The study provides the first national data on the personal, professional, and research characteristics of faculty members who serve on IRBs in the nation's medical schools and hospitals. IRBs were set up to protect human subjects in clinical research, but many reports have criticized IRBs for failing to adequately protect people participating in research. Some have charged that IRB members were not experienced enough. Others have suggested financial conflicts of interest involving the pharmaceutical industry.
Faculty members, who make up about half of those who serve on IRBs, have extensive research experience and knowledge and often serve as opinion leaders and may guide the board's activities. But the fact that 47 percent of the faculty IRB members who are also researchers served as consultants to industry within three years of the time of the study period (October 2001 to March 2002) may be a reason for concern.
"Our previous research with faculty has shown us that ties to industry can affect scientific behavior, leading to such things as trade secrecy and delays in publishing research," says Eric G. Campbell, PhD, lead author of the study and an assistant professor in medicine at the Institute for Health Policy, Massachusetts General Hospital (MGH) and Harvard Medical School. "It's possible that similar relationships with companies could affect IRB members' activities and attitudes, although our current study did not directly address this issue."
Almost all faculty who participate on IRBs are involved with research, especially clinical research. This means they tend to have personal research experience and knowledge that may inform their IRB-related activities. But this knowledge could also lead to conflicts of interest of a non-financial nature that should be explored in future research. For example:
- Clinical researchers serving on IRBs may feel pressure not to impede studies important to their individual areas of research, their departments, or to their colleagues - representing a potential non-financial conflict of interest.
- Some faculty IRB members who conduct clinical research may feel pressure to block studies of other investigators when the proposed research might compete with their own studies.
According to Joel S. Weissman, PhD, of the MGH Institute for Health Policy, a co-author of the study, "It is important to note that clinical research experience and relationships with industry can benefit IRBs since these areas are fundamental considerations when deciding on the appropriateness of a study. However, these benefits must be weighted against the potential risks"
The study, which surveyed 2,989 faculty members from 125 medical schools across the country between October 2001 and March 2002, determined several characteristics of researchers most likely to serve on IRBs. Among the findings:
- The strongest predictor of IRB participation was race/ethnicity. Under-represented minorities were 3.2 times more likely than white faculty to serve on an IRB. This higher participation may lead to greater attention paid to issues of race/ethnicity in the design and conduct of culturally sensitive clinical trials.
- Of those surveyed who served on IRBs, 73 percent were male, 81 percent were white, 8 percent were Asian, and 11 percent were under-represented minorities.
- Clinical researchers were 1.64 times more likely to serve on an IRB than were faculty who conducted non-clinical research.
- Consulting relationships with industry are common among faculty IRB members.
Finally, the study data indicate that serving on an IRB is not associated with decreased levels of research productivity as measured by publications. The authors indicate several possible reasons: the demands of IRBs are not sufficient enough to impede research activities; IRB service provides members with research ideas and insights; IRB members may be more efficient than non-IRB faculty; or faculty members with high rates of publications are drawn to IRB service.
The study, which was funded by the Burroughs Welcome Fund, the Commonwealth Fund Task Force on Academic Health Centers, The Doris Duke Charitable Foundation and the Pew Charitable Trusts, was conducted by Campbell, Weissman, Recai Yucel, PhD, Nancyanne Causino, EdD, and David Blumenthal, MD, MPP, all of the Institute for Health Policy, Massachusetts General Hospital and Harvard Medical School; and Brian Clarridge, PhD, of the Center for Survey Research at the University of Massachusetts Boston.
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 $350 million and major research centers in AIDS, cardiovascular research, cancer, cutaneous biology, medical imaging, neurodegenerative disorders, transplantation biology and photomedicine. In 1994, MGH and Brigham and Women's Hospital joined to form Partners HealthCare System, an integrated health care delivery system comprising the two academic medical centers, specialty and community hospitals, a network of physician groups, and nonacute and home health services.