Scientific Review Committees as Part of Institutional Review of Human Participant Research: Implementation at Institutions with Clinical and Translational Science Awards | Weatherhead School at Case Western Reserve University

Scientific Review Committees as Part of Institutional Review of Human Participant Research: Implementation at Institutions with Clinical and Translational Science Awards

Scientific Review Committees as Part of Institutional Review of Human Participant Research: Implementation at Institutions with Clinical and Translational Science Awards

Authors

  • Harry P . Selker
  • Lisa C . Welch
  • Elizabeth Patchen
  • Janis L . Breeze
  • Norma Terrin
  • Anshu Parajulee
  • Amy LeClair
  • Arash Naeim
  • Rebecca Marnocha
  • Julie M . Novak
  • Christine S . Caldwel
  • Philip Cola
  • Jennifer A . Croker
  • David X . Cifu
  • Kristen M . Wiliams
  • Denise C . Snyder
  • Darlene Kitterman

Published

Clinical and Translational Science, vol. 4, issue 2, pp. 115-124., April (2nd Quarter/Spring) 2020

Website

http:// https://doi.org/10.1017/cts.2019.439

Abstract

Introduction: Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs). Scientific Review Committees (SRCs) were proposed to facilitate this assessment by the Clinical and Translational Science Award (CTSA) SRC Consensus Group. This study assessed SRC feasibility and impact at CTSA-affiliated academic health centers (AHCs).<br><br>Methods: SRC implementation at 10 AHCs was assessed pre/post intervention, using quantitative and qualitative methods. Pre-intervention, four AHCs had no SRC, and six had at least one SRC needing modifications to better align with Consensus Group recommendations.<br><br>Results: Facilitators of successful SRC implementation included broad-based communication, an external motivator, senior-level support, and committed SRC reviewers. Barriers included limited resources and staffing, variable local mandates, limited SRC authority, lack of anticipated benefit, and operational challenges. <br><br>Research protocol quality did not differ significantly between study periods, but respondents suggested positive effects. During intervention, median total review duration did not lengthen for the 40% of protocols approved within three weeks. For the 60% under review after three weeks, review was lengthened primarily due to longer IRB review for SRC-reviewed protocols. <br><br>Site interviews recommended designing locally-effective SRC processes, building buy-in by communication or by mandate, allowing time for planning and sharing best practices, and connecting SRC and IRB procedures.<br><br>Conclusions: The CTSA SRC Consensus Group recommendations appear feasible. Although not conclusive in this relatively short initial implementation, sites perceived positive impact by SRCs on study quality. Optimal benefit will require local or federal mandate for implementation, adapting processes to local contexts, and employing SRC stipulations.<br>