| This is a computer translation of the original webpage. It is provided for general information only and should not be regarded as complete nor accurate. |  |
| This is a computer translation of the original webpage. It is provided for general information only and should not be regarded as complete nor accurate. | |
AHRQ POLICY ON THE INCLUSION OF PRIORITY POPULATIONS IN RESEARCH
RELEASE DATE: February 27, 2003
NOTICE: NOT-HS-03-010 April 13, 2011 - See Notice NOT-HS-11-013 Special Emphasis Notice (SEN):
AHRQ Announces Interest in Grants focused on Health Issues of Minority Women.
April 13, 2011 - See Notice NOT-HS-11-014 Special Emphasis Notice (SEN):
AHRQ Announces Interest in Priority Populations Research .
Agency for Healthcare Research and Quality (AHRQ)
(http://www.ahrq.gov)
BACKGROUND
The mission of the Agency for Healthcare Research and Quality (AHRQ) is to
enhance the quality, appropriateness, and effectiveness of health services,
and access to such services, through establishing a broad base of scientific
research and implemented improvements in clinical and health systems practices,
including the prevention of diseases and other health conditions. AHRQ
achieves this mission through health services research designed to (1)
improve clinical practice; (2) improve the health care system's ability to
provide access to and deliver high quality, high-value health care and (3)
provide policymakers with the ability to assess the impact of system changes
on outcomes, quality, access to, cost, and use of health care services.
AHRQ's research agenda is designed to be responsive to the needs of
Consumers, patients, clinicians and other providers, institutions, plans,
purchasers, and public policymakers for the evidence-based information they
need to improve quality and outcomes, control costs, and assure access to
needed services.
The purpose of this notice is to announce a new AHRQ policy on the inclusion
of priority populations in research conducted and supported by the Agency.
On December 6, 1999, the Healthcare Research and Quality Act of 1999 was
signed (http://www.ahrq.gov/hrqa99a.htm), reauthorizing the Agency through
fiscal year 2005. The authorizing legislation directed AHRQ, in carrying out
our mission, to conduct and support research and evaluations, and to support
demonstration projects, with respect to the delivery of health care in inner-
City and rural areas (including frontier areas) and health care for priority
populations, which include low income groups; minority groups women;
Children the elderly and individuals with special health care needs,
including individuals with disabilities and individuals who need chronic care
or end-of-life health care.
The re-authorization further directed AHRQ to establish a process to ensure
that these requirements are reflected in the overall portfolio of research
conducted and supported by the Agency. It directed AHRQ to establish
an Office of Priority Populations to assist in carrying out the requirements.
In response to these directives set forth in the AHRQ re-authorization, the
Agency established an Office of Priority Populations Research (OPPR) in 2001,
with the mission of coordinating, supporting, managing, and conducting health
services research on priority populations. OPPR also serves as a resource to
implement the Agency's priority population research agenda. With this policy
announcement, the Agency is providing notice that it is establishing a new
policy on the inclusion of priority populations in the health services
research it conducts and supports. 
End of
Translation
Beginning with the October 1, 2003
receipt date for grant applications, this policy will be in effect.
POLICY
It is the policy of AHRQ that the overall portfolio of health services
research it conducts and supports shall include the following priority
populations: inner-city; rural; low income; minority; women; children;
elderly; and those with special health care needs, including those who have
disabilities, need chronic care, or need end-of-life health care. This
policy will be broadly implemented across the research that AHRQ supports and
conducts, so that the portfolio of research is inclusive of all priority
populations. It is the intent of AHRQ that priority populations be included
in studies such that the research design explicitly allows for valid analyses
to be conducted.
The Agency will maintain its current policy on the inclusion of women and
members of minority groups in research involving human subjects, and
applicants must continue to comply with these requirements. That policy
requires that women and members of minority groups be included in all AHRQ-
supported research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. That AHRQ policy results from the NIH Revitalization Act of
1993 (Section 492B of Public Law 103-43). Investigators proposing research
involving human subjects should read the AMENDED "NIH Guidelines on the
Inclusion of Women and Minorities as Subjects in Clinical Research" published
in the NIH Guide for Grants and Contracts on October 9, 2001
(https://grants.nih.gov/grants/funding/women_min/women_min.htm).
This amended policy provides a consolidated and concise document of the
updates and changes to the original NIH policy.
ROLES AND RESPONSIBILITIES
A. Applicants
Beginning with grant applications submitted to AHRQ on October 1, 2003,
applicants will be required to include in their applications a narrative
describing the inclusion of AHRQ priority populations in the proposed project
or providing a rationale for exclusion of priority populations when the
requirement for inclusion would be inappropriate with respect to the purpose
of the study. Thus, in addition to the requirement to include women and
members of minority groups as subjects in all studies involving human
subjects, investigators should also consider including subjects from one or
more AHRQ priority populations within the context of developing a research
design appropriate to the scientific objectives of the planned study. The
proposed priority populations to be included in the study should be discussed
within the research plan section of the PHS 398 grant application. The
narrative should also contain a description of the proposed outreach
activities for recruiting and retaining priority populations as research
participants. Applicants should assess the feasibility of subgroup analyses
to provide specific research results relevant to one or more priority
population and include this assessment with the research application. There
is no pre-specified format for the narrative.
It is important to note that with this Priority Populations Inclusion Policy,
AHRQ strongly encourages investigators to consider including one or more of
these populations. It is not AHRQ's intent that all studies must include all
priority populations.
B. Peer Review Groups
In conducting peer review for scientific and technical merit, the
appropriately constituted initial review group (including study sections),
and technical evaluation groups will:
o evaluate the proposed plan and justification for the inclusion of
priority populations or evaluate the proposed justification when priority
populations are absent.
o evaluate the proposed exclusion of priority populations when a
requirement for inclusion would be inappropriate with respect to the purpose
of the research.
o evaluate the plans for outreach and recruitment of study participants
where appropriate.
o evaluate the proposed plan for conducting subgroup analyses so that study
results will be relevant to one or more priority populations where
appropriate.
o include these criteria as part of the scientific assessment and assigned
score.
C. AHRQ
As noted above, AHRQ will consider the inclusion of priority populations as
one factor in making decisions concerning the funding of extramural research.
AHRQ is committed to maintaining a portfolio of health services research that
is broadly inclusive of the full spectrum of priority populations; thus, all
of the populations listed are important.
AHRQ staff will provide educational opportunities for the extramural research
community concerning this policy. AHRQ will also publish a list of
frequently asked questions and answers about the policy on its web site.
That list can be found at http://www.ahrq.gov/fund/ppopfaq.htm.
The Agency will monitor its implementation during the development, review,
award, and conduct of research. Over time, the Agency will evaluate its
portfolio to identify areas where there are gaps or where special attention
may be needed.
WHERE TO SEND INQUIRIES
The following senior extramural staff from AHRQ may be contacted for further
information about this policy and relevant priority population issues:
Robin Weinick
Research on Inner City Populations, Research on Low Income Populations
Center for Primary Care Research
6010 Executive Boulevard
Rockville, MD 20852
Telephone: (301) 594-2010
Email: rweinick@ahrq.gov
Carole Dillard
Rural Populations Research
Center for Primary Care Research
6010 Executive Boulevard
Rockville, MD 20852
Telephone: (301) 594-1358
Email: cdillard@ahrq.gov
Kaytura Felix-Aaron
Minority Populations Research
Office of Priority Populations Research
2101 East Jefferson Street
Rockville, MD 20852
Telephone: (301) 594-6198
Email: kfaaron@ahrq.gov
Linda Franklin
Women's Health Research
Office of Priority Populations Research
2101 East Jefferson Street
Rockville, MD 20852
Telephone: (301) 594-4037
Email: lfrankli@ahrq.gov
Denise Dougherty
Children's Health Research, Research on Populations with Disabilities
Office of Priority Populations Research
2101 East Jefferson Street
Rockville, MD 20852
Telephone: (301) 594-2051
Email: ddougher@ahrq.gov
William Spector
Older Adult Population Research
Center for Organization and Delivery Studies
2101 East Jefferson Street
Rockville, MD 20852
Telephone: (301) 594-6820
Email: wspector@ahrq.gov
Ronda Hughes
Research on Populations Needing End of Life Health Care
Center for Primary Care Research
6010 Executive Boulevard
Rockville, MD 20852
Telephone: (301) 594-0198
Email: rhughes@ahrq.gov
For general questions about the new inclusion policy contact:
Debbie Rothstein
Office of Research Review, Education, and Policy
2101 East Jefferson Street
Rockville, MD 20852
Telephone: (301) 594-2918
Email: drothste@ahrq.gov
Information about research and research training grant and cooperative
agreement announcements as well as other AHRQ policy notices can be found at http://www.ahrq.gov (see Funding Opportunities). Applicants are encouraged
to review this information and contact the Agency staff contact (listed under
WHERE TO SEND INQUIRIES) who matches their research interests to seek
additional guidance.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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