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Enhanced Public Access to National Institutes of Health (NIH) Research Information

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With this notice, NIH announces and seeks public comments regarding its plans to facilitate enhanced public access to NIH health-related research information. The NIH intends to request that its grantees and supported Principal Investigators provide the NIH with electronic copies of all final version manuscripts upon acceptance for publication if the research was supported in whole or in part by NIH funding. This would include all research grants, cooperative agreements, and contracts, as well as National Research Service Award (NRSA) fellowships. We define final manuscript as the author's version resulting after all modifications due to the peer review process. Submission of the final manuscript will provide NIH-supported investigators with an alternate means by which they will meet and fulfill the requirement of the provision of one copy of each publication in the annual or final progress reports. Submission of the electronic versions of final manuscripts will be monitored as part of the annual grant progress review and close-out process.

The NIH considers final manuscripts to be an important record of the research funded by the Government and will archive these manuscripts and any appropriate supplementary information in PubMed Central (PMC), NIH's digital repository for biomedical research. Six months after an NIH-supported research study's publication-or sooner if the publisher agrees-the manuscript will be made available freely to the public through PMC. If the publisher requests, the author's final version of the publication will be replaced in the PMC archive by the final publisher's copy with an appropriate link to the publisher's electronic database.

As with NIH's DNA sequence and genetics databases, this digital archive in PMC is expected to be fully searchable to enhance retrieval and can be shared with other international digital repositories to maximize archiving and to provide widespread access to this information. It is anticipated that investigators applying for new and competing renewal support from the NIH will utilize this resource by providing links in their applications to their PubMed archived information. This practice will increase the efficiency of the application and review process.

The NIH trusts that the up-to-six-month delay to public archiving in PMC recommended by the policy will not result in unreasonable or disproportionate charges to grantees. As with all other costs, NIH expects its grantees to be careful stewards of Federal funds and to carefully manage these resources. We will carefully monitor requested budgets and other costing information and would consider options to ensure that grantees' budgets are not unduly affected by this policy.

Background: The NIH is dedicated to improving the health of Americans by conducting and funding biomedical research that will help prevent, detect, treat, and reduce the burdens of disease and disability. In order to achieve these goals, it is essential to ensure that scientific information arising from NIH-funded research is available in a timely fashion to other scientists, health care providers, students, teachers, and the many millions of Americans searching the Web to obtain credible health-related information. The NIH's mission includes a long-standing commitment to share and support public access to the results and accomplishments of the activities that it funds.

Establishing a comprehensive, searchable electronic resource of NIH-funded research results and providing free access to all, is perhaps the most fundamental way to collect and disseminate this information. The NIH must balance this need with the ability of journals and publishers to preserve their critical role in the peer review, editing, and scientific quality control process. The economic and business implications of any changes to the current paradigm must be considered as the NIH weighs options to ensure public access to the results of studies funded with public support without compromising the quality of the information being provided. The NIH has established and intends to maintain a dialogue with publishers, investigators, and representatives from scientific associations and the public to ensure the success of this initiative.

Request for Comments: The NIH encourages comments concerning its intentions to enhance public access to NIH-funded health-related research information as outlined in this notice. Comments on short-term impacts and suggestions for mitigating these are especially welcome.

Persons, groups, and organizations interested in commenting on NIH's intentions should direct their comments to the following NIH Web site:​grants/​guide/​public_​access/​add.htm. As an alternative, comments may be submitted by e-mail to or sent by mail to the following address: NIH Public Access Comments, National Institutes of Health, Office of Extramural Research, 6705 Rockledge Drive, Room 350, Bethesda, MD 20892-7963.


Comments must be received on or before November 16, 2004.

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Dated: September 14, 2004.

Elias A. Zerhouni,

Director, National Institutes of Health.

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[FR Doc. 04-21097 Filed 9-15-04; 3:04 pm]