How Closely Do Institutional Review Boards Follow the Common Rule?

Abstract

Purpose To determine how closely institutional review board (IRB) discussions reflect the ethical criteria specified in the Common Rule federal regulations Method Between November 2006 and July 2009, the authors observed, audio-recorded, transcribed, and coded protocol reviews from 20 IRB meetings at 10 leading academic medical centers. They also reviewed each of the applications discussed to identify the Common Rule criteria--(1) risk minimization, (2) risk/benefit comparison, (3) equitable subject selection, (4) informed consent, (5) data monitoring to ensure safety, (6) privacy protection and confidentiality, and (7) protection of vulnerable subjects--that were both relevant to the study and not adequately addressed in the application. They then determined if the IRB addressed each of the relevant and not discussed Common Rule criteria in their discussions. Results IRBs made no mention of many of the Common Rule criteria that required their discussion--in 17/82 (21%) reviews, they failed to address risk minimization; in 52/91 (57%), risk/benefit comparison; in 31/52 (60%), equitable subject selection; in 32/59 (54%), data monitoring; in 13/52 (25%), privacy and confidentiality; and in 7/55 (13%), protection of vulnerable populations. However, they discussed informed consent in 102/104 (98%) reviews and raised questions about, or requested changes about, informed consent for 92/104 (88%) protocols. Conclusions These findings suggest that essential elements of human subjects protection are not implemented uniformly across IRBs. While not directly addressing this issue, the current proposed changes to the Common Rule offer an opportunity to improve, in general, the effectiveness of IRBs to protect human subjects.

Barriers to Effective Deliberation in Clinical Research Oversight

“…Recent empirical research has examined several dimensions of IRBs governing clinical research. Studies have sought to characterize the composition of IRBs (Schuppli and Fraser 2007), differences in IRB process (Larson et al 2006), the nature and cause of outcome differentials (Abbott and Grady 2011;Klitzman 2011), how IRBs interact with their broader institutional settings (Klitzman 2013c), the extent to which IRBs successfully apply the Common Rule federal regulations for ethical research (Lidz et al 2012a), as well as how IRB members perceive and address a variety of different issues that arise during prospective review (Klitzman 2012b(Klitzman , 2013a(Klitzman , 2013b. Such research helps to highlight where oversight processes may break down or have room for improvement.…”

Prioritizing initiatives for institutional review board (IRB) quality improvement

“…One previous approach focused on assessing administrative compliance rather than quality, per se (Tsan, Smith, and Gao 2010). Another approach examined the nature of IRB deliberations qualitatively, based on a prohibitively labor intensive coding effort (Lidz et al 2012).…”

Institutional Review Boards

“…57 Existing studies describe IRB structure, process, or outcomes and show that IRB judgments are inconsistent, as is their application of a standard set of regulations. 58,59 Practices and decisions vary between and within IRBs oft en without justifi cation, including determinations about risk level, inclusion criteria, and the appropriateness of methods of recruitment and consent. 55,60 Despite complaints about inconsistency, independence and local evaluation make some IRB variation inevitable.…”