Information act opens data and debate

Funding agencies and scientific organizations fight a regulation that could allow data scrutiny under a new law.

By Beth Azar
Monitor staff

While researchers and research fund-ing agencies debate how best to archive and share data, the federal government is wrangling with legislation that would require such data sharing on a sweeping scale.

Last fall, Sen. Richard Shelby (R-Ala.) added a provision into the massive omnibus spending bill making any data generated through federal grants subject to public release under the Freedom of Information Act (FOIA). The law, as originally written, would allow anyone who files a FOIA request--researchers, industries or private citizens--to gain access to raw research data; without further definition that could mean lab notebooks, tissue samples and any other research-related information. The law tries to apply one rule--public access to "all data"--to every type of research.

Under the premise that "the public should be able to obtain and review research data funded by taxpayers," Shelby rewrote language in last year's spending bill that ordered the Office of Management and Budget (OMB), which will oversee implementation of the law, to modify the regulation governing data sharing. He became interested in the issue when Harvard School of Public Health researchers would not release data from a study that was the basis of an EPA regulation that had broad impact on industrial pollution standards.

Funding agencies and scientific organizations, including APA, have publicly criticized the provision, arguing that FOIA is not the right tool for opening federally funded research to the public. It would force researchers to release sensitive information and would put a chilling effect on U.S. research, they say.

"It's like trying to crack a nut by driving a Mack truck over it," says University of Missouri psychologist Fredric Wolinsky, PhD, who has worked on data-sharing issues at the National Institutes of Health (NIH).

"Our feeling is that FOIA is a very blunt instrument to try to get at a very specific issue," adds Thomas Bates, press secretary for Rep. David Price (D-N.C.), who co-sponsored an amendment with Rep. David Walsh (R-N.Y.) that would have stalled implementation of the provision for a year while a study was conducted on its merits.

That and several other attempts to repeal or stall the provisions--called Circular A-100--failed. And OMB was moving to develop a final version of the law by Sept. 30.

The latest version, released Aug. 11 and open for comment until Sept. 10, appears to have taken into account researchers' concerns, says Geoff Mumford, PhD, APA senior and legislative affairs officer. It clarifies the definition of several terms including "data," and emphasizes that the rule applies to research used by the federal government in developing policy or rules. The revision also includes language intended to protect the privacy of research subjects, researchers' proprietary interests and the premature release of data. Despite the changes, APA and other research groups are watching the process with caution.

Although NIH and most professional organizations encourage researchers to share data with their colleagues--and require such sharing to reproduce or confirm contested study results--the issues around data sharing are so complex that most funding agencies have yet to implement a regulation that would cover all types of research.

"The problem with data sharing is that no one size fits all," says Wendy Baldwin, PhD, deputy director of extramural affairs at NIH, who has followed the Circular A-110 issue closely. "That's why FOIA won't work for this purpose."

The issue isn't whether the public should have access to research data, says George Leventhal, director of the Association of American Universities (AAU), it's whether FOIA provides the protection research data deserves. Although FOIA safeguards the release of proprietary and personal information, critics of the Shelby provision fear such exemptions are not strong enough and that some sensitive data could be at risk of being released to the public, he says. That could open the door to insurance companies accessing personal medical records, research competitors filching critical data or political groups misinterpreting raw data.

As a result, FOIA may inhibit people from participating in research and might squelch collaborations between industry and federally funded researchers, says Bates from Rep. Price's office.

Demanding dialogue

In July, APA--with the endorsement of 122 organizations representing professional associations, industry and universities--successfully spearheaded a push to have a hearing about the provision on Capitol Hill. Because Shelby pushed the law through Congress quickly, supporters and opponents of the law never had a chance to state their cases.

On July 15, the Government Reform and Oversight Committee, Subcommittee on Government Management, Information and Technology, which has been mulling over a request by the late Rep. George Brown to repeal Shelby's provision, heard testimony on the merits and pitfalls of using FOIA for data sharing. The testimony against using FOIA by experts including NIH Director Harold Varmus, MD, and National Academy of Sciences Director Bruce Alberts, PhD, was compelling, says APA's Mumford. And some of what was said appears to have made it into OMB's latest revision of the law.

Despite the seemingly positive developments in the move toward implementing Circular A-110, researchers are encouraged to read the new law carefully and evaluate how it may affect their research. To view a version, visit APA's Web Page www.apa.org/ppo/foia.html.



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