LGBTQIA+ Inclusion by Design in Clinical Research Toolkit

Sexual orientation and gender identity (SOGI) may influence disease risk, incidence, severity, manifestation, and treatment response. In line with the clinical research guiding principles in the Belmont Report of respect for persons, beneficence, and justice, we have developed a toolkit to support equitable participation of people who are LGBTQIA+. The toolkit contains seven tools. Any audience can use the full toolkit, although it should be noted that first four tools are directed more toward sponsors and research teams, and the latter three are directed more toward participants. The first four tools were publicly released individually in the spring of 2024, and the latter were released in November 2004. We invite you to explore the full toolkit or to focus on the specific tools that you find most important to your individual or organizational journey in clinical research.