By Lisa Seachrist

Washington Editor

WASHINGTON - Late in the appropriations process last year, when Congress was trying to hammer out a compromise on the large Omnibus Appropriations Bill that was eventually passed into law, Sen. Richard Shelby (R-Ala.) added an amendment that made all data generated under federal awards at universities and non-profit institutions available to the public through the Freedom of Information Act (FOIA).

The 106th Congress now finds itself considering the consequences of that hastily attached amendment, with several House Democrats attempting to repeal the provision led by Rep. George Brown (D-Calif.), who introduced H.R. 88 to repeal the Shelby amendment and start anew.

"I believe it was unfair, undemocratic, and unwise of Congress and the administration to enact a significant change in law without ever providing members of the academic scientific community and their private-sector partners, representatives of research hospitals, and other non-profit organizations an opportunity to participate in a legislative process that directly impacted them," said Rep. Rush Holt (D-N.J.) "This is a 'sunshine' provision enacted in the dark."

The House Committee on Government Reform's Subcommittee on Government Management, Information and Technology heard from scientists who warned the amendment could decimate university research by placing volunteer privacy at risk, economists who argued Congress must have access to the data to make regulatory decisions, and lawyers who maintained FOIA provides adequate protections.

"The amendment ... could have unintended, but nonetheless grave consequences," said National Institutes of Health Director Harold Varmus. "The regulatory requirements embodied in the law are far more complex than the apparent mandate to share data. The kind of widespread access to data envisioned by the act could result in unforeseen abuses. Unless otherwise protected, patient privacy rights could be violated."

Holt told the subcommittee the Shelby amendment has four major problems that make it imperative that Congress repeal the law. He maintained it could force researchers to breech the confidentiality of their subjects; it is an infringement of intellectual property, which could force release of data before researchers gain the benefits of their work; it creates an opportunity for harassment of scientists and politicization of science; and it would impose a significant administrative burden on institutions and scientists.

National Academy of Sciences President Bruce Alberts agreed, noting the FOIA is fundamentally flawed as the mechanism for sharing scientific data because it fails to require evidence from the requester that the disclosure in question is in the public interest. As a result, Alberts maintained, it invites harassment of researchers by people opposed to their research or by competitors.

Varmus pointed out that provisions of the Shelby amendment also risk the private-public partnerships that now lead to the eventual marketing of life-saving drugs and medical devices. Because the amendment is so broad, it could be interpreted to include preliminary data and unpublished scientific data. The Office of Management and Budget (OMB) is drafting regulations that would exempt unpublished data, but there are questions whether such an exemption could stand up to a court challenge.

James O'Reilly, visiting professor of law at the University of Cincinnati College of Law, disagreed with the view that FOIA would inadequately protect patient privacy. He noted there is an FOIA exemption for personal medical data collected by or for the government. He also pointed out there was an FOIA exemption for disclosure that would damage proprietary interests.

Nevertheless, O'Reilly told the subcommittee, "I would not grade the Shelby amendment well if it were a law school exam. It needs to be more detailed and specific."

Robert Hahn, director of the joint center for regulatory studies at the American Enterprise Institute, said environmental regulations were responsible for the Shelby amendment finding its way into law late in the appropriations process. The controversy fueling the amendment arose in 1997 when the EPA finalized a regulation on particulate matter that gave the agency vast new powers to regulate a variety of emissions sources.

That regulation was based on a Harvard University study that suggested reducing emissions of fine particles could lead to substantial reductions in premature mortality. Some have estimated the cost of the regulation between $9 billion and $37 billion annually. However, Hahn noted that when Congress requested the agency release the data supporting the study, the Harvard researchers refused.

"They subsequently agreed to an alternate plan, whereby the Health Effects Institute, an independent research institute funded by industry and the EPA, would convene an expert panel to reanalyze the data," Hahn said. "Those results are not expected to be available until later this year - two years after the regulation was made final. In this case, the EPA administrator argued the Harvard study had been peer reviewed, and that was sufficient for using the findings in a public policy setting. I think the peer-review process is wonderful, but not necessarily adequate for making public policy decisions."

Rather than supporting H.R. 88, Hahn recommended the data-access requirements be restricted to economically significant regulations developed by all regulatory agencies, and that the requirements be limited to new federally funded grants. Hahn said the researchers should be required to provide as full a rendering of the data set as possible and that the requirements should be reviewed by an expert panel selected by the National Academy of Sciences in five years to evaluate the impact of the law. In addition, Hahn recommended Congress create an agency to replicate findings for economically significant regulations.