Comments from Science (1999)

Plan for Divulging Raw Data Eases Fears

Science, 2/12/99
Jocelyn Kaiser

Congress dropped a bombshell on the scientific community last fall, when it quietly passed a law that appeared to open up to public scrutiny the data of all federally funded researchers. Now the Administration has drawn up a blueprint for implementing this law that would limit its reach to "published" data used to develop policy. Although relieved, agency officials and scientific groups say the Administration must still clarify gray areas in a rule that threatens to undermine scientists' sovereignty over one of their most precious resources: raw data.

Slipped into the 1999 omnibus spending bill by Senator Richard Shelby (R-AL), the directive requires that the White House Office of Management and Budget (OMB) amend its rules for extramural grants such that "all data" collected using federal funds would be accessible under the Freedom of Information Act (FOIA). Until now, only data already in an agency's possession have been subject to FOIA. Shelby and others, backed by several business groups--including one that in 1997 tried unsuccessfully to get its hands on data from a federally funded air pollution study--argue that data paid for by taxpayers and used to craft regulations ought to be made available whenever a citizen demands it.

Many voices in the scientific community have registered deep concern about the new law, with organizations ranging from the National Institutes of Health (NIH) to the Association of American Universities citing worries over the law's apparent reach (Science, 15 January, p. 307). Among other things, these groups argued, the law could deprive researchers of the chance to analyze and publish their data before it becomes public; it might lead to invalidated clinical trails by allowing subjects to find out what treatment they are getting; and it could give companies access to privileged information. In a letter to OMB last month, Bruce Alberts, president of the National Academy of Sciences, argued that the law would bring "an enormous change in federal policy" that "will have serious, unintended consequences for the nation's research enterprise."

Some of those concerns were addressed in OMB's proposed rule, which appeared on 4 February in the Federal Register. The Administration's proposal would apply only to data from "published research findings produced under an award that were used by the Federal Government in developing policy or rules." Furthermore, agencies would have broad powers to withhold data under FOIA guidelines that aim to protect national security, proprietary information, and individual privacy. "They've taken a very constructive first step in drawing some boundaries," says Wendy Baldwin, NIH deputy director for extramural research.

The Administration acknowledges that the plan leaves many issues unresolved. "We're publishing our first cut," says an OMB spokesperson. Yet to be worked out is how to define "data"--whether to include lab notebooks, for example--and whether the term "published" should include, say, data described at a talk or in a press release. Another ambiguity is where to draw the line on data used to develop public policies: Could it include an entire "body of research?" Baldwin asks. The public has 60 days to submit comments on the proposal before a final version is hammered out. "The community needs to think very seriously about what the implications of this would be," Baldwin says.

Don't expect the final rule to be the last word. The Administration's narrow interpretation is likely to be challenged in court "by anybody who wants more information than they can get," Alberts told Science, a process that could drag out for months or years.

Volume 283, Number 5404 Issue of 12 Feb 1999, pp. 914 - 915
(c)1999 by The American Association for the Advancement of Science.