Dr. Elias A. Zerhouni, director of the National Institutes of Heath (NIH), opened the 22nd Annual FLICC Forum on Federal Information Policies with a keynote speech on NIH's new policy on open access to federally funded research.
Elias Zerhouni, director of the National Institutes of Health - Robin Smith
"The fluidity of scientific information and the new ways in which it can be exploited require us to think about new, advanced public access models," said Zerhouni.
Announced last February and implemented last May, the policy governing "Enhanced Public Access to NIH Research Information" calls on scientists to release to the public manuscripts from research supported by NIH as soon as possible, and, at the latest, within 12 months of final publication.
The initial proposal mandated that scientific reports supported by NIH be made available at NIH's digital repository, PubMed Central (www.pubmedcentral.nih.gov), no later than six months after publication. The announcement was made in the NIH Guide, the Federal Register and at numerous conferences and public meetings.
Subsequently, the agency reviewed more than 6,000 comments and revised the policy "to provide flexibility to ensure maximum participation," by emphasizing the "voluntary" nature of authors' submissions and allowing authors to decide when to post their final manuscripts on the site. The final policy calls for electronic access to all final version, peer-reviewed manuscripts reporting results of research, fully or partially supported by NIH funding, within 12 months after publication—or sooner if the publisher agrees.
"In developing this policy, we made a concerted effort to balance the importance of this archives to NIH's public health mission with the need to provide flexibility for authors, their institutions and publishers in those cases where immediate release [of federally funded research reports] is not possible," said Zerhouni. "NIH recognizes the importance of preserving quality peer review and diversity of publishing models. Nevertheless, we expect that only in limited cases will authors deem it necessary to select the longest publication period."
According to Zerhouni, the public is empowered through the sharing information of thus encouraging causing larger numbers of people to participate in clinical trials, which in turn will lead to faster and more comprehensive research results. Zerhouni noted that less than 5 percent of cancer patients participate in clinical trials.
NIH currently funds 212,000 scientists around the country, accounting for about 10 percent of all printed world literature dealing with biomedical research. The increase in chronic conditions in patients, an aging population and emerging diseases are all reasons why NIH feels strongly about providing access to that printed material for research and public use. NIH is also concerned about the integrity and reliability of medical information available on the Internet.
"As electronic articles increasingly become the authoritative and most useful documents for researchers and scientists, the impermanence of individual publishers' Web sites presents a substantial problem," said Zerhouni. "Creating a permanent archives of these articles is NIH's responsibility."
Zerhouni also discussed major concerns surrounding the new policy, such as the potentially harmful effect on the financial stability of publishers and the effect on peer-reviewed materials. He said that while there may be some initial economic affect on those nonprofit organizations that rely heavily on revenue from journal subscriptions, commercial and not-for-profit journal publishers will benefit from this government-funded research by publishing articles generated by federal research dollars.
With an annual budget of about $28 billion, NIH estimates that the annual incremental costs of the public access policy will be $2 million to $4 million. In addition to improving public access and creating a stable electronic archives of publications from NIH-funded research, NIH plans to use its databases to improve the management of its research investment, to monitor scientific productivity and to help set research priorities.
NIH also believes the new policy will have a positive effect on health care costs by increasing access to information about disease prevention.
"The only way to control the rise of health care costs is to push prevention as opposed to treatment of disease once it has struck the patient," said Zerhouni.
A webcast of Zerhouni's keynote address, as well as coverage of the rest of the 2005 FLICC forum is available at www.loc.gov/flicc/vidlib.html.
Additional information concerning the NIH policy on Enhanced Public Access to NIH Research Information can be found at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-064.html.
