
Sexual orientation and gender identity (SOGI) may influence disease risk, incidence, severity, manifestation, and treatment response. Yet, researchers rarely collect or report standard demographic variables for SOGI in clinical trials, as they do for other common demographic variables. We don’t know what we aren’t measuring and therefore don’t know if people who are LGBTQIA+ are represented in clinical trials or what the outcomes of trials are for those populations.
While the existing portfolio of MRCT Center Representation in Clinical Research resources has been widely used to reduce common barriers to trial participation, we are continuing to develop tailored resources to address population-specific barriers to clinical research participation. The MRCT Center has convened voices from across different clinical research stakeholder groups (sponsors, CROs, researchers, regulators), LGBTQIA+ communities, and allies, and is working to complement existing resources in the clinical care and research spaces with resources to support LGBTQIA+ participants. These tools are not meant to be rigidly prescriptive but rather show potential avenues for a more representative design of clinical trial processes and communications (where possible and appropriate). As for any individual, it is important that people who are LGBTQIA+ have the choice to opt-in (or out) of sharing their data and experiences, opportunities to ask questions and receive thoughtful responses, and access to high-quality health research in caring environments.
Related Assets
- May 2025: LGBTQIA+ Inclusion by Design in Clinical Research Toolkit – updated 2.0
- November 2024: Site Feasibility Decision Tree from the LGBTQIA+ Perspective
- November 2024: Participant Questionnaire from the LGBTQIA+ Perspective
- November 2024: Exit Survey Inclusive of the LGBTQIA+ Perspective
- June 2024: Webinar – Data Collection and Privacy: Tools and Resources for LGBTQIA+ Inclusion by Design
- June 2024: SOGI Data Privacy Checklist
- June 2024: SOGI Data Collection Checklist
- April 2024: LGBTQIA+ Inclusive Imagery Case Study
- April 2024: LGBTQIA+ Inclusive Language Checklist
- November 2023: MRCT Center Comment on the American Community Survey SOGI Test
Please note: The tools in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit are living documents and will be improved with use. We welcome feedback, suggestions, useful references and resources, and concerns.
Acknowledgments
Many thanks to everyone who has so thoughtfully collaborated on these products. Members who have chosen to be publicly acknowledged are listed in the links below, with the titles and organizational affiliations that they had at the time of the product launch. Please note that each member served in their individual capacity, and the views and findings expressed are those of the authors and do not imply endorsement or reflect the views or policies of the U.S. Food and Drug Administration or the affiliated organization or entity of any member who contributed to this work.
Leadership
- Dr. Barbara Bierer, Faculty Director, The MRCT Center
- Dr. Willyanne DeCormier Plosky (she/her/hers), Program Director, The MRCT Center
- Aaron Kirby, Bioethics Fellow, Harvard Medical School
Working Group
- Batisha Anson, Global Head of Patient Diversity & Health Equity, Syneos Health
- Dr. Katarina Vukojicic Belcher, Sr. Medical Director, Medical & Scientific Management, General Medicine and Infectious Diseases, Syneos Health
- Amy Ben-Arieh, The Fenway Institute at Fenway Health
- Isabel Brown (she/her/hers), Diversity Program Lead, Associate Director of Clinical Operations, Merck
- Andrew Camarena (he/him/his), MPH, Community Engagement and Recruitment Manager, The Fenway Institute
- Ravina Cerreta-Dial (she/her/hers), VPM- Community Lead, PRIDE ERG Lead, Novartis
- Savine DaCosta, Clinical Trial Diversity Site Lead, Biogen
- Dr. Keith Dawson (he/him/his), Principal Portfolio Leader, Global Health Equity & Population Science Roche/Genentech
- Christina Dragon (she/her/hers)
- Marichu Endraca, Senior Global Trial Manager, CPO-Global Clinical Dev, Amgen
- Dr. Frances Grimstad, Assistant Professor in Obstetrics, Gynecology, and Reproductive Biology, Boston Children’s Hospital
- Dr. Ruben Hopwood (he/him/his), Founding Director, Psychologist, Hopwood Counseling & Consulting, LLC.
- Jennafer Kwait, PhD, MHS (she, her/hers), Research Scientist, Whitman – Walker Institute
- Dean J. Mariano, DO (he/him/his), Eli Lilly & Company
- Meghan McKenzie (she, her/hers), Patient Inclusion and Health Equity, Chief Diversity Office, Genentech
- Kim Meeking, MRes, Co-Lead, Queering Cancer
- Shir Netanel (she/her/hers), Associate Director of Patient Advocacy and Clinical Trials Advocacy
- Michelle Ouellette (she/her/hers)
- Corey Prachniak, J.D., M.P.H. (no or any pronouns)








