More than one-third of the members of Institutional Review Boards (IRBs) – committees at medical research organizations charged with ensuring that clinical studies uphold patient rights and follow ethical guidelines – have financial relationships with commercial firms. In the Nov. 30 New England Journal of Medicine, investigators from the Massachusetts General Hospital (MGH) Institute for Health Policy report the results of a survey of IRB members from academic medical centers across the U.S. While most IRB members did not believe that industry relationships have compromised the review process, a few reported that they had participated in discussions or voted on studies despite having industry relationships that could be conflicts of interest.
“The IRB process must be independent and objective,” noted Eric G. Campbell, PhD, of the MGH Institute for Health Policy, the study’s principal investigator. “Financial relationships with study sponsors create competing interests that could undermine the objectivity of the IRB process. Policies and practices regarding the disclosure and management of such relationships among IRB members need to withstand intense scrutiny, and our results suggest that we can do much better.”
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. While researchers’ industry relationships have been an area of concern for several years, no previous studies have examined the extent and impact of such relationships among IRB members.
During 2005, the MGH research team conducted an anonymous survey of almost 900 members of IRBs at medical schools and research hospitals across the country. Questionnaires were sent to a random sample of IRB members asking whether they had specific relationships with companies – including paid consultant, officer or director, scientific advisory board or speakers bureau member, and recipient of royalties or research funds. Some respondents noted the potential benefits to the research process of industry relationships – such as giving IRB members a better understanding of industry standards and how products may relate to others currently on the market.
Survey respondents also were asked if their IRBs had established processes for disclosing industry relationships and written standards defining when those relationships become conflicts of interest. They were asked whether in the previous year their IRBs had reviewed protocols sponsored either by companies with which they had relationships or by competitors. Those faced with reviewing such studies were asked to indicate whether they had disclosed the relationship, how fully they had participated in discussions of the protocols, and whether or not they had voted.
Among the 574 IRB members who responded to the survey, 36 percent reported having some kind of industry relationship. The great majority of respondents did not believe that other IRB members’ relationships had an inappropriate impact on their decisions or on how protocols had been presented. However, only 67 percent of respondents said their IRBs had a procedure for disclosing industry relationships, and only half were aware of written definitions of conflicts of interest. While only 15 percent of respondents reported that their IRBs had reviewed studies that posed conflicts of interest for them, almost half of them – 7 percent of all respondents – said they had either freely participated in IRB discussions of those protocols or voted on such studies.
“While many IRB members have financial relationships with sponsors, those relationships are not presently seen by IRB members as having a major impact on their activities,” said Greg Koski, MD, PhD, a senior member of the MGH research team and formerly director of the Office for Human Research Protections at the U.S. Department of Health and Human Services. “The bad news is that our policies and procedures, as well as our efforts to educate IRB members about conflicts of interest, are clearly inadequate.”
Additional co-authors of the NEJM report are Joel S. Weissman, PhD, Christine Vogeli, PhD, Melissa Abraham PhD, and Jessica Marder of the MGH Institute for Health Policy and Brian Clarridge, PhD, of the University of Massachusetts, Boston. The study was supported by a grant from 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 nearly $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, transplantation biology and photomedicine. MGH and Brigham and Women's Hospital are founding members of Partners HealthCare HealthCare System, a Boston-based integrated health care delivery system.
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