This toolkit focuses on the implementation stage of training sites to successfully engage and retain LGBTQIA+ participants. Within the toolkit, you will find information on foundational LGBTQIA+ concepts and terminology, best practices for affirming transgender and gender diverse participants, and recommendations for collecting SOGI data as part of participant demographics. By learning these competencies, all study staff can become skilled and confident in supporting the dignity of LGBTQIA+ participants, and ultimately, can contribute to improving health equity for LGBTQIA+ communities.
Creating Welcoming and Affirming Clinical Studies for LGBTQIA+ Participants Toolkit
Purpose: This toolkit provides strategies, tools, and learning resources to advance LGBTQIA+ inclusion in clinical research studies across the world.
Audience: Anyone involved in clinical study design and implementation, including principal investigators, study site staff, academic partners, and study sponsors, will find useful information to guide their work.
How to Use: Click on each toolkit component to learn more and access resources. We encourage you to share this toolkit with your colleagues and partners!
Questions or Comments: Please email us at [email protected]. We will be happy to help you.
Acknowledgments: This toolkit was funded by and co-developed with Johnson & Johnson Innovation Medicine.
Toolkit Publication
This concise but comprehensive document covers essential LGBTQIA+ health-related topics and practical tools for creating more inclusive, welcoming, and affirming clinical study environments. We offer many ways to access and distribute the toolkit, including both digital and print-ready versions. You can share links or hand out printed copies to share with colleagues and partners.
Creating Welcoming and Affirming Clinical Studies for LGBTQIA+ Participants Toolkit
Journal Article
This Nature Medicine article covers important considerations for clinical studies:
- Collaborating with LGBTQIA+ community partners in developing research questions and designs
- Recruiting and retaining LGBTQIA+ participants
- Broadening study eligibility criteria to include transgender and gender diverse participants
- Working with institutional review boards
Forming industry partnerships
A roadmap for engagement and inclusion of LGBTQIA+ people in clinical research
A roadmap for engagement and inclusion of LGBTQIA+ people in clinical research
This peer-reviewed journal article in Nature Medicine offers recommendations for engaging LGBTQIA+ communities in the design and implementation of clinical studies.
If your institution does not provide free access to this journal, please contact us at [email protected] for a copy of the article.
Learning Module
Coming in March, this interactive, self-paced Learning Module will enhance your capacity to understand and apply the concepts presented in the toolkit document. The module includes case scenarios, videos, and knowledge checks. Presented in three parts (10-30 minutes each), this module can be completed in one sitting or taken over as many sittings as needed.