Sexual Orientation and Gender Identity (SOGI) Data Collection Checklist


Published on: June 11, 2024

Abstract: All study participants should be able to see themselves in the research data. However, standard demographic variables of sexual orientation and gender identity (SOGI) have rarely been reported for clinical trials. We therefore don’t know whether LGBTQIA+ people are able to participate in clinical trials, or whether the safety and efficacy of tested products differs for any LGBTQIA+ participants. To begin to address this gap in respect for participants, study generalizability, and beneficence, the National Institutes for Health and Institute for Medicine now recommend collecting SOGI data. To support research teams, sites, and sponsors in following this recommendation we developed the SOGI Data Collection Checklist. 

This SOGI Data Collection draws together key points from published guidance and the insights of LGBTQIA+ Inclusion by Design in Clinical Research Working Group members who have been leading in this field and piloting survey methodology. It provides prompts to think the process of SOGI data collection, which includes steps like defining the purpose of the data collection, mapping the proposed data elements, and working with groups and/or advisory boards that are inclusive of people who are lesbian or gay, and people who are transgender, non-binary, or intersex. While we do not provide standardized data collection questions (e.g., gender identity, sex at birth), response choices (e.g., [for sexual orientation] lesbian or gay, straight, bisexual, other), and response formats (e.g., open response), we do provide references with links to current guidance. Finally, please note that this SOGI DATA Collection Checklist is meant to be utilized in tandem with the SOGI Data Privacy Checklist.

Related Resources

LGBTQIA+: Inclusive Imagery Case Study
LGBTQIA+: Inclusive Language Checklist
SOGI: Data Privacy Checklist
MRCT Center Comment on the American Community Survey SOGI Test