When IRBs Say No to Participating in Research about Single IRBs

Abstract

In response to a policy of the National Institutes of Health and requirements in the revised Common Rule, a protocol for a multisite study must be reviewed by a single institutional review board (IRB), rather than by the IRB at each study site. The goal of the single IRB approach is to increase the efficiency of IRB review of multisite research without jeopardizing protections for research subjects. Yet the extent to which these joint goals are being achieved is unclear. To better understand how single IRBs function, we recruited academic, government, and commercial single IRBs (N = 49) to participate in a study involving observation of protocol review meetings and/or interviews with their members, chairs, and administrators. Twenty (40.8%) agreed to participate, of which 50% agreed to both interviews and observation. While 81.8% (9/11) of academic and 50% (4/8) of government single IRBs participated in some way, only 23.3% (7/30) of commercial single IRBs did so. The four largest commercial single IRBs declined to participate. Because evaluation of single IRBs is important to inform development, implementation, monitoring, and refinement of federal policies, single IRBs should be encouraged to participate in research that examines how they function.

Exempting low-risk health research from ethics reviews to better serve the interests of the patients and public: a qualitative analysis of survey responses

“…For example, in a recent study of how Institutional Review Boards function in the United States, only 40% of Boards agreed to participate. (19) This is consistent with our experience, as our maximal response rate from HREC members was approximately 24%. Other commonly identified difficulties with conducting this type of research is that there is much uncertainty about the best methods to do so(17, 18, 20) and absence of a ‘gold standard’ for evaluating research ethics review processes.…”

Improving the Quality and Performance of Institutional Review Boards in the U.S.A. Through Performance Measurements

“…Department of Health and Human Services, 2018), increasing numbers of institutions are relying on freestanding commercial IRBs for such studies. It is important that the quality and performance of these IRBs also be monitored closely (Klitzman et al, 2020;Tsan, 2019b).…”

What are the most common reasons for return of ethics submissions? An audit of an Australian health service ethics committee

“…A significant portion of the literature on this topic takes the form of researcher commentary or case studies that describe review of a single submission/project. This may be, in part, because HRECs can be reluctant to participate in research which evaluates their activities (Klitzman et al, 2020).…”

“…The ethics review process is often perceived as ‘red tape’ by researchers, or even worse, a barrier to conducting research, rather than an important process for protecting research participants (Burris and Welsh, 2007; Guta et al, 2013). Key criticisms of the process include role creep (Angell et al, 2008; Guta et al, 2013), an increasing regulatory approach (Guta et al, 2013), perceived lack of competence with some research approaches (Colnerud, 2015; Guta et al, 2013), variability between HRECs with the same submission (Coleman and Bouesseau, 2008; Colnerud, 2015; Glasziou and Chalmers, 2004), unnecessary review of scientific merit (Angell et al, 2008; Page and Nyeboer, 2017) and lack of transparency of decision making (Klitzman et al, 2020; Glasziou and Chalmers, 2004; Guta et al, 2013; Lynch, 2018).…”