Comments provided to: National Institutes of Health, Office of Science Policy
Summary: The MRCT Center submitted public comments on a proposed glossary of innovative clinical research terms published jointly by FDA and NIH, “FDA-NIH Terminology for Clinical Research.” We encouraged clarification of the scope and intended audience of the draft glossary and recommended additional terms for inclusion in the final version. The FDA-NIH glossary will complement the MRCT Center’s Clinical Research Glossary efforts.
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Published in: The Journal of Law, Medicine & Ethics
Summary: COVID-19 illuminated the need for equity-informed practices in public health. This manuscript, to which Sylvia Baedorf Kassis and Dr. Barbara Bierer contributed, presents a community-led Ethics and Equity Framework and Workflow Checklist to guide ethical and equitable engagement with between community health centers and the populations they serve.
The critical role of representation in clinical research, particularly for LGBTQIA+ communities, and an overview of the foundations supporting the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit.
Essential considerations for collecting SOGI data, covering survey and form design, appropriate language in study materials, and the protocols for collecting, storing, and sharing SOGI data.
Practical implementation examples and areas that require further research and guidance.
Federal Committee on Statistical Methodology (FCSM) Sexual Orientation, Gender Identity, and Sex Characteristics Subcommittee: https://www.fcsm.gov/groups/sogisc/
Hafeez H et al. Health Care Disparities Among Lesbian, Gay, Bisexual, and Transgender Youth: A Literature Review. Cureus. 2017;9:e1184. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5478215/
Institute of Medicine (US) Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. (2011). The health of lesbian, gay, bisexual, and transgender people. National Academies Press (US). Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/books/NBK64806/
Landers SJ et al. Sexual Orientation Differences in Asthma Correlates in a Population-Based Sample of Adults. Am J Public Health. 2011:101:2233-2244. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3222437/
Fredriksen-Goldsen KI et al. Health and Access to Care and Coverage for Lesbian, Gay, Bisexual, and Transgender Individuals in the U.S. Am J Public Health. 2017:107:1332-1338. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5508186/
Hughes LD et al. Differences in All-Cause Mortality Among Transgender and Non-Transgender People Enrolled in Private Insurance. Demography. 2022;59:1023-1043. Accessed August 30, 2023. https://doi.org/10.1215/00703370-9942002
Morris M et al. Training to reduce LGBTQ-related bias among medical, nursing, and dental students and providers: a systematic review. BMC Medical Education. 2019;19:325. Accessed August 30, 2023. https://doi.org/10.1186/s12909-019-1727-3
Dahlhamer JM et al. Barriers to Health Care Among Adults Identifying as Sexual Minorities: A US National Study. Am J Public Health. 2016;106:1116. Accessed August 29, 2023. https://doi.org/10.2105/AJPH.2016.303049
Sterling J et al. Cancer screening in the transgender population: a review of current guidelines, best practices, and a proposed care mode. Transl Androl Urol. 2020;9(6):2771-2785. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7807311/
Cahill S et al. Do Ask, Do Tell: High Levels of Acceptability by Patients of Routine Collection of Sexual Orientation and Gender Identity Data in Four Diverse American Community Health Centers. PLoS ONE. 2014;9:e107104. Accessed August 7, 2023. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0107104
Daniel H et al. Lesbian, Gay, Bisexual, and Transgender Health Disparities: Executive Summary of a Policy Position Paper From the American College of Physicians. Ann Intern Med. 2015;163:135-137. Accessed August 7, 2023. https://doi.org/10.7326/M14-2482
Badgett MVL. (2009). Best Practices for Asking Questions about Sexual Orientation on Survey. Los Angeles: The Williams Institute. Accessed August 7, 2023. https://escholarship.org/uc/item/706057d5
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Brown I, McKenzie M, Srirangam A, Patel S. Making an Inclusive Impact: LGBTQ+ Health Equity in Clinical Trials. Poster presented at Drug Information Association Global Annual Meeting: June 25-29, 2023; Boston, MA.
Data on File. Genentech, Inc. South San Francisco, CA.
The MRCT Center and the Research Ethics Action Collaborative for HRPPs (REACH) presented the first webinar in the Accessibility 101 series on July 9, 2024
People with disabilities are the largest minority population in the United States, yet they are often excluded from clinical trials, both as participants and as researchers. Federal regulations, such as the recently updated Section 504 of the Rehabilitation Act, prohibit discrimination based on disability. Many accommodations are easy and low or no cost. It is incumbent upon all of us to build accessibility into our everyday thinking, meetings, presentations, and planning.
This webinar featured two interactive exercises in which participants learned:
Basic information about disability statistics and disability rights, and, as shown through the Accessibility by Design in Clinical Research Toolkit, different types of support that you can readily implement.
How to find the Check Accessibility and Alt Text features in PowerPoint and write appropriate Alt Text.
How to map out the participant’s (and family caregiver’s or supporter’s) journey from different disability perspectives, from getting to/into the site location, navigating within the site to the different areas they must access, and interacting with different forms of medical equipment and technology.
More about REACH: Research Ethics Action Collaborative for HRPPs (REACH) is an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community. Click here to learn more.
Published on: June 11, 2024 and updated on May 30, 2025
Abstract: 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 safeguardsto 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.
Published on: June 11, 2024 and updated on May 30, 2025
Abstract: 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 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.
Learn how four organizations, Mass General Brigham (MGB) Rally, HonorHealth, the Society for Clinical Data Management (SCDM), and the CureMito Foundation, are implementing the MRCT Center’s Clinical Research Glossary and how you can participate in Public Review, a vital process to ensure the glossary is a CDISC global standard.
