Researchers find wide variation in consent forms for gender-related care

The content, style and elements of consent forms for pubertal suppression and gender-affirming hormone therapies vary greatly, according to research presented at this year’s virtual Women in Medicine Summit.

“Currently, clinical guidelines for both pubertal suppression and gender-affirming hormones for transgender youth emphasize protection against harm, the presence of mental health providers, and both youth and parental involvement in decision making,” Samhita L. Nelamangala, a fourth-year medical student at the University of Virginia, said during the oral abstract presentation. “However, the guidelines do not delineate how providers should go about obtaining minor assent and parental permission and did not address the complex issues that concern consenting for these treatments.”

Nelamangala and colleagues compared the consent process for pubertal suppression and gender-affirming hormones at different clinical sites that provided these treatments. The consent forms were collected as part of a larger study or were publicly available online.

They used guidance from the Endocrine Society and the World Professional Association for Transgender Health to develop a coding instrument that assesses the content, tone and style of consent forms. Researchers used 11 core elements of informed consent to analyze pubertal suppression forms and 15 core elements to analyze gender-affirming hormonal therapy forms.

In addition to these elements, Nelamangala and colleagues evaluated informational codes, including information on the expectations for follow-up care, impact on fertility and reference to mental health providers within the treatment process. They also evaluated whether risks or benefits were listed on the form, and whether this information was implicit — not clearly listed as either a risk or benefit — or explicit — clearly marked as a list or benefit.

Nelamangala and colleagues also evaluated whether youth assent was included on consent forms, or if these forms included information on the importance of shared decision making that included the minor.

A total of 28 consent forms were analyzed in the study. Of those, just 14% contained all the identified core elements, and 18% contained less than half of these elements.

Researchers found that 87.5% of pubertal suppression consent forms referred to mental health providers in the treatment process, but only 50% of forms for gender-affirming hormonal therapy did so.

While all forms included some information on the risks of treatment, 82% of forms mentioned the benefits to these treatments.

During the presentation, Nelamangala said that 93% of forms explicitly named the risks associated with treatment, but only 29% explicitly identified the benefits of treatment.

“Overall, while the risks of treatment were well-categorized and communicated, there was little consistency in the way that benefits were portrayed or defined, with several forms using vague language to suggest that certain changes may be interpreted as a benefit or a side effect depending on the patient,” Nelamangala said.

Additionally, just 50% of forms included information on the value of shared decision making between parents and minors and included information on the importance of the minor’s understanding.

Another concerning finding, Nelamangala noted, was that nearly 20% of forms did not include any element of youth assent and just required parent or guardian signature to indicate consent for treatment.

Due to the considerable variability between consent forms, the researchers concluded that the role of these forms in engaging participation and assent of minors in these treatments needs additional development and clarification.

“Moving forward, we will further explore the implication of certain stylistic choices within consent forms and explore ways in which active minor assent can be prioritized, thereby improving the health and experience of transgender adolescents,” Nelamangala said.