LEGISLATION
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Among the potential pitfalls outlined:

• loss of confidentiality, particularly with respect to medical files;
• premature release of data before peer review and publication in science journals;
• damaging disclosure of research data with potential commercial value;
• possible high costs associated with responding to such requests; and
• possible harassment of scientists (through the use of burdensome FOIA requests) by opponents of their research or the researcher’s findings.

Opponents of the new requirements also are concerned about how such key terms as “data” and “publication” will be defined as the new law is put into effect by federal agencies and, undoubtedly, addressed by the courts.

Other members of the research community also are weighing in. For example, Bruce Alberts, president of the prestigious National Academy of Sciences, told the federal Office of Management and Budget that the law represents “an enormous change in federal policy regarding federally funded research. We are convinced that the new legislation will have serious, unintended consequences for the nation’s research enterprise.”

“We must not allow the entire federally funded research establishment in the United States to be seriously burdened by compliance with new bureaucratic requirements that are intended to address a legislative concern that is irrelevant to the vast majority of federally funded research projects,” Albert’s Jan. 26 letter concluded.

The controversy was triggered by language inserted in an omnibus spending bill at the end of the last Congressional session. The provision, sponsored by Sen. Richard Shelby (R-Ala.), directed the OMB to amend its Circular A-110 “to ensure that all data produced under an award will be made available to the public” through FOIA.

It has been reported that Shelby’s move was in response to a controversy, now more than two years old, involving research performed at Harvard University for the Environmental Protection Agency. The research formed the basis for new federal regulations involving some types of particulate matter, and opponents of those regulations demanded to see the underlying data. Harvard refused to make the data available.

OMB has asked for public comment on how to put the changes required by the new law into effect, and research universities are using this opportunity to highlight potential problems. The 60-day comment period ends April 5.

Vanderbilt intends to submit a formal response, as will many other individual universities, researchers and the 62-member Association of American Universities.

In a preview of its comments to OMB, AAU sent a letter to selected members of Congress last month, warning that “release of data in some cases could jeopardize protection of patient confidentiality and commercial interests and result in intimidation of continued research work.” AAU urged the lawmakers to express similar concerns to OMB.

Not all of the comments to OMB are so negative. In fact, AAU reported last week that approximately 60 percent of the 171 comments filed to date have been in favor of making data from federally funded research available to the public.

Meanwhile, Rep. George Brown (D-Calif.), ranking minority member of the House Science Committee, has introduced legislation to repeal the new law. So far, Brown’s bill has not generated significant support in the Congress.