Advanced Track (SBER)
2019 SBER Conference
Advanced
A02 - Clinical Trials in SBER (NIH and OHRP Overview)—Part I
Yvonne Lau, MBBS, MBHL, PhD
Director, Division of Education and Development, HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Cynthia S. Shindledecker, B.A., CIP
Director, Health Sciences and Behavioral Sciences Institutional Review Board, University of Michigan
Wendy J. Weber, ND, PhD, MPH
Clinical Research Branch Chief, Division of Extramural Research, National Center for Complementary and Integrative Health
Speaker(s)
NIH has implemented policies designed to improve stewardship, accountability, and transparency of clinical trials, including some research characterized as basic science. SBER IRBs (and their research communities) need to understand the special NIH requirements for clinical trials. The revised Common Rule also imposes additional requirements for projects identified as clinical trials. Before attending this session, attendees should have a basic knowledge of NIH clinical trial policies and 45 CFR 46. During this session, speakers and attendees will:
Learning Objectives:
- Consider the similarities and differences between NIH and OHRP requirements related to SBER clinical trials, including the requirements associated with "basic research"
- Discuss NIH and OHRP requirements related to SBER clinical trials
- Provide examples of SBER studies that fall under these requirements
- Note: Part II of this session will take place on from 3:15-4:30 PM (Session C4).