AHRQ Policy on the Inclusion of Priority Populations in Research
Notice Number:
NOT-HS-21-015

Key Dates

Release Date:

May 18, 2021

Related Announcements

NOT-HS-03-010 - AHRQ Policy on the Inclusion of Priority Populations in Research
NOT-HS-20-017 - Changes to the HHS Notice of Award (NoA) Beginning October 1, 2020
NOT-HS-20-011 - The Agency for Healthcare Research and Quality Data Management Plan Policy
NOT-OD-20-077 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020—New Grant Application Instructions Now Available
NOT-HS-20-006 - Salary Limitation on AHRQ FY2020 Grants, Cooperative Agreements, and Contracts
NOT-HS-20-005 - AHRQ Guide Notice on Implementation of the Use of a Single Institutional Review Board (IRB) for Cooperative Research at 45 CFR 46.114 (b)
NOT-HS-19-007 - AHRQ Announces Change in Grant Recipient Purchasing of Identifiable CMS Data, effective FY2019

Issued by

Agency for Healthcare Research and Quality (AHRQ)

Purpose

This revised Notice replaces NOT-HS-03-010. The Agency for Healthcare Research and Quality (AHRQ) is revising its policy on the Inclusion of Priority Populations in Research. The purpose of this policy is to ensure that all individuals are included in health services research in a manner appropriate to the specific question under study so that the knowledge gained from AHRQ-funded research is equally applicable to all populations. AHRQ is also expanding its definition of priority populations to include members of the underserved communities specified in Section 2(a) of Executive Order 139895 (Advancing Racial Equity and Support of Underserved Communities Through the Federal Government), issued January 20, 2021.

BACKGROUND:

The mission of AHRQ is to make healthcare safer, higher quality, more accessible, equitable, and affordable, and to work within the US Department of Health and Human Services (HHS) and with other partners to make sure that the evidence is understood and used. AHRQ achieves this mission by focusing on its three core competencies: health services research; practice improvement; and data and analytics.

AHRQ’s authorizing legislation provides that AHRQ shall, in carrying out its mission, conduct and support research and evaluations, and 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. 42 U.S.C. 299(c)(1). AHRQ was also directed to establish a process to ensure that these requirements are reflected in the overall portfolio of research conducted and supported by the Agency. 42 U.S.C. 299(c)(2).

POLICY:

With the reissuance of this policy, AHRQ informs the research community that it continues its commitment to the inclusion of priority populations in health services research. The overall portfolio of health services research that AHRQ conducts and supports shall include the populations specifically named in AHRQ’s authorizing legislation: 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. In addition to the priority populations specifically named in 42 U.S.C. 299(c)(1), AHRQ will include in its definition of priority populations those groups identified in Section 2(a) of Executive Order 13985 as members of underserved communities: Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.

This updated policy will be broadly implemented across the research that AHRQ supports and conducts so that the portfolio of research is inclusive of all populations. AHRQ intends that these populations be included in studies such that the research design explicitly allows conduct of valid analyses. The policy applies to all grant applications, solicitations for research contracts, and AHRQ intramural studies.

ROLES AND RESPONSIBILITIES

A. Applicants

Applicants are required to include in their applications a narrative describing the inclusion of AHRQ priority populations, including the underrepresented populations listed above, in the proposed project. The narrative should also contain a description of the proposed plans for recruiting and retaining priority populations as research participants. In the uncommon situation where the goals of the proposed studies exclude priority populations, applicants should provide a sufficient rationale for excluding priority populations.

Plans for conducting studies among persons from one or more priority populations should be indicated at the time of submission as aligned with the study objectives. Accordingly, the study design and methodology should be suitable for the priority population(s) that are included with sufficient attention to the nuances, characteristics, needs, and most important outcomes for each group and subgroup included in the study. When appropriate for the study question, outcome assessments should be provided with an accurate estimate of outcomes and differences in outcomes between two of more groups of participants (e.g. disparities). Such between-group differences should be reported for both large and small studies, even when statistical power to detect significant differences among subgroups is lacking. Minimizing risk of biased allocation and assessment is essential. For example, for an intervention study, randomization of participants and blinding of investigators and outcome assessors is expected in order to ensure unbiased results and conclusions. There is, however, no pre-specified format for the narrative.

B. Peer Review Groups

The AHRQ peer review regulation (42 CFR Part 67) governs the scientific and technical assessment of submitted grant and research contract applications. Peer reviewers must include their assessment of the proposed inclusion plan for priority populations in evaluating the overall scientific and technical merit of the application and assigning the impact score.

In conducting peer review for scientific and technical merit, the peer review groups will:

  • Evaluate the application for the presence or absence of the inclusion plan based on the proposed research objectives.
  • Evaluate the adequacy of the proposed plan for the inclusion of priority populations.
  • Evaluate the proposed justification for the exclusion of priority populations when a requirement for inclusion is described as inappropriate with respect to the purpose of the research.
  • Evaluate the plans for outreach and recruitment of study participants, including priority populations, where appropriate.
  • Evaluate the proposed plan for study design, execution and outcome assessments so that study results will be relevant to one or more priority populations, where appropriate.
  • Assess the plan as being “acceptable” or “unacceptable” with regard to the appropriateness of the inclusion or exclusion of priority populations in the proposed research

C. AHRQ

AHRQ will consider the inclusion of priority populations as one factor in making decisions concerning the funding of grants and research contracts.

AHRQ will monitor policy implementation during the development, review, award, and conduct of research. AHRQ award recipients must submit data on the inclusion of priority populations in progress and final reports.

Inquiries

Please direct all inquiries to:

Brenda Harding
AHRQ/Division of Priority Populations
Office of Extramural Research, Education, and Policy
Brenda.harding@ahrq.hhs.gov


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