10 - Involving Transgender and Gender Diverse (TGD) Individuals in Research: A Collaborative Process Improvement Project

Background:  Guidance on research involving transgender and gender diverse individuals is limited. As such, our institution's IRB collaborated with institutional stakeholders to design a guidance document for studies specifically targeting these populations and for studies that want to be inclusive of these individuals in their population.

Program

Description:  The creation of the guidance document resulted from a conversation with our institution's Gender Clinic, a group comprised of adolescent medicine specialists, behavioral health therapists, endocrinologists, social workers, and psychiatrists who work with families of transgender and gender diverse youth and adolescents. As this group is the subject matter expert, we partnered with them along with our Office of Inclusion & Culture and our LGBTQ+ employee resource group. We published a best practice guidance for our institution to promote inclusion of trans and gender diverse people in human subjects’ research. Our team built upon their expert knowledge and our previous experiences to develop a guidance that was accessible and educational. Our IRB and HRPP teams discussed three key areas in the guidance: gender-inclusive language, chosen and preferred names, and gender demographic options.

Program

Assessment:  We conducted two surveys – one before and one after the guidance was disseminated to our institution's research staff. On average, research staff reported feeling more prepared and more comfortable enrolling trans and gender diverse individuals after reading the guidance. We also found almost half of respondents reported they will plan to use gender inclusive language and make changes to how they record gender demographic information after reading the guidance. We also requested open-ended feedback on this topic. Research staff identified challenges for trans and gender diverse inclusion such as PI not using gender information in data analysis, difficulty changing IRB-approved language in study forms, and what to do when parents are not aware or not accepting of the subjects’ gender identity.

Limitations: The sample size for the survey was very small. Since the surveys were anonymized, we did not track difference across individuals and cannot be certain that any changes reported are due to the guidance. There is also a potential response bias, where research staff that are already inclusive of trans and gender diverse individuals were more likely to respond to both surveys.

Discussion:  The goal of this project is to provide research staff with best practice guidance for our institution to promote inclusion of trans and gender diverse people in human subjects’ research. In today’s culture, it is important for HRPPs and IRBs to have established plans regarding the involvement of trans and gender diverse populations, especially when local context review is requested. Our goal in sharing this experience is to encourage other institutions (especially pediatric institutions) to prepare guidance for their research staff to protect the rights and welfare of this at-risk minority population.