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State funding and data disclosure
THE LANCET Volume 353, Number 9158
State funding and data disclosure Researchers in the USA are scrambling to stop implementation of a regulation that would require many scientists who receive federal funds to release their raw data to anyone who files a formal request. The regulation stems from a provision, slipped into the 4000-page 1999 federal budget bill by Senator Richard Shelby, that allows the public to use the Freedom of Information Act—originally enacted to allow public access to internal government documents—to obtain “all data” collected as part of federally funded research. Shelby introduced the legislation after university researchers refused to turn over data from a federally funded air-pollution study to industry groups opposing air-quality regulations issued by the US Environmental Protection Agency. The EPA had relied heavily on the researchers’ findings, and the industry groups, which felt the new regulations were unnecessary, wanted to reanalyse the data. The researchers, however, said they could not release the data because they included confidential information from medical records. Under US law at the time, the researchers were within their rights; such data, even if collected with federal funding, were considered the private property of the university. In a compromise, the data were released for reanalysis to an independent organisation jointly funded by the EPA and the car industry. The US Office of Management and Budget, which must draw up regulations to implement the Shelby provision, has proposed language that narrowly interprets his original wording. Data subject to freedom-of-information requests would be limited to published studies of federally funded research that has been used by the US government in developing rules and policy. But even this narrow interpretation raises many troubling issues. For example, what falls under the definition of “data”? Does it include a scientist’s laboratory notebooks? Field notes? Early drafts of papers? Tissue cultures? For how long does a researcher have to store such data? How will confidentiality and intellectual property rights be THE LANCET • Vol 353 • March 27, 1999
protected? What does it mean to “publish” research—is presenting a poster at a conference enough? And when is a study to be considered to have been used by the government to make policy? Is it sufficient, for example, if the study is cited in a committee hearing that leads to new legislation? The law could impose a crushing burden on scientific research. Its supporters shrug off such concerns, saying that these issues can be addressed with further legislation or through the courts— hardly the ideal way to draft scientific policy. Perhaps the most serious concern is that specialinterest groups will now be able to harass scientists whose research they do not like. Increasingly, corporations and other special-interest groups are using subpoenas, freedom-of-information requests allowed under state laws, and other legal devices to demand from researchers enormous amounts of material, including not only all their data but also correspondence and meeting notes, background details on everyone involved in the study, and even the names and telephone numbers of study participants. This information has then been used in attempts to discredit researchers in court or in the press. Clearly, the results of scientific research, especially those used to decide public policy, must be published and held up to scientific scrutiny. At the same time, researchers need to be able to work free of the kind of harassment this new law will expose them to. Otherwise scientists may decide not to pursue research that might attract the ire of well-financed interest groups. A bill (HR 88) has been submitted to Congress to repeal the Shelby legislation. Congress should pass this bill and then pause to think if legislation is the way to resolve perceived conflicts between the twin principles of making available to the public research findings the public has paid for and letting researchers work without fear of harassment and intimidation. We suspect that no bill can be drafted that would rule out all potential for abuse. The Lancet 1027
State funding and data disclosure Researchers in the USA are scrambling to stop implementation of a regulation that would require many scientists who receive federal funds to release their raw data to anyone who files a formal request. The regulation stems from a provision, slipped into the 4000-page 1999 federal budget bill by Senator Richard Shelby, that allows the public to use the Freedom of Information Act—originally enacted to allow public access to internal government documents—to obtain “all data” collected as part of federally funded research. Shelby introduced the legislation after university researchers refused to turn over data from a federally funded air-pollution study to industry groups opposing air-quality regulations issued by the US Environmental Protection Agency. The EPA had relied heavily on the researchers’ findings, and the industry groups, which felt the new regulations were unnecessary, wanted to reanalyse the data. The researchers, however, said they could not release the data because they included confidential information from medical records. Under US law at the time, the researchers were within their rights; such data, even if collected with federal funding, were considered the private property of the university. In a compromise, the data were released for reanalysis to an independent organisation jointly funded by the EPA and the car industry. The US Office of Management and Budget, which must draw up regulations to implement the Shelby provision, has proposed language that narrowly interprets his original wording. Data subject to freedom-of-information requests would be limited to published studies of federally funded research that has been used by the US government in developing rules and policy. But even this narrow interpretation raises many troubling issues. For example, what falls under the definition of “data”? Does it include a scientist’s laboratory notebooks? Field notes? Early drafts of papers? Tissue cultures? For how long does a researcher have to store such data? How will confidentiality and intellectual property rights be THE LANCET • Vol 353 • March 27, 1999
protected? What does it mean to “publish” research—is presenting a poster at a conference enough? And when is a study to be considered to have been used by the government to make policy? Is it sufficient, for example, if the study is cited in a committee hearing that leads to new legislation? The law could impose a crushing burden on scientific research. Its supporters shrug off such concerns, saying that these issues can be addressed with further legislation or through the courts— hardly the ideal way to draft scientific policy. Perhaps the most serious concern is that specialinterest groups will now be able to harass scientists whose research they do not like. Increasingly, corporations and other special-interest groups are using subpoenas, freedom-of-information requests allowed under state laws, and other legal devices to demand from researchers enormous amounts of material, including not only all their data but also correspondence and meeting notes, background details on everyone involved in the study, and even the names and telephone numbers of study participants. This information has then been used in attempts to discredit researchers in court or in the press. Clearly, the results of scientific research, especially those used to decide public policy, must be published and held up to scientific scrutiny. At the same time, researchers need to be able to work free of the kind of harassment this new law will expose them to. Otherwise scientists may decide not to pursue research that might attract the ire of well-financed interest groups. A bill (HR 88) has been submitted to Congress to repeal the Shelby legislation. Congress should pass this bill and then pause to think if legislation is the way to resolve perceived conflicts between the twin principles of making available to the public research findings the public has paid for and letting researchers work without fear of harassment and intimidation. We suspect that no bill can be drafted that would rule out all potential for abuse. The Lancet 1027