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Accountability in science and government: is access the answer?

Last year, scientific and academic organizations were immersed in efforts to minimize the negative impact of a new federal law. The new law increases public access to data produced in federally funded research projects. Supporters portray it as a "good government" reform, but the research community believes the measure is seriously flawed. The Provision and Its Interpretation The controversial legislation instructs the Office of Management and Budget to hold federal funding agencies responsible for "ensuring that all data produced under an award will be made available to the public through the procedures established under the Freedom of Information Act: Provided ... that if the agency obtaining the data does so solely at the request of a private party, the agency may authorize a reasonable user fee equaling the incremental costs of obtaining the data."[1] Under prior law, data were considered the property of the grantee institution, which could control whether and how they should be released to the public. Although funding agencies had the right to obtain raw data, they typically asked investigators to submit only summary data, published papers, or other more finished products. Senator Richard Shelby (R-AL) proposed the new legislation after discovering that the administrator of the Environmental Protection Agency did not have data from a federally funded study the agency relied on in setting air quality standards. Harvard University researchers had the data, but refused to supply them to Congress because the study involved confidential information from patients' medical records. The dispute was resolved when Harvard officials and researchers agreed to give the data to independent analysts funded jointly by the EPA and industry.[2] Although the Senate had discussed the general possibility of making data more accessible, the provision's last minute enactment caught the research community off guard. Scientific and academic organizations initially supported congressional efforts to delay or repeal the law. When these strategies failed, the focus of activity became the OMB, which was responsible for drafting the precise text of the new rules. Although OMB officials had some leeway to interpret the provision, principles of administrative law barred them from straying too far from the statutory language. The new law alarmed researchers, academic officials, and funding agency personnel for four main reasons. First, the research process would be cut short if raw data had to be released before scientists could analyze the information, formulate conclusions, and obtain peer review. Premature release could have harmful consequences, such as public health scares based on erroneous data interpretations. Second, clinical research data often contain identifying information about study participants. Public release would violate confidentiality promises and deter people from volunteering for future studies. The third problem was the laws potential impact on scientists whose data were requested. Instead of pursuing their scientific projects, research teams would be forced to spend time assembling information for public distribution. They would also be vulnerable to harassment by industry and other groups that perceived those studies as threats to their economic or ideological interests. Fourth, the law could impair the ability of scientists and academic institutions to protect intellectual property from their competitors' watchful gaze. This last concern was shared by biotechnology and other firms interested in collaborating with academic scientists on research. Though the law's supporters pointed out that the Freedom of Information Act exempts from disclosure certain confidential information, such as medical records and trade secrets, opponents said the exemptions might be inadequate to protect important interests in the research context. A particular problem is that the FOIA authorizes government officials to decide when information qualifies as exempt. …