Legal Considerations for HRPPs Track
2019 AER Conference
B11 - Navigating State Law Differences in the Era of Single IRB (sIRB) Review
David G. Forster, JD, MA, CIP
Chief Compliance Officer, WIRB-Copernicus Group
Michael J. Linke, PhD, CIP
IRB Chair; Professor, Internal Medicine, University of Cincinnati College of Medicine
Adjunct Professor, University of Cincinnati
Speaker(s)
Variances in state laws present complex challenges in the era of sIRB review. Relying organizations have the responsibility to identify and communicate their state law requirements, and institutional interpretation of these requirements, to an external entity. Reviewing IRBs now have a unique responsibility to understand and apply these differences in the context of their review. This session will highlight select areas where state laws have great variability, identify how these differences affect the IRB review process, and propose potential practical solutions for reviewing IRBs and relying organizations in navigating these variances. During this session, speakers and attendees will:
Learning Objectives:
- Review key areas where state laws vary, and identify how these variances impact the IRB review process
- Provide guidance on identifying/communicating state law requirements to reviewing IRBs
- Share practical tips for reviewing IRBs in considering/applying these variances as part of their review