How good does the science have to be in proposals submitted to Institutional Review Boards? An Interview Study of Institutional Review Board personnel

Abstract

Background 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. Methods I contacted the leadership of 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed IRB chairs, co-chairs, administrators and a director from 34 (response rate=55%), and an additional 7 members. Results Interviewees 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) vs. 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 – e.g., if a “perfect” study is not feasible. For protocols already approved elsewhere (e.g., by the National Institutes of Health [NIH]), IRB's 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. Conclusions IRBs 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.

Views of South African biomedical research ethics committee members on their own ethics review outcomes

“…While national [17] and international [18] ethical guidelines clearly state that REC approval should require proof of sufficient scientific validity to answer the primary research question, it remains unclear what researchers themselves think about the role of RECs in reviewing the scientific quality of their proposals. Klitzman [19] found that IRB members often encounter dilemmas about whether proposals should have a separate science review, and how good the science needs to be for the study to be valid.…”

Differences and structural weaknesses of institutional mechanisms for health research ethics: Burkina Faso, Palestine, Peru, and Democratic Republic of the Congo

“…Third, issues of form (in relation to the content of the various documents) and of substance—in particular, standards to be respected and rigidity in compliance with them—have also been examined with unsatisfactory conclusions [ 17 , 18 ]. On this issue, a study, also in the United States, showed that ethics committees are often embarrassed when it comes to evaluating the scientificity of the protocols submitted to them.…”

Deciding how many embryos to transfer: ongoing challenges and dilemmas

“…This technique generates new analytic categories and questions, and checks them for reasonableness. These methods have been used in several other studies examining key aspects of health behaviour and doctor-patient relationships and communications in genetics and other areas ( Klitzman, 2012 , Klitzman, 2013 , Klitzman and Daya, 2005 , Klitzman et al, 2007 , Klitzman et al, 2013 ).…”