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Invitation to Comment: AHRQ Preliminary Policy on Inclusion of Priority Populations in Research

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The Agency for Healthcare Quality and Research (AHRQ) invites comments on its preliminary policy on the Inclusion of Priority Populations in Research. This preliminary policy was written to implement a directive of the Healthcare Research and Quality Act. It directed AHRQ "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."

AHRQ plans to publish a policy on Inclusion of Priority Populations in Research in the NIH Guide during summer 2002.

The purpose of this notice is to encourage feedback and comment on the preliminary policy from the extramural community of researchers and users of AHRQ-sponsored research. Feedback can be submitted to to https://info.ahrq.gov or to the Office of Extramural Research, Education and Priority Populations; 540 Gaither Road, Suite 2000; Rockville, MD 20850; Attn.: Priority Populations Policy.

Comments and responses will be available for public inspection at AHRQ's Information Resource Center (IRC) public reading room between the hours of 8:30 a.m. and 5:00 p.m. on regular business days at 540 Gaither Road, Suite 1000, Rockville, MD 20850. Arrangements for viewing public comments may be made by calling (301) 427-1287. Responses may also be accessed through AHRQ's Electronic Freedom of Information Reading Room.


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 (https://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 effective immediately it is establishing a new policy on the inclusion of priority populations in the health services research it conducts and supports.

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. 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, 2002, applicants will be required to include in their applications a narrative describing the inclusion of AHRQ priority populations in the proposed project or justifying the exclusion of priority populations when a 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:

  • Evaluate the proposed plan and justification for the inclusion of priority populations or evaluate the proposed justification when priority populations are absent.
  • Evaluate the proposed exclusion of priority populations when a requirement for inclusion would be inappropriate with respect to the purpose of the research.
  • Evaluate the plans for outreach and recruitment of study participants where appropriate.
  • Evaluate the proposed plan for conducting subgroup analyses so that study results will be relevant to one or more priority populations where appropriate.
  • 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. 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.

How to Submit Comments

The purpose of this notice is to encourage feedback and comment on the preliminary policy from the extramural community of researchers and users of AHRQ-sponsored research. Feedback can be submitted to to https://info.ahrq.gov or to the Office of Extramural Research, Education and Priority Populations; 540 Gaither Road, Suite 2000; Rockville, MD 20850; Attn.: Priority Populations Policy.

Comments and responses will be available for public inspection at AHRQ's Information Resource Center (IRC) public reading room between the hours of 8:30 a.m. and 5:00 p.m. on regular business days at 540 Gaither Road, Suite 1000, Rockville, MD 20850. Arrangements for viewing public comments may be made by calling (301) 427-1287. Responses may also be accessed through AHRQ's Electronic Freedom of Information Reading Room.

Current as of April 2002

The information on this page is archived and provided for reference purposes only.

 

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