Harvard University Guidelines: NIH Public Access Policy

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On July 1st 2025 the NIH Public Access Policy will undergo several major changes.

Most significantly will be the requirement that all "Author Manuscripts" (as accepted for publication) MUST be made freely available in PubMedCentral on the date of publication. With the original NIH Public Access Policy of 2008, a "12 Month Embargo" (from the date of publication) was allowed prior to the mandatory public access to NIH supported author manuscripts. That delay will no longer be allowed for manuscripts deposited after July 1st 2025.

More detailed information will be posted here as we increase the number of training materials, workshops, and FAQs that specifically relate to the new NIH Public Access Policy requirements.

The majority of the workflows remain the same, however, authors should consider how to more rapidly ensure that their manuscripts are being deposited into the NIH Manuscript Submission System (NIHMS), so that they are available within PubMed Central (with PMCID#) by the date of publication.

It is recommended that one deposit the manuscript into NIHMS as soon as possible after the final edits have been made to the manuscript accepted for publication. (Deposit into NIHMS can be initiated by anyone the author delegates, but at least 1 author will need to ensure this process begins. The same author will need to ensure the process concludes before the official publication date of the article.

What are the requirements?

There are two main requirements of the 2008 NIH Public Access Policy (effective until July 1st 2025) :

Effective April 7, 2008, Principal Investigators must ensure that electronic versions of any peer-reviewed manuscripts arising from NIH funding and accepted for publication after that date are deposited in PubMed Central (PMC), NIH's digital archive of biomedical and life sciences journal literature, and that the articles may be made publicly available by PMC no later than 12 months after publication.

Effective May 25, 2008, anyone submitting an application, proposal, or progress report to NIH must include the PubMed Central reference number (PMCID) when citing articles that arise from their NIH funded research.

See policy details: http://publicaccess.nih.gov/policy.htm

Who is required to do this?

Authors of any paper supported by and/or acknowledging an NIH grant.
The NIH Policy applies to any peer-reviewed article that is based on work in one or more of the following categories:

Funded by NIH grant or cooperative agreement active in Fiscal Year 2008 (October 1, 2007 - September 30, 2008) or beyond;
Funded by a contract with NIH signed on or after April 7, 2008;
Funded by the NIH Intramural Program; or
If NIH pays your salary (example: Harvard postdocs and fellows supported by NIH training grants)

Why am I required to do this?

The NIH Policy is mandated by law, and implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which states:

SEC. 218. The Director of the National Institutes of Health shall require 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. (See: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)

Requiring NIH-funded research to be publicly available allows NIH to easily monitor all published research funded by NIH. The research is more prominent, integrated and accessible, making it easier for all scientists to pursue NIH's research priority areas competitively and advance science and improve human health.

What is my responsibility?

Both investigators, authors, and grantee institutions have the obligation to ensure that sufficient rights under copyright are reserved to allow full compliance with the NIH Policy, and that the final, peer-reviewed manuscript is submitted to PubMed Central upon acceptance for publication. The Harvard Open Access Policy helps to ensure that Harvard faculty will have automatically retained sufficient rights. When publishing papers that are subject to the NIH Public Access Policy, Harvard faculty members must be careful not to waive their rights to submit their manuscru\ipt into PubMed Central nor sign publishing agreements that would be incompatible with the NIH Policy. This would include, for example, agreements that transfer the entire copyright in your article to the publisher, or that grant the publisher exclusive rights, or contain other restrictions, that prohibit authors' ability to deposit their NIH supported manuscripts into PubMed Central. If you fail to make appropriate modifications to such an agreement, you could breach the agreement and violate the NIH Policy.

What steps should I take?

All Harvard paid investigators working under NIH grants should consider how to communicate this requirement to any researcher, postdoc, trainee, and colleague who will be associated with their award.
Be sure to convey the importance of this policy and inform all authors who may be acknowledging support from your NIH grant within their future research publications. The Countway Library provides regular information seminars on understanding the various nuances within the NIH Public Access Policy, grant reporting, and depositing manuscripts into the PubMed Central repository.

As Principal Investigators, you will want your researchers to be made aware of your NIH Grant Award number so that they can acknowledge this award within their publications. Doing so will obviously strengthen your NIH progress reports and demonstrate published research activities that are expected "products" of any NIH grant funding. For that reason, be sure to indicate to your researchers not only that they acknowledge your grant number when they publish, but also that they be aware of the NIH Public Access Policy obligations that go along with that acknowledgement.
Ensure that you pro-actively monitor publication activity which is acknowledging your NIH Grant Number
Since 2010, the NIH has provided Principal Investigators with monitoring tools within the eRA Commons utility as well as the MyNCBI Bibliography utility. Investigators can easily set up delegate accounts into these online tools, and allow administrative assistants to pro-actively monitor publications which are being indexed within PubMed for which your grant number has been acknowledged. Identifying these publications well before any NIH Progress Reports are due will allow time to address any potentially non-compliant publications.

Here, too, the Countway Library can assist your department or lab in understanding how these tools work, and which actions need to be executed when non-compliant publications are discovered. The Harvard Public Access Policy helps simplify our obligation to submit manuscripts into PubMed Central. By depositing into DASH any manuscript that is authored within your lab or research center, Harvard will have a permanent archive copy of the manuscript if we should need to submit a copy of the paper to PubMed Central.
Authors entering into copyright or publishing agreements with publishers must reserve sufficient rights to enable full compliance with the NIH Policy.
The Harvard Open Access Policy will automatically reserve sufficient rights to comply with the NIH Public Access Policy, however using a waiver will trigger that specific paper to "opt out" of the Harvard Open Access Policy. Therefore, it is still important to be aware that certain publishers have varying method of how they "accommodate" manuscript deposit into PubMed Central. Sometimes the publisher will begin the submission process, sometimes the author will be expected to begin the submission process

The Copyright Transfer Agreement (as received from the publisher) will often include an NIH disclosure check-box, or wording which will indicate how the author can accommodate this obligation. Watch for any NIH Public Access disclosure check-boxes on your publishing contract, and take note of the publisher's submission methods (or expectations) with regard to PubMed Central and the NIH Public Access requirements. Also, note who will be expected to accomplish what after the submission is made into PubMed Central. Frequently, no matter who begins the NIH Public Access submission into the system, it will be "one author" who will complete the PMC submission. The NIH has developed a handy chart of the 4 dominant work-flows that have evolved for submitting manuscripts into PubMed Central: http://publicaccess.nih.gov/submit_process.htm