Commentary on “Regulatory Support Improves Subsequent IRB/REC Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution’s Experience”

Abstract

In response to researcher concerns a number of initiatives have been developed to support individual researchers seeking ethics review and approval. In this issue, Sonne et al. (2017) outline an example of an intervention to support researchers, which they refer to as a Regulatory Knowledge Support (RKS) service. While the study points to potential benefits, other studies have not had the desired impact on key performance measures. There is a need to develop a community of practice and expand the burgeoning evidence base regarding what interventions work, for whom, and under what circumstances. Advancing the research agenda requires: the development of theoretical models for intervention design and evaluation; developing consensus on key data for collection and measures of effectiveness; conducting evaluations using the strongest possible study designs, and; publishing the findings of evaluations.