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
Related Announcements NOT-OD-18-014
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.