Advanced Track (SBER)
2019 SBER Conference
Advanced
A03 - Scientific Merit and SBER
Julie Slayton, JD, PhD
Director, Office for the Protection of Research Subjects, University of Southern California
Professor of Clinical Education, University of Southern California
Matt D. Stafford, MPH
Assistant Director, Clinical Research Compliance, Boston Children's Hospital
Co-Chair, Regulatory Working Group and SBER Subcommittee, Harvard Catalyst
Speaker(s)
Review for scientific merit is a perennial and often thorny issue. Is assessing scientific merit something IRBs should engage in? What are the differing perspectives regarding this issue? Before attending this session, attendees should have an understanding of SBER methodology and study challenges related to risk assessment, risk mitigation, and informed consent, as well as a working knowledge of 45 CFR 46. During this session, speakers and attendees will:
Learning Objectives:
- Discuss the concept of scientific merit in SBER
- Examine and discuss whether review for scientific merit is an IRB obligation (e.g., what do IRBs need to review and evaluate scientific merit in a study? If it's not the IRB's obligation, should it be conducted by someone else at an institution? Who and under what circumstances?)
- Share strategies for assessing scientific merit and training resources for IRB members