conflict of interest also provide more resources than are available to academic committees, resources that, in fact, allow the independent review boards to perform robust reviews (Thacker, 2002). Individual member conflicts can be addressed as described earlier, but a further concern is involved if the independent board members, who are paid for their services, have a vested interest in approving research and facilitating friendly relations with sponsors to ensure their own income (Lemmens and Freedman, 2000; Thacker, 2002). Moreover, if a given review board does not satisfy a client, the client can end the business relationship and go “IRB shopping.”

In addressing these concerns, independent boards point out that they are paid regardless of the review outcome and that business management aspects should be, and often are, completely separated from the review function (Jacobs, 2001; Thacker, 2002). A recent FDA proposal for rulemaking aims to counter the IRB shopping concern somewhat by requiring sponsors and investigators to inform boards of any prior reviews (FDA, 2002a; Lemmens and Thompson, 2001; OIG, 1998c).10 In addition, independent Research ERBs must adhere to the federal regulations governing human research; if a board was censured by the Office for Human Research Protections (OHRP) for failing to perform its duties or was cited by FDA for compliance violations, it would lose credibility within the research community, adversely affecting its income and possibly its entire business.

ETHICS REVIEW: CLARIFYING THE ROLES AND RESPONSIBILITIES OF RESEARCH ERBS

Independent review of proposed research by Research ERBs to determine ethical acceptability should provide a comprehensive ethical assessment of protocols from the perspective of the local community and the institution. However, despite the central role of these review boards in the federal regulations and the research review process, their ability to keep pace with the enormous volume of work and the high-quality services expected of them has been in question for some time (AAU, 2001; GAO, 1996; Levine, 2001a; NBAC, 2001b; OIG 1998a, 2000a).

The Research ERB’s role is to review human research proposals that have passed scientific review to ensure that they comply with federal and institutional policies regarding the ethical treatment of research participants throughout a project. The board should focus solely on the protection of research participants and should consider itself an advocate for these volunteers. It should refer issues of organizational interest (e.g., institutional conflicts of interest, adequate reimbursement, or risk management

10  

Proposed legislation also currently contains language directed at disclosure of this practice.



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