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2024 PRIM&R Annual Conference

Advancing Equity and Justice

E01 - PLENARY: Fast Forward: Update on Inclusion of Sexual and Gender Minorities in Clinical Research

Tuesday, November 19, 2024
1:45 PM – 3:00 PM PT
Location: Ballroom 1
Human Subject Research - HSR Thought Leader Series Call for Session Proposal - CSP Live Streamed Session Live Session Recorded CIP Accredited
CLICK HERE to view captioning for this session! 

In the 2023 PRIM&R Annual Conference Plenary Session "It's About Time: Inclusion of Sexual and Gender Minorities in Clinical Research" the panel outlined barriers to LGBTQIA+ participation and/or visibility in clinical research, strategies to encourage appropriately expansive eligibility criteria, and emerging practices around sexual orientation, gender identity (SOGI), and variations in sex characteristic data collection. Equitable and diverse representation in clinical research is a rapidly evolving area and just one year can involve a broad scope of change in the regulatory environment, available guidance and tools, and practical experience through testing of novel approaches. This panel aims to provide an overview of these changes, implications for clinical trial oversight and practice, and new challenges on the road ahead.

Learning Objectives:

  • Review emerging guidance from the federal level and clinical research organizations for collection of sexual orientation and gender identity (SOGI) data, and the development of interoperable data standards
  • Explore new tools for LGBTQIA+ Inclusion by Design in clinical research, on topics such as inclusive language, data collection and privacy, and accountability
  • Understand how different clinical research stakeholders, such as IRBs and sponsors, have navigated adding SOGI questions to data collection templates and surveys, and discuss lessons learned