LGBTQIA+ Inclusion

Abstract:
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.

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.

Abstract:
The “Site Feasibility Decision Tree from the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit, and the first of three tools in the section of the Toolkit directed more toward participants. This tool is meant to empower potential LGBTQIA+ participants to assess whether a site may be trustworthy and welcoming. This tool is structured in tiers, with checkpoints in between. The first tier is potential capacity, where we provide prompts, or “determination factors” based on what IS happening at a site (or in the area nearby) that LGBTQIA+ people can use in considering whether the site is potentially a good place to participate in a study. In the second tier we focus on “historical capacity,” or the things that the site HAS/HAD done to support the well-being of LGBTQIA+ people that may inspire confidence that the site is trustworthy.

Abstract:
The “Participant Questionnaire from the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit, and the second of three tools in the section of the Toolkit directed more toward participants. There are numerous questions that participants may want to ask as they move from thinking about possible trials and sites to starting the process of enrolling and participating in a trial. Some of these questions may be covered by informational materials given to participants during the informed consent process and study visits, and some may not be. This list is to help participants prepare so that they can get the answers that they need and feel comfortable before continuing with the trial. The Participant Questionnaire tool is divided into sections that include questions to ask the research team, questions you may want to ask family, friends, and others you trust, and questions to ask yourself. It includes questions that anyone might want to ask and adds questions that LGBTQIA+ people (and/or their accompanying friends and family) might also want to ask.

Abstract:
The “Exit Survey Inclusive of the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit, and the third of three tools in the section of the Toolkit directed more toward participants. It is important for participants in clinical research activities to give feedback about their experiences. This feedback helps research teams and organizations better understand the participant’s experience of the research activity and learn where they can improve on efforts to empower research participants and the participants’ supporting families, friends, and communities. One way to gather feedback is through a survey, which may be given to participants periodically (e.g., once a month), and/or (as an exit survey) at the end of research activities. In this tool, we aim to show examples of the topics that participants may be asked about in a survey or interview or, if not asked, that the participant may wish to share with the research team in a patient portal, email, or other format.

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)