Journal of Empirical Research on Human Research Ethics :: Regulatory Support

Journal of Empirical Research on Human Research Ethics
Volume 13, Issue 2, April 2018
http://journals.sagepub.com/toc/jre/current
Ethical Issues in Biobanking and use of Biospecimens

Improving IRB/REC Approval Rates
Regulatory Support Improves Subsequent IRB Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution’s Experience
Susan Sonne, Stephanie Gentilin, Royce R. Sampson, Leslie Bell, Toni Mauney, Summer Young, Katherine Bright, Patrick Flume
First Published January 18, 2018; pp. 139–144
Abstract
We evaluated the impact of a regulatory support service (known as the Regulatory Knowledge and Support [RKS] program), part of the Medical University of South Carolina’s Clinical and Translational Science Award, on the success of Institutional Review Board (IRB) applications that have previously been deemed by the IRB to be Not Ready for Review (NRR). At the time of this evaluation, 77 studies had been deemed NRR, 53 of which came from trainees and junior faculty. All the applications that received regulatory support either received IRB approval or were deemed to not be research, and therefore did not require IRB review. In all, 39.1% (n = 18) of the research teams who did not accept regulatory support successfully received IRB approval. Providing regulatory support, particularly to trainees and junior faculty, may be associated with better success in obtaining IRB approval as well as preventing the unnecessary submission of projects that are not research and would therefore not require IRB review or approval.
Commentary on “Regulatory Support Improves Subsequent IRB/REC Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution’s Experience”
Stuart G. Nicholls
First Published January 18, 2018; pp. 145–147
Response to Commentary: Regulatory Support Improves Subsequent IRB Approval Rates in Studies Initially Deemed Not Ready for Review—A CTSA Institution’s Experience
Susan Sonne, Stephanie Gentilin, Royce R. Sampson, Leslie Bell, Toni Mauney, Summer Young, Katherine Bright, Patrick Flume