Duke, Congress fight over research data

The debate stems from a provision that Sen. Richard Shelby (R-Ala.) slipped into an appropriations bill last year, mandating that all data from federally funded research be open to public inspection through the Freedom of Information Act. The universities -- and their allies in Congress -- reacted harshly, claiming that the law could violate the confidentiality of research subjects and have a chilling effect on business-academic collaborations. "In some ways, this is a no-brainer. This [law] is simply bad public policy," said John Burness, Duke's senior vice president for public affairs and government relations, who along with President Nan Keohane has lobbied for a repeal or narrowing of the so-called Shelby amendment. And it seems like they have partially succeeded, as regulations proposed by the Office of Management and Budget have limited the law's scope. But these regulations have not ended the battle, a tug of war that will likely land the dispute in court. Shelby initially proposed the amendment after a frustrating experience trying to gain access to data supporting the formulation of an Environmental Protection Agency regulation about emission control. Industry leaders support the bill because it allows them to understand where those regulations are coming from. "Whenever people are regulated, you would like those rules to make as much sense as possible, to be as open as possible," said Louis Renjel, associate director for environment and regulatory affairs for the U.S. Chamber of Commerce. Unfortunately, said Rep. David Price (D-N.C.), Shelby slipped the proposal into a huge bill late at night, without any debate or hearings. In response, Price co-sponsored a failed effort to delay the amendment's implementation for a year. Initially, academic leaders worried that the Shelby amendment would cover all sorts of unpublished data, including preliminary analyses, identities of research subjects and trade secrets produced in collaboration with private companies. OMB, which issues the regulations that govern the Freedom of Information Act, determined in February that the law would only cover research that contributed to the formulation of policy or rules. This initial narrowing satisfied industry leaders, including the U.S. Chamber of Commerce. But the OMB's August clarifying of regulations sparked controversy all over again. The second revision limited the amendment scope to regulations -- not policies or guidelines -- that play a major role in developing federal rules. OMB's regulations make a sharp departure from the relatively simple text of the Shelby amendment, calming some of the fears of university officials, but upsetting the business community by limiting access to a very small percentage of studies. OMB is expected to complete the final regulation by the end of this month.