This course guides IRB protocol reviewers to “ask the right questions” to enable an informed and comprehensive protocol review in keeping with 45 CFR 46, Subpart A.
This first module dives into the IRB review criteria at 45 CFR 46.111 (frequently called the 111 criteria). Learners can then review case study modules (Biomed Case Study and SBE Case Study). These modules address asking the right questions as an IRB reviewer based on the type of research. The final module discusses how to review the informed consent process and documentation practices for regulatory compliance.
This course is meant to be role-specific and go beyond basic human subjects research training covered in CITI Program’s Human Subjects Research (HSR) series. The intent of this course is to train IRB members in the process of effective protocol review based on regulatory criteria.
IRB Administrators, IRB Chairs, IRB Directors, IRB Members/Reviewers
Meet the Authors
Cecilia Brooke Cholka, PhD, CIP – Weill Cornell Medicine
Cecilia Brooke Cholka serves Weill Cornell Medicine as a Human Research & QA Manager and consultant for the PEER Consulting Group. She works to demystify IRB processes and expectations so that researchers and the IRB can work together collaboratively to ensure ethical conduct of research.
Linda E. Mayo, BA, CIP – The University of New Mexico
Linda Mayo, BA, CIP is the Director, Office of Research Integrity and Compliance at the University of New Mexico. She is a site visitor and Step 1 Reviewer for AAHRPP and in 2016 she co-founded PRIM&R’s SBER Network. In 2020, Linda was awarded the PRIM&R Arena Legacy award.
Ilene Wilets, PhD, CIP – Icahn School of Medicine at Mount Sinai
Ilene Wilets, PhD, CIP, is an IRB Chair with the Icahn School of Medicine at Mount Sinai in New York. She is an Associate Professor in the Department of Environmental Medicine and Public Health, an Associate Professor in the Department of Global Health and Health Systems Design at Mount Sinai, and Adjunct Associate Professor with the Clarkson University-Mount Sinai Program in Bioethics.