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Government-Financed Medical Research to Go Online

NIH announces voluntary program that will give taxpayers access to studies

THURSDAY, Feb. 3, 2005 (HealthDay News) -- The U.S. government's National Institutes of Health (NIH) on Thursday announced a new policy that should give the public speedier access to thousands of published medical studies.

The policy, the first of its kind for the NIH, calls on scientists whose research was financed by the federal agency to release their manuscripts to the public "as soon as possible and within 12 months of final publication."

The policy is described as voluntary, and starts May 2. Articles will eventually be available in a Web-based archive managed by the National Library of Medicine, part of the NIH.

"What we're really trying to do is create a momentum towards earlier publication while maximizing participation," Dr. Elias A. Zerhouni, director of the NIH, said at a news conference. "We want to accomplish a change in the landscape of how scientific information is made available to the public while preserving the viability of the peer-review process which guarantees the integrity of that research."

The issue of public access to scientific studies has been debated. Many feel the NIH should not be a conduit to the public for scientific research, but the agency's leadership felt the public had the right to see how its tax money was being spent.

"We felt very strongly that change was needed," Zerhouni said. "Over 93 million Americans visit the Internet for medical information, and we strongly felt that it was not sufficient for us to maintain the status quo. Research is supported by the public, and it is essential in improving public health and public access to these publications."

The policy will achieve three main goals, including providing electronic access to NIH-funded research to patients, families, doctors and other members of the public; building a searchable, central archive of research; and advancing science.

A draft policy released for public comment in September called for a six-month time window. This is twice as long "to provide more flexibility," Zerhouni stated.

Starting in May, NIH grantees are being asked to submit an electronic version of their final manuscript as soon as it has been accepted for publication by a peer-reviewed journal and has completed the peer review process.

Zerhouni stated the new policy would not preempt scientific and medical journals. "We do not propose that we will be putting something to the public before the publication data," he said. "What we're asking is that between zero months and 12 months of the publication date by the publisher that we will post the author's copy for public access."

Representatives from two major medical research journals welcomed the change, and said it wouldn't affect their operations.

Dr. Catherine D. DeAngelis, editor-in-chief of the Journal of the American Medical Association (JAMA), said, "I think it's great. This is nothing new for us. If it's important, we make it free to everybody in the world and everything [in JAMA] is free after six months. It's very important for the public to have access."

A spokeswoman for the New England Journal of Medicine (NEJM) said that it already provided public access to much of its research for free. "Any material that's six months old or older is available on our Web site to the general public free of charge," said NEJM spokeswoman Karen Pedersen. "It just requires [online] registering."

The policy is voluntary, and authors will be able to stipulate the timeframe for release to the public through PubMed Central, Norka Ruiz Bravo, NIH deputy director for extramural research, said at the same press conference. PubMed Central is part of the NIH's National Library of Medicine, electronic database of peer-reviewed journals. It is publicly accessible and searchable.

"We are strongly encouraging scientists to comply with the request," Zerhouni added. "We trust our scientists, and believe they will do what's right for the public who funds them."

Authors will be able to negotiate with different journals if policies conflict, Ruiz Bravo said.

And the policy will not interfere with copyright. "We feel confident that we are protecting the copyright of publishers," Zerhouni said.

Officials would not say how many studies would end up in the database every year, but Dr. David Lipman, director of the National Center for Biotechnology Information at the National Library of Medicine, pointed out that NIH supports about 60,000 papers every year. "The percent that decide to participate will determine that," he said. "The goal is to have a comprehensive and up-to-date archive. The purpose of flexibility is to let it evolve."

It has been a busy week for Zerhouni. On Wednesday, he announced a new ethics policy to some of the NIH's 18,000 employees, many of whom are physicians and research scientists. The new rules call, in part, for the agency's employees to divest themselves of any stock they may own that could cause a possible conflict of interest with companies that have business with the NIH.

More information

For more information on the new policy, visit the National Institutes of Health.

SOURCES: Feb. 3, 2005, news conference with Elias A. Zerhouni, M.D., director, National Institutes of Health (NIH); Norka Ruiz Bravo, Ph.D., deputy director, extramural research, NIH; and David Lipman, M.D., director, National Center for Biotechnology Information, National Library of Medicine; Catherine D. DeAngelis, M.D., editor-in-chief, Journal of the American Medical Association; Karen Pedersen, spokeswoman, New England Journal of Medicine
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