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Protocol - Biological Sex Assigned at Birth

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Description:

Participants (or proxy) indicate the biological sex assigned at birth. It can be self-administered or interviewer administered.

Specific Instructions:

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. 

Protocol:

What was your biological sex assigned at birth?

[ ] Female

[ ] Male

[ ] Intersex

[ ] None of these describe me (optional free text)

[ ] Prefer not to answer

Protocol Name from Source:

All of Us Research Program Participant Provided Information (PPI)

Availability:

Publicly available

Personnel and Training Required

None

Equipment Needs

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.

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
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

Life Stage:

Adult, Senior

Participants:

Adults 18 years and older

Selection Rationale

This protocol was selected because it is both the most up-to-date and in use by the national All of Us research program.

Language

English, Spanish

Standards
StandardNameIDSource
Common Data Elements (CDE) Person Gender Text Type 2200604 CDE Browser
Derived Variables

None

Process and Review

Not applicable.

Source

All of Us Research Program Participant Provided Information (PPI) Version:

 Version: December 17, 2018

General References

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).

Google Scholar

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.

Protocol ID:

11601

Variables:
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX011601_Biological_Sex_Assigned_Birth
PX011601010100 What was your biological sex assigned at birth? N/A
PX011601_Biological_Sex_Assigned_Birth_Other
PX011601010200 What was your biological sex assigned at more
birth? Other show less
N/A
Demographics
Measure Name:

Biological sex assigned at birth

Release Date:

June 4, 2019

Definition

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.

Purpose

Biological sex is an important piece of demographic information impacting many health outcomes.

Keywords

Female, Male, Intersex, Gender