Policies and Management of Conflicts of Interest Within Medical Research Institutional Review Boards: Results of a National Study

Massachusetts General Hospital, Department of Medicine, Institute for Health Policy, and Harvard Medical School, Boston, MA 02038, USA.
Academic medicine: journal of the Association of American Medical Colleges (Impact Factor: 2.93). 05/2009; 84(4):488-94. DOI: 10.1097/ACM.0b013e31819a8ae7
Source: PubMed


To examine institutional review board (IRB) policies and practices with regard to conflicts of interest (COIs) among IRB members who review and approve research protocols and to assess IRB policies and procedures in light of federal policies and guidance.
An anonymous survey of IRB chairs serving the most research-intensive medical institutions in the United States was conducted in fall 2005. The survey collected information about the chairs, the IRBs, and the processes IRBs had in place to manage member relationships and COIs.
Two hundred eleven out of 296 eligible chairs responded (71.7%). One third of IRBs in the nation's medical schools and major academic medical centers did not require voting members to disclose relationships with industry. In practice, IRB member industry relationships were disclosed to the entire IRB (75.9%), the IRB chair (62.1%), and/or a group or entity separate from the IRB but within the institution it serves (52.5%). One in five chairs of IRBs did not feel confident that their IRB's policies and procedures ensured appropriate disclosure of industry relationships in every case. Finally, one in four IRBs did not have written policies defining appropriate actions when IRB member COIs were identified.
The relatively high proportion of IRBs without a requirement that voting members disclose industry relationships is inconsistent with current guidance, and likely results in lapses in awareness of when members with conflicts vote on protocols. There was no clear consensus on where oversight responsibility for member-industry relationships should lie.

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    • "Yet in one study, though 36% of IRB members had financial relationships with industry, 23% of those never disclosed it to the IRB, and 19.4% nonetheless always voted on the protocol [11]. Of medical center IRBs, one-third do not require that members disclose financial COI [15], yet one-third of IRB chairs do not always arrange for members with COI to leave the room when the protocol is discussed. Others argue that IRB members should disclose COIs, but still participate in IRB deliberations, as they may have relevant expertise [16]. "
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    ABSTRACT: Conflicts of interest (COIs) in research have received increasing attention, but many questions arise about how Institutional Review Boards (IRBs) view and approach these. I conducted in-depth interviews of 2 hours each with 46 US IRB chairs, administrators, and members, exploring COI and other issues related to research integrity. I contacted leaders of 60 IRBs (every fourth one among the top 240 institutions by NIH funding), and interviewed IRB leaders from 34 of these institutions (response rate = 55%). Data were analyzed using standard qualitative methods, informed by Grounded Theory. IRBs confront financial and non-financial COIs of PIs, institutions, and IRBs themselves. IRB members may seek to help, or compete with, principal investigators (PIs). Non-financial COI also often appear to be "indirect financial" conflicts based on gain (or loss) not to oneself, but to one's colleagues or larger institution. IRBs faced challenges identifying and managing these COI, and often felt that they could be more effective. IRBs' management of their own potential COI vary, and conflicted members may observe, participate, and/or vote in discussions. Individual IRB members frequently judge for themselves whether to recuse themselves. Challenges arise in addressing these issues, since institutions and PIs need funding, financial information is considered confidential, and COI can be unconscious. This study, the first to explore qualitatively how IRBs confront COIs and probe how IRBs confront non-financial COIs, suggests that IRBs face several types of financial and non-financial COIs, involving themselves, PIs, and institutions, and respond varyingly. These data have critical implications for practice and policy. Disclosure of indirect and non-financial COIs to subjects may not be feasible, partly since IRBs, not PIs, are conflicted. Needs exist to consider guidelines and clarifications concerning when and how, in protocol reviews, IRB members should recuse themselves from participating, observing, and/or voting.
    Full-text · Article · Jul 2011 · PLoS ONE
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    • "This is in agreement with the International Committee of Medical Journal Editors, World Association of Medical Editors, Committee on Publication Ethics, American Medical Association, and Association of American Medical Colleges. Despite no industry involvement, conflicts of interest must be disclosed.47,49,51-53 "
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