Scientific Review Committees as part of institutional review of human participant research: Initial implementation at institutions with Clinical and Translational Science Awards

Harry P. Selker; Lisa C. Welch; Elizabeth Patchen-Fowler; Janis L. Breeze; Norma Terrin; Anshu Parajulee; Amy LeClair; Arash Naeim; Rebecca Marnocha; Julie Morelli Novak; Christine Sego Caldwell; Philip A. Cola; Jennifer A. Croker; David X. Cifu; Kirsten M. Williams; Denise C. Snyder; Darlene Kitterman

doi:10.1017/cts.2019.439

Journal of Clinical and Translational Science (Apr 2020)

Scientific Review Committees as part of institutional review of human participant research: Initial implementation at institutions with Clinical and Translational Science Awards

Harry P. Selker,
Lisa C. Welch,
Elizabeth Patchen-Fowler,
Janis L. Breeze,
Norma Terrin,
Anshu Parajulee,
Amy LeClair,
Arash Naeim,
Rebecca Marnocha,
Julie Morelli Novak,
Christine Sego Caldwell,
Philip A. Cola,
Jennifer A. Croker,
David X. Cifu,
Kirsten M. Williams,
Denise C. Snyder,
Darlene Kitterman

Affiliations

Harry P. Selker: Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA
Lisa C. Welch: Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA
Elizabeth Patchen-Fowler: Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA
Janis L. Breeze: Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA
Norma Terrin: Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA
Anshu Parajulee: Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA
Amy LeClair: Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA
Arash Naeim: UCLA Clinical and Translational Science Institute, University of California, Los Angeles (UCLA), Los Angeles, CA, USA
Rebecca Marnocha: University of Wisconsin Institute for Clinical and Translational Research, University of Wisconsin-Madison, Madison, WI, USA
Julie Morelli Novak: Tufts Health Sciences Institutional Review Board, Tufts University, Boston, MA, USA
Christine Sego Caldwell: Indiana Clinical and Translational Sciences Institute, Indiana University, Indianapolis, IN, USA
Philip A. Cola: Clinical and Translational Science Collaborative (CTSC) of Cleveland, Case Western Reserve University, Cleveland, OH, USA
Jennifer A. Croker: Center for Clinical and Translational Science, University of Alabama at Birmingham, Birmingham, AL, USA
David X. Cifu: VCU C. Kenneth and Dianne Wright Center for Clinical and Translational Research, Virginia Commonwealth University, Richmond, VA, USA
Kirsten M. Williams: Clinical and Translational Science Institute at Children’s National, George Washington University, Washington, DC, USA
Denise C. Snyder: Duke Clinical and Translational Science Institute, Duke University School of Medicine, Durham, NC, USA
Darlene Kitterman: Oregon Clinical and Translational Research Institute, Oregon Health and Science University, Portland, OR, USA

DOI: https://doi.org/10.1017/cts.2019.439
Journal volume & issue: Vol. 4
pp. 115 – 124

Abstract

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AbstractIntroduction: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).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.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. 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 3 weeks. For the 60% under review after 3 weeks, review was lengthened primarily due to longer IRB review for SRC-reviewed protocols. 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.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.

Published in Journal of Clinical and Translational Science

ISSN: 2059-8661 (Online)
Publisher: Cambridge University Press
Country of publisher: United Kingdom
LCC subjects: Medicine
Website: https://www.cambridge.org/core/journals/journal-of-clinical-and-translational-science

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