4 - Evaluation of Gender-Neutral Language in IRB Guidance and Informed Consent Templates

Background:
The use of gender-neutral language helps ensure all individuals are represented and respected. This survey evaluated the use of and attitudes towards gender-neutral language in consent forms and IRB guidance to pinpoint areas for improvement to foster meaningful informed consent, representation, respect, and inclusivity for all gender identities and expression.

Methods:
This research was conducted via an electronic Qualtrics survey instrument with automatic weekly reminders for 1 month. Email invitations were sent to contacts obtained from Health and Human Services, Office of Human Research Protections’ FWA and IRB Registration database. Respondents included IRB Members, HRPP Administrators, IRB Chairs, IRB Staff, Institutional Officials, Research Coordinators, and Investigators. After confirming they are adults and reading additional information about the survey they agreed to participate and answered a series of up to 26 questions, including up to 12 research questions on the status of gender-neutral language in their IRB and their attitudes towards it, 6 demographic questions, and an optional response to provide the link to IRB guidance on their institution’s public website. It was noted on the survey that the researchers will not link this website to any responses. Responses were recorded through Qualtrics and anonymized without record of identifiers including IP addresses.

Results:
Most respondents (76%) felt that use of gender-neutral language in IRB guidance, templates, and forms is appropriate. Thirty-three percent reported that their IRBs use gender-neutral language in consent forms, 37% didn’t, 30% unsure. Among respondents who indicated their IRBs don’t use gender-neutral language, the top four reasons (17%-26%) were: lack of resources; low priority; is not required under federal regulations; didn’t think about making changes. Only 3% of participants chose philosophical differences and too political as reasons. Among responses about specific terminology, 65% agreed that the pronoun “they” is appropriate for an individual. Fifty-four percent agreed that, for pregnancy, the term “pregnant person,” was appropriate instead of “pregnant woman.” Forty-five percent agreed that “pregnant woman or pregnant person” was appropriate. Forty-six percent disagreed with use of “pregnant woman” without a gender-neutral term. Sixty-five percent of respondents indicated that the FDA and OHRP should provide guidance on gender-neutral language use.

Limitations:
The overall response rate to the survey was low, with 642 validated and analyzed responses out of 11,748 delivered surveys (5.5% response rate); representativeness of respondents remains uncertain. Respondents were predominantly non-Hispanic white (80%). It is unclear whether respondents accurately reflected the diversity of the target group. Given the low response rate and the predominant desire for change among respondents, this could indicate selection (non-response) bias.

Discussion:
The responses to the question about appropriateness of gender-neutral language indicated an overwhelming majority support this. However, respondents reported that a minority of IRBs are currently using this language in consent template forms, although almost an equal number are not sure, showing discrepancy between support and implementation. Reasons for lack of implementation indicate they are largely not due to philosophical/political disagreements. There is also majority agreement with the gender-neutral terminology presented in the survey, showing support for language revision. Future areas of analysis will include comparing responses by subgroups: age, gender, type of institutional research, respondent’s role in IRB, and IRB accreditation.