Notice Number: NOT-HS-16-008

Key Dates
Release Date: February 19, 2016

PA-22-051 - AHRQ Mentored Career Enhancement Awards for Established Investigators in Patient-Centered Outcome Research (K18)

PA-22-050 - AHRQ Patient-Centered Outcomes Research (PCOR) Mentored Clinical Scientist Career Development Award (K08)

PA-22-049 - AHRQ Patient-Centered Outcomes Research (PCOR) Mentored Research Scientist Career Development Award (K01)

• October 21, 2021 - Large Research Projects for Combating Antibiotic-Resistant Bacteria (CARB) (R01). See Announcement PA-22-047
• October 21, 2021 - Large Health Services Research Demonstration and Dissemination Projects for Combating Antibiotic-Resistant Bacteria (CARB)(R18). See Announcement PA-22-048

Issued by
Agency for Healthcare Research and 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. 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. This Agency for Healthcare Research and Quality (AHRQ) policy regarding public access to scientific publications resulting from AHRQ funding is in response to this requirement. AHRQ will issue a separate policy related to public access to scientific data resulting from AHRQ funding. AHRQ intends, to the fullest extent possible and contingent on the availability of funds, to make available to the public all scientific publications and data arising from unclassified research and programs funded wholly or in part by AHRQ.

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 Policy) promotes the following objectives:

• Establish AHRQ’s commitment to public access to scientific research results
• Helps 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
• Facilitate the education of new researchers and enable the exploration of topics not envisioned by the initial investigators

Policy
The AHRQ 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 within 12 months of the publisher’s date of publication.

The AHRQ Policy will be fully effective on the date of publication. This Policy applies to AHRQ intramural researchers, extramural recipients of AHRQ grants and cooperative agreement awards; and AHRQ contractors conducting research. This Policy applies to all peer-reviewed scientific publications arising from AHRQ funding. Implementation will be prospective and will not apply to any publication arising from an AHRQ-funded grant, cooperative agreement award, or research contract, funded prior to publication of the 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 Policy applies to all research grants and career development award mechanisms, cooperative agreements, contracts conducting research, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as 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 policy requires that authors make their final manuscript publically accessible as soon as possible, but no later than 12 months after the publisher's official date of final publication.

The AHRQ Policy for Public Access to Publications mirrors the NIH Public Access Policy. AHRQ grantees are encouraged to utilize the significant NIH resources available at https://publicaccess.nih.gov/

New Requirements for AHRQ Researchers Related to Public Access

Publications
The AHRQ Policy applies to peer-reviewed scientific publications that have been supported, in whole or in part, with AHRQ funds. In order to ensure full integration of this Policy with the AHRQ research and award management systems, AHRQ is partnering with the NIH National Library of Medicine to use PubMed Central (PMC) as the repository of publications resulting from AHRQ-funded grants, contracts, cooperative agreements, and intramural research. For peer-reviewed scientific publications, the AHRQ Policy will require 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 copyedited version 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 publically-accessible, stable, permanent, and searchable electronic archive. AHRQ will use 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
- Accept any additional files of figures, tables, or supplementary information included with the manuscript, and

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 RPPR for monitoring compliance by AHRQ grantees.

Management
AHRQ will use PMC as a repository of full-text scientific publications. The system will:

- Store, organize, and manage the publications collected or submitted under this Policy
- Use an open architecture and follow 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
- PMC provides easy access to AHRQ-supported papers, as well as over three million other papers, 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
- Enable AHRQ to monitor compliance with this Policy

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,

Provide funding to foster successful implementation of this Policy, and

AHRQ will coordinate the collaboration and cooperation of public access with other federal agencies

To implement the elements above, AHRQ will provide guidance in funding opportunity announcements (FOAs) and training, education, and workforce development for AHRQ employees about the new requirements of this Policy. FOA guidance to awardees will describe any necessary changes to the conditions of awards. 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 FOAs, respectively. AHRQ will allow the inclusion of appropriate costs for public access in applications and proposals for AHRQ funding. The appropriateness of requested funding levels will be assessed on a case-by-case basis through technical evaluation, and by program and grants management staff.

AHRQ’s Public Access Policy recognizes proprietary interests, business confidential information, and intellectual property rights and avoids significant negative impact on intellectual property rights, innovation, and U.S. competitive research grants and cooperative agreements and a requirement of appropriate contracts.

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

• Ensure that authors are aware of and comply with the AHRQ Policy,
• Ensure all terms and conditions of awards are met,
• Where necessary, include reasonable cost 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)
Section 465 of the Public Health Service Act, 42 U.S.C. 286
42 C.F.R. Part 67
45 C.F.R. Part 74
Section 103 of The America COMPETES Reauthorization Act of 2010 Pub. L. 111-358)

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

Public Comments

All comments and inquiries regarding this Policy should be directed to:

Teresa Hammond
Office for Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality (AHRQ)
Telephone: 301-427-1544
Email: [email protected]