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Making Clinical Research Inclusive: Strategies to Include the LGBTQIA+ Community in Research Trials

In the last few years there has been an increase in attention to and awareness of the long-standing problems with diversity and the inclusion of under-represented populations in clinical research. Much of the work and discussion about diversity has focused on the important issues around racial and ethnic diversity, but there are other aspects of diversity we need to consider as well.

In order to appropriately include all communities in clinical research, and to answer important research questions that impact all communities, we also need to make sure that research is welcoming to and inclusive of people who are of all genders and sexual orientations. Unfortunately, the traditional structures of studies, templates that we use for protocols and informed consent documents, and data that we collect are often designed in ways that fail to address the specific needs and demographics of the LGBTQIA+ population. In this paper, we will talk about why it is important to collect information in clinical research studies about gender identity and sexual orientation and will discuss specific ideas for making studies inclusive of and respectful to the LGTBQIA+ community.

Why it is Important to Collect Information About Gender Identify and Sexual Orientation

As we look at the epidemiology of diseases and conditions, there are several issues which disproportionally impact the LGBTQIA+ community. Existing data demonstrates that

  • People who identify as lesbian, gay or bisexual use tobacco at rates that are 40% higher than in people who identify as straight/heterosexual; tobacco use is a major risk factor for multiple different cancers1
  • People who identify as lesbian, gay or bisexual have a higher prevalence of depression and mood disorders compared to straight/heterosexual people, which is often linked to discrimination, bullying and harassment2

However, failing to collect information about gender identity and sexual orientation means that there may be other diseases, conditions, and risk factors which are a significant problem in this community that we are not aware of. It may also mean that we are missing the opportunity to learn about how interventions or treatments have different efficacy or safety issues in LGBTQIA+ persons which could inform both individual decisions and public health efforts. Inclusiveness in health care considerations for transgender persons is essential as well; for example, transgender men (assigned female at birth) can have “women’s diseases” such as endometriosis that are often misdiagnosed3, and transgender women (assigned male at birth) may still need regular screening for prostate cancer.

Even for risk factors that we know are disproportionally affecting the LGBTQIA+ community, we still may not collect the necessary information, as pointed out by the Deputy Director of the National LGBT Cancer Network:

“…I was very excited when the FDA funded Tobacco Centers for Regulatory Science, research centers tasked with understanding how tobacco affects people, especially vulnerable populations like LGBTQ persons. Yesterday I read the analysis of all the science produced by these centers in their first round of funding. After the FDA and NIH invested $273M in 14 different centers, the centers published 71 research manuscripts on vulnerable populations. How many included mention of LGBTQ persons? Two. If those other studies had simply asked if their participants were LGBTQ, they could have done an analysis of how our communities were affected and reported the results in all the manuscripts.”4

Collecting information about gender identity and sexual orientation would, in most studies, mean the addition of just a few demographic questions at a screening visit. The collection of this data would contribute to the understanding of health issues of, and treatments for, the LGBTQIA+ community as a whole, and for the individuals and groups who comprise this community.

“By not asking questions about these characteristics, our health care and public health systems are forgoing critical information necessary for designing and implementing effective strategies not just for closing disparities affecting specific populations but also for providing person-centered care and services to the U.S. population as a whole.”

Ensuring That LGBTQI+ People Count — Collecting Data on Sexual Orientation, Gender Identity, and Intersex Status5

Making Sure That Protocols Are Designed to be Inclusive

Differentiating Between Sex and Gender

While often used as synonyms, the terms “sex” and “gender” have different meanings. “Sex” refers to the assignment of the male or female label, usually at birth, based on physical and biological characteristics. While sex is often thought of as binary, about 1/1500 newborns will have genetic or physical characteristics which do not clearly fall into either male or female categories, and the parents may choose which sex to assign. These individuals are often referred to as “intersex” or “difference of sexual development“ (DSD) and their identity as they grow up may or may not match the sex to which they were initially assigned.

“Gender” refers to the social construct of how a person identifies themselves within society. A “gender identity” is a person’s own gender and how they want to be seen in the world, and the sex they were assigned at birth may not align with the gender they know themselves to be. In the collection of demographic data, clinical studies should collect information about both sex (assigned at birth) and gender; there may be scientific reasons why recording sex at birth is necessary (e.g., for interpretation of drug pharmacokinetics, etc.), and recording current gender is respectful and provides additional information about how the study data can be interpreted and generalized (see Table 1 for examples of inclusive and appropriate language).

Avoid Gender-Specific Pronouns

Over the last few decades, we have generally moved away from assuming the gender of persons in certain roles; that is, we no longer default to assuming that physicians are probably male or nurses are female, or refer to an unknown physician as “he” or unknown nurse as “she”. However, the frequent terminology of using “he/she” or “he or she” to refer to a person who might be any gender still excludes persons who may not define themselves as traditionally only male or only female. Using the singular “they” is appropriate not just for persons who may define themselves as non-binary, it is appropriate as an inclusive and gender-neutral term to refer to an unknown person.

Be Careful About Assumptions of Heterosexuality

In many clinical protocols (and informed consent documents) it is common to see statements like “all women of child-bearing potential must use contraception.” This statement assumes both that all females are in sexual relationships in which they may become pregnant, and that all persons who
can become pregnant identify as female. Similarly, the statement that “all males must use contraception” assumes that all males are in heterosexual relationships and that all persons who are sperm-producing identify as male. Minor wording changes (see examples in table) can ensure that the precautions about contraception are conveyed to the appropriate participants, without making assumptions about either gender identity or sexual orientation.

Consider Study Materials and Trial Awareness Campaigns

If your study uses printed or online recruitment materials or participant information materials, look at them carefully to ensure they present an inclusive and welcoming message. Do the photos in the materials include only images of pairs who appear to be traditionally male/female? Are there images of persons who present as gender non-binary? Is the language used gender-neutral? Are you planning outreach efforts into LGBTQIA+ communities? All of these considerations will convey a message of inclusion. Asking LGBTQIA+ patients, and patient advocacy groups, to participate in the development of outreach and communication materials may be helpful and appropriate.


While efforts to advance the diversity of clinical trial populations and to expand the inclusion of under-represented populations in research studies often focus on race and ethnicity, we should also be addressing the systemic issues
that have prevented the development of comprehensive health information about the LGBTQIA+ community. Minor changes to clinical protocols, informed consent documents and data collection forms can have a tremendous impact on both allowing the analysis of data in a way that allows us to better understand and treat the health care needs of this community, and can make studies more welcoming and inclusive so that persons who are part of the LGTBQIA+ community feel comfortable and safe in participating.

Examples of Language Revisions for Protocols, informed Consent Documents and Data Collection Forms

Protocol Language

Exclusive & Gender Specific LanguageInclusive & Gender Neutral Language
“Inclusion criterion: male or female adults”“Inclusion criterion: adult persons of any sex and
“Women of childbearing potential must use
“Persons who are having sexual relationships in which they may become pregnant must use contraception…”
“All males must use contraception…”“Persons who are having sexual relationships in whichtheir partner may become pregnant…” -OR-
“Sperm-producing persons in a sexual relationship
with someone who could become pregnant…”

Informed Consent Language

Exclusive & Gender Specific LanguageInclusive & Gender Neutral Language
“If you are a woman of child-bearing potential, you
must use two forms of birth control”
“If you are able to become pregnant, and having sexual relationships in which you may become pregnant, you must use two forms of birth control”
“All males must use contraception”“Persons who are having sexual relationships in which their partner may become pregnant…” -OR-
“Sperm-producing persons in a sexual relationship
with someone who could become pregnant…”
“The investigator and his/her team”“The investigator and their team”
“Each study participant must allow access to his/her
medical records”
“Each study participant must allow access to their
medical records”

Data Collection Forms (demographic data)

Exclusive & Gender Specific LanguageInclusive & Gender Neutral Language
“Gender: male/female”“Sex assigned at birth: Male/female
Current Gender: male/female/non-binary
Sexual Orientation: Lesbian, gay or homosexual/
straight or heterosexual/ bisexual/ something else/
don’t know6


  1. Wang TW, Asman K, Gentzke AS, et al. Tobacco Product Use Among Adults — United States, 2017. MMWR Morb Mortal Wkly Rep 67:1225–1232, 2018
  2. Haas AP, Eliason M, Mays VM, et al. Suicide and suicide risk in lesbian, gay, bisexual, and transgender populations: review and recommendations. J Homosex. 2011;58(1):10-51. doi:10.1080/00918369.2011.534038
  3. Lipstein, Emily. Treating Endometriosis as a Woman’s Disease Hurts Patients of All Genders. Vice Health, 11 November 2020.
  4. Hiding In Plain Sight: LGBTQ People and Clinical Trials; Blog post 29 June 2019.
  5. Baker, KE, Streed, CG, and Durso LE. Ensuring That LGBTQI+ People Count — Collecting Data on Sexual Orientation, Gender Identity, and Intersex Status. N Engl J Med; 384; 1 April 2021
  6. Suggested demographic data options are from the New Patient Registration Form, Fenway Health, Boston, MA with slight modifications.

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