SGIM Forum

Ensuring Equitable Research Participation—Explicit Inclusion of Sexual and Gender Minority Populations 

06-27-2022 12:06

Researchers’ Corner

Ensuring Equitable Research Participation—Explicit Inclusion of Sexual and Gender Minority Populations

Dr. Streed (carl.streed@bmc.org) is an assistant professor of medicine in the Section of General Internal Medicine at the Boston University School of Medicine and research lead in the Center for Transgender Medicine and Surgery. Ms. Ben-Arieh (aben-arieh@fenwayhealth.org) is the director of research compliance at The Fenway Institute housed within Fenway Community Health. Dr. Patel (shilpenp@gmail.com) is an affiliate associate clinical professor in the Department of Global Health at the University of Washington and is Principal Health Equity & Inclusive Research Medical Director at Genentech. Mr. Godwin (eggodwin@hsph.harvard.edu) is a research specialist in the Department of Pediatrics, Division of Adolescent and Young Adult Medicine at Boston Children’s Hospital and a member of the Institutional Review Board for the Fenway Institute. Dr. McNair (lmcnair@wcgclinical.com) is the chief medical officer at WCG and WCG IRB and an adjunct faculty in the Department of Epidemiology at the Boston University School of Public Health.

Despite increasing awareness of health disparities affecting sexual and gender minority (SGM) populations, lesbian, gay, bisexual, transgender, queer, and Two Spirit (LGBTQ/2S) persons, explicit inclusion of these populations in clinical research remains absent.1 The goal of clinical research is to effectively assess, prevent, diagnose, or treat conditions that affect health and well-being. Successful and well-designed research studies must identify, recruit, and retain participants representative of the communities to which the results will apply in order to ensure research yields generalizable knowledge. The dearth of appropriate sexual orientation and gender identity (SOGI) data collection and absence of SGM persons in clinical research foreclose opportunities to understand their unique needs in clinical care. This absence renders SGM persons and their needs invisible in the medical literature and fails to adequately capture the impact of sex, sexual orientation, and gender on health.

There are many SGM-specific issues that warrant investigation, but SGM inclusion in all randomized controlled trials must be expanded to allow for robust subpopulation analysis. While clinical research has advanced preventive, diagnostic, and treatment modalities for HIV, particularly for cisgender men who have sex with men, it has often excluded transgender men and/or erroneously grouped transgender women with cisgender men.2 A cadre of cardiovascular clinical research trials has led to significant advances in predicting and preventing cardiovascular disease. However, the tools generated from such research remain limited in application to only binary categories of sex and do not take into account the various factors that affect cisgender men and women (e.g., early menopause, hypogonadism) as well as transgender persons receiving gender-affirming hormone therapy.3 These and other deficiencies in research design and conduct have resulted in troubling limitations in clinical care.

Regulatory directives and public calls for greater diversity in research participation led to improvements in the inclusion of cisgender women and marginalized racial and ethnic populations in clinical trials. According to the Food and Drug Administration’s Center for Drug Evaluation and Research Drug Trials Snapshots Summary, the proportion of Black or African-American persons participating in novel drug trials increased between 2015 (4%) and 2020 (8%). This increase offers critical lessons in improving the participation of populations often excluded from clinical research. Yet, calls to assess and address the health and well-being of SGM persons1 and for improved collection of SOGI data4 have remained unanswered.

Within the resulting regulatory vacuum, Institutional Review Boards (IRBs) are well positioned to actively address existing gaps in inclusion of SGM persons. Included within the IRB mandate to protect the rights and welfare of study participants is the responsibility to consider the equitable selection of subjects. This concept of equity is embedded within the principle of justice, emphasized within the Belmont Report as one of the pillars of research bioethics, a touchstone of IRBs. By explicitly considering the inclusion of SGM participants as part of their research ethics oversight function, IRBs appropriately exercise their responsibility to ensure research benefits are maximized (i.e., what’s learned is maximally generalizable and nuanced for the benefit of society) and that risks are shared. While the Belmont Report seems to narrow the lens of review to the four corners of a single trial within a specific locale, it provides space within the principle of justice to evaluate the larger social context: “injustice arises from social, racial, sexual and cultural biases institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social patterns may nevertheless appear in the overall distribution of the burdens and benefits of research.”

Consequently, IRBs can evaluate community involvement in research design, identify potential harms based on sex, gender, and/or sexual orientation, and propose mitigation strategies. Failure to consider how a research question may pathologize SGM persons can lead to study delay, harm participants, cause the suspension of approval or study closure, and lead to further loss of trust from SGM communities.

In evaluating a research protocol, IRBs routinely interrogate the appropriateness of inclusion and exclusion criteria—but often without awareness of how any particular criterion may discriminate against SGM populations. Bringing an SGM-inclusive lens to this review will ensure that the most appropriate and largest number of potential study participants is considered to answer the proposed research questions. IRBs must also evaluate data collection and ensure appropriate collection of sex, gender, behavior, and additional demographics germane to the research question.4 Insufficient collection of participant demographic information can lead not only to less robust conclusions being drawn by any particular study being evaluated but also to weakened conclusions of future studies (e.g., meta-analyses) that may inform development of clinical tools,5 risking propagating bias downstream to healthcare delivery.

Further, IRBs can review and advise revision of recruitment materials and consent documents to foster inclusion of SGM participants. This may include ensuring participant-facing materials accurately delineate inclusion and exclusion criteria (e.g., sex, gender, and other participant demographics), utilize community-informed language, and avoid assumptions of who may be interested in participating in research. IRBs can also correct gender-specific language in protocols and informed consent documents where necessary or appropriate to convey accurate information. For example, it is common practice to use “female” as an inclusion criterion when the population of interest is any individual with a cervix. IRBs can flag this for investigators, who are then able to assess their descriptors more critically. IRBs may find that providing general education and direction to researchers and research sponsors and working with them as they develop research proposals and recruitment plans is more effective than responding to individual submissions during the protocol review process.

Finally, in fulfilling their responsibility to protect the welfare of study participants, IRBs must evaluate the potential harms associated with participating in clinical research. Research studies that recruit from marginalized populations in settings that criminalize behavior (e.g., anti-sodomy laws) must have adequate protections in place to ensure not only confidentiality of study participants but also their safety. Even routine or minimal risk study activities may carry higher risks for SGM participants than cisgender heterosexual ones. Could they be “outed” by a focus group held in a community center? Will gender-affirming care be billed to a parent or guardian’s insurance policy? Do data collection instruments contain cis- or hetero-normative language or assumptions? IRBs are situated to inquire deeply about local context, understand the significance of local laws and policies, and ensure investigators consider the situational vulnerabilities of SGM participants (e.g., those living with family who are not aware or supportive of their SGM identity).

Further upstream from the purview of IRBs is the clinical trial sponsor, who can also advance research standards to ensure inclusion of SGM persons. However, progress is slow and disjointed across study sponsors, researchers, and IRBs. Ultimately, regulatory bodies that oversee clinical research conduct must explicitly call for and incentivize improvements to ensure equity in clinical research participation and inclusion of SGM persons.

References

  1. National Academies of Sciences Engineering and Medicine (NASEM). Understanding the Well-Being of LGBTQI+ Populations. Washington, DC: The National Academies Press; 2020.
  2. Poteat T, German D, Flynn C. The conflation of gender and sex: Gaps and opportunities in HIV data among transgender women and MSM. Global Public Health. Aug-Sep 2016;11(7-8):835-848. doi:10.1080/17441692.2015.1134615.
  3. Streed CG, Jr., Beach LB, Caceres BA, et al. Assessing and addressing cardiovascular health in people who are transgender and gender diverse: A scientific statement from the American Heart Association. Circulation. Jul 8 2021:CIR0000000000001003. doi:10.1161/CIR.0000000000
    001003.
  4. Baker KE, Streed CG, Durso LE. Ensuring that LGBTQI+ people count—Collecting data on sexual orientation, gender identity, and intersex status. N Engl J Med. 2021;384(13):1184-1186. doi:10.1056/NEJMp2032447.
  5. Caughey AB, Krist AH, Wolff TA, et al. USPSTF approach to addressing sex and gender when making recommendations for clinical preventive services. JAMA. 2021;326(19):1953-1961. doi:10.1001/jama.2021.15731.

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