Regulatory Knowledge and Support: Standardization of Scientific Review Committees Across Clinical Translational Science Programs

Philip Cola, PhD, CTSC Regulatory Knowledge Support lead and Associate Director of Academic Affairs Doctor of Management Programs at CWRU Weatherhead School of Management
Case Western Reserve University

A major goal of creating Clinical Translational Science Award (CTSA) Programs across the United States was to provide standard infrastructure for the effective and efficient conduct of clinical research across Academic Medical Centers (AMCs). This represented opportunities for novel process approaches. It was a way for the National Institutes of Health (NIH) to assist institutions and investigators alike in the transformation of the clinical research enterprise in order to meet the demands of contemporary society [1] . It is within this context that awardee institutions created regulatory knowledge and support components within their CTSA infrastructure. These components have been charged with finding ways to reduce investigator regulatory burden as well as finding novel approaches that lend themselves to standardization across other AMCs and CTSA programs [2] .

An important area within the regulatory knowledge and support components is the protection of human subjects in research through ethical principles for human subject research [3] . The intent of these protections have always been that independent review committees should review research to ensure respect for participant rights while minimizing risks in relation to anticipated benefits [4] . In order to accomplish this Institutional Review Boards (IRBS) must have mechanisms to consider a study’s scientific quality and operational feasibility in order to ensure that protocols can be completed while achieving goals and objectives to answer study question(s) and ensure that the fewest number of participants are exposed to risk. Additionally, study question(s) must be deemed worthwhile to answer [5] .

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[1] Zerhouni, E. A. (2005). Translational and clinical science-time for a new vision.  New England Journal of Medicine ,  353 (15), 1621.

[2] Strasser, J. E., Cola, P. A., & Rosenblum, D. (2013). Evaluating various areas of process improvement in an effort to improve clinical research: discussions from the 2012 Clinical Translational Science Award (CTSA) Clinical Research Management workshop.  Clinical and Translational Science ,  6 (4), 317-320.

[3] U.S. Department of Health and Human Services. The Belmont Report 1979. Retrieved May 11, 2020. https://www.hhs.gov/ohrp/regulations- and-policy/belmont-report/index.html

[4] U.S. Department of Health and Human Services. Federal Policy for the Protection of Human Subjects (Common Rule, 45 CFR 46) 2018. Retrieved May 11, 2020.  https://www.ecfr.gov/cgi-bin/retrieveECFR?%20gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=%20pt45.1.46&r=PART&ty=HTML

[5] Institute of Medicine. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. 2003.

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