The US National Institutes of Health has unveiled a new policy that aims to speed up public access to government-funded clinical trial data.

As of May 2 this year, NIH-funded investigators will be asked to voluntarily submit an electronic version their final manuscripts to the NIH’s PubMed Central website for publication “as soon as possible within twelve months of… final publication.” The NIH estimates that research it had funded was described in as many as 65,000 published papers in 2003. “We believe that widespread access to and sharing of peer-reviewed research publications generated with NIH support will advance science and improve communication of peer-reviewed, health-related information to scientists, health care providers, and the public,” it said in an official statement.

The policy, which is a first for the NIH, comes at a time when clinical research is under heightened scrutiny, and follows hot on the heels of pledges from pharmaceutical companies to publish their clinical trial data [[07/01/05a]]. Under proposals drawn up by the world’s major pharmaceutical industry trade associations from Europe, Japan and the USA, the results of all Industry-sponsored clinical trials, regardless of outcome, will be included on a global database.

However, the NIH’s move has not been welcomed with open arms by all parties, and Public Knowledge – a US organisation that claims it “seeks to promote a balanced approach to intellectual property law and technology policy” – expressed concern that the new policy would be voluntary and called it a “step backward” from an original draft proposal. Peter Suber, director of Public Knowledge’s open access project, said: “I regret that the [NIH] has scaled back its open-access policy. It is a retreat from the version the agency first proposed… The chief problem with the new rule is that it could significantly delay public access to publicly-funded medical research. It could even mean that the public will never have access to some of it at all…. The policy is better than nothing, but is a lot less than taxpayers deserved.”