A measure quietly inserted into the 1999 US Federal budget bill has some researchers 'crying foul.' By extending the Freedom of Information Act (FOIA) to include raw data from government–funded extramural research, the law would force many scientists to provide their data to anyone who pays a fee and requests them.

Senator Richard Shelby (R–AL), who drafted the measure, explains that "the taxpayers have a right to much of this information, and I believe the results of these changes will be very positive." Not everyone is as enthusiastic. Some fear that the provision—apparently inserted at the insistence of special interest groups—will have far–reaching and possibly disastrous implications for scientists.

The FOIA, implemented in 1966 to improve accountability, was not designed to cover scientific data and as a result the White House Office of Management and Budget (OMB), which must formulate regulations to enforce the new measure, will be working in uncharted territory. On December 7th, Congressman George Brown (D–CA), who opposes the provision, sent a letter signed by 23 members of Congress to OMB to urge caution in crafting the new rules.

The letter, a copy of which was obtained by Nature Medicine, identifies several areas of concern. Although the FOIA includes protections for certain types of information, it is unclear whether these would be sufficient to guarantee patient confidentiality in medical studies. "Even if they were," the letter states, "we believe individuals will be reluctant to divulge sensitive personal information knowing that this information effectively becomes the property of the U.S. Government as an official record."

Brown also argues that the measure could facilitate the theft of intellectual property. The timing of data release could have a dramatic impact on publication and peer review, possibly placing US government–funded researchers at a disadvantage compared with their counterparts in other countries. And because many scientists receive funding from a combination of government and non–government sources, determining which data fall under the FOIA may pose a considerable challenge.

Wendy Baldwin, Deputy Director of Extramural Research at the National Institutes of Health, agrees that the measure raises a host of questions. "Issues that will need to be clarified are the definition of 'data,' the timing of the release of data, protection of confidentiality and privacy issues, concerns regarding intellectual property and the costs of compliance... and those are just the first to come to mind," says Baldwin.

The measure could also lead to harassment of researchers. George Thurston, a professor in the Department of Environmental Science at New York University, argues that industry groups, activists and lobbyists could abuse the measure by reinterpreting raw data out of context to discredit studies. "Thus, policies as democratic as [the FOIA] can be subverted and employed as mechanisms for vested interests to 'attack the messenger' when the research is financially or politically unwelcome," Thurston told Nature Medicine.

Michael Gough, Director of Science and Risk Studies at the Cato Institute, a conservative think–tank in Washington, DC, counters that good scientists need not worry: "Either your data are good and your interpretations are justifiable, or you're going to hide behind these things." He concedes that the possibility of harassment is real, but asserts that additional legislation could fix problems that might arise.

The OMB is expected to release its proposed regulations for comment soon, and sources close to the issue estimate that rules could be finalized within six months. No matter what form the details of the regulations take, Baldwin states that "there will be considerable burden both on the agencies and on the researchers."