Research Involving Data and Biospecimens Track

Breakout Session Series C

C16 - Considerations for Return of Results Under the Revised Common Rule

Speaker(s)

• 

  Angela Bradbury, MD

  Associate Professor
  University of Pennsylvania Perelman School of Medicine
• 

  Michelle Francis Grienauer, JD, MPH, CIP

  Attorney
  Microsoft
• 

  Jody Shoemaker Roberts, MS, CCRP, CIP

  Chief Operating Officer, Director of Research
  Mind Research Network

The return of individual research results seems like a simple enough expectation that respects a subject’s rights to information about themselves. In practice, though, the highly complex considerations, finding the right balance for protecting autonomy, and promoting beneficence are not easy. Have recent regulatory changes made this already challenging area easier or harder to navigate? Attendees should have a basic understanding of the ethical and regulatory challenges related to the return of individual research results before attending this session. During this session, speakers and attendees will:

Learning Objectives:

• Explore the complexities related to differences in the Health Insurance Portability and Accountability Act, Clinical Laboratory Amendments requirements, as well as other ethical and legal issues related to sharing of results, and how recent changes to the Common Rule and other statutory frameworks impact the analysis
• Understand how IRBs and researchers grapple with the ethical considerations of sharing results and address the new requirements for inclusion of consent language related to plans for sharing clinically relevant results
• Review the potential benefits and limitations on sharing various kinds of research results
• Discuss whether new questions should be added to IRB applications regarding whether results will be shared, and when, as well as what other concrete steps institutions can take to return research results under the revised Common Rule and other applicable legal and ethical frameworks
• Explore real world scenarios for return of results from participant and researcher perspectives
• Note: This session will end at 1:30 PM. Attendees should get their boxed lunch in the exhibit hall before going to the session room.