Policies and Management of Conflicts of Interest Within Medical Research Institutional Review Boards: Results of a National Study
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.
Available from: Robert Klitzman
- "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 . Of medical center IRBs, one-third do not require that members disclose financial COI , 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 . "
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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.
Available from: Alexander Rapidis
- "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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ABSTRACT: Objectives: To review outcomes and complications of endoscope-assisted submandibular sialadenectomy (EASS) and to analyze this innovative technique with regard to ethical issues. Methods: We used a systematic review study design to identify clinical studies on EASS, published in English, French, German, and Thai. The last electronic search was conducted in September 2009. We checked the bibliographies of the identified articles, relevant local journals, and congress abstracts. Publications were further assessed and assigned their respective levels of evidence. We also investigated reporting on human subject protection, conflicts of interest, funding support, and commercial relationships. Results: Five case series reporting a total of 28 patients met the inclusion criteria. There was no need of recourse to open surgery. All of the authors claimed satisfactory cosmetic results. Complications were uncommon. However, no controlled trial was available, and outcome measures varied between studies. Human subject protection and funding sources were mentioned in only 2 articles. Commercial relationships and conflicts of interest could not be identified. Conclusions: All of the reports favor outcomes of EASS. However, their level of evidence is low, and the superiority of this procedure over the conventional surgery remains unknown. The success of this procedure should not be overemphasized in information for consent and mislead surgeons to begin it without adequate training and elaborate environment. The lack of ethical documentation creates a high degree of suspicion of the studies.
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ABSTRACT: Horse Named Jim and other events in history affecting clinical research - horse Jim, for preparing antitoxin for diphtheria;King John of England, and the Assize of Bread - law prohibiting adulteration of bread with ingredients as ground peas or beans;National Commission for Protection of Human Subjects of Biomedical and Behavioral Research - ethical principles in clinical researches;Nuremberg Code - ethical standards and biomedical experiments;children and death, contaminated antitoxin preparation from tetanus developed horse;genetically altered cold viruses infusion - triggering multiple-organ failure;long term usage of thalidomide and peripheral neuritis;elixir of sulfanilamide, mislabeled drug
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