How good does the science have to be in proposals submitted to Institutional Review Boards? An interview study of Institutional Review Board personnel.

backgroundInstitutional Review Boards (IRBs) have been increasingly criticized for how they review protocols, but how IRBs perceive, and make decisions about, the quality of the science of protocols has not been examined. PURPOSE: To explore how and when IRBs view and make decisions about the quality of the science of studies they review.

methodsI contacted the leadership of 60 IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding) and interviewed IRB chairs, co-chairs, administrators, and a director from 34 IRBs (response rate = 55%), and an additional 7 members.

resultsInterviewees faced several ambiguities and questions concerning the quality of the science of protocols. IRBs are often not sure how and to what extent to evaluate the science of protocols, whether the science should be 'good enough' (and if so, what that means) versus as good as possible. Federal regulations state that IRBs should ensure that risks are minimized, and commensurate with benefits. Thus, at times IRBs feel that changing the science is ethically necessary. But IRBs also then struggle with whether to adopt a higher threshold (1) that social and thus scientific benefits be maximized and (2) that scientific efforts and resources should not be wasted. Committees face dilemmas - for example, if a 'perfect' study is not feasible. For protocols already approved elsewhere (e.g., by the NIH), IRBs vary in how much they feel they can request alterations, and sometimes make changes nonetheless. Larger institutional contexts and biases can shape these issues, and IRBs differ in how much they are 'pro-research', and have sufficient expertise. IRBs at times also approve studies despite reservations about the science. LIMITATIONS: This study includes interviews with IRBs, but not observations of IRB meetings.

conclusionsIRBs often face ambiguities and conflicting goals in assessing scientific quality. Many IRBs try to improve the science beyond what the regulations mandate. These data have important implications for improving practice, education, research, and policy.