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. Session Note: This session was presented at SBER19. We’re offering on-demand access during SBER21 for additional access to SBER-related content.
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)