Key Dates

Related Announcements

NOT-OD-21-013 Final NIH Policy for Data Management and Sharing

NOT-OD-08-033 - Revised Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

NIH seeks public input on the NIH Plan to Enhance Public Access to the Results of NIH-Supported Research (NIH Public Access Plan). NIH has a decades-long history of providing public access to scholarly publications and data resulting from the research it supports, including through the 2008 NIH Public Access Policy and the 2023 Data Management and Sharing Policy. In 2022, the White House Office of Science and Technology Policy (OSTP) released a memorandum on Ensuring Free, Immediate, and Equitable Access to Federally Funded Research that establishes new guidance for improving public access to scholarly publications and data resulting from Federally supported research. The NIH Public Access Plan outlines the proposed approach NIH will take to implement the new guidance, consistent with its longstanding commitment to public access.

Background

For decades, NIH has pioneered efforts to increase public access to publications and research data resulting from its supported research. The NIH Public Access Policy, in effect since 2008, requires that NIH-supported researchers submit their peer-reviewed manuscripts to the PubMed Central (PMC) digital archive of full-text biomedical literature upon acceptance for publication, making them freely available to the public after an allowable embargo period of not more than 12 months after the publication date. This policy has to-date resulted in more than 1.4 million articles reporting on NIH-supported research being freely available to the public in PMC. NIH has also established a series of policies to improve access to data resulting from its supported research. In 2003, NIH implemented the first NIH Data Sharing Policy, which was replaced by the NIH Policy on Data Management and Sharing (the NIH DMS Policy) that went into effect on January 25, 2023. The NIH DMS Policy requires submission of a Data Management and Sharing Plan for research generating scientific data.

Increasing access to publications and data resulting from federally funded research offers many benefits to the scientific community and the public. Access can accelerate research, generate higher quality scientific results, encourage greater scientific integrity, and enable future inquiry, discovery, and translation for NIH-supported research. Importantly, these efforts also uphold NIH’s commitment to responsible stewardship of the Nation’s investment in biomedical research by improving transparency and accessibility of taxpayer-funded research.

NIH efforts align with public access directives, policies, and programs across the U.S. Government. Since 2013, federal public access policy has been guided by the OSTP Memorandum on Increasing Access to the Results of Federally Funded Research , which directed all federal departments and agencies with more than $100 million in annual research and development expenditures to develop a plan to support increased public access to scholarly publications and digital data resulting from federally funded research. On August 25, 2022, OSTP released updated policy guidance ( 2022 OSTP Memorandum ) that focuses on accelerated access to scholarly publications (most notably, by removing the currently allowable 12-month embargo period for free access), increased access to scientific data, and enhanced tracking of research products through persistent identifiers (PIDs) and metadata.

The NIH Public Access Plan (see Supplemental Information) provides a roadmap for how NIH proposes to accelerate access to scholarly publications and scientific data and will help ensure these research products are findable and equitably accessible to support further scientific discovery. As outlined in the NIH Public Access Plan, the NIH DMS Policy addresses all elements of the 2022 OSTP Memorandum related to scientific data. NIH plans to modify implementation of the NIH Public Access Policy to accommodate novel elements of the 2022 OSTP Memorandum related to scholarly publications. NIH plans to update its Public Access Plan for meeting the provisions of the 2022 OSTP Memorandum related to PIDs and metadata in a future update to OSTP.

NIH looks forward to working across the U.S. Government to support our shared commitment to responsible stewardship of the Nation’s investment in biomedical research by improving transparency and accessibility of taxpayer-funded research.

Request for Information

NIH seeks information regarding the NIH Public Access Plan from all interested individuals and communities, including, but not limited to, authors, investigators, research institutions, libraries, scholarly publishers, scientific societies, healthcare providers, patients, students, educators, research participants, and other members of the public. While comments are welcome on all elements of the NIH Public Access Plan, input would be most welcome on Section III related to scholarly publications and on the particular issues identified below.

1. How to best ensure equity in publication opportunities for NIH-supported investigators. The NIH Public Access Plan aims to maintain the existing broad discretion for researchers and authors to choose how and where to publish their results. Consistent with current practice, the NIH Public Access Plan allows the submission of final published articles to PMC (in cases where a formal agreement is in place) to minimize the compliance burden on NIH-supported researchers and also maintains the flexibility of NIH-supported researchers to submit the final peer-reviewed manuscript. These submission routes are allowed regardless of whether or not the journal uses an open access model, a subscription model of publishing, or other publication model. This flexibility aims to protect against concerns that have been raised about certain publishing models potentially disadvantaging early career researchers and researchers from limited-resourced institutions or under-represented groups. NIH policy already allows supported researchers to charge reasonable publishing costs against their awards. NIH seeks information on additional steps it might consider taking to ensure that proposed changes to implementation of the NIH Public Access Policy do not create new inequities in publishing opportunities or reinforce existing ones.
2. Steps for improving equity in access and accessibility of publications. Removal of the currently allowable 12-month embargo period for NIH-supported publications will improve access to these research products for all. As noted in the NIH Public Access Plan, NIH also plans to continue making articles available in human and machine-readable forms to support automated text processing. NIH will also seek ways to improve the accessibility of publications via assistive devices. NIH welcomes input on other steps that could be taken to improve equity in access to publications by diverse communities of users, including researchers, clinicians and public health officials, students and educators, and other members of the public.
3. Methods for monitoring evolving costs and impacts on affected communities. NIH proposes to actively monitor trends in publication fees and policies to ensure that they remain reasonable and equitable. NIH seeks information on effective approaches for monitoring trends in publication fees and equity in publication opportunities.
4. Early input on considerations to increase findability and transparency of research. Section IV of the NIH Public Access Plan is a first step in developing the NIH’s updated plan for PIDs and metadata, which will be submitted to OSTP by December 31, 2024. NIH seeks suggestions on any specific issues that should be considered in efforts to improve use of PIDs and metadata, including information about experiences institutions and researchers have had with adoption of different identifiers.

How to Submit a Response

Comments must be submitted at https://osp.od.nih.gov/nih-plan-to-enhance-public-access-to-the-results-of-nih-supported-research. Responses will be accepted through April 24, 2023.

Responses to this RFI are voluntary and may be submitted anonymously. You may also voluntarily include your name and contact information with your response. Other than your name and contact information, please do not include in the response any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response. After the Office of Science Policy (OSP) has finished reviewing the responses, the responses may be posted to the OSP website without redaction.

Supplemental Information:

NIH Plan to Enhance Public Access to the Results of NIH-Supported Research

I. Introduction

Increasing access to publications and data resulting from federally funded research offers many benefits to the scientific community and the public. Importantly, doing so upholds NIH’s commitment to responsible stewardship of the Nation’s investment in biomedical research by improving transparency and accessibility of taxpayer-funded research.

NIH has a decades-long record of making the results of the research it supports freely available to the public. Since 2008, NIH’s Public Access Policy has required researchers to submit their final, peer-reviewed manuscripts to the digital archive PubMed Central (PMC), making them publicly available no later than 12 months after publication. More recently, NIH implemented a new NIH Data Management and Sharing Policy (NIH DMS Policy) which requires submission of a Data Management and Sharing Plan (DMS Plan) for research generating scientific data.

The U.S. Government as a whole continues to champion policies and practices for leveraging the results of federally funded research to benefit the public. On August 25, 2022, the White House Office of Science and Technology Policy (OSTP) released updated policy guidance for improving public access policies across federal agencies that support research and development to promote the rapid sharing of federally funded research publications and data, to promote equity and advance the work of restoring the public’s trust in Government science, and to advance American scientific leadership. Entitled Ensuring Free, Immediate, and Equitable Access to Federally Funded Research (2022 OSTP Memorandum), the 2022 OSTP Memorandum sets forth three broad expectations for public access to federally funded research:

• Accelerated access to scholarly publications
• Increased access to scientific data
• Enhanced tracking of research products through persistent identifiers (PIDs)[1] and metadata[2]

This NIH Plan to Enhance Public Access to the Results of NIH-Supported Research (NIH’s Public Access Plan) provides a roadmap for how NIH will enhance access to research products, namely scholarly publications and scientific data, and will ensure these research products are useful and accessible to the public through mechanisms such as PIDs and metadata. NIH will seek public input on any specific policy proposals to meet these goals. NIH will work closely with OSTP and other Federal agencies to improve consistency of approaches while continuing to meet the specific needs of our research communities. NIH is enthusiastic to move forward on these important efforts to make the results of its research more accessible to scientists and the public.

II. Scientific Data

The NIH DMS Policy, issued on October 29, 2020, aims to ensure scientific data generated from NIH-supported research are made freely available and publicly accessible, as appropriate. With an effective date of January 25, 2023, the NIH DMS Policy was developed via a stepwise process, seeking community feedback at multiple stages, and was designed to reflect the breadth of the NIH research community’s data sharing needs. The implementation of the NIH DMS Policy will allow NIH to meet all aspects of the scientific data expectations of the 2022 OSTP Memorandum.

The NIH DMS Policy applies to all research supported in whole or in part by NIH that results in the generation of scientific data. It applies to extramural research supported by grants, contracts, and other funding agreements, as well as to the NIH Intramural Research Program. The NIH DMS Policy requires researchers subject to the NIH DMS Policy to prospectively plan for how scientific data will be preserved and shared, through submission of a DMS Plan. Upon NIH approval of a DMS Plan, researchers and institutions are required to comply with the approved DMS Plan. The NIH DMS Policy also establishes the expectation to maximize the appropriate sharing of scientific data generated from NIH-supported research, with justified limitations or exceptions.

NIH Plan for Scientific Data

NIH’s plan to address the individual expectations laid out in the 2022 OSTP Memorandum relevant to scientific data is described below.

II.A. For the purposes of this Memorandum, scientific data include the recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings. Such scientific data do not include laboratory notebooks, preliminary analyses, case report forms, drafts of scientific papers, plans for future research, peer-reviews, communications with colleagues, or physical objects and materials, such as laboratory specimens, artifacts, or field notes. The definition of scientific data is similar to but broader than the term research data defined by 2 CFR 200.315 (e) and 45 CFR 75.322 (e). (Section 3.b.1., 2022 OSTP Memorandum)

NIH will employ the definition of scientific data[3] used in the NIH DMS Policy. Consistent with the 2022 OSTP Memorandum, the NIH DMS Policy defines scientific data as the recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. The definition specifies that scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens.

II.B. Scientific data underlying peer-reviewed scholarly publications resulting from federally funded research should be made freely available and publicly accessible by default at the time of publication, unless subject to limitations as described [in Section II.F.1] below and should be subject to federal agency guidelines for researcher responsibilities regarding data management and sharing plans. (Section 3.b.1, 2022 OSTP Memorandum)

NIH will retain the expectations for data sharing and the timing of data availability contained in the NIH DMS Policy. The NIH DMS Policy requires submission of a DMS Plan outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations. NIH expects that in drafting DMS Plans, NIH-supported investigators will maximize the appropriate sharing of scientific data, acknowledging certain factors (i.e., legal, ethical, or technical) may affect the extent to which scientific data are preserved and shared. The NIH Institute, Center, or Office (ICO) will assess whether DMS Plans appropriately consider and describe these factors. NIH has clarified through frequently asked questions that federal, state, local, or Tribal laws, regulations, and policies are examples of justifiable factors that may limit data sharing under the NIH DMS Policy. Importantly, the NIH DMS Policy establishes the expectation that shared scientific data is to be made accessible as soon as possible, and no later than the time of an associated peer-reviewed scholarly publication.

II.C. Develop approaches and timelines for sharing other federally funded scientific data that are not associated with peer-reviewed scholarly publications. (Section 3.b.ii., 2022 OSTP Memorandum)

NIH will rely on the approaches and timelines for data sharing specified in the NIH DMS Policy. The NIH DMS Policy indicates that scientific data that are not associated with peer-reviewed scholarly publications should be made accessible as soon as possible, and no later than the end of the performance period for the research award. NIH has specified through frequently asked questions that these scientific data may underlie unpublished key findings, developments, and conclusions; or findings documented within preprints, conference proceedings, or book chapters. For example, scientific data underlying null and negative findings are identified as important to share even though these key findings are not always published.

The NIH DMS Policy encourages NIH-supported investigators to consider relevant requirements and expectations (e.g., data repository policies, award record retention requirements, journal policies) as guidelines for the minimum time frame that scientific data should be available. The Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan also encourages NIH-supported investigators to make scientific data available for as long as they anticipate it being useful for the larger research community, institutions, and/or the broader public.

II.D. Provide guidance to researchers that ensures the digital repositories used [for sharing scientific data] align, to the extent practicable, with the National Science and Technology Council document, Desirable Characteristics of Data Repositories for Federally Funded Research. (Section 3.b.iii., 2022 OSTP Memorandum)

NIH plans to rely on supplemental information issued in support of the NIH DMS Policy. The NIH DMS Policy strongly encourages the use of established repositories to the extent possible for preserving and sharing scientific data and encourages NIH-supported investigators to select data repositories that exemplify desired characteristics consistent with the National Science and Technology Council’s Desirable Characteristics of Data Repositories for Federally Funded Research. NIH issued Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research to assist NIH-supported investigators in selecting suitable data repositories or cloud-computing platforms for preserving and sharing scientific data. NIH aims to reduce investigator burden by providing information on repositories consistent with other federal agencies and allowing NIH-supported investigators to select any established, suitable repositories to preserve and share scientific data, if no data repository is specified by NIH. NIH-supported investigators use of repositories exemplifying the desired characteristics promotes data management and sharing in ways that are consistent with FAIR (findable, accessible, interoperable, reusable) data principles.[4]

II.E. Clarify that federal researchers must follow federal laws and OMB policies that govern federal agencies information management practices and protect certain types of data, to the extent that the scientific data created by, collected by, under the control or direction of, or maintained by the federal researchers is subject to those laws and policies. (Section 3.b.iv., 2022 OSTP Memorandum)

NIH has provided such clarification in the NIH DMS Policy, which states that federal laws, regulations, statutes, guidance, and policies govern research, specifically research involving human participants, as well as the sharing and use of scientific data generated from research. The NIH DMS Policy prioritizes the responsible management and sharing of scientific data derived from human participants and emphasizes that NIH-supported investigators should manage and share data in ways consistent with all applicable federal, Tribal, state, and local laws, regulations, statutes, guidance, and institutional policies. The NIH DMS Policy is consistent with federal regulations for the protection of human research participants and other NIH expectations for the use and sharing of scientific data derived from human participants, including the NIH’s 2014 Genomic Data Sharing Policy, the NIH 2015 Intramural Research Program Human Data Sharing Policy, and the HHS regulations for the protection of human subjects in research at 45 CFR 46. The NIH DMS Policy expects NIH-supported investigators proposing to generate scientific data derived from human participants to outline in their DMS Plans how privacy, rights, and confidentiality of human research participants will be protected (e.g., through de-identification, Certificates of Confidentiality, and other protective measures).

II.F. Outline the policies that federal agencies will use to establish researcher responsibilities on how federally funded scientific data will be managed and shared, including:

II.F.1. Details describing any potential legal, privacy, ethical, technical, intellectual property, or security limitations, and/or any other potential restrictions or limitations on data access, use, and disclosure, including those defined in terms and conditions of funding agreement or award or that convey from a data use agreement or stipulations of an Institutional Review Board; (Section 3.c.i., 2022 OSTP Memorandum)

NIH has provided such information in the NIH DMS Policy, which expects that, in drafting DMS Plans, researchers will maximize the appropriate sharing of scientific data, acknowledging that certain factors (i.e., legal, ethical, or technical) may necessitate limiting data sharing to some extent. NIH has issued responses to frequently asked questions that provide the following non-exhaustive list of examples of justifiable limitations on data sharing:

(1) informed consent does not permit or limits the scope or extent of sharing and future research use

(2) existing consent (e.g., for previously collected biospecimens) prohibits sharing or limits the scope or extent of sharing and future research use

(3) privacy or safety of research participants would be compromised or participants would be at greater risk of re-identification or suffering harm, and protective measures such as de-identification and Certificates of Confidentiality would be insufficient

(4) explicit federal, state, local, or Tribal law, regulation, or policy prohibits disclosure

(5) existing or anticipated agreements (e.g., with third party funders, with partners, with repositories, with Health Insurance Portability and Accountability Act (HIPAA) covered entities that provide Protected Health Information under a data use agreement, through licensing limitations attached to materials needed to conduct the research) impose restrictions

(6) datasets cannot practically be digitized with reasonable efforts

II.F.2. Plans to maximize appropriate sharing of the federally funded scientific data... such as providing risk-mitigated opportunities for limited data access; (Section 3.c.ii., 2022 OSTP Memorandum)

NIH will rely on risk mitigation approaches used in the NIH DMS Policy and other NIH data sharing policies. The NIH DMS Policy expects researchers to maximize the appropriate sharing of scientific data, taking into account potential limitations on access and use. It addresses risk-mitigated controls for limited data access to maximize the appropriate sharing of scientific data. The NIH DMS Policy expects researchers to consider whether access to scientific data derived from humans, even if de-identified and lacking explicit limitations on subsequent use, should be controlled.

The Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research encourages the use of a repository for human participant data that allows for various features, such as controls on data access. The Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data provides points to consider to help NIH-supported investigators decide whether to share scientific data through controlled access. Factors described include whether the scientific data are sensitive and whether the scientific data can be adequately de-identified. This Supplemental Information also identifies factors that may indicate that scientific data can be shared openly, such as when participants have consented to data sharing without restrictions. Additionally, the Supplemental Information outlines best practices for de-identification and highlights institutional review of data sharing to mitigate risks while also maximizing data sharing.

NIH will also continue to develop and promulgate approaches for maximizing access while mitigating risks associated with sharing of specific classes of data. For example, related to its Genomic Data Sharing Policy, NIH has established policies and procedures for data access committees to review requests to access controlled, de-identified, individual-level genomic data contained in repositories such as the NIH Database of Genotypes of Phenotypes (dbGaP) and ensure proposed re-use is consistent with limitations on the data that reflect informed consent. Such approaches help mitigate risks to individuals resulting from access to human participants data and can be extended to other classes of scientific data.

II.F.3. The specific online digital repository or repositories where the researcher expects to deposit their relevant data, consistent with the federal agency’s guidelines. (Section 3.c.iii., 2022 OSTP Memorandum)

NIH will rely on existing supplemental information developed to support the NIH DMS Policy. The NIH DMS Policy does not expect use of a specific data repository but strongly encourages use of existing data repositories that exemplify the desirable data repository characteristics consistent with the 2022 OSTP Memorandum. The Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research helps NIH-supported investigators choose data repositories suitable for the preservation and sharing of data (i.e., scientific data and metadata). The Supplemental Information indicates that, for some programs and types of data, NIH and/or ICO policy(ies) and Notice of Funding Opportunity (NOFOs) may identify particular data repositories (or sets of repositories) to use to preserve and share data and that any designated data repositories should be used. If no data repository is specified by NIH, the Supplemental Information encourages NIH-supported investigators to select a data repository(ies) that is appropriate for the data generated from the research project and provides considerations for selection. If no appropriate discipline or data-type specific repository is available, the Supplemental Information points investigators to examples of other suitable data repository options, including generalist and institutional data repositories, and cloud-based data repositories for large datasets.

II.G. Allow researchers to include... costs associated with submission, curation, management of data, and special handling instructions as allowable expenses in all research budgets. (Section 3.d., 2022 OSTP Memorandum)

NIH will rely on existing supplemental information provided as part of the NIH DMS Policy. NIH recognizes that making data accessible and reusable for other users may incur costs. The NIH DMS Policy allows costs associated with data management and data sharing to be included in budget requests for the proposed project. NIH has issued Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing that outlines categories of allowable costs associated with data management and sharing, including the costs of curating data and developing supporting documentation costs, local data management considerations, and preserving and sharing data through established repositories.

Conclusion

The NIH DMS Policy accommodates the breadth of NIH-supported research by allowing project-specific consideration of the data that are appropriate to share and the approaches that can maximize data sharing while respecting legal, ethical, and technical factors that may limit the extent of data sharing. Both NIH and the NIH-supported research community will continue to gain experience with data management and sharing as the NIH DMS Policy takes effect, and such experience will inform future implementation and guidance. NIH will also continue to take steps to modernize the data repository ecosystem, as outlined in NIH’s Strategic Plan for Data Science, to better support storage, sharing, and use of data generated by NIH-supported research.

III. Scholarly Publications[5]

NIH’s approach to accelerating equitable public access to peer-reviewed scholarly publications[6] will build on the success of the long-standing NIH Public Access Policy. In effect since 2008, the NIH Public Access Policy implements Division F, Section 217 of Public Law 111-8, which states that the NIH Director:

shall require in the current fiscal year and thereafter that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.

Between 2008 and 2022, NIH collected and made approximately 1.4 million articles[7] reporting on its supported research freely and publicly available under the NIH Public Access Policy through PMC, the National Library of Medicine’s (NLM s) free full-text archive of biomedical and life sciences journal literature. These articles, along with millions of others submitted to PMC, are accessed by millions of users every day, including researchers, clinicians, entrepreneurs, students and educators, and other members of the public. Making NIH-supported articles publicly available in PMC has enabled the public to have access to research results on some of the most critical public health concerns facing their communities, although access may be delayed for a period of up to 12 months after publication, consistent with the allowable embargo period.

NIH has taken steps to accelerate public access to publications in areas of considerable public interest. Starting in March 2020, NIH launched a new collaboration with scholarly publishers to ensure that all scholarly publications related to COVID-19 and the broader family of coronaviruses were freely available to the public without embargo, including in machine-readable[8] forms that support computational analysis.[9] By the end of 2022, more than 300,000 such publications were available in PMC and had been used to both inform research and public health responses to the COVID-19 pandemic and to engage artificial intelligence researchers in improving search algorithms.[10] In addition, NIH initiatives like the Cancer Moonshot and Helping to End Addiction Long-term (HEAL) Initiative have piloted efforts to make publications accessible without embargo after publication. NIH will build on these efforts to better ensure that publications resulting from NIH-supported research are freely and publicly accessible without embargo to enable use by researchers, clinicians, students, and other members of the public.

Finally, to clarify terminology, the efforts described herein are focused on public access, which is the free availability of federally funded scholarly materials to the public (including publications, data, and other research outputs). [11] Open access models, which include publishing models for scholarly communication that make research information available to readers without embargo at no cost, are one of many approaches to meeting the goal of public access.[12] NIH does not anticipate requiring a specific publication model as part of a revised NIH Public Access Policy, recognizing that it will be important to monitor costs and impacts on various communities as the ecosystem evolves to ensure equity.

NIH Plan for Scholarly Publications

NIH’s plan to address the individual expectations laid out in the 2022 OSTP Memorandum relevant to scholarly publications is described below:

III.A. Peer-reviewed scholarly publications... are made freely available and publicly accessible by default in agency-designated repositories without any embargo or delay after publication. (Section 3a, 2022 OSTP Memorandum)

To meet NIH’s commitment to enhance accessibility to the public, NIH:

III.A.1. will modify implementation of the NIH Public Access Policy to ensure that scholarly publications resulting from NIH-supported research are made available in PMC without embargo following publication.

NIH plans to modify procedures to remove the allowable embargo period that submitters may select when submitting articles to PMC under the Public Access Policy. Currently, a submitter may request an embargo period of up to 12 months after the official date of publication before NIH will make submitted articles freely accessible to the public through PMC. To meet our commitment to the public to accelerate access to publications, NIH will modify its procedures to make publications available without embargo following the official date of publication.[13],[14]

III.A.2. proposes to clarify the official date of publication to be when the article is first published, either online or in print.

Currently, when calculating embargo periods, NIH bases the date of publication on the issue or print publication date, when available. For consistency with expectations under the NIH DMS Policy (see frequently asked questions) and to reflect current practice in scholarly communications, NIH proposes to interpret official date of publication as the date on which the publisher first makes an article available, either online or in print. Aligning definitions across the NIH DMS Policy and the NIH Public Access Policy will provide consistency and clarity to those researchers who are subject to both policies.

III.A.3. will maintain other aspects of implementation of the existing Public Access Policy.

NIH plans to keep unchanged other elements of its implementation of the NIH Public Access Policy. NIH will continue to make scholarly publications stemming from NIH-supported research publicly accessible through PMC, NIH’s agency-designated repository, consistent with its legislative mandate. NIH will continue to expect NIH-supported investigators to submit or have submitted on their behalf the peer-reviewed manuscript to PMC via the NIH Manuscript Submission (NIHMS) upon acceptance for publication, as required by legislative mandate. NIH will also continue to consider compliant those NIH-supported investigators who publish in a journal that has a formal agreement with NLM to submit final published articles to PMC at the time of publication.[15] ^[16] Doing so can be effective in improving compliance while minimizing burden on impacted communities.

This approach will maintain two existing channels for policy compliance:

III.A.3.a. Manuscript[17] submission: NIH-supported investigators may deposit, or have deposited on their behalf, the final peer-reviewed manuscript to the NIHMS System at the time of acceptance for publication in a journal. NIH will make the manuscript accessible in PMC after the later of the date of publication or the date PMC processing is completed. The investigator will be responsible for completing or for having an author on the paper complete all NIHMS approval steps in a timely manner.

III.A.3.b. Final published article[18] submission: NIH will continue to consider compliant those NIH-supported investigators who choose to publish in journals that have formal agreements with NLM to submit final published articles to be available in PMC at the time of publication. NIH will make these articles available in PMC once PMC processing is completed. In cases where journals have a formal agreement to submit directly to PMC but with an embargo period that extends beyond the date of publication, the NIH-supported investigator will be expected to either ensure the final peer-reviewed manuscript is submitted to PMC upon acceptance for publication, to be made publicly available at the time of publication,[19] or arrange with the journal to deposit the individual published article to PMC without a post-publication embargo.

This approach aims to provide free, public availability of articles without embargo after publication, acknowledging there may be some PMC processing period prior to release. While permitting the submission of final published articles to minimize the compliance burden on NIH-supported researchers, it maintains the flexibility of NIH-supported researchers to publish in the journal of their choice and submit the peer-reviewed manuscript, regardless of whether or not the journal uses an open access model, a subscription model of publishing, or other publication model. This flexibility is important in protecting against concerns that have been raised about the potential of some publishing models to disadvantage researchers from limited-resourced institutions and under-represented groups.[20]

III.B. Maximize equitable reach of public access to peer-reviewed scholarly publications, including by providing free online access to peer-reviewed scholarly publications in formats that allow for machine-readability and enabling broad accessibility through assistive devices. (Section 3.a.ii, 2022 OSTP Memorandum)

To continue to meet our commitment to the public to ensure broad accessibility of scholarly publications, NIH:

III.B.1. will continue current practice and make scholarly publications stemming from NIH-supported research available in accessible and machine-readable[21] formats through PMC and PMC services.

NIH will continue to convert all articles submitted to PMC to the most recent American National Standards Institute (ANSI) NISO Journal Article Tag Suite (JATS) XML format. This format represents the structure and meaning of a document in a simple and human-readable form that can easily be processed by a computer without human intervention. In addition, NIH will continue to render articles in a richly structured HTML format that is responsive to different screen sizes and devices and compatible with assistive technologies to enable broad accessibility. The HTML elements in PMC are in line with the World Wide Web Consortium (W3C) Accessible Rich Internet Applications Recommendation.

To support text mining and other applications of artificial intelligence and machine learning, NIH will continue the current practice of making manuscript files and other article files submitted with permissive licenses available through services that enable easy downloading and automated retrieval.[22] The primary purpose of these services is to enable download of specific subsets of the PMC corpus for analysis.

III.B.2. will continue to make improvements to its procedures to ensure that articles are broadly available through assistive devices.

Accessibility of articles in PMC depends on the completeness of accessibility information provided in the article submissions. NIH will improve guidance for submitters on how they can supply more accessible content. NIH will continue to work with the broader community to develop standards for article accessibility and improve PMC procedures for processing submitted articles. NIH will provide additional educational materials and resources to assist the investigator community in improving the accessibility of articles. Through these improvements and resources, NIH will help ensure clarity for NIH-supported investigators, so as to minimize burden and maximize consistency in approach.

III.C. Make the publications freely and publicly available by default, including any use and re-use rights, and which restrictions, including attribution, may apply. (Section 3.a.iii., 2022 OSTP Memorandum)

To continue to meet our commitment to the public to ensure use and re-use rights to peer-reviewed publications, NIH:

III.C.1. proposes to clarify how NIH-supported investigators may retain sufficient rights to NIH-supported peer-reviewed manuscripts. NIH will continue to require NIH-supported investigators to retain the rights necessary to comply with the requirements of the NIH Public Access Policy, and NIH proposes to clarify how this may be accomplished. To assist with this process, NIH proposes to develop language that NIH-supported investigators may use for submission with their peer-reviewed manuscripts to journals to retain rights to make the peer-reviewed manuscript available post-publication in PMC as soon as processing is complete, without an embargo period.

III.C.2. will continue to enable metadata reuse and operationalize principles of article reuse. NIH will continue to enable broad reuse of NIH-supported articles through services that allow for automated retrieval and downloading of full text and metadata, consistent with available license terms. NIH-supported peer-reviewed manuscripts, other article files as license terms allow, and article metadata are made available by PMC in formats and through channels that enable text mining, large-scale machine-analysis, and computation. These machine-readable article datasets also include retractions, corrections, and expressions of concern.[23]

NIH will continue to promote the broadest possible reuse of its supported articles, while limiting inappropriate uses, such as redistribution of PMC content for sale. NIH supports these efforts so the results of NIH-supported research become the bases for downstream discovery.

III.D. Allow researchers to include reasonable publication costs... as allowable expenses in all research budgets. (Section 3.d., 2022 OSTP Memorandum)

To continue to meet the commitment to the public that reasonable costs for publication are part of research budgets, NIH:

III.D.1. will continue to allow reasonable publication costs for all NIH-supported or authored scholarly publications consistent with current policy and guidance.

As noted previously in this Plan, the NIH Public Access Policy does not affect authors' freedom to choose the vehicle or venue for publishing their results. NIH does not propose requiring authors to publish in any particular type of journal or journal with any specific type of business model (e.g., subscription model, open access model). NIH expects that NIH-supported investigators will continue to publish the results of their research consistent with their professional autonomy and judgment to advance science as efficiently and comprehensively as possible. As previously stated through this Guide Notice, NIH encourages authors to publish in reputable journals that follow accepted standards of publishing practices and ethics.

NIH currently allows funding to be used to cover costs of publication, consistent with the NIH Grants Policy Statement, 7.9 Allowability of Costs/Activities. Under the NIH Public Access Policy, NIH has clarified that publication costs, including article processing charges often associated with open access publishing, may be charged to NIH grants and contracts on three conditions:

1. such costs incurred are actual, allowable, and reasonable to advance the objectives of the award;

2. costs are charged consistently regardless of the source of support; and

3. all other applicable rules on allowability of costs are met. Allowable publication costs for electronic and print media include distribution, promotion, and general handling (see Frequently Asked Questions about the NIH Public Access Policy)

NIH intends to develop supplemental information that elaborates on and clarifies allowable costs for publication, consistent with these conditions.

III.D.2. proposes to continue to monitor trends in publication fees and policies to ensure that they remain reasonable.

NIH seeks to ensure that costs associated with the publication of findings from NIH-supported research are reasonable and do not serve as an impediment to publishing by researchers from limited-resourced institutions or under-represented groups. As such, NIH expects that NIH funds be used for costs that are not disproportionately or inequitably charged based on NIH being the source of funding. In addition, NIH reinforces that NIH-supported authors should retain rights to the final peer-reviewed manuscript, regardless of the pathway to publication. NIH proposes to continue to monitor trends in publication fees and policies to ensure that they remain reasonable and do not disproportionally burden one or more segments of the NIH-supported community, and that opportunities to publish are equitable and consistent with NIH’s strategic priorities.

Building upon the success of the NIH Public Access Policy, NIH is well-positioned through PMC to ensure that scholarly publications resulting from NIH-supported research are made available without embargo following publication. Additionally, NIH will continue to support machine-readability and broad accessibility so that the results of taxpayer-funded research are available to all. NIH anticipates that the planned modifications and clarifications to the NIH Public Access policy addressed in the NIH Public Access Plan will help ensure that we continue to meet our commitment to the public to make research results broadly accessible. This approach also aims to provide NIH-supported investigators broad discretion to publish in the journal of their choice, regardless of whether those journals use a traditional subscription-based model, an open access model, or other publication model. NIH encourages NIH-supported investigators to select publication venues that will maximize the impact of their work. In addition to seeking public comment on this Plan, NIH will identify opportunities for convenings of relevant affected communities to work through these complex issues. NIH is committed to evaluating the impacts of any future policy changes on impacted communities, and to adapt policies, as needed, accordingly.

The 2022 OSTP Memorandum instructs Federal agencies to take steps to ensure that public access policies support scientific and research integrity by transparently communicating to the public critical information, including information related to the authorship, funding, affiliations, and development status of federally funded research. Such actions allow members of the public to be able to identify which federal agencies support given investments in science, the scientists who conduct that research, and the extent to which peer review was conducted.

NIH recognizes that public access to the products of research (i.e., data, publications) depend on the findability of these products along with metadata describing the investigators who performed the research, where the research was conducted, and with what funding resources. To facilitate findability, PIDs may be associated with a researcher, their institutions, their funding agency, and their research outputs. Together, PIDs empower researchers, clinicians, students, and the public to rapidly locate, contextualize, and interrogate the outcomes of research. Such transparency increases scientific integrity and bolsters public trust in scientific research.

NIH has considerable experience with PIDs and metadata that will inform its plan. NIH will update the NIH Public Access Plan regarding PIDs and metadata and submit it to OSTP by December 31, 2024. Additionally, NIH will provide opportunities for public comment on any proposed policies related to PIDs and metadata and will publish final policies by December 31, 2026, with an effective date no later than one year later. Below are some considerations that will inform the NIH planning process.

To develop its plan for PIDs and metadata, NIH will engage in an iterative process and consult with broad groups of impacted communities. NIH will look to lessons learned through several agency efforts to date that make use of PIDs and metadata, to address the specific elements of the 2022 OSTP Memorandum as described below:

IV.A. Collect and make publicly available appropriate metadata associated with scholarly publications and data resulting from federally funded research, to the extent possible at the time of deposit in a public access repository. Such metadata should include at minimum: all author and co-author names, affiliations, and sources of funding, referencing digital persistent identifiers, as appropriate; the date of publication; and a unique digital persistent identifier for the research output. (Section 4.a., 2022 OSTP Memorandum)

NIH has considerable experience with metadata and PIDs for research outputs that will inform its approach. NLM, for example, collects metadata and assigns PIDs to each full-text article submitted to PMC (PMCID), each clinical trial registered with ClinicalTrials.gov (NCT number), and each genetic sequence submitted to GenBank (Genbank accession number).

Several recent efforts will also provide near term data points on best practices for utilizing PIDs for different research products and metadata. The NIH DMS Policy directs NIH-supported investigators to deposit data in repositories that meet the National Science and Technology Council’s Desirable Characteristics of Data Repositories for Federally Funded Research. These characteristics include assignment of PIDs to submitted data to ensure that the data are findable. To facilitate repositories meeting these goals, the NIH Office of Data Science and Strategy (ODSS) awarded supplemental funding that will enable data discoverability, interoperability, and reuse by aligning with the FAIR and TRUST principles and using metrics to measure their effectiveness. Furthermore, ODSS established the Generalist Repository Ecosystem Initiative (GREI), which includes seven established generalist repositories that will work together to establish consistent metadata, develop use cases for data sharing, train and educate researchers on FAIR data, and harness the importance of data sharing.

Ultimately, individual PIDs for research outputs are most useful for findability and transparency when they can be unambiguously linked in standardized ways and are therefore searchable. Through engagement with affected communities, the NIH will determine how to address this systematic challenge.

IV.B. Instruct federally funded researchers to obtain a digital persistent identifier that meets the common/core standards of a digital persistent identifier service defined in the NSPM-33 Implementation Guidance, include it in published research outputs when available, and provide federal agencies with the metadata associated with all published research outputs they produce, consistent with the law, privacy, and security considerations. (Section 4.b., 2022 OSTP Memorandum)

In developing its plan for researcher identifiers, NIH will take into consideration its experience with identifiers for trainees. In 2019, NIH established a requirement for individuals supported by research training, fellowship, research education, and career development awards to have Open Researcher and Contributor Identifiers (ORCID iDs) beginning in FY2020. This requirement was made in response to recommendations from the Advisory Committee to the NIH Director [24] and the National Science and Technology Council's Working Group on Research Business Models that federal agencies adopt tools and approaches to simplify applicant reporting and improve the tracking of career outcomes.

IV.C. Assign unique digital persistent identifiers to all scientific research and development awards and intramural research protocols that have appropriate metadata linking the funding agency and their awardees through their digital persistent identifiers. (Section 4.c., 2022 OSTP Memorandum)

NIH currently assigns alpha-numeric identifiers to all awards including grants, cooperative agreements, other transactions, and fellowships. Within the NIH system, these award identifiers are persistent, unique, and have meaningful structure that provides information on the type of award, primary funding source, and year of support. Forms of these identifiers are used to identify NIH awards in public sites (e.g., NIH Research Portfolio Online Reporting Tools (RePORT), HHS Tracking Accountability in Government Grants System (TAGGS), and USASpending.gov).

NIH recognizes that although these award identifiers are unique within the NIH database, they have limitations, as they are not registered or indexed to ensure uniqueness beyond NIH and they are not retrievable using a standardized communications protocol that would allow for interoperability. NIH is exploring use of the digital object identifier (DOI) system that would overlay existing NIH grant identifiers to resolve these issues. NIH will coordinate this exploration with efforts of other Federal agencies and relevant external/internal impacted communities to assess how to best develop a robust, connected ecosystem where institutions, researchers, research outputs, and funding sources are linked consistent with FAIR principles.

To increase findability and transparency of research products, NIH plans to build upon our experience with the initiatives described above, consult with other Federal agencies through the National Science and Technology Council Subcommittee on Open Science, and solicit input from broad sets of impacted communities. By integrating lessons learned and best practices through public engagement, NIH will determine an appropriate plan to improve the discoverability of research products, maximize their utility, and support scientific integrity.

NIH has long championed public access to publications and data to enable its mission to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. NIH strongly supports the expectations included in the 2022 OSTP Memorandum, which are consistent with NIH’s longstanding commitment to the public to ensure research products are broadly accessible.

As described in this Public Access Plan, NIH has a robust strategy for further enhancing equitable access to the results of its supported research. For expectations related to scientific data, NIH will proceed with implementation of the NIH DMS Policy. For expectations related to scholarly publications, NIH plans to update the NIH Public Access Policy no later than December 31, 2024, with an effective date no later than December 31, 2025. For the elements related to PIDs and metadata, NIH will submit a revised NIH Public Access Plan to OSTP no later than December 31, 2024. A final policy incorporating those additional elements will be issued by December 31, 2026, with an effective date not more than one year later.

NIH will continue to work with OSTP and interagency partners to ensure close coordination across the federal government as we implement this Public Access Plan. NIH will seek public comment on this Public Access Plan upon its release and will provide opportunity for public comment as policy development continues. NIH will iterate on approaches, as needed, to ensure that supported research produces maximal benefits for the scientific community and the public. NIH recognizes that its policy efforts are only one vehicle for achieving the aims of broader public access to research results. We look forward to an ongoing partnership with colleagues in academia, scientific societies, the publishing community, libraries, and the private sector to ensure that efforts to increase public access are equitable and allow all to benefit from NIH-supported scientific results.