Key Dates

Related Announcements

• December 18, 2024 - Agency for Healthcare Research and Quality (AHRQ) Data Management and Sharing Policy. See Notice NOT-HS-25-010.
• May 26, 2020 - The Agency for Healthcare Research and Quality Data Management Plan Policy. See NOFO NOT-HS-20-011. 
• February 19, 2016 - AHRQ Announces New Policy for Public Access to AHRQ-Funded Scientific Publications. See NOFO NOT-HS-16-008.

Issued by

AGENCY FOR HEALTHCARE RESEARCH & QUALITY (AHRQ)

Purpose

Background

On February 22, 2013, the White House Office of Science and Technology Policy (OSTP) released a memorandum entitled “Increasing Access to the Results of Federally Funded Scientific Research” (https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf) (2013 Memo). This memorandum requires certain federal agencies to make the results of federally funded scientific research available to and useful for the public, industry, and the scientific community.

The AHRQ Public Access Policy for Scientific Publications, in effect since 2016, was in response to the 2013 Memo, requiring that AHRQ-supported researchers submit their final peer-reviewed manuscripts to the PubMed Central® digital archive of full-text biomedical literature upon acceptance for publication. Since then, AHRQ has made manuscripts freely available to the public after an allowable embargo period of not more than 12 months after the official date of publication.   

On August 25, 2022, the OSTP released updated policy guidance (2022 OSTP Memo) to further promote equity and advance trust in science. In 2023 AHRQ published a Request for Information seeking public comments on proposed updates to its public access plan for peer reviewed scholarly publications and scientific data resulting from AHRQ funding. AHRQ updated its Plan for Establishing a Policy for Public Access to Scientific Publications and Scientific Data in Digital Format Resulting from AHRQ Funding (Plan). AHRQ is now updating its Public Access Policy for Scientific Publications. The updates are intended to accelerate access to scholarly publications, consistent with the expectation to remove the currently allowable 12-month embargo period before public availability.

The AHRQ mission is to produce evidence that makes health care safer, higher quality, more accessible, equitable and affordable, and to work within the U.S. Department of Health and Human Services (HHS) and with other partners to make sure the evidence is understood and used.

The AHRQ Public Access Policy for Scientific Publications (the “AHRQ Public Access Policy” or “this Policy”) promotes the following objectives:

• Establish AHRQ’s commitment to public access to scientific research results;
• Help ensure that the public can read, download, and analyze in digital format final published documents;
• Facilitate easy public search, analysis of, and access to peer-reviewed scholarly publications directly arising from research funded by AHRQ;
• Promote full public access to publications without charge;
• Provide for continued attribution to the authors and publishers of scientific publications;
• Ensure that publications are in an archival solution;
• Advance the expedited translation of research results into knowledge, products, and procedures to improve health; and
• Facilitate the education of new researchers and enable the exploration of topics not envisioned by the initial investigators.

Policy

The AHRQ Public Access Policy requires that AHRQ-funded authors submit an electronic version of the author’s final peer-reviewed accepted manuscript to the National Library of Medicine's PubMed Central (PMC) upon acceptance by the journal, and to be made publicly available without embargo upon the Official Date of Publication.

This Policy applies to all peer-reviewed scientific publications arising from AHRQ-funded research grants and career development award mechanisms, cooperative agreements, contracts conducting research, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, and AHRQ intramural research studies. In cases where AHRQ-funded research is administered or performed by a partner agency with a comparable public access policy, AHRQ will defer to the partner agency’s policies on the management of scientific publications.

The AHRQ Public Access Policy requires an acknowledgment in the manuscript and Final Published Article that satisfies the requirements regarding communicating and acknowledging federal funding. AHRQ requests that recipients notify the Office of Communication (OC) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to [email protected] at least four to six weeks in advance of the journal’s expected publication date.

The AHRQ Public Access Policy requires that when a manuscript is submitted to NIH PMC, AHRQ-funded authors provide AHRQ with a standard license that mirrors that of the Government Use License at 45 CFR 75.322(b), or its successor regulation, explicitly granting AHRQ the right to make the manuscript publicly available through PubMed Central without embargo upon the Official Date of Publication.

The AHRQ’s updated Public Access Policy for Scientific Publications will become effective for manuscripts accepted for publication after the date this Policy is published and will not apply to any publication arising from an AHRQ-funded grant, cooperative agreement award, or research contract, funded prior to publication of this Policy. However, AHRQ encourages researcher with publications resulting from AHRQ funding prior to publication of this policy to submit final manuscripts for public access.

The AHRQ Public Access Policy is intended to be consistent with the NIH Public Access Policy. AHRQ recipients are encouraged to utilize the significant NIH resources available at https://publicaccess.nih.gov/

Definitions

Research Data: Research data is defined in OMB Circular A-110 as the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues. This 'recorded' material excludes physical objects (e.g., laboratory samples).

Research data also do not include:

• Trade secrets, commercial information, materials necessary to be held confidential by a researcher until they are published, or similar information which is protected under law.
• Personnel and medical information and similar information, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular person in a research study.

Digital Scientific Data: For the purpose of this plan and consistent with OMB Circular A-110, digital scientific data is defined as "the digital recorded factual material commonly accepted in the scientific community as necessary to validate research findings including data sets used to support scholarly publications, but does not include laboratory notebooks, preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens."

For the purpose of this plan, the definition of digital scientific data does not include software. However, AHRQ recognizes that in some cases, software and other tools such as interview protocols, measures, coding guides, or manuals may be necessary to interpret data. In such cases, the data management plan will be expected to include a description of these tools.

A published data set consists of at least one formal metadata document, the digital scientific data described by that metadata, and supplemental information provided to assist the data user. The metadata for scientific data will include, at a minimum, the common core metadata schema in use by the Federal Government, found at https://project-open-data.cio.gov/.

A published data set can be cited in the scientific literature and, following the practice used by most publishers of scholarly journals, has a persistent and unique identifier associated with it. A published data set is expected to persist over time, just like the scholarly articles that are based on the digital scientific data.

Data Sharing Plan: A data sharing plan outlines whether and how data will be made available to others. The plan must also explicitly describe how the data that underlies scientific publications will be available for discovery, retrieval, and analysis. It may include the expected timeline for when the data will be available, the format of the final dataset, the documentation and any analytic tools that will be provided, and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal Web site, through a data archive or enclave). A plan might also specify whether or not a data sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use). If data sharing is not possible, the plan would provide an explanation.

Data Management Plan: Data management plans are more comprehensive than data sharing plans in that they include additional elements such as descriptions of the data to be produced in the proposed study, any standards to be used for collected data and metadata, mechanisms for providing access to and sharing of the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights), provisions for reuse and redistribution, and plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified.

Final peer-reviewed manuscript: A final peer-reviewed manuscript is defined as an author's final manuscript of a peer-reviewed paper accepted for journal publication, including all modifications from the peer-review process.

Final published article: A final published article is defined as a publisher's authoritative copy of the paper, including all modifications from the publishing peer-review process, copy editing, stylistic edits, and formatting changes.

Requirements for AHRQ Researchers Related to Public Access

Publications

The AHRQ Public Access Policy applies to peer-reviewed scientific publications that have been supported, in whole or in part, with AHRQ funds. To ensure full integration of this policy with the AHRQ research and award management systems, AHRQ has been partnering with the NIH National Library of Medicine to use PubMed Central (PMC) as the repository of publications resulting from AHRQ-funded research. For peer-reviewed scientific publications, the AHRQ Public Access Policy requires that authors submit an electronic version of the author's final peer-reviewed accepted journal manuscripts to PMC. The author's final manuscript is defined as the final version accepted for journal publication and includes all modifications from the publishing peer review process. In lieu of the final peer-reviewed manuscript, AHRQ will accept the final published article provided the awardee can ensure AHRQ has the rights to make the published version public. Under this Policy, the final manuscript will not be made available to the public through PMC until after the final published article is published by the journal.

Submission of Manuscripts/Publications

Under this Policy, electronic submission will be made directly to PMC: http://www.pubmedcentral.nih.gov. PMC is the NIH digital repository of full-text, peer-reviewed biomedical, behavioral, and clinical research journals. It is a publicly accessible, stable, permanent, and searchable electronic archive. AHRQ uses PMC to enable the submission of final peer-reviewed manuscripts or final published articles that includes the following functionalities:

- Allow users to submit and manage manuscripts directly
- Allow submission by the author or the publisher
- Accept manuscripts in a range of common electronic formats, and
- Accept any additional files of figures, tables, or supplementary information included with the manuscript.

At the time of submission authors will specify the timing of the posting of the final manuscript for public accessibility through PMC. During the active project period, using quarterly reports, where applicable, annual progress reports, and final progress reports authors will regularly report on the status of their deposit of materials. AHRQ will also utilize the eRA Commons Research Project Progress Report (RPPR) for monitoring compliance by AHRQ recipients.

Federal agencies have, by law, certain rights to products resulting from federal funding. For works (e.g., manuscripts) under the Government Use License (45 CFR 75.322(b)), or its successor regulation, AHRQ “reserves a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so. By accepting AHRQ funding, the recipient grants to AHRQ, as the funding agency, a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use the work for federal purposes, and to authorize others to do so. This includes making Manuscripts publicly available in PubMed Central upon the Official Date of Publication. A statement expressly reserving these rights in AHRQ-funded research awards will be incorporated into Notices of Award and applicable research contracts.

AHRQ encourages inclusion of a statement in the Manuscript that indicates it is subject to the AHRQ Public Access Policy and that this means that AHRQ as the funding agency, has the right to make the Manuscript publicly available in PubMed Central upon the Official Date of Publication: I hereby grant to AHRQ, a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use this work for Federal purposes, and to authorize others to do so. This grant of rights includes the right to create derivative works and make the final, peer-reviewed manuscript publicly available upon the Official Date of Publication.

Authors are not expected to provide rights to AHRQ to the Final Published Article. However, as noted in “Compliance and Enforcement,” AHRQ will accept submission of the Final Published Article to PubMed Central from journals with formal agreements with NLM as compliant with the Policy when its release meets public access requirements outlined in this Policy.

Compliance and Enforcement

Regarding submission to PubMed Central, compliance with the AHRQ Public Access Policy may be achieved through either:

Submission of the electronic version of the final peer-reviewed manuscript to PubMed Central upon its acceptance for publication, for public availability without embargo upon the Official Date of Publication or

Submission of the Final Published Article to PubMed Central from a journal with a formal agreement with NLM, upon the Official Date of Publication, for public availability without embargo.

Communicating and acknowledging federal funding enables a clear, public-facing indication of AHRQ funding in Manuscripts and Final Published Articles. Failure to include required acknowledgments may result in non-compliance with the AHRQ Public Access Policy, in addition to resulting in non-compliance with terms and conditions of funding regarding communicating and acknowledging federal funding.

Non-compliance with the AHRQ Public Access Policy may be considered by AHRQ regarding future funding decisions for the recipient institution. Non-competing continuation grant awards may be subject to a delay in award processing for non-compliance with the AHRQ Public Access Policy.

Management

 AHRQ uses PMC as a repository of full-text scientific publications. The system:

• Stores, organizes, and manages the publications collected or submitted under this Policy;
• Uses an open architecture and follows industry standards to facilitate open government, enable integration, and promote interoperability. AHRQ currently has interoperability through its use of the NIH’s grant management system eRA Commons, used by several federal agencies and HHS operating divisions. NIH has integrated eRA Commons with public access compliance information using My NCBI; and
• Enables AHRQ to monitor compliance with this Policy.

PMC provides easy access to AHRQ-supported publications, as well as over three million other publications, while taking appropriate steps to prevent unauthorized mass redistribution. NLM has established sophisticated monitoring systems to detect and prevent potential misuse that are very similar to the processes used by publishers' websites. NLM systems detect and prevent bulk downloading and will immediately cut off any sites, foreign or domestic, that appear to be abusing copyrighted property. Unless publishers have chosen PMC as the sole distributor of the electronic contents of their journals, all articles that are accessible on PMC are also accessible on publisher websites.

Costs

Reasonable costs associated with publication that are allowable may be requested in the budget for the project as direct or indirect costs.

Submission of Manuscripts to PubMed Central remains free for authors under the AHRQ Public Access Policy. If, during the course of the publication process, an author is asked to pay a fee for submission of the Manuscript to PubMed Central, such costs are not allowable.

Roles and Responsibilities

AHRQ will:

 Establish, manage, implement, and evaluate this Policy,

• Oversee compliance with the Policy by including the Policy objectives as terms and conditions of funding for grants, contracts, and cooperative agreements, and
• Coordinate the collaboration and cooperation of public access with other federal agencies.

To implement the elements above, AHRQ will provide guidance in funding announcements and training, education, and workforce development for AHRQ employees about the new requirements of this policy. The capability for AHRQ and the science communities it supports to help one another through on-going dialogue is expected to be a key part of a successful policy implementation.

AHRQ will include a clause/notice of this policy in contract solicitations and grant funding announcements, respectively.

AHRQ’s Public Access Policy recognizes proprietary interests, business confidential information, and intellectual property rights.

Grant, Cooperative Agreement, and Contract Recipients and their institutions will:

• Ensure that authors are aware of and comply with the AHRQ policy,
• Ensure that all terms and conditions of awards are met,
• Where necessary, include reasonable costs for public access to publications as a component of grant, cooperative agreements, and research contract applications, in accord with applicable cost principles,
• Ensure that all authors on an AHRQ-funded project work with the publisher before any publication rights are transferred to make sure that all conditions of the AHRQ policy can be met, and
• Report publications covered by this policy in interim and final progress reports.

Legal Authorities
Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a)
Section 944(a) of the Public Health Service Act, 42 U.S.C. 299c -3(a)

42 C.F.R. Part 67
45 C.F.R. Part 75

 

Disclaimer
This policy is subject to applicable statutory and regulatory requirements, the availability of agency appropriations, and resource constraints. Nothing in this policy shall be construed to undermine any right under provisions of Title 17 or 35, United States Code. This policy is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity, by any party against the United States or the Agency for Healthcare Research and Quality.

Inquiries

Please direct all inquiries to:

Email: [email protected]  
Office for Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality (AHRQ)