Release Date: April 16, 2013
National Institutes of Health (NIH)
The purpose of this Notice is to announce that NIH will limit reporting of racial and ethnic information on participants in NIH-supported clinical research to the 1997 Office of Management and Budget (OMB) standards. Effective May 25, 2013, NIH will no longer accept inclusion reporting forms using the OMB standards of 1977.
In 1997, OMB issued guidelines revising the racial and ethnic categories for Directive 15. In August 2001, the NIH issued a policy on reporting of race and ethnicity data for subjects in clinical research in response to the revised OMB guidance. With implementation of that policy, under certain circumstances, some studies were permitted to continue using the previous ("old") OMB standards (1977) when reporting to the NIH. Current reviews of incoming reports indicate few studies are still using these "old" forms. Investigators using the "old" form will be contacted by program staff of their funding Institute or Center (IC) at NIH to discuss the data transition to the forms using the 1997 standards that are currently approved for use. This applies to both competing and non-competing applications and awards.
Please direct all inquiries to:
Meredith D. Temple-O'Connor, Ph.D.
NIH Inclusion Policy Officer
Office of Extramural Research (OER)
Office of the Director, NIH
6705 Rockledge Drive, Suite 5040
Bethesda, MD 20892
Phone: (301) 435-7124
Fax: (301) 435-2003