Policies and Management of Conflicts of Interest Within Medical Research Institutional Review Boards: Results of a National Study

The often close relationship between academia—specifically academic medicine—and industry has been highlighted in a number of sensational stories in the popular and academic press.1–3 Often the focus of such articles is on individuals with close ties to industry, but conflicts of interest (COIs) also exist at the institutional level, and these may pose far greater threats to the integrity of science and medicine. Institutional conflicts can arise through close institutional ties to industry, via patent agreements or financial investments, for example, but can also arise through the individual conflicts of officers or others who act on behalf of the institution. One such group is members of institutional review boards (IRBs) who review and approve research protocols on behalf of the institution. These persons serve the institution, and yet are often seasoned investigators who frequently have relationships with industry. Prior research has found that some IRB members in academic medical centers receive research funding from industry or financial compensation for participation in meetings and conferences; serve as paid consultants or members of speakers’ bureaus or scientific advisory boards; serve as an officer, executive, or paid employee in industry; receive royalties or equity; or serve on a board of directors. Altogether, more than one third of IRB members may have one or more such relationship with industry in any given year.4 The ramifications of IRB members’ industry relationships and COIs are not well understood, but the perception is that the risks to IRB functions are real. For example, in 1999, at least 2000 studies involving human subjects at Duke University were suspended after the federal government determined that Duke did not adequately protect patients involved in such studies.5 Among the 20 deficiencies cited by the Office for Protection from Research Risks (now the Office of Human Research Protections, or OHRP) was that the COIs of senior level administrators at Duke had compromised the ability of the IRB to make independent and unbiased decisions regarding research protocols. The concern over the potential impact of industry relationships on institutional and IRB decisions with regard to medical research has led to a number of discussions and recommendations from both federal and non-federal organizations6–8, with the most recent report issued by a joint Association of American Medical Colleges (AAMC) and Association of American Universities (AAU) advisory committee in February 2008. 9 However, despite the promulgation of federal guidance by the U.S. Department of Health and Human Services,10 there are currently no regulatory requirements placed on IRBs. Current Federal regulations state only that IRB members may not participate in discussions or decisions on any protocol in which they may have a conflicting interest, except to provide information.10(45 CFR 46.107e) This policy provides no standards on what constitutes a meaningful COIs, nor does it suggest policies and procedures to protect IRB-related activities from conflicts. The most recent recommendation by the joint AAMC-AAU advisory committee asks institutions to require the routine reporting of data on all financial interests from all IRB members and to establish clear policies for defining COIs, but lacks a concrete recommendation about who should be responsible for these activities within the institution.9 Establishing a Conflict of Interest Committee, separate from the IRB, is one possible approach suggested by the National Human Research Protections Advisory Committee in their comments to the Deputy Assistant Secretary for Health on draft interim guidance in 2001.11 This recommendation was based in part on an internal investigation by the National Institutes of Health (NIH), which found that only 25% of all IRBs routinely deal with investigators’ and IRB members’ industry relationships and financial COIs during IRB deliberations.12 There is no recent data on the management of conflicts during deliberations, or other tactics IRBs use to manage relationships and COIs prior to final deliberations. This study seeks to provide information on IRB-specific policies and practices with regard to industry relationships and conflicts, and to determine if current policies and procedures are consistent with existing federal guidance. This study examines how IRBs at the most research-intensive medical institutions in the United States manage industry relationships and COIs among their members, and whether IRB chairs feel that current policies are sufficient to ensure the integrity of the IRB’s activities.