Final data-access regulations bring temporary consensus

In the ongoing battle over access to data produced from federally funded research, a finalized federal regulation released Oct. 8 seems to have temporarily pacified both sides of the debate.

The rules, announced by the Office of Management and Budget and scheduled for implementation next month, make mostly minor wording changes to the August version.

In perhaps the most significant change, OMB decided open access should not apply to studies that lead to federal regulations, just ones that undergird any federal agency action with the force and effect of law.

This change came partially in response to complaints from several senators, including Sen. Richard Shelby, R.-Ala, who last year sponsored the controversial law that opened "all data" in federally funded studies to requests under the Freedom of Information Act.

OMB was charged with the task of creating regulations to implement the so-called Shelby amendment, which passed Congress with little debate because it was added into a large regular appropriations bill.

Earlier this summer, the agency issued its first two drafts of regulations-the second of which allowed research university leaders to breathe a collective sigh of relief when it severely limited the number of affected studies. Administrators had been concerned about the negative effects of unrestricted access, specifically that a broad implementation of the Shelby amendment could violate the confidentiality of research subjects and cause other problems.

However, Shelby and a group of senators and industry groups complained that the agency was inappropriately narrowing the scope of the law.

But the most recent changes managed to satisfy Shelby.

"The OMB's final revision to Circular A-110, while still narrow in scope, is a good first step to giving the American people access to the research and science used in federal policies that affect the lives of Americans each day," he said in a statement.

"If properly implemented by the agencies, this new provision will serve to enhance public accountability and provide a higher level of transparency in government," Shelby continued.

University leaders said they were gratified the final version was not as broad as it could have been.

"The way we initially thought it might appear, it would be the kind of thing where we would have to hire people to take all the requests that were coming at us," said John Burness, Duke's senior vice president for public affairs and government relations.

Several federal agencies had similar fears about needing more support if the original law were put into effect.

"We were worried about it," said Robert McDonald, a scientific research grants adviser for the U.S. Department of Agriculture.

"I think every federal agency that in any significant way supports research had a detailed comment about it."

USDA will not need to do additional hiring, but McDonald said he foresaw a few potential problems with the rule, including one that might arise because any project that receives federal funding is subject to the rule.

"There's going to be a real conflict in there because some of these companies may decide they no longer want to fund research of this kind if there are federal monies involved," he said.

The future of the Shelby amendment remains in doubt, however, as universities and their allies in Congress fight to repeal the provision.

"We will continue to work with members of Congress who are concerned about the legislation itself because we think it's bad public policy the way the original law was written," Burness said.

One of these congressmen is Rep. David Price, a Democrat who represents the Triangle. Thomas Bates, Price's spokesperson, said he will continue to address the issue.

Furthermore, as companies and other groups begin to request access to data, it's likely that one side or the other will file a lawsuit to block or compel release, Burness said.

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