It’s an increasingly common scenario: The patient filling out the traditional “gender” question on the demographic form was assigned female at birth, but may identify as male (transgender) or as neither male or female (non-binary). In this scenario, the simple binary male/female choices under gender on a demographic form are exclusive and create an uncomfortable situation for the patient, says Katie Dry, PT, DPT, MS, ACRP-CP, a research physical therapist with the Military Health System via the Geneva Foundation.
We’ve entered a brave new world where sexual orientation and gender identity labels and terminology aren’t always keeping pace with the complexities of the human expression and self-identification. The implications for clinical trial professionals are significant. For Dry, it’s nothing less than “a call for self-reflection and understanding our own biases when we approach people.”
The stakes are high. “How you interface with this person is going to influence if they’re going to come back for follow-ups,” Dry says. There is a clear “implication for patient retention,” she adds.
Clear and honest informed consent discussions between patient and practitioners form the very bedrock of quality clinical trials. Active in clinical research in the military for three years coordinating clinical trials out of primary care, Dry notes “this is something that is very much in the forefront of what I do every day.”
Rapid Fire: 8 Hot Topics in Research
Join Katie Dry from the Military Health System via the Geneva Foundation at ACRP 2019 this April to learn more about sex, gender, and how to demonstrate respect for clinical trial volunteers through inclusive questioning. This exciting new session format will also touch on study communication, source documentation, quality, and more.
While the issue is acute in several clinical trial arenas, nowhere is it more so in the sometimes-underserved LGBTQ population, Dry says. “Individuals might not seek healthcare because they don’t feel like they are going to be treated equally,” she explains. “If you’re not creating a culture that’s inclusive and educated, people aren’t seeking care.”
It’s incumbent upon the clinical trial industry to build as broad a tent as possible, Dry says. For example, a patient should be asked what sex they were assigned at birth, including designations for male, female, other, or choose not to answer as well as the patient’s current gender identity. “It’s important to be clear about what information you are asking for. If you really are asking about gender, there should be a multitude of choices that are much more inclusive,” Dry advises.
Author: Michael Causey