Correspondence

Financial Relationships of Institutional Review Board Members

N Engl J Med 2007; 356:965March 1, 2007

Article

To the Editor:

Campbell et al. (Nov. 30 issue)1 provide valuable data on financial conflicts of interest of members of institutional review boards (IRBs). However, they do not address potentially more problematic conflicts of interest inherent in the IRB system. Industry-sponsored protocols are reviewed and approved by IRBs consisting almost entirely of employees of the academic medical center, many of whom may be involved in the conduct of industry-sponsored research. Disapproval of such protocols means that less money will flow into the institution and its clinical-trials operation, with a potential deleterious financial effect. Consider, for example, a placebo-controlled trial evaluating an investigational (“me too”) drug with a minimal change from a standard drug. Such a trial arguably lacks clinical value, thus failing to justify exposing patients to placebo.2 Are IRBs prepared to reject such protocols when their members know that industry sponsors can go to other academic medical centers with IRBs that are more industry-friendly? Institutional conflicts of interest are just one reason favoring the use of regional ethics review committees as an alternative to IRBs.3

Franklin G. Miller, Ph.D.
National Institutes of Health, Bethesda, MD 20892-1156
fmiller@nih.gov

The views expressed in this letter are those of the author and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the Department of Health and Human Services.

3 References

1. 1

   Campbell EG, Weissman JS, Vogeli C, et al. Financial relationships between institutional review board members and industry. N Engl J Med 2006;355:2321-2329
   Full Text | Web of Science | Medline

2. 2

   Miller FG, Shorr AF. Ethical assessment of industry-sponsored clinical trials: a case analysis. Chest 2002;121:1337-1342
   CrossRef | Web of Science | Medline

3. 3

   Wood A, Grady C, Emanuel EJ. Regional ethics organizations for protection of human research participants. Nat Med 2004;10:1283-1288
   CrossRef | Web of Science | Medline

Author/Editor Response

It seems likely that institutional conflicts of interest of the type that Miller describes could arise at medical schools and teaching hospitals around the country. In the focus-group and individual interviews performed for our study, participants voiced concern about this very issue. However, to our knowledge, there are no national, quantitative data demonstrating how frequently such conflicts of interest occur and the extent to which IRBs are unwilling to reject a study of questionable scientific value because to do so would result in a loss of research funding for their institution. We believe future research should explore this issue before new policies are made regarding the use of regional ethics review committees in lieu of traditional IRBs.

Eric G. Campbell, Ph.D.
Christine Vogeli, Ph.D.
Joel S. Weissman, Ph.D.
Massachusetts General Hospital, Boston, MA 02114
ecampbell@partners.org

Citing Articles (1)

Citing Articles

1. 1

   Eduardo Montero Ruiz, Joaquín López Álvarez. (2008) Fiabilidad de los ensayos clínicos aleatorizados publicados. Medicina Clínica 131:15, 583-584
   CrossRef