Scientific Review Committees as part of institutional review of human participant research: Initial implementation at institutions with Clinical and Translational Science Awards
| Autor: | Philip A. Cola, Janis L. Breeze, Anshu Parajulee, Christine Sego Caldwell, Rebecca Marnocha, Elizabeth Patchen-Fowler, Amy LeClair, Harry P. Selker, Darlene Kitterman, Norma Terrin, Kirsten M. Williams, Jennifer A. Croker, Lisa C. Welch, Julie Morelli Novak, David X. Cifu, Denise C. Snyder, Arash Naeim |
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| Rok vydání: | 2020 |
| Předmět: |
Protocol (science)
Medical education 030505 public health Ethics review Best practice Staffing Research Methods and Technology Review Committees General Medicine operational feasibility 03 medical and health sciences 0302 clinical medicine Scientific Review Committee quantitative and qualitative methods Clinical and Translational Science Award Mandate 030212 general & internal medicine Translational science scientific quality 0305 other medical science Psychology Research Article Qualitative research |
| Zdroj: | Journal of Clinical and Translational Science |
| ISSN: | 2059-8661 |
| DOI: | 10.1017/cts.2019.439 |
| Popis: | 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).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. |
| Databáze: | OpenAIRE |
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