Protocol - Biological Sex Assigned at Birth

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

Availability

Available

Download PDF

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 Category	Required
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

Lifestage

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, Other languages available at source

Standards

Standard	Name	ID	Source
caDSR Common Data Elements (CDE)	Person Gender Text Type	2200604	CDE Browser

Derived Variables

None

Process and Review

Not applicable.

Protocol Name from Source

All of Us Research Program, Participant Provided Information (PPI), 2018

Source

All of Us Research Program Participant Provided Information (PPI) 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

Collins, F. S. and Varmus, H. (2015). A New Initiative on Precision Medicine. N Engl J Med, 372, 793-795

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.

Protocol ID

11601

Variables

Export Variables

Variable Name	Variable ID	Variable Description	dbGaP 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

biological sex assigned at birth, female, male, Intersex, gender, Demographics-Populations with HD

Measure Protocols

Protocol ID	Protocol Name
11601	Biological Sex Assigned at Birth