AMENDMENT:  NIH POLICY AND GUIDELINES ON THE INCLUSION OF WOMEN AND MINORITIES 
AS SUBJECTS IN CLINICAL RESEARCH - OCTOBER, 2001

Release Date:  October 9, 2001

(11/06/06 - See updated list of NIH contacts (MS Word) for this policy)

NOTICE:  NOT-OD-02-001

National Institutes of Health

The National Institutes of Health policy on the Inclusion of Women and 
Minorities as Subjects in Clinical Research has been amended.  A complete 
copy of the amended policy may be found on the "Inclusion of Women and 
Minorities Policy Implementation" web site: 
http://grants.nih.gov/grants/funding/women_min/women_min.htm.  The October 
2001 policy provides a consolidated, concise, and clear document of the 
updates and changes to the NIH policies to implement the original legislation 
(PL 103-43), the 1994 Federal Register notice 
(http://grants.nih.gov/grants/guide/notice-files/not94-100.html) and the 
August 2000 notice in the NIH Guide to Grants and Contracts 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html).  

EFFECTIVE DATE: This amended policy is effective immediately and applies to 
all grants and cooperative agreements currently active and to be awarded. 
Contract solicitations issued as of October 2001 must adhere to the amended 
policy.

The amended policy incorporates the following four points: 

1.  The definition of clinical research as reported in the "1997 Report of 
the NIH Director’s Panel on Clinical Research" is used to implement the 
NIH policy on the inclusion of women and minorities as subjects in 
clinical research.  In June 2001, NIH adopted the definition of clinical 
research as: (1) Patient-oriented research. Research conducted with human 
subjects (or on material of human origin such as tissues, specimens and 
cognitive phenomena) for which an investigator (or colleague) directly 
interacts with human subjects. Excluded from this definition are in vitro 
studies that utilize human tissues that cannot be linked to a living 
individual. Patient-oriented research includes: (a) mechanisms of human 
disease, (b) therapeutic interventions, (c) clinical trials, and (d) 
development of new technologies, (2) Epidemiologic and behavioral studies, 
and (3) Outcomes research and health services research 
http://www.nih.gov/news/crp/97report/execsum.htm 

2. Racial and ethnic categories have been updated in order to comply with the 
new standards issued by the Office of Management and Budget (OMB) in 
Directive No. 15 http://www.whitehouse.gov/omb/fedreg/ombdir15.html.  This 
directive defines the minimum standards for maintaining, collecting, and 
presenting data on race and ethnicity for all Federal reporting.  NIH is 
required to use these definitions to allow comparisons to other federal 
databases, especially the census and national health databases. The 
categories in this classification are social-political constructs and 
should not be interpreted as anthropological in nature.

3. Language governing NIH-defined Phase III clinical trials has been 
clarified in order to be consistent with the mandate for the inclusion of 
women and minorities as subjects in clinical research (PL103-43), the new 
PHS 398 form and OMB Directive 15. The amended policy provides additional 
guidance on the analyses and reporting of analyses of sex/gender, 
racial/ethnic and relevant subpopulation differences in intervention 
effects for NIH-defined Phase III clinical trials. 

4. Roles and responsibilities of NIH staff and the extramural community have 
been updated with regard to the implementation of the NIH policy on the 
inclusion of women and minorities as subjects in clinical research. While 
this policy applies to all applicants/offerors for NIH-fundeded clinical 
research, certain individuals and groups have special roles and 
responsibilities with regard to its implementation.



Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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