LGBTQIA+ Inclusion

LGBTQIA+ Inclusion

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 are for clinical trials, as they do for other common demographic variables (e.g., age, race/ethnicity). We don’t know what we aren’t measuring, and therefore don’t know if people who are sexual and gender diverse (SGD) are being fairly included in trials or what the outcomes of trials are for SGD populations. We do know that people who are LGBTQIA+ experience discrimination in many areas of life, and some report not feeling welcome by healthcare providers and in clinical facilities.

While the existing portfolio of MRCT Center DEI resources (e.g., Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document, IRB/HRPP DEI Toolkit) has been widely used to reduce common barriers to trial participation, we are continuing to develop tailored resources where there are population-specific barriers to clinical research participation. To support a focus on LGBTQIA+ inclusion, the MRCT Center conducted listening sessions to learn more about potential areas for action. Respondents focused on welcoming spaces, imagery, language, data collection (when and how), privacy and safety, site feasibility, and the challenges of multi-site and decentralized trials conducted in disparate environments.

Following the listening sessions, the MRCT Center has convened an LGBTQIA+ Inclusion by Design in Clinical Research working group, with voices at the table from across different clinical research stakeholder groups (sponsors, CROs, researchers, regulators), LGBTQ communities, and allies. This working group is endeavoring to complement existing resources in the clinical care and research spaces (e.g., how to create or fill out medical record forms for LGBTQIA+ inclusion, training on LGBTQIA+ inclusion for health professionals) with resources to support LGBTQIA+ inclusion that have a focus on clinical research.

The MRCT Center will be releasing tools for the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit on a rolling basis throughout 2024. The first two tools, the LGBTQIA+ Inclusive Imagery Case Study and the LGBTQIA+ Inclusive Language Checklist, are available now. The compilation of tools (formal toolkit) will be released later in the year.

Related Assets

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.

Inclusive Imagery Case Study

Each of us feels more welcome to participate in a clinical trial if we see ourselves represented in the visual information communicated about the study, study site/s, and study staff. In the case study below, we illustrate how the MRCT Center worked to build LGBTQIA+ representation into the imagery that was developed for a specific product, the Clinical Research Glossary. The tool shares lessons learned by the MRCT Center based on insights and comments shared by the LGBTQIA+ Inclusion by Design in Clinical Research working group and mock-ups of two of the resulting images.

Inclusive Language checklist

In the checklist below, the MRCT Center provides recommendations for the use of language that is respectful to and inclusive of LGBTQIA+ populations. The checklist can be used by stakeholders across the clinical research spectrum, from sponsors to patient navigators, when creating participant-facing documents (e.g., recruitment materials, informed consent forms), drafting study protocol eligibility criteria, and speaking with participants face-to-face. It is our shared responsibility to listen to participants’ and communities’ choice of wording and address, continually learn from each other, and ensure that all eligible people are encouraged to participate by the language that we use.


Many thanks to everyone who has so thoughtfully collaborated on the scoping, advancement, and maturity of this project. They have come from medical practices and research teams, academic research centers, pharmaceutical companies, contract research organizations, local clinics, employee resource and patient and advocacy groups, and across different LGBTQIA+ communities. We are especially grateful to the members of the LGBTQIA+ Inclusion by Design in Clinical Research Working group. Members who have chosen to be publicly acknowledged are listed here:

  • 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
  • Batisha Anson, Global Head of Patient Diversity & Health Equity, Syneos Health
  • Todd Bazin, Head of Data Standards, Biogen
  • Amy Ben-Arieh, The Fenway Institute at Fenway Health
  • Isabel Brown (she/her/hers), Associate Global Clinical Trial Leader, Genentech
  • 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
  • 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
  • Dean J. Mariano, DO (he/him/his), Eli Lilly & Company
  • Meghan McKenzie (she, her/hers), Patient Inclusion and Health Equity, Chief Diversity Office, Genentech
  • Michelle Ouellette (she/her/hers)