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2023 PRIM&R Annual Conference

FDA Regulated Research

Emerging Research Challenges and Breaking Issues

Shared Research Oversight Challenges

D02 - [IN-PERSON/RECORDED] Ethical and FDA Regulatory Considerations for Returning Individual Genetic Testing Results

Tuesday, December 5, 2023
1:00 PM – 2:00 PM ET
Location: Ballroom C
Live Session Recorded Human Subjects Research Deep Dive Series Call for Session Proposal CIP Accredited
This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

Next Generation Sequencing (NGS) tests are capable of rapidly identifying or 'sequencing' large sections of a person's genome and are key advances in the clinical applications of precision medicine. Researchers can use these tests to find genetic variants that help them diagnose, treat, and understand more about human disease, but there are no best practices for the return of health-related genetic information in a research setting. This session will discuss ethical strategies and applicable FDA requirements for the genetic return of research results directly to research participants.

Learning Objectives:

  • Describe the applicability and requirements of FDA device and human subjects regulations to research involving the return of health-related genetic sequencing results
  • Compare and contrast different strategies that research studies have taken to return health-related genetic sequencing results to research participants
  • Recognize the complexities of returning health-related genetic sequencing results to research participants