Race USA category : FITBIR : Federal Interagency Traumatic Brain Injury Research Informatics System

Listed below are the details for the data element.

Version

1.16

Element Type

Common Data Element

Title

Race USA category

Variable Name

RaceUSACat

Short Description

The subject self declared racial origination, independent of ethnic origination, using OMB approved categories.

Definition

The subject self declared racial origination, independent of ethnic origination, using OMB approved categories.

Biomedical Terminologies and Standards

Notes

cdRNS|eyeGene|FITBIR|NIA|PDBP; Core CDEs from ONC SET OF DATA CLASSES TO SUPPORT NATIONWIDE INTEROPERABILITY

Creation Date

2014-04-01

Historical Notes

Race USA category

References

The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget (OMB) Directive No. 15 defines the minimum standard of basic racial and ethnic categories. (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, September 2005 - http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm) Jorde LB and Wooding SP. Genetic variation, classification and "race". Nature Genetics. 2004;36(11):S28-S33. Bhopal R and Donaldson L. White, European, Western, Caucasian, or What? Inappropriate labeling in Research on Race, Ethnicity, and Health. Amer J of Publ Health. 1998;88:1303-1307.

Data Type

Alphanumeric

Input Restrictions

Multiple Pre-Defined Values Selected

Pre-Defined Values

External Schema Permissible Value Mapping

Population

Adult and Pediatric

Guidelines/Instructions

Choose all that apply. Response is obtained by report of the participant/subject or caretaker. Collecting information on race may not be allowed in some countries for concerns related to discrimination. In other countries, however, these concerns are considered a reason for recording race in order to guarantee equal access to care. Investigators receiving funding from the US National Institutes of Health (NIH) are required to report the number of subjects enrolled on an annual basis using the racial categories listed.The Office of Management and Budget (OMB) Directive No. 15 (revised from 200) defines the minimum standard of basic racial and ethnic categories - https://nces.ed.gov/programs/handbook/data/pdf/Appendix_A.pdf). Final Guidance on Maintaining, Collecting and Reporting Racial and Ethnic Data to the U.S. Department of Education is available from the USED at the Federal Register web site at http://edocket.access.gpo.gov/2007/E7-20613.htm.

Preferred Question Text

What is the subject's race (as defined by OMB)?

Category Groups and Classifications

Disease	Domain	Sub-Domain
General (For all diseases)	Participant/Subject Characteristics	Demographics
Traumatic Brain Injury	Participant/Subject Characteristics	Demographics

Classification

Acute Hospitalized :

Core

Concussion/Mild TBI :

Core

General (For all diseases) :

Core

Moderate/Severe TBI: Rehabilitation :

Core

Epidemiology :

Core

Keywords

COVID19

Labels

Effective Date

Until Date

Last Change Date

Fri Aug 11 15:01:53 EDT 2023

Change History