrity of science.
“Plagiarism is the copying of ideas, data or text (or various combinations of the three) without permission or acknowledgment” according to the Royal College of Physicians.(9) Plagiarism is a form of scientific misconduct; it is dishonest and misleading to readers. Authors frequently regard use of their own previously published material without quotation not as “self-plagiarism” but as a legitimate use of their own work. Though there is little consensus on the acceptability this practice, it is, however, often a violation of copyright.
Publication bias is defined by the US National Library of Medicine as “unrepresentative publication of research reports that is not due to the quality of the research but to other characteristics, e.g., tendencies of investigators to submit, and publishers to accept, positive research reports (i.e., ones with results showing a beneficial treatment effect of a new intervention).(10) Both authors (as less likely to submit papers with negative results) and editors (as less likely to publish studies with negative results) have been suggested to be responsible for its occurrence. (11)
The publication of the same information in more than one paper is variously referred to as divided, duplicate, dual, prior, repetitive, or redundant publication. The practice is wasteful of the resources of reviewers, editors, and publishers, and of readers. In biomedicine, it can have serious consequences for the accuracy of meta-analyses and the occurrence of diseases and conditions. Authors may sometimes have legitimate reasons for wishing to publish parts of one study as several different papers or for different journals. In this case, authors should be sure to cite prior papers, inform editors of their existence and any overlap with a paper submitted for publication, and enclose copies of work submitted elsewhere but not yet published. (12)
Responsibilities of reviewers
Peer review is a time-honoured tradition in science, which aims to improve the quality of the published literature. Editors of scientific journals depend upon the advice of expert reviewers for assessing the originality, accuracy, and importance of papers submitted to their journals. There are a number of generally accepted standards for peer review. Those that follow are adapted from WAME Recommendations on Publication Ethics Policies for Medical Journals: (13)
- Reviewers should assess:
- strengths and weaknesses of study design and methodology, and of the paper as a written communication,
- the quality of the interpretation of the data, including acknowledgment of its limitations,
- and, any ethical concerns raised by the study, or any evidence of low standards of scientific conduct.
- Reviewers should provide authors with useful suggestions for improving the paper, through constructive, professional comments.
- Reviewers should provide editors with the proper context and perspective to make a decision on the acceptability of the paper for publication. (Some journals may ask for a recommendation on whether the article should be published).
- Reviewers should treat a paper as a privileged, confidential communication.
- Reviewers must not share a paper with anyone, unless the journal’s policies permit this, without explicit permission from the editor.
- Reviewers must not use information gained from a paper for their own use before publication.
- Reviewers should notify the editor, and no one else, if they suspect misconduct.
Misconduct may include fabrication or falsification of data, fraud, plagiarism, misappropriation of the work and ideas of others, serious deviations from standard research practices, deception, manipulation of data (including figures, graphs, and other elements), and failure to comply with laws and regulations governing research. This does not include honest error.
Cases of research misconduct receive a great deal of attention when they occur in medicine because of their implications for public health, but egregious instances have also occurred in other scientific fields. (14)
Journals should have policies in place for handling allegations of misconduct. Most editors do not have the expertise, and most journals do not have the resources, to conduct formal investigations into such allegations. The responsibility for this usually falls upon a researcher’s employer or funding agency. (15)
One example of a procedure for responding to allegations of misconduct is described below: (16)
All allegations of misconduct will be referred to the Editor-In-Chief, who will review the circumstances in consultation with the deputy editors. Initial fact-finding will usually include a request to all the involved parties to state their case, and explain the circumstances, in writing. In questions of research misconduct centring on methods or technical issues, the Editor-In-Chief may confidentially consult experts who are blinded to the identity of the individuals, or if the allegation is against an editor, an outside editor expert. The Editor-In-Chief and deputy editors will arrive at a conclusion as to whether there is enough evidence to lead a reasonable person to believe there is a possibility of misconduct. Their goal is not to determine if actual misconduct occurred, or the precise details of that misconduct.
When allegations concern authors, the peer review and publication process for the manuscript in question will be halted while the process above is carried out. The investigation described above will be completed even if the authors withdraw their paper, and the responses below will still be considered. In the case of allegations against reviewers or editors, they will be replaced in the review process while the matter is investigated.
All such allegations should be kept confidential; the number of inquiries and those involved should be kept to the minimum necessary to achieve this end. Whenever possible, references to the case in writing should be kept anonymous.
Journals have an obligation to readers and patients to ensure that their published research is both accurate and adheres to the highest ethical standard. Therefore, if the inquiry concludes there is a reasonable possibility of misconduct, responses should be undertaken, chosen in accordance with the apparent magnitude of the misconduct. Responses may be applied separately or combined, and their implementation should depend on the circumstances of the case as well as the responses of the participating parties and institutions. The following options are ranked in approximate order of severity:
- A letter of explanation (and education) sent only to the person against whom the complaint is made, where there appears to be a genuine and innocent misunderstanding of principles or procedure.
- A letter of reprimand to the same party, warning of the consequences of future such instances, where the misunderstanding appears to be not entirely innocent.
- A formal letter referring the concerns to the relevant head of educational institution and/or funding body, with all the commentary and evidence collected by the journal. This will occur when it is believed that genuine misconduct is likely to have occurred, and its goal will be to submit the case for consideration of formal review and judgment by organisations better suited to that task than a peer review journal.
- A formal letter as above, including a written request to the supervising institution that an investigation be carried out and the findings of that inquiry reported in writing to the journal.
- Publication of a notice of redundant or duplicate publication or plagiarism, if appropriate (and unequivocally documented). Such publication will not require approval of authors, and should be reported to their institution.
- Formal withdrawal or retraction of the paper from the scientific literature, published in the journal, informing readers and the indexing authorities (National Library of Medicine, etc), if there is a formal finding of misconduct by an institution. Such publication will not require approval of authors, should be reported to their institution, and should be readily visible and identifiable in the journal. [For medical journals, it] should also meet other requirements established by the International Committee of Medical Journal Editors.(17) It is recommended that editors inform readers and authors of their reservation of the right to publish a retraction if it meets these conditions, thereby helping decrease arguments with authors.
- Editors or reviewers who are found to have engaged in scientific misconduct should be removed from further association with the journal, and this fact reported to their institution.
Sponsorship generally refers to the funding of research. In biomedical journals, the appropriate role of sponsors has been carefully elaborated: Sponsors should allow researchers full access to data and must not be able to veto the publication of results. Many journals require authors to disclose, in the methods section of the paper, the role of the study sponsor(s), if any, in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication.
Books and articles:
- American Medical Association Manual of Style, 9th ed. Baltimore: Williams & Wilkins, 1998.
- Godlee F, Jefferson T. Peer Review in Health Sciences, 2nd ed. London: BMJ Books, 2003.
- Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct. Washington DC: National Academies Press, 2002.
- International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. .
- Jones AH, McLellan F. Ethics in Biomedical Publication. Baltimore: Johns Hopkins University Press, 2000.
- Shamoo AE, Resnik DB. Responsible Conduct of Research. Oxford: Oxford University Press, 2003.
(1) See Cho MK, Shohara R, Schissel A, Rennie D. Policies on faculty conflicts of interest at US universities. JAMA. 2000 Nov 1;284(17):2203-8.
(2) See Bero LA, Galbraith A, Rennie D. The publication of sponsored symposiums in medical journals. N Engl J Med 1992 Oct 15;327(16):1135-40; Stelfox HT, Chua G, O'Rourke K, Detsky AS. Conflict of interest in the debate over calcium-channel antagonists. N Engl J Med 1998 Jan 8;338(2):101-6.
(3) See Blumenthal D, Campbell EG, Anderson MS, Causino N, Louis KS. Withholding research results in academic life science. Evidence from a national survey of faculty. JAMA. 1997 Apr 16;277(15):1224-8; Cho MK, Bero LA. The quality of drug studies published in symposium proceedings. Ann Intern Med. 1996 Mar 1;124(5):485-9; and Bero LA, Rennie D. Influences on the quality of published drug studies. Int J Technol Assess Health Care. 1996 Spring;12(2):209-37.
(7) See Rennie D, Yank V, Emanuel L. When authorship fails. A proposal to make contributors accountable. JAMA 1997 Aug 20;278(7):579-85
(8) See, for example, Rennie D. Thyroid storm. JAMA. 1997 Apr 16;277(15):1238-43.
(9) Royal College of Physicians. Fraud and misconduct in medical research: Causes, investigation, and prevention. London: Royal College of Physicians, 1991, p. 3
(11) See Olson CM, Rennie D, Cook D, Dickersin K, Flanagin A, Hogan JW, Zhu Q, Reiling J, Pace B.
Publication bias in editorial decision making. JAMA. 2002 Jun 5;287(21):2825-8
(12) For a full discussion of the consequences of and remedies for repetitive publication, see Huth EJ. Repetitive and divided publication. In: Jones AH, McLellan F. Ethical Issues in Biomedical Publication. Baltimore: Johns Hopkins University Press, 2000: 112-136.
(14) For an analysis of a case in physics, see http://publish.aps.org/reports/lucentrep.pdf.
For elaboration of this definition as it applies to biomedical research in the USA, see http://ori.dhhs.gov/documents/institutional_policies.pdf.
For information about definitions of scientific misconduct as applied in various disciplines internationally, see the following websites:
(15) A very useful resource is Managing Allegations of Scientific Misconduct: A Guidance Document for Editors (http://ori.dhhs.gov/documents/masm_2000.pdf).
(16) Taken from http://www.wame.org/pubethicrecom.htm#misconduct, with permission.
(17) See http://www.icmje.org/#correct.