NHLBI Policy for Inclusion of Women and Minorities in Clinical Research

PURPOSE

The NIH Revitalization Act of 1993 requires that women and members of minority groups and their subpopulations be included in all NIH-supported biomedical and behavioral research projects involving human subjects. Published NIH guidelines are intended to ensure that all such research is carried out in a manner sufficient to elicit information about individuals of both genders and the diverse racial and ethnic groups that constitute the U.S. population and, in the case of clinical trials, to examine differential effects on such groups.

DEFINITIONS

Refer to NHLBI Clinical Research Guide Glossary

POLICY DETAILS

Prior to making awards, the NHLBI will examine each grant application to ensure that it complies with the NIH Revitalization Act of 1993. The expectation for NHLBI-funded studies is that the targeted study population will reflect the composition of the overall U.S. population (51 percent women, 30 percent minorities) or the gender/race/ethnic distribution of the population affected by the disease/condition under study, if such information is available. Exceptions are permitted only when a valid scientific justification for limited inclusion exists; the law states explicitly that cost is not a permissible justification.

REFERENCES

• NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
• Questions and Answers on Inclusion of Minorities and Women in Study Populations at NHLBI

RELATED DOCUMENTS     

• Procedures for Implementing the Policy on the Inclusion of Women and Minorities in Study Populations - STAFF ONLY

CONTACT

Ms. Sharry Palagi
National Heart, Lung and Blood Institute
31 Center Drive, Room 5A-07
Bethesda, MD 20892
Telephone: (301) 402-3424
Email: palagis@mail.nih.gov

Last Updated: January 12, 2011

For questions and/or concerns regarding the content of this page, please contact the Clinical Research Policy Manager