Protocol - Biological Sex Assigned at Birth
Participants (or proxy) indicate the biological sex assigned at birth. It can be self-administered or interviewer administered.
This protocol can be used in conjunction with the Gender Identity protocol. This use of the protocol may be preferred to allow a research participant to differentiate their biological sex assigned at birth with how they currently define their gender.
What was your biological sex assigned at birth?
[ ] Female
[ ] Male
[ ] Intersex
[ ] None of these describe me (optional free text)
[ ] Prefer not to answer
Personnel and Training Required
The PhenX Steering Committee acknowledges these questions can be administered in a computerized or noncomputerized format (i.e., paper-and-pencil instrument). Computer software is necessary to develop computer-assisted instruments. The interviewer will require a laptop computer/handheld computer to administer a computer-assisted questionnaire.
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Self-administered or interviewer-administered questionnaire
Adults 18 years and older
This protocol was selected because it is both the most up-to-date and in use by the national All of Us research program.
|caDSR Common Data Elements (CDE)||Person Gender Text Type||2200604||CDE Browser|
Process and Review
Protocol Name from Source
All of Us Research Program Participant Provided Information (PPI)
All of Us Research Program Participant Provided Information (PPI) Version:
Version: December 17, 2018
The Precision Medicine Initiative Cohort Program – Building a Research Foundation for 21st Century Medicine Precision Medicine Initiative (PMI) Working Group Report to the Advisory Committee to the Director, NIH September 17, 2015
A New Initiative on Precision Medicine
Francis S. Collins, M.D., Ph.D., and Harold Varmus, M.D. January 30, 2015, at NEJM.org
National Research Council. Toward precision medicine: building a knowledge network for biomedical research and a new taxonomy of disease. Washington, DC: National Academies Press, 2011 (http://www.nap.edu/catalog/13284/toward-precision-medicine-building-a-knowledge-network-for-biomedical-research).
The GenIUSS Group. (2014). Best Practices for Asking Questions to Identify Transgender and Other Gender Minority Respondents on Population-Based Surveys. J.L. Herman (Ed.). Los Angeles, CA: The Williams Institute.
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
|PX011601010100||What was your biological sex assigned at birth?||N/A|
|PX011601010200||What was your biological sex assigned at more||N/A|
Biological sex assigned at birth
June 4, 2019
The indication of the biological sex assigned to an individual at the time of birth. This usually aligns with a person’s anatomical sex, chromosomal sex, and phenotype.
Biological sex is an important piece of demographic information impacting many health outcomes.
Female, Male, Intersex, Gender