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NIH Requires Open Access for Its Funded Medical Research
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Posted On September 13, 2004
After months—if not years, seen from a historical perspective—of dispute, the National Institutes of Health (http://www.nih.gov) has established a policy mandating open access to the full text of research results from projects it funds. Conservative estimates have placed at least a quarter of the quality medical research done in the world as funded by NIH grants and contracts. Current estimates place the number of documents affected by the new policy as around 60,000 items each year. Before coming to this decision, the NIH heard from all the many stakeholders—publishers, abstracting and indexing services, authors, disease-specific advocacy groups, librarians, etc. The final push came from the prodding of the subcommittee of the House Committee on Appropriations that controls NIH's budget. With the posting of the notice (http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-064.html) on Sept. 3, a 60-day period began for public comment. Revisions may ensue at the end of that period, but the policy should go into effect before the end of the year. All the material will end up deposited at PubMed Central (http://www.pubmedcentral.nih.gov), administered by the National Library of Medicine (NLM), which ranks as an NIH institute.

Dated Sept. 3, 2004, Notice: Enhanced Public Access to NIH Research Information recognizes the NIH's mission of ensuring "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." To this end, "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." However, the NIH still wants to "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," as well as concern with the "economic and business implications of any changes to the current paradigm."

The system the NIH is establishing would alter the conditions of every NIH grant to include one requiring "grantees and supported Principal Investigators [to] 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." The mandate would cover "all research grants, cooperative agreements, contracts, as well as National Research Service Award (NRSA) fellowships." Documents would have gone through the peer-review process with the author making all appropriate revisions before submission to the NIH. Author incentives to comply should be high, as the submission of the electronic manuscripts will become "part of the annual grant progress review and close-out process."

When will users be able to reach this newly archived full-text material on PubMed Central (PMC)? Six months after the research study's appearance in a publication or "sooner if the publisher agrees." PubMed Central will also be happy to replace the author's final version with the publisher's final copy through "an appropriate link to the publisher's electronic database." However, free public access remains the standard for compliance in this area. Access includes PMC participation in international digital repositories.

The NIH also encourages authors to cite to the links in PMC when writing grant applications to improve NIH's efficiency in processing the proposals. The NIH clearly does not expect this policy to "result in unreasonable or disproportionate charges to grantees"; however, they will "consider options to ensure that grantees' budgets are not unduly affected by this policy."

Public comments on the policy must be received within 60 days of publication of this notice—namely, by Nov. 2. Comments should go to PublicAccess@nih.gov or to the NIH Web site at http://grants.nih.gov/grants/guide/public_access/add.htm. The Notice also appeared in the Federal Register.

PubMed Central already has a policy for handling open access content. A number of the available journals subscribe to open access for all or most of their content, and PMC also started receiving individual open access articles from journals not in the PMC system in October 2003. All journals must be covered by a major indexing and abstracting service (Medline, AGRICOLA, BIOSIS, Chemical Abstracts, EMBASE, PsycINFO, Science Citation Index) or, if new, have letters submitted by three members of the journal editorial boards serving as principal investigators on grants from major funding agencies. The stipulations for inclusion of electronic copy include specific standard formats for electronic data.

Looking at the new procedure along with established open access and publisher policies of PubMed Central, one can clearly see that its success—at least, initially—depends significantly on the existing publishing infrastructure holding up. Scholarly publishers, whether commercial or professional associations, have voiced concerns that the continued growth of open access—especially when backed by major government funding organizations—may bring down the existing system of scientific communication in time. Will publishers continue to support editorial and peer reviews for journals with fast-dropping subscription and advertising revenues? Will they shut down whole collections of less prestigious or narrowly focused journals, leaving fewer editors or peer reviewers to "accept for publication" all the articles coming out of NIH funding?

Fewer journals from publishers might also lead to a collapse of secondary service coverage, especially if PubMed Central's full-text collecting makes abstracting and indexing look less desirable. Even today, PMC has a program for digitizing archives of participating open access journals back to first issues. PMC doesn't even charge the publisher for the digitization—it pays for it out of a fund collaboration of the NLM, the Wellcome Trust, and the U.K. Joint Information Systems Committee (JISC). Dozens of journals already participate in the program.

What next? If the public access initiative taken by the NIH does lead to serious damage or collapse of the current publishing "paradigm," will the NIH/NLM take over the role of publishers or provide support for a new "paradigm"? Already self-archiving open access activists like Steven Harnad of the American Scientist forum argue against the centralized archive approach of PubMed Central, preferring a network of institutional repositories.

Nonetheless, the forces for open access have enveloped the NIH. In August, the Alliance for Taxpayer Access (http://www.taxpayeraccess.org), a group of professional associations representing libraries, health researchers, and disease-specific patient advocacy groups, launched to push the NIH to open access. Late in August, 25 Nobel-prize winning scientists sent an open letter to Congress recommending open access, in particular for the NIH. The House of Representatives voted for an appropriations bill for the Departments of Labor, Health and Human Services, and Education as well as related agencies (H.R. 5006) that included a strongly worded section directing the NIH to open public access to its research results:

The Committee is very concerned that there is insufficient public access to reports and data resulting from NIH-funded research. This situation, which has been exacerbated by the dramatic rise in scientific journal subscription prices, is contrary to the best interests of the U.S. taxpayers who paid for this research. The Committee is aware of a proposal to make the complete text of articles and supplemental materials generated by NIH-funded research available on PubMed Central (PMC), the digital library maintained by the National Library of Medicine (NLM). The Committee supports this proposal and recommends that NIH develop a policy, to apply from FY 2005 forward….

With the NIH's decision, the fast-paced open access movement has picked up even more momentum. Already, other federal information professionals are speaking about pressing for open access in the physical sciences as well as the life sciences. One interesting aspect of the NIH development, though Congress pressed for the move—the NIH did not require statutory action to implement the policy, just a change in the boilerplate conditions of grants and contracts. This means other major federal research and development funding agencies could also establish open access policies without bothering Congress. They might even want to move before Congress starts bothering them.


Barbara Quint was senior editor of Online Searcher, co-editor of The Information Advisor’s Guide to Internet Research, and a columnist for Information Today.


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