University of Nebraska–Lincoln

National Institutes of Health public access proposal gets mostly positive comments, agency says

A preliminary analysis of comments submitted on NIH's proposed public access policy reveals a majority of respondents approve of the agency's plan to post author manuscripts from research it funds on the PubMed Central digital repository six months after publication acceptance, Deputy Director of Extramural Research Norka Ruiz Bravo said Dec. 3.

Among the 5,839 commentors submitting a Web response, 2,402 agreed with the concept of the plan and 3,874 agreed with its implementation, 41% and 66% of responses respectively. Disagreement with the plan netted 454 responses (8%), whereas 1,275 respondents (22%) did not find implementation of the plan feasible.

Bravo reported that 2,983 respondents (51%) did not check a box indicating whether they agreed or disagreed with the concept of the plan, and 690 (12%) similarly did not check whether they agreed or disagreed with the plan's implementation. Results were described during the Dec. 2 - 3 meeting of the NIH Advisory Committee to the Director in Bethesda, Md.

An ongoing analysis of the responses could reveal duplicate comments, which may lead to a slight alteration in the numbers, Bravo cautioned.

Moreover, "Something that is counted as one [comment] can also be representative of a society," Bravo qualified. "It doesn't mean one person for each comment.

It could mean a number of people that are behind that one comment." Implementing the plan is expected to cost NIH $2 million in FY 2005 and between $2 million and $4 million in FY 2006, Bravo predicted. The preliminary analysis of public comments revealed those in favor of the public access policy say they support taxpayer access to research in a "timely manner," and believe the policy would strengthen and expand the impact of research and improve health outcomes.

Supporters also see the NIH plan as one that will provide "equal access to less wealthy individuals" and maintain that an online archive would be "less expensive" and improve the visibility of important research. On the other hand, Bravo said, critics of the proposal believe NIH did "not allow for adequate dialogue on the topic" and that implementation is proceeding too quickly. They assert that the proposal is fiscally unsound, "redundant to existing information sources and systems," and may lead to an increase in publication costs or an increase in submission costs to researchers.

Since its publication in the Federal Register in September, a variety of publishers and scientific societies have similarly voiced their opposition to the public access proposal, saying it is unfairly imposing a "one size fits all" business model on scientific publishing. (see Washington Fax 11/16/04)

Bravo used her presentation to ACD to clarify a few aspects of the plan that she said may have been misinterpreted. Contrary to several reports, NIH researchers are not required to submit their work to PubMed Central (PMC) following acceptance for publication, she said. "The draft policy requests, it does not require." Also, the policy does not identify PMC as the sole repository for NIH-funded research. "There are no plans -- I want to dispel that myth once again -- to make PubMed Central the only source or the only archive for biomedical literature," Bravo said. "There are many archives that are flourishing and will continue to flourish and provide different services."

ACD member and biochemist Bettie Sue Masters, University of Texas Health Science Center, San Antonio, confronted Bravo with a list of considerations she said need to be settled before implementing the final policy. Costs to NIH and to researchers need to be thoroughly evaluated, she said, because "despite denials to the contrary, [they] will be substantial." Masters also said she doubted the capacity of PMC to serve as a repository for all federally funded research -- a concern echoed by many opposed to the NIH plan. "The capabilities of the online publishers that are out there at the present time are better and more comprehensive than what PubMed Central has," she said.

The UT biochemist pointed to the potential "danger of making a federal agency the repository of all biomedical publications." Masters said, "The political climate does not give one confidence in the preservation of all scientific information, particularly if it's controversial." "Weighing all the aspects of any policy regarding archiving should be done considering the impact on professional societies and other non-profit publishers, which are responsible.for the peer review and publication of much of the scientific literature," Masters said.

"We don't want to kill the goose that lays the golden egg." Masters' litany of concerns also included considering the impact NIH's plan would have internationally, coming up with a standard definition of "final manuscript" and explaining how "redundancies, redactions and corrections" to the published research would be handled. In response to the latter concern, Bravo assured the committee that NIH has a team investigating how best to deal with redundancies, redactions and corrections as well as other "ramifications of the policy."

Bravo contested Masters claim that the costs would be "substantial," reminding the committee that PMC already exists and that the agency would not be "starting from scratch." In response to concerns about the possibility of damaging the quality of scientific peer review, Bravo pledged it would not be harmed. "Peer review is quite frankly the hallmark of quality in a journal," she said. "That is unlikely to change. And we will continue to support the peer review process by supporting the intramural and extramural investigators that voluntarily serve on peer review editorial boards." She also reminded the committee that the proposal affects only research funded by NIH and not research benefiting from private dollars. "Apparently, only about 10% of the publications in the 5,000 scientific journals are in fact NIH-supported," Bravo said.

Looking ahead, Bravo said, NIH will continue to analyze comments received and, upon completion, will develop and publish its final policy.

--Andrew Hawkins

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