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      Conflicts of Interest in GM Bt Crop Efficacy and Durability Studies

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      PLoS ONE
      Public Library of Science

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          Abstract

          Public confidence in genetically modified (GM) crop studies is tenuous at best in many countries, including those of the European Union in particular. A lack of information about the effects of ties between academic research and industry might stretch this confidence to the breaking point. We therefore performed an analysis on a large set of research articles ( n = 672) focusing on the efficacy or durability of GM Bt crops and ties between the researchers carrying out these studies and the GM crop industry. We found that ties between researchers and the GM crop industry were common, with 40% of the articles considered displaying conflicts of interest (COI). In particular, we found that, compared to the absence of COI, the presence of a COI was associated with a 50% higher frequency of outcomes favorable to the interests of the GM crop company. Using our large dataset, we were able to propose possible direct and indirect mechanisms behind this statistical association. They might notably include changes of authorship or funding statements after the results of a study have been obtained and a choice in the topics studied driven by industrial priorities.

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          Pharmaceutical industry sponsorship and research outcome and quality: systematic review.

          To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support. Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus. 30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality. Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias.
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            Making Sense of Non-Financial Competing Interests

            Imagine you're a peer reviewer who's received a request to referee a paper. The paper reports the results of a study using cell lines derived from an aborted fetus as a diagnostic tool in identifying certain viral infections. You are also a member of a religious organization morally opposed to fetal cell research. In your review, you raise questions about the study's validity and methodology that might undermine the paper's chance of publication. Imagine you're an editor and you receive a paper from the scientist who supervised your postdoctoral fellowship. It's been a couple of years since you left his lab, but he has supported your career and you have warm feelings toward him; plus you still join your former lab mates occasionally at their monthly pub night. You select sympathetic reviewers and you fight hard for the paper at the editorial meeting. These two scenarios reflect true ones; and each provides an example of how a personal interest might conflict with your responsibility to ensure the integrity of the publication process. Are such non-financial competing interests of less concern than commercial interests in the publication of research? Not if they disrupt honest reporting, fair review, and transparent publication. Non-financial competing interests (sometimes called “private interests”) can be personal, political, academic, ideological, or religious. Like financial interests, they can influence professional judgment. Much as we'd like to believe that the reporting and evaluation of research are always objective, there is substantial evidence to the contrary [1]. Like all human activity, academic research and scientific publishing are inherently subjective, imperfect, and prone to bias, corruption, and self-interest. Indeed, because professional affinities and rivalries, nepotism, scientific or technological competition, religious beliefs, and political or ideological views are often the fuels for our passions and for our careers, private competing interests are perhaps even more potent than financial ones. Furthermore, the very nature of academic and editorial work ensures that none of us are immune. Expertise in itself presents a kind of conflict of interest. Ask one of the top malarial researchers to declare her competing interests when reviewing a transmission modeling paper and she may say, “I am a direct competitor. Who could review this paper who was not?” But how detrimental are private interests to the publication process? And what kind of guidance is out there to make sense of non-financial competing interests? Like commercial interests, non-financial competing interests can influence professional judgment. Taking a tour through the archives of COPE, the Committee on Publication Ethics (an advisory service for editors), reveals many cases of undeclared and problematic competing interests, and many of these go beyond the financial (http://www.publicationethics.org.uk/). Harvey Marcovitch, chair of COPE, notes that half of the conflict of interest cases brought by editors and publishers to the last COPE Forum for advice involved non-financial interests (personal communication). But he also says that he isn't yet convinced that bad publication behavior arising from non-financial competing interests is on the increase. It would be fair to say, however, that awareness of the existence and impact of non-financial competing interests remains tiny relative to our awareness of financial bias. Studies continue to show that many if not most authors have some sort of financial stake in their publications, that these are often not declared, and that having a financial interest in research affects not only an author's interpretation and conclusions, but the very design and execution of studies [2–4]. But no such evidence base exists for private interests. Because more is known about the impacts of financial interests, they have been easier for journals to define and to regulate. But it's time to start taking non-financial competing interests more seriously. As with all competing interests, what's in dispute is not that they exist, but how to manage them. The responsibility of journals and the wider research communities is to safeguard the credibility of the scientific and editorial processes. Three things are needed to start making sense of non-financial competing interests. First, Disclosure Everyone has competing interests; financial or private, or both. The main problem with competing interests is nondisclosure [5]. As with all competing interests, it is not possible to reliably judge our own biases. Instead, declaring them allows others to make informed judgments about whether the competing interests are relevant or not. It's necessary to establish a standard by which authors, reviewers, and editors are required to disclose whether they have non-financial interests that (1) might influence their reporting or review of the paper and/or (2) would negatively or positively be influenced by the publication of the paper. These interests would include unpaid board, governmental, or committee memberships; political or religious views; and personal relationships such as friendships or family relations, as well as mentoring and adversarial professional interactions. For example, authors should declare if they serve on the editorial board of the journal to which they are submitting or if they have acted as an expert witness in relevant legal proceedings. Reviewers should be expected to declare if they have held grants, co-authored papers, or worked in the same institution with the authors of the study they are reviewing. Establishing such a standard is by no means easy. The BMJ abandoned attempts to require declarations of non-financial competing interests (it now simply encourages disclosure) because the definitions were disputed and the policy unworkable [6]. Neither JAMA, Nature Medicine, The New England Journal of Medicine, nor Science require disclosure of private interests. A recent discussion on the listserv of the World Association of Medical Editors (WAME), whose editorial policy committee (of which JC is a member) is currently updating its conflict of interest policy, affirms how difficult it is to define and regulate private interests. In the end, because WAME members felt that non-financial conflicts were so nebulous and unquantifiable, WAME decided that the policy should remain focused on financial interests. Second, More Policy Development Nevertheless, it is possible and, we believe, necessary to encourage openness in addressing some of the clearer sources of non-financial bias. Journals can't police non-financial competing interests any more than they can police commercial interests. But they can develop clear and explicit policies that outline definitions of non-financial conflicts of interests and expectations for author, reviewer, and editorial behavior. PLoS has a comprehensive competing interest policy (http://journals.plos.org/plosmedicine/competing.php) that builds upon those of other organizations such as the Council of Science Editors (http://www.councilscienceeditors.org/editorial_policies/policies_endorsement.cfm), the International Committee of Medical Journal Editors (http://www.icmje.org/#conflicts), and WAME (http://www.wame.org/resources/policies#fundres). Our policy states that no decision on papers submitted to PLoS journals will be made until the competing interests—financial, personal, and professional—of all authors are declared, and that we will publish all relevant positive and negative statements of competing interests. Reviewers are required to declare any interests that might interfere with their objective assessment of a manuscript, and these are considered by the editors in determining the suitability of the reviewer. Editors are by no means above these standards of best practice. PLoS Medicine, along with a very small number of other medical journals such as the BMJ [7], posts the competing interests of its editors in the interest of full disclosure (http://journals.plos.org/plosmedicine/editors_interests.php), and this seems a reasonable community standard for all journals. The PLoS policy also requires that individual editors recuse themselves from deliberations about papers authored by friends, colleagues, or adversaries [8]. Third, More Research One impediment to good policy in this area is a lack of evidence. The development and implementation of explicit policies on non-financial competing interests will clearly benefit from being based upon strong evidence of the extent, nature, and impact of private interests. Although the evidence base on commercial influences on the scientific and editorial enterprises continues to mount, very little research has tackled non-financial competing interests. There are a few notable exceptions. In a systematic review, Luborsky and colleagues found that a researcher's allegiance to a given school of thought exerted a bias on the study design and outcomes of psychotherapy research comparable to that which has been documented for financial interests [9]. Examining the editorial process, Goldsmith and colleagues reviewed 228 consecutive manuscripts submitted to the Journal of Investigative Dermatology in 2003 [10] and found the odds of acceptance to be two times higher for manuscripts from which authors had excluded reviewers, compared to those whose authors had not done so. Quoted in Science [11], Goldsmith said “Excluding reviewers ends up being very, very important. People know their assassins.” Similarly, separate studies by Sara Schroter [12] and Liz Wager [13] support the idea that reviewers favorably biased toward the authors are more likely to recommend acceptance and less likely to advocate rejection than the (presumably) more objective editor-selected reviewers. These examples are intriguing, but many questions remain. Is it fair to assume editor-identified reviewers are more objective than author-suggested ones? Is it reasonable to prohibit a reviewer from refereeing the paper of his ex-wife, but allow him to review those of his ex-sister-in-law? What is the appropriate time period for excluding a reviewer on the basis of co-authorship or working in the same institution—one year, two years, five? Can a government employee report on the findings of her department's research any more objectively than a pharmaceutical company employee reports his industry-funded work? Do religious views exert a more powerful effect than political ones? Who should judge editors' competing interests? Is disclosure a panacea, or can it perversely provide a license to present more biased assertions [1]? And in specialized fields, isn't almost everyone a friend, colleague, or competitor? Despite the messy and imprecise nature of private interests, researchers and editors must persist in establishing a better understanding of their extent and impact. Any assumption that non-financial competing interests are less common or influential than financial incentives is probably misguided. It's accepted that political interference in science is dangerous, that governments and funders do not make decisions on the basis of science alone, and that intellectual and professional commitments often lead to strong personal views. When it comes to making sense of non-financial competing interests, why shouldn't we be interested?
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              Financial relationships between institutional review board members and industry.

              Little is known about the nature, extent, and consequences of financial relationships between industry and institutional review board (IRB) members in academic institutions. We surveyed IRB members about such relationships. We surveyed a random sample of 893 IRB members at 100 academic institutions (response rate, 67.2%). The questionnaire focused on the financial relationships that the members had with industry (e.g., employment, membership on boards, consulting, receipt of royalties, and paid speaking). We found that 36% of IRB members had had at least one relationship with industry in the past year. Of the respondents, 85.5% said they never thought that the relationships that another IRB member had with industry affected his or her IRB-related decisions in an inappropriate way, 11.9% said they thought this occurred rarely, 2.4% thought it occurred sometimes, and 0.2% thought it occurred often. Seventy-eight respondents (15.1%) reported that at least one protocol came before their IRB during the previous year that was sponsored either by a company with which they had a relationship or by a competitor of that company, both of which could be considered conflicts of interest. Of these 78 members (62 voting members and 16 nonvoting members), 57.7% reported that they always disclosed the relationship to an IRB official, 7.7% said they sometimes did, 11.5% said they rarely did, and 23.1% said they never did. Of the 62 voting members who reported conflicts, 64.5% reported that they never voted on the protocol, 4.8% said they rarely did, 11.3% said they sometimes did, and 19.4% said they always did. Most respondents reported that the views of IRB members who had experience working with industry were beneficial in reviewing industry-sponsored protocols. Relationships between IRB members and industry are common, and members sometimes participate in decisions about protocols sponsored by companies with which they have a financial relationship. Current regulations and policies should be examined to be sure that there is an appropriate way to handle conflicts of interest stemming from relationships with industry. Copyright 2006 Massachusetts Medical Society.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                15 December 2016
                2016
                : 11
                : 12
                : e0167777
                Affiliations
                [1 ]Inra, Univ. Nice Sophia Antipolis, CNRS, UMR 1355–7254 Institut Sophia Agrobiotech, Sophia Antipolis, France
                [2 ]Inra, UMR 1062 Centre de Biologie pour la Gestion des Populations (CBGP) Inra-IRD-CIRAD-Montpellier SupAgro, 755 avenue du Campus Agropolis, CS, Montferrier / Lez cedex. France
                Universidade Federal de Vicosa, BRAZIL
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                • Conceptualization: TG DB.

                • Formal analysis: TG EL DB.

                • Investigation: TG EL DB.

                • Methodology: TG DB.

                • Supervision: TG DB.

                • Writing – original draft: TG EL DB.

                • Writing – review & editing: TG EL DB.

                Article
                PONE-D-16-28648
                10.1371/journal.pone.0167777
                5157974
                27977705
                0efb2de0-4769-4c62-aeb6-a3541e0868f5
                © 2016 Guillemaud et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 22 July 2016
                : 2 November 2016
                Page count
                Figures: 4, Tables: 1, Pages: 14
                Funding
                The authors received no specific funding for this work.
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                Agricultural Biotechnology
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