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 promoting 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 
its 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 also 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.  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 
(http://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: [email protected]

Carole Dillard
Rural Populations Research 
Center for Primary Care Research
6010 Executive Boulevard
Rockville, MD 20852
Telephone: (301) 594-1358
Email: [email protected]

Kaytura Felix-Aaron 
Minority Populations Research
Office of Priority Populations Research 
2101 East Jefferson Street 
Rockville, MD 20852
Telephone: (301) 594-6198
Email: [email protected]

Linda Franklin
Women's Health Research
Office of Priority Populations Research
2101 East Jefferson Street
Rockville, MD 20852
Telephone: (301) 594-4037
Email: [email protected]

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: [email protected]

William Spector 
Older Adult Population Research
Center for Organization and Delivery Studies
2101 East Jefferson Street
Rockville, MD 20852
Telephone: (301) 594-6820
Email: [email protected]

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: [email protected]

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: [email protected]

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.

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