The Fenway Institute released Creating Welcoming and Affirming Clinical Studies for LGBTQIA+ Participants, a free, multi-component toolkit to help advance LGBTQIA+ inclusion in clinical research studies across the world.
Access the toolkit here.
The toolkit provides practical strategies for everyone involved in clinical study design and implementation, including principal investigators, study site staff, academic partners, and study sponsors. Inside the toolkit you will find:
- A comprehensive publication covering essential LGBTQIA+ health-related topics and practical tools for creating more inclusive, welcoming, and affirming clinical study environments.
- Flyers and desk cards to make study environments more welcoming.
- Translations in eight languages.
- An interactive Learning Module designed to enhance one’s capacity to understand and apply the concepts presented in the toolkit.
- A glossary of LGBTQIA+ terms relevant to clinical studies.
The toolkit explores key topics such as the rationale for focusing on LGBTQIA+ clinical research, LGBTQIA+ concepts and terminology, strategies for engaging LGBTQIA+ participants in clinical study settings, and culturally responsive approaches for collecting sexual orientation and gender identity (SOGI) data.
In tandem with the toolkit, The Fenway Institute published an article in the peer-reviewed medical journal Nature Medicine, titled “A roadmap for engagement and inclusion of LGBTQIA+ people in clinical research”. This publication covers additional important considerations for clinical studies, including involving LGBTQIA+ community partners in designing research, recruiting LGBTQIA+ participants, broadening study eligibility criteria to include transgender and gender diverse participants, working with institutional review boards, and forming partnerships with community groups.
“The toolkit and roadmap provide comprehensive guidance to support creating safe, welcoming, inclusive, and affirming clinical study environments and experiences for LGBTQIA+ people. This is necessary to ensure the quality, safety, relevance, and acceptability of clinical trials,” said Alex Keuroghlian, MD MPH, Director of the Division of Education and Training at The Fenway Institute and senior author of the Nature Medicine article.
You can access both the toolkit and the publication here.
Founded in 1971, Fenway Health advocates for and delivers innovative, equitable, accessible health care, supportive services, and transformative research and education. We center LGBTQIA+ people, BIPOC individuals, and other underserved communities to enable our local, national, and global neighbors to flourish. The Fenway Institute at Fenway Health is an interdisciplinary center for research, training, education and policy development focusing on national and international health issues.