2 - Use of Gender-inclusive Language in Subject Recruitment Materials and other Participant-Facing Documents in Clinical Trials

Background:  Gender-inclusive language in subject-facing materials is an important conscious step toward health equity and inclusion of transgender and gender-diverse individuals. The lack of such efforts may contribute to health inequity. This study evaluates the experience of one Independent IRB with the use of gender-inclusive language in subject-facing materials.

Methods:  We utilized a database from an Independent IRB to identify protocols reviewed by the IRB in January, February and March 2022. Participant-facing PDF documents were selected for review. PDFs were selected as a proxy from the larger pool of document types. These documents included recruitment materials (used before an individual enters the study) and other participant-facing documents (used throughout the course of the study) provided throughout the course of the study. Recruitment materials selected for review included flyer/poster/brochure, Webpages, banners, social media content, and script/emails. Other participant-facing documents reviewed included standardized and non-standardized questionnaires, standalone HIPAA authorization, thank you note/retentions items, payment system information, diaries, patient card, instructions, or other guides to subjects. The language in each document was analyzed and categorized as gender-inclusive, gendered- language, or not applicable.

Results:  A total of 234 documents consisting of 48 recruitment materials and 186 participant-facing documents were reviewed. In recruitment materials, we found that 36 documents used only gender-inclusive language in the forms of ‘you/your’ or ‘I’, 11 documents used gendered language mainly in the forms of ‘women of childbearing potential’ or ‘his/her’, and 1 document was lacking an opportunity to utilize gender inclusive or gendered language. Of the participant-facing documents, 144 used only gender-inclusive language in the forms of ‘you/your’ or ‘I’, 16 documents used gendered language mainly in the forms of ‘his/her’ and non-standardized surveys offering only binary (male/female) gender options and 26 documents were lacking an opportunity to mention gendered language. This data is significantly different from our previous work, which looked at gender-inclusive language in the contraception requirements section of research consent form documents and found that gender inclusive language was rarely present.

Limitations: The exclusive reliance on PDF documents potentially poses a limitation, as it may exclude valuable insights from other file formats. That said, the selection of PDFs included a representative sample of subject-facing materials submitted during the given time frame. This approach acknowledges the practical constraints of analysis while still striving to capture a diverse range of relevant content for examination.

Discussion:  In our experience, gender-inclusive language is more frequently used than gendered language. While there may be multiple factors contributing to this trend, the fact that these documents are often written in the first-person, reducing the need for gendered language, is an important observation. Additionally, these materials typically have limited space to convey information, creating a practical requirement for language choices. While use of gender-inclusive language in these materials appears to reflect formatting challenges more so than a focused effort to utilize inclusive language, language used in these materials could provide model for how to improve language in consent form documents.