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

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

2014-04-01

Race USA category

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.

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.

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