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It has been suggested that having many different sponsors with different interests protects against COI-induced bias. As of 2006, there was no evidence for or against this hypothesis.<ref name=wouldsaythat_JRSM_2006/>
It has been suggested that having many different sponsors with different interests protects against COI-induced bias. As of 2006, there was no evidence for or against this hypothesis.<ref name=wouldsaythat_JRSM_2006/>

==Effect on conclusions of research==
There is evidence that industry funding of studies of medical devices and drugs results in these studies having more positive conclusions regarding efficacy.<ref>{{Cite journal |last=Lundh |first=Andreas |last2=Lexchin |first2=Joel |last3=Mintzes |first3=Barbara |last4=Schroll |first4=Jeppe B. |last5=Bero |first5=Lisa |date=2017-02-16 |title=Industry sponsorship and research outcome |language=en |publisher=John Wiley & Sons, Ltd |doi=10.1002/14651858.mr000033.pub3}}</ref> A similar relationship has been found in clinical trials of surgical interventions, where industry funding leads to researchers exaggerating the positive nature of their findings.<ref>{{Cite journal |last=Probst |first=Pascal |last2=Knebel |first2=Phillip |last3=Grummich |first3=Kathrin |last4=Tenckhoff |first4=Solveig |last5=Ulrich |first5=Alexis |last6=Büchler |first6=Markus W. |last7=Diener |first7=Markus K. |date=2016-07 |title=Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery |url=http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00000658-201607000-00015 |journal=Annals of Surgery |volume=264 |issue=1 |pages=87–92 |doi=10.1097/sla.0000000000001372 |issn=0003-4932}}</ref> Not all studies have found a statistically significant relationship between industry funding and study outcome.<ref>{{Cite journal |last=Chartres |first=Nicholas |last2=Fabbri |first2=Alice |last3=Bero |first3=Lisa A. |date=2016-12-01 |title=Association of Industry Sponsorship With Outcomes of Nutrition Studies |url=http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jamainternmed.2016.6721 |journal=JAMA Internal Medicine |language=en |volume=176 |issue=12 |pages=1769 |doi=10.1001/jamainternmed.2016.6721 |issn=2168-6106}}</ref><ref>{{Cite journal |last=Voineskos |first=Sophocles H. |last2=Coroneos |first2=Christopher J. |last3=Ziolkowski |first3=Natalia I. |last4=Kaur |first4=Manraj N. |last5=Banfield |first5=Laura |last6=Meade |first6=Maureen O. |last7=Chung |first7=Kevin C. |last8=Thoma |first8=Achilleas |last9=Bhandari |first9=Mohit |date=2016-02 |title=A Systematic Review of Surgical Randomized Controlled Trials |url=http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00006534-201602000-00061 |journal=Plastic and Reconstructive Surgery |volume=137 |issue=2 |pages=453e–461e |doi=10.1097/01.prs.0000475767.61031.d1 |issn=0032-1052}}</ref>


== Interests of research participants ==
== Interests of research participants ==

Revision as of 19:02, 6 July 2018

Conflicts of interest undermine the reliability of some academic journal articles cited on Wikipedia. The Sponsored Point of View panel discusses this problem in 2012

Conflicts of interest (COIs) often arise in academic publishing. Such interests do not necessarily imply wrongdoing if managed in an ethical manner. Academic publishing has some ethical standards in place for handling conflicts of interest, and is continuing to develop new standards. Standards vary between journals and are unevenly applied. According to the International Committee of Medical Journal Editors, "Authors have a responsibility to evaluate the integrity, history, practices and reputation of the journals to which they submit manuscripts."[1]

Conflicts of interest make research bias more likely. Both disclosed and undisclosed conflicts of interest can harm research quality and the public good.[2] Conflicts of interest can involve research sponsors, authors, journals, journal staff and peer reviewers.

Avoidance, disclosure, and tracking

Some COIs may be prohibited

Avoiding conflicts of interest, and changing the structure of institutions to make them easier to avoid, is frequently advocated. Some institutional ethics policies ban academics from entering into specific types of COIs, for instance by prohibiting them from accepting gifts from companies connected to their work.[3] Education in ethical COI management is also a tool for avoiding COIs.[3]

Disclosure of conflicts of interest has been debated since the 1980s; there is a general consensus favouring disclosure.[2] However, there is also a view that COI concerns and some measures to reduce them are excessive.

Criticisms of disclosure policies include:

  • authors disclosing COIs may feel pressure to present their research in a more biased manner to compensate[2]
  • disclosure of COIs may discourage beneficial academic–industry collaboration[4]
  • disclosure of COIs may decrease public trust in research[4]
  • researchers who have declared their COIs may feel license to behave immorally[4][5]
  • disclosure of COIs may be taken as a sign of honesty or expertise, and thus increase trust[4]
  • some types of COI may be more likely to go unnoticed or unreported[4]
  • awareness of a COI does not make people immune to being influenced by bias; generally, people do not discount biased advice sufficiently.[4][5]
  • disclosure of COI discourages the judging of work purely on its merits[4]
  • disclosure of COIs causes more intense scrutiny for wrongdoing[4]

While COI disclosure is widely favoured, other COI management measures have narrower support. Some publications hold that certain COIs disqualify people from certain research roles; for instance that testing medicines should be done only by people who neither develop medicines nor take funding from their manufacturers.[2][5]

Conflicts of interests have also been considered as a statistical factor confounding evidence[clarification needed], which must therefore be measured as accurately as possible and analysed, requiring machine-readable disclosure.[2]

Codes of conduct

Journals have individual ethics policies and codes of conduct, but there are also some cross-journal voluntary standards.

The International Committee of Medical Journal Editors (ICMJE) publishes Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals, and a list of journals who pledge to follow it. The guideline lays down detailed rules for conflict-of-interest declaration by authors. It also says: "All participants in the peer-review and publication process — not only authors but also peer reviewers, editors, and editorial board members of journals — must consider their conflicts of interest when fulfilling their roles in the process of article review and publication and must disclose all relationships that could be viewed as potential conflicts of interest."[1] The Recommendations have been criticised and revised to remove loopholes allowing the non-disclosure of conflicts of interest.[6]

The Council of Science Editors publishes a White Paper on publication ethics. Citing the ICMJE that "all participants in the peer-review and publication process must disclose all relationships that could be viewed as potential conflicts of interest", it highly recommends COI disclosure for sponsors, authors, reviewers, journals, and editorial staff.[7]

The Good Publication Practice (GPP) guidelines, covering industry-sponsored medical research only, are published by the International Society of Medical Publication Professionals.[8]

The Committee on Publication Ethics (COPE) publishes a code of conduct, stating that "There must be clear definitions of conflicts of interest and processes for handling conflicts of interest of authors, reviewers, editors, journals and publishers, whether identified before or after publication"[9]

The Open Access Scholarly Publishers Association's Principles of Transparency and Best Practice in Scholarly Publishing is intended to separate legitimate journals from predatory publishers,[10] and lays out a minimal standard: clear COI policies, clearly stated.[11]

A 2009 US Institute of Medicine report on medical COIs states that conflict of interest policies should be judged on their proportionality, transparency, accountability, and fairness; they should be effective, efficient, and targeted, known and understood, clearly identify who is responsible for monitoring, enforcement, and amendment, and apply equally to everyone involved. Review by conflict-of-interest committees is also recommended, and the lack of transparency and COI declaration in developing COI guidelines criticized.[3]

Journal COI policies often have no enforcement provisions, as of 2015.[12] COI disclosure obligations have been legislated, but not specifically for journals.[3]

COIs by agent

COIs of journals

These are institutional COIs. They cannot, therefore, be altered simply by replacing the people facing them.

Journals are often not transparent about their institutional COIs, and apply stricter disclosure standards to authors than to themselves.[13][14] Four out of six major general medical journals contacted for a 2010 COI study refused to provide information on the proportion of their income from advertisements, reprints, and industry-supported supplements, citing policies on non-disclosure of financial information.[14]

Owners and governing bodies

Journals are more likely to accept papers by authors who work at the journals' hosting institutions.[15][16] This may be due to conflicts with social interests or institutional loyalties. The owner of an academic journal has ultimate power over hiring and firing of editorial staff;[17] the editor's interest in pleasing their employer conflicts with some of their other editorial interests.[18][19]

Some journals are owned by publishers. When a journal run book reviews of books published by their own publisher, they rarely (as of 2003) add COI disclosures.[20] The publisher's legal obligations to maximize profit conflict with any interests behind profit-lowering decisions. In the case of closed-access publications, the publisher's desire for high subscription income may conflict with an editorial desire for broader access and readership. There have been multiple mass resignations of editorial boards over such conflicts,[21] often followed by the editorial board founding a new nonprofit journal to compete with their former one (examples).[22]

Some journals are owned by academic societies and professional organisations. Leading journals can be very profitable,[23][24] and there is often friction between the journal and the member society that owns it over revenue.[23][23][17][24] Some academic societies and professional organizations are themselves funded by membership fees and/or donations. If the owners benefit financially from donations, the journal has a conflict between its financial interest in satisfying the donors, and therefore the owners, and its journalistic interests. Such COIs with industry donors have drawn criticism.[25]

Reprints

A reprint is a copy of an individual article,[26] printed and sold as a separate product by the journal (or its publisher or agent).[14][18] Reprints are often used in pharmaceutical marketing and other medical marketing of products to doctors.[26] This gives journals an incentive to produce good marketing material.[14][18] Journals sell reprints at high very profit margins, often around 70%, as of 2010. A journal may sell a million dollars' worth reprints of a single article, if, say, it is a large industry-funded clinical trial.[24] It is thus unsurprising that selling reprints can bring in over 40% of a journal's total income.[14]

Impact factors, reputation, and subscriptions

The impact factor of a journal is often used to rate the journal, although this practice is widely criticized. A journal will generally want to increase its impact factor, in hope of more subscriptions, better submissions, and more prestige.[24] As of 2010, industry-funded papers generally get cited more than others, likely partly due to industry-paid publicity.[14][19]

If a journal is accused of managing COIs badly, its reputation is harmed.[27]

Advertising

Many academic journals contain advertising. The proportion of a journal's revenue coming from advertising varies widely, according to one small study from over 50% to 1%.[14] As of 2010, advertising revenues are generally falling for academic journals.[24] A 1995 survey of North American journal editors found that 57% felt responsible for the honesty of the pharmaceutical ads they ran, and 40% supported peer-review of such ads.[18] An interest in increasing ad revenue can, therefore, conflict with interests in journalistic independence and truthfullness.

As of 2002, some journals publish supplements, which often either cover an industry-funded conference or are "symposia" on a given topic. These supplements are often subsidized by an external sponsor with a financial interest in the outcome of research in that field (for instance, a drug manufacturer or food industry group). Such supplements can have guest editors,[1] are often not peer-reviewed to the same standard as the journal itself, and are more likely to use promotional language.[18] Many journals do not publish sponsored supplements.[14] Small-circulation journals are more likely to publish supplements than large, high-prestige journals.[28]

The ICMJE code of conduct specifically addresses guest-editor COIs: "Editors should publish regular disclosure statements about potential conflicts of interests related to their own commitments and those of their journal staff. Guest editors should follow these same procedures." It also states that the usual journal editor must maintain full control and responsibility, and "Editing by the funding organization should not be permitted."[1]

The US Food and Drug Administration states that supplement articles should not be used as medical-marketing reprints, but as of 2009, had no legal authority to prohibit the practice.[26]

COIs of journal staff

Personal conflicts of interest faced by journal staff are individual, and if a person leaves the journal, their personal COIs will go with them (contrast with the COIs of journals as institutions above).

COIs of journal staff are less commonly reported than those of authors, as of 2015.[12] For instance, one 2009 World Association of Medical Editors (WAME) policy document states that "Some journals list editors’ competing interests on their website but this is not a standard practice."[29] However, the ICMJE requires that the COIs of editors and journal staff be regularly declared and published.[1]

One 2017 Open Payments study of influential US medical journals found that half of the editors received payments from industry;[30] another, using a different sample of editors, made it two-thirds.[31] As of 2002, there is often not a system for reporting wrongdoing by editors.[18]

Many journals have policies on what COIs staff can enter into; for instance, accepting gifts of travel, accommodation, or hospitality may be prohibited. Such policies are rarely published as of 2006.[32] Most journals do not offer COI training, and many report wanting better guidance on COI policy, as of 2015.[12]

COIs of peer reviewers

The ICJME recommendations require peer reviewers to disclose conflicts of interest.[1] Half to two-thirds of journals (depending on subject area) did not follow this recommendation in the first two decades of the 21st century.[33] As of 2017, if a peer reviewer fail to disclose a conflict of interest, the paper will generally not be withdrawn, corrected, or re-reviewed, but the reviews may be reassessed.[34]

If peer reviewers are anonymous, their COIs cannot be published. Some experiments with publishing the names of reviewers have been undertaken; in others, the identities of reviewers were disclosed to authors, allowing authors to identify COIs.[35] Some journals now have an open review process, in which everything, including the peer reviews and the names of the reviewers, and editor and author comment, is published transparently online.[30]

The duties of peer review may conflicts with social interests or institutional loyalties. To avoid such COIs, reviewers may be excluded if they have some forms of COI, such as having collaborated with the author.[33]

COIs of article authors

Authors of individual papers may face conflicts with their duty as an author to report truthfully and impartially. Financial, career, political, and social interests are all sources of conflict.[29] Authors' institutional interests become sources of conflict when the research might harm the institution's finances, or offend the author's superiors.[3]

Many journals require authors to self-declare their conflicts of interest when submitting a paper; they also ask specific questions about conflicts of interest. The questions vary substantially between journals.[32] However, author declarations are rarely verified by the journal. As of 2018, "most editors say it’s not their job to make sure authors reveal financial conflicts, and there are no repercussions for those who don’t".[36] Even if a conflict of interest is reported by a reader after publication, COPE does not suggest independent investigation, as of 2017.[37]

As a result, as of 2018, authors with conflicts of interest often simply do not declare them.[38][36] Rates of nondisclosure vary widely in reported studies.[2]

The COPE retraction guidelines state that "Retractions are also used to alert readers to... failure to disclose a major competing interest likely to influence interpretations or recommendations"[39] However, as of 2018, if an author fails to disclose a COI, the paper will usually be corrected;[40] it will usually not be retracted.[41] However, paper retractions, notifications to superiors, and publication bans are possible. Non-disclosure incidents harm academic careers.[40] Authors are held to have collective responsibility for the contents of an article;[42] if one author fails to declare a conflict of interest, the peer review process may be deemed compromised, and the whole paper retracted.

Public registries of author COIs have been suggested.[2] Authors face administrative burdens in declaring COIs; standardized declarations[3] or a registry could reduce these.[2]

Ghost authors and non-contributing authors

Ghost authorship, where a writer contributes but is not credited, has been estimated to affect a significant proportion of the research literature. Honorary authorship, where authors are credited but did not contribute, is more common.[43] Appearing as an author on many papers is good for an academic's career. Failure to adhere to authorship standards is rarely punished.[43] To avoid misreported authorship, requiring that all authors described the contribution they made to the study ("movie-style credits") has been advocated.[44]

The ICMJE criteria for authorship require that authors contribute.

  • Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
  • Drafting the work or revising it critically for important intellectual content; AND
  • Final approval of the version to be published; AND
  • Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
— ICMJE[42]

The ICMJE requires that "All those designated as authors should meet all four criteria for authorship, and all who meet the four criteria should be identified as authors. Those who do not meet all four criteria should be acknowledged".[42] Academics who have had publication ethics training and those who are aware of the ICMJE authorship criteria are more stringent in their concepts of authorship, and more likely to consider breaches of authorship as misconduct, as are more junior researchers. Awareness is low; one study found that only about half of researchers had read the ICJME criteria.[43]

Ghostwriters may be legally liable for fraud.[45][46]

COIs of study sponsors

If a study requires outside funding, this can be a major source of conflicting interests; for instance, if the manufacturer of a drug is funding a study into its safety and efficacy,[14] or the sponsor hopes to use the research to defend itself in litigation.[47] Sponsors of a study may involve themselves in the design, execution, analysis, and write-up of a study. In extreme cases, they may carry out the research and ghostwrite the article with almost no involvement from the nominal author.[46][45] Movie-style credits are advocated as a way to avoid this.[44]

In some cases, a contract with a sponsor may mean that those named as investigators and authors on the papers may not have access to the trial data, or control over the publication text, or the freedom to talk about their work.[48][49] While authors and institutions have an interest in avoiding such contracts, it conflicts with their interest in competing for funding from potential study sponsors.[50] Institutions which set stricter ethical standards for sponsor contracts lose contracts, and funding, when sponsors go elsewhere.[48]

Sponsors have required contractual promises that the study not be reported without the sponsor's approval (gag clauses),[48][51] and sued authors over compliance.[52][51] Trials may go unpublished to keep commercial information secret, or because the trial results were unfavourable.[53] Some journals require that human trials be pre-registered in order to be considered for publication;[53] some require that any gag clause be declared as a conflict of interest;[1]: 4  since 2001, some also require a statement that the authors have not agreed to a gag clause.[48][49] Some journals require a promise to provide access to the original data to researchers intending to replicate the work.[54] Some research ethics boards,[55] universities,[51] and national laws[56] prohibit gag clauses. Gag clauses may not be legally enforceable if compliance would cause sufficient public harm.[51] Non-publication has been found to be more common in industry-funded trials, contributing to publication bias.[55]

It has been suggested that having many different sponsors with different interests protects against COI-induced bias. As of 2006, there was no evidence for or against this hypothesis.[32]

Effect on conclusions of research

There is evidence that industry funding of studies of medical devices and drugs results in these studies having more positive conclusions regarding efficacy.[57] A similar relationship has been found in clinical trials of surgical interventions, where industry funding leads to researchers exaggerating the positive nature of their findings.[58] Not all studies have found a statistically significant relationship between industry funding and study outcome.[59][60]

Interests of research participants

Chronically ill medical research participants report expecting to be told about COIs, and some report that they would not participate if the researcher had some sorts of COIs.[32] Multiple ethical guidelines forbid researchers with a financial interest in the outcome from being involved in human trials, with few exceptions.[3]

The consent agreements entered into with study participants may be legally binding on the academics, but not on the sponsor, unless the sponsor has a contractual commitment saying otherwise.[61]

Ethical rules, including the Declaration of Helsinki, require that the results of human trials be published,[53] and human trial participants are often motivated by a desire to improve medical knowledge.[62] Patients may also be harmed if safety data, such risks to patients, are kept secret.[49] Duties to human-research participants, therefore, can conflict with interests in nonpublication[49] (such as gag clauses, detailed above[48]).

Publication of COI declarations

Some journals place COI declarations at the beginning of an article, but most put it at the end in smaller print.[32] Positioning makes a difference; if a reader feels that they are being manipulated from the beginning of a text, they read more critically than if the same feeling is produced at the end of a text.[63]

The ICMJE says only that "each journal should develop standards with regard to the form the [COI] information should take and where it will be posted".[1] It is often placed after the body of the article, just before the reference section.[64] Some COI statements, like the COI statements of anonymous reviewers, may not be published at all. (see COIs of peer reviewers) COI statements are sometimes paywalled, so that they are not visible to anyone who has not paid for fulltext access.[65][66]

In 2017 PubMed began including COI statements at the end of the abstract, before the body of the article,[64] after complaints that, as COI declarations were only included in article fulltexts, they often went unseen for paywalled articles.[66]

Science journalism rarely reports COI information from the academic article reported upon (in some studies, <1% of stories reported COI information).[2]

False statements of COIs

Failing to disclose a conflict of interest may, depending on the circumstances, be considered a form of corruption[67] or academic misconduct.[68]

See also

References

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External links

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