Meeting Summary
Released in: January 2024
Developed by: MRCT Center Bioethics Collaborative
Language: English
Blurring Boundaries: Revisiting the Distinction Between Research and Care
A Federally Qualified Health Center-led Ethics & Equity Framework & Workflow Checklist: An Invited Commentary in Response to a Relational Public Health Framing of FQHCs During COVID-19
Publication
Published on: May 31, 2024
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.
Data Collection and Privacy: Tools and Resources for LGBTQIA+ Inclusion by Design
Webinar
Presented on: June 11, 2024
The MRCT Center added two new tools to the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit: the SOGI Data Collection Checklist and the SOGI Data Privacy Checklist.
During this webinar we discussed:
- 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.
Related Resources
MRCT Center Resources
- MRCT Center DEI Main page: https://mrctcenter.org/diversity-in-clinical-research/
- MRCT Center. (2020). Diversity, Inclusion, and Equity Guidance Document: https://mrctcenter.org/diversity-in-clinical-research/guidance/guidance-document/
- MRCT Center. (2020). Diversity, Inclusion, and Equity Guidance Toolkit and User Guide: https://mrctcenter.org/diversity-in-clinical-research/tools/toolkit/
- MRCT Center. Equity by Design in Clinical Research Metrics Framework: https://mrctcenter.org/diversity-in-clinical-research/tools/ebd-metrics-framework-and-user-guide/
- Diversity Convergence Project. (2024). Toward a National Action Plan for Achieving Diversity in Clinical Trials: https://mrctcenter.org/resource/toward-a-national-action-plan-for-achieving-diversity-in-clinical-trials/
- MRCT Center. (2024). Research Ethics Action Collaborative for HRPPs: https://mrctcenter.org/resource/reach-advancing-dei-in-human-participant-research/
- MRCT Center. (2023). Accessibility by Design in Clinical Research Toolkit: https://mrctcenter.org/diversity-in-clinical-research/tools/abd_toolkit/
- Equitable Access to Clinical Trials Project (EACT): https://www.eactproject.org/
- MRCT Center. (2024). LGBTQIA+ Inclusion by Design in Clinical Research Toolkit: https://mrctcenter.org/lgbtqia-inclusion/
Other Resources – by slide:
(slide 19)
- The White House. (2023). Federal Evidence Agenda on LGBTQI+ Equity: https://www.whitehouse.gov/wp-content/uploads/2023/01/Federal-Evidence-Agenda-on-LGBTQI-Equity.pdf
(slide 24)
- Federal Committee on Statistical Methodology (FCSM) Sexual Orientation, Gender Identity, and Sex Characteristics Subcommittee: https://www.fcsm.gov/groups/sogisc/
- FCSM. (2021). Why Do Federal Agencies Ask About Sexual Orientation and Gender Identity (SOGI) on Surveys? https://apps.bea.gov/icsp/fcsm/assets/docs/FCSM%2021%2001%20062221.pdf
- FCSM. (2020). Updates of Terminology of Sexual Orientation and Gender Identity Survey Measures: https://apps.bea.gov/icsp/fcsm/assets/docs/FCSM_SOGI_Terminology_FY20_Report_FINAL.pdf
- Federal Interagency Working Group on Improving Measurement of Sexual Orientation and Gender Identity in Federal Surveys. (2016). Current Measures of Sexual Orientation and Gender Identity in Federal Surveys: https://dpcpsi.nih.gov/sites/default/files/WorkingGroupPaper1_CurrentMeasures_08-16_508.pdf
- Federal Interagency Working Group on Improving Measurement of Sexual Orientation and Gender Identity in Federal Surveys. (2016). Evaluations of Sexual Orientation and Gender Identity Survey Measures: What Have We Learned? https://dpcpsi.nih.gov/sites/default/files/Evaluations_of_SOGI_Questions_20160923_508.pdf
- Federal Interagency Working Group on Improving Measurement of Sexual Orientation and Gender Identity in Federal Surveys (2016). Toward a Research Agenda for Measuring Sexual Orientation and Gender Identity in Federal Surveys: Findings, Recommendations, and Next Steps: https://dpcpsi.nih.gov/sites/default/files/SOGI_Research_Agenda_Final_Report_20161020_508.pdf
- Executive Office of the President of the United States. (2023). Federal Evidence Agenda on Lesbian, Gay, Bisexual, Transgender, Queer, and Intersex (LGBTQI+) Equity (Factsheet): https://www.whitehouse.gov/wp-content/uploads/2023/01/Federal-Evidence-Agenda-on-LGBTQI-Equity.pdf
- The White House. (2023). Recommendations on the Best Practices for the Collection of Sexual Orientation and Gender Identity Data on Federal Statistical Surveys: https://www.whitehouse.gov/wp-content/uploads/2023/01/SOGI-Best-Practices.pdf
- National Academies of Science, Engineering, and Medicine (NASEM). (2022). Measuring Sex, Gender Identity, and Sexual Orientation: https://nap.nationalacademies.org/catalog/26424/measuring-sex-gender-identity-and-sexual-orientation
- Department of Health and Human Services (HHS). (2023). HHS SOGI Data Action Plan: https://www.hhs.gov/sites/default/files/hhs-sogi-data-action-plan.pdf
- National Institutes of Health (NIH) Sexual & Gender Minority Research Office: https://dpcpsi.nih.gov/sgmro
- HHS. Healthy People 2030: https://health.gov/healthypeople
- United States Census Bureau. (2021). SOGI on the Census Bureau’s Household Pulse Survey: https://www.census.gov/newsroom/press-releases/2021/household-pulse-phase-3-2-aug11.html?utm_medium=email&utm_source=govdelivery
- NIH Sexual & Gender Minority Research Office: https://dpcpsi.nih.gov/sgmro
- Sign up for the NIH SGM Listserv: https://tinyurl.com/NIHSGMLIST
- Sign up for the SGM Health SIG Listserv: https://tinyurl.com/SGMGROUP
(slide 40)
- National LGBTQIA+ Health Education Center, A Program of the Fenway Institute. SO/GI Data Collection Demonstration Videos: https://www.lgbtqiahealtheducation.org/courses/so-gi-data-collection-training/
- National LGBTQIA+ Health Education Center, A Program of the Fenway Institute. Collecting Sexual Orientation and Gender Identity Data: https://www.lgbtqiahealtheducation.org/resources/in/collecting-sexual-orientation-and-gender-identity-data/
- National LGBTQIA+ Health Education Center, A Program of the Fenway Institute. Guidelines and Tips for Collecting Patient Data on Sexual Orientation and Gender Identity. https://www.lgbtqiahealtheducation.org/publication/ready-set-go-a-guide-for-collecting-data-on-sexual-orientation-and-gender-identity-2022-update/
- National LGBTQIA+ Health Education Center, A Program of the Fenway Institute. SOGI Patient Handout with FAQs: https://www.lgbtqiahealtheducation.org/publication/sexual-orientation-and-gender-identity-questions-information-for-patients/
(slide 44)
- 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/
- Quinn GP et al. Cancer and lesbian, gay, bisexual, transgender/transsexual, and queer/questioning (LGBTQ) populations. CA Cancer J Clin. 2015:65:384-400. Accessed August 7, 2023. https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21288
- Obedin-Maliver J et al. Lesbian, Gay, Bisexual, and Transgender–Related Content in Undergraduate Medical Education. JAMA. 2011;306:971-977. Accessed August 7, 2023. https://jamanetwork.com/journals/jama/fullarticle/1104294
- Jackson SS et al. Analysis of Mortality Among Transgender and Gender Diverse Adults in England. JAMA Netw Open. 2023;6(1):e2253687. Accessed August 28, 2023. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2800814
- NIH. Notice of special interest. Administrative supplements for research on sexual and gender minority (SGM) populations. Accessed August 7, 2023. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-032.html
- 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/
- Alper J et al. Institute of Medicine of the National Academies. (2013). Collecting sexual orientation and gender identity data in electronic health records. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/books/NBK132859/pdf/Bookshelf_NBK132859.pdf
- Lunn MR et al. A digital health research platform for community engagement, recruitment, and retention of sexual and gender minority adults in a national longitudinal cohort study–—The PRIDE Study. J Am Med Inform Assoc. 2019;26:737-748. Accessed August 7, 2023. https://academic.oup.com/jamia/article-abstract/26/8-9/737/5509461?redirectedFrom=fulltext&login=true
- All of Us Research Program. Accessed August 7, 2023. https://allofus.nih.gov/news-events/announcements/research-roundup-research-pride-lgbtqia-representation-all-us
- 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/
- National Alliance on Mental Illness. Accessed August 7, 2023. https://www.nami.org/Your-Journey/Identity-and-Cultural-Dimensions/LGBTQ
- Kates J et al. Updated May 2018. Accessed August 7, 2023. http://files.kff.org/attachment/Issue-Brief-Health-and-Access-to-Care-and-Coverage-for-LGBT-Individuals-in-the-US
- 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
- Trevor Project. Bullying and Suicide Risk among LGBTQ Youth. Accessed Aug 30, 2023. https://www.thetrevorproject.org/research-briefs/bullying-and-suicide-risk-among-lgbtq-youth/
(slide 45)
- Houghton A. (2018). Maintaining Dignity: A Survey of LGBT Adults Age 45 and Older. AARP Research. Accessed Aug 29, 2023. https://www.aarp.org/research/topics/life/info-2018/maintaining-dignity-lgbt.html
- 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/
- American Medical Association. Organizational Strategic Plan to Embed Racial Justice and Advance Health Equity 2021-2023. Accessed August 7, 2023. https://www.ama-assn.org/system/files/ama-equity-strategic-plan.pdf
- European Commission. How is data on my religious beliefs/sexual orientation/health/political views protected? Accessed August 7, 2023. https://commission.europa.eu/law/law-topic/data-protection/reform/rights-citizens/how-my-personal-data-protected/how-data-my-religious-beliefssexual-orientationhealthpolitical-views-protected_en
- 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
- Pérez-Stable EJ. (2016). Director’s Message: Sexual and Gender Minorities Formally Designated as a Population Experiencing Health Disparities for Research Purposes. National Institutes of Health. Accessed August 7, 2023. https://www.nimhd.nih.gov/about/directors-corner/messages/message_10-06-16.html
- 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
- Badgett MVL et al; the GenIUSS Group. (2014). Best Practices for Asking Questions to Identify Transgender and Other Minority Respondents on Population-Based Surveys. Los Angeles: The Williams Institute. Accessed August 7, 2023. https://williamsinstitute.law.ucla.edu/wp-content/uploads/Survey-Measures-Trans-GenIUSS-Sep-2014.pdf
- Spade D. Normal Life: Administrative Violence, Critical Trans Politics, and the Limits of Law. Durham, NC: Duke University Press; 2015.
- 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.
- Cleveland Clinic Impact Report. Health Equity Symposium. Accessed August 7, 2023. https://drive.google.com/file/d/13sg7VGfm12geGFfZYc_2ZVCZc369kipK/view
- VCU Massey Cancer Center. On the Road to Trust. Accessed August 7, 2023. https://drive.google.com/file/d/16ej8SZaj8grI0W1pjedJdiw370iElibb/view
- Washington Health Alliance. DEI Summary Report. Accessed August 7, 2023. https://docs.google.com/document/d/1yQ6vrlyM7QQp76c5o-BhOVUG6NwLJ3qW/edit
Sexual Orientation and Gender Identity (SOGI) Data Privacy Checklist
Tool
Published on: June 11, 2024
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 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.
Related Resources
LGBTQIA+: Inclusive Imagery Case Study
LGBTQIA+: Inclusive Language Checklist
SOGI Data Collection Checklist
SOGI: Data Privacy Checklist
Site Feasibility Decision Tree from the LGBTQIA+ Perspective
Participant Questionnaire from the LGBTQIA+ Perspective
Exit Survey Inclusive of the LGBTQIA+ Perspective
Sexual Orientation and Gender Identity (SOGI) Data Collection Checklist
Tool
Published on: June 11, 2024
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.
Related Resources
LGBTQIA+ Inclusion by Design in Clinical Research Toolkit
LGBTQIA+: Inclusive Imagery Case Study
LGBTQIA+: Inclusive Language Checklist
SOGI Data Collection Checklist
SOGI: Data Privacy Checklist
Site Feasibility Decision Tree from the LGBTQIA+ Perspective
Participant Questionnaire from the LGBTQIA+ Perspective
Exit Survey Inclusive of the LGBTQIA+ Perspective
MRCT Center Comment on the American Community Survey SOGI Test
Action and Influence: Implementing the Clinical Research Glossary and Your Critical Role in Public Review
Webinar
Presented on: June 4, 2024
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.
Related Resources
Webinar Biobook
The Clinical Research Glossary: Learn More
The Clinical Research Glossary: Working Group
Implementing the Clinical Research Glossary: How to Attribute the MRCT Center
On-Demand Webinar: The Clinical Research Glossary: New Words, New Opportunities
On-Demand Webinar: A Global Standard for Plain Language in Clinical Research: an MRCT Center and CDISC Collaboration
First, do no harm: a global perspective on diversity and inclusion in clinical trials
Publication
Published on: May 8, 2024
Published in: Nature Reviews Drug Discovery
Description: New requirements for clinical trial sponsors to submit diversity action plans to the US Food and Drug Administration (FDA) are an important step to embed planning for diverse representation in clinical trial research. These must not, however, be implemented in ways that are detrimental to other countries’ health and research interests. It is possible for those making operational decisions on country and site selection to address the needs of underserved populations in other countries at the same time as meeting US regulatory expectations — for example, by addressing barriers to diverse recruitment. Site selection should follow purposeful engagement in the local and regional culture, considering the needs of the local population, and proceed only if the trial is responsive to those needs.
Public Comments submitted: “Draft Guidance, Key Information and Facilitating Understanding in Informed Consent”
Public Comments
Comments provided on: April 30, 2024
Comments provided to: U.S. Food and Drug Administration
Public Comments submitted: “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”
Public Comments
Comments provided on: April 29, 2024
Comments provided to: U.S. Food and Drug Administration