LGBTQIA+ Inclusion

Abstract:
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.

Abstract:
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.

All study participants should be able to see themselves in the research data. However, standard demographic variables of sexual orientation and gender identity (SOGI) have rarely been reported for clinical trials. We therefore don’t know whether LGBTQIA+ people are able to participate in clinical trials, or whether the safety and efficacy of tested products differs for any LGBTQIA+ participants. To begin to address this gap in respect for participants, study generalizability, and beneficence, the National Institutes for Health and Institute for Medicine now recommend collecting SOGI data. To support research teams, sites, and sponsors in following this recommendation we developed the SOGI Data Collection Checklist. 

This SOGI Data Collection Checklist draws together key points from published guidance and the insights of LGBTQIA+ Inclusion by Design in Clinical Research Working Group members who have been leading in this field and piloting survey methodology. It provides prompts to think the process of SOGI data collection, which includes steps like defining the purpose of the data collection, mapping the proposed data elements, and working with groups and/or advisory boards that are inclusive of people who are lesbian or gay, and people who are transgender, non-binary, or intersex. While we do not provide standardized data collection questions (e.g., gender identity, sex at birth), response choices (e.g., [for sexual orientation] lesbian or gay, straight, bisexual, other), and response formats (e.g., open response), we do provide references with links to current guidance. Finally, please note that this SOGI DATA Collection Checklist is meant to be utilized in tandem with the SOGI Data Privacy Checklist.

Data privacy is a critical not only for the safe and ethical conduct of clinical trials, but also for supporting and maintaining the trust of clinical trial participants. For clinical trial participants who may be discriminated against or otherwise harmed if their personal identifying information were to be disclosed, data privacy all the more important. In the SOGI Data Collection Checklist we advocate for the collection of sexual orientation and gender identity (SOGI) data, where appropriate and feasible. In the SOGI Data Privacy Checklist, which is meant to accompany the SOGI Data Collection Checklist, we provide thinking prompts to support researchers, sites, and sponsors, and others in maintaining privacy when collecting, storing, and sharing SOGI data. These prompts center on how to make the research environment/site a welcoming a place where individuals can trust that they and their data will be respected and protected, and where to consider implementing necessary safeguards to protect participant identity and privacy. We also include an addendum on special considerations for pediatric populations, in addition to a list of references with links to more detailed guidance.

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)