Policies regarding IRB members' industry relationships often lacking

March 25, 2009

At a time of heightened concern about conflicts of interest posed by relationships between academic medical researchers and commercial firms, a new study finds that a significant number of academic institutions do not have clear policies covering the industrial relationships of members of Institutional Review Boards (IRBs), committees charged with ensuring that clinical studies uphold patient rights and follow ethical guidelines. In the April issue of Academic Medicine, researchers from the Massachusetts General Hospital (MGH) Institute for Health Policy report that many IRBs do not require members to disclose industrial relationships and that procedures for defining, reporting and handling conflicts vary widely among institutions.

"This study points to an obvious need for more consistent policies and accountability in regards to industry relationships within IRBs," says lead author Christine Vogeli, PhD. "IRBs and medical schools can't manage what they don't know, so consistent reporting among IRB members is vital to ensuring the integrity and safety of medical research."

Every institution in the U.S. that conducts research involving human participants must have an IRB, which is responsible for reviewing proposed studies to make sure the rights and safety of participants are protected and that study protocols are scientifically valid and follow ethical and regulatory guidelines. IRBs also monitor the conduct of studies to make sure that appropriate practices are maintained. In 2006 MGH Institute of Health Policy researchers, including the authors of the current study, published a survey of IRB members regarding their personal industrial relationships, whether their IRBs had policies or processes regarding such relationships, and their own actions regarding protocols related to companies with which they had relationships.

The current study surveyed the chairs of IRBs at 107 U.S. medical schools and research hospitals regarding how their committees managed members' industrial relationships, whether members were required to disclose such relationships, how and to whom conflicts were disclosed, and where responsibility for overseeing such conflicts should reside. While nearly 75 percent of chairs reported their IRBs had a defined process for disclosure of industry relationships, of the 25 percent without such processes, only one had any requirement that voting members disclose relationships.

Written policies defining conflicts of interest were reported by 68 percent of chairs, the others indicating they did not have or were not aware of such policies. Chairs of IRBs without written conflict definitions indicated that responsibility for determining whether a conflict existed was left to the chair, the whole IRB, another group or individual, or that members would assess their own relationships. Policies describing how conflicts should be handled were reported by 74 percent of chairs.

Among chairs who reported dealing with a member conflict of interest in the past year, 68 percent indicated that conflicted members had never participated in discussions about the protocols in question or left the room when votes were taken. Although all of the chairs that had dealt with a recent conflict reported no conflicted members ever voted on protocols in which they had an interest, in the 2006 survey of IRB members, one third of respondents reported that they had voted on such a protocol at least once.

"It is shocking that, after more than 20 years of talking about industry relationships and conflicts of interest, there are still IRBs out there that haven't dealt with this issue," says Eric G. Campbell, PhD, of the MGH Institute for Health Policy, the study's senior author. "It also is clear that many IRB chairs have no clue about the behavior of their members who have industry relationships. The IRB is the primary mechanism medical schools and hospitals have to ensure the appropriate conduct of clinical research, and IRBs without clear, well-defined and enforced policies about conflicts of interest cannot accomplish their fundamental mission,"
-end-
Campbell is an associate professor of Medicine at Harvard Medical School, where Vogeli is an instructor of Medicine. Greg Koski, PhD, MD, an associate professor of Anesthesia at HMS, member of the MGH Institute for Health Policy, and former director of the Office for Human Research Protections at the U.S. Department of Health and Human Services, is also a co-author of the Academic Medicine report. The study was supported by the Research on Ethical Issues in Human Subjects Research program of the National Institutes of Health.

Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $500 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.

Massachusetts General Hospital

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