Responsible Conduct of Research Track
2019 AER Conference
A16 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
Lisa R. Buchanan, MAOM
Director, Division of Compliance Oversight, DHHS, Office for Human Research Protections (OHRP)
Kate Gallin Heffernan, JD
Partner; Chair, Academic and Clinical Research Group, Verrill Dana LLP
Jim Kroll
Director, Research Integrity and Administrative Investigations, National Science Foundation
Speaker(s)
Two separate, yet overlapping, regulatory structures govern research with human subjects: the Common Rule (45 CFR 46) and research misconduct (42 CFR 93). These regulations have different requirements and enforcement mechanisms, yet suspected violations of both sets of regulations often occur simultaneously. How should IRBs handle this? What do they need to know? During this session, speakers and attendees will:
Learning Objectives:
- Discuss of the scope and focus of various regulations governing research with human subjects and research misconduct, and the mechanisms prescribed for oversight and investigation
- Identify the overlapping and independent responsibilities of committees tasked with investigating possible violations of human subjects research regulations and research misconduct
- Explore various scenarios and case studies highlighting appropriate mechanisms and best practices for handling situations in which violations of human subjects and research misconduct regulations may have occurred simultaneously