New Rule Would Make Research Data ‘Public Information’

BETHESDA, Md—Few people on Capitol Hill—or off—were aware of a brief provision written into an appropriations act in the waning days of last fall’s budget battles. Now the research community, including the National Cancer Institute and the National Cancer Advisory Board (NCAB), is assessing the legislation’s potential damage and how best to soften its blow.

In appropriating money for the Executive Office of the President, which includes the Office of Management and Budget (OMB), Congress directed the OMB to amend its administrative rules “to require Federal awarding agencies to ensure that all data produced under an award will be made available to the public through the procedures established under the Freedom of Information Act.”

NCI director Richard D. Klausner, MD, told NCAB members that the amendment “has very disruptive, if not paralyzing implications for research.” Philip S. Schein, MD, adjunct professor at the University of Pennsylvania School of Medicine, expressed concern about “investigators having their data raided, probed, and discussed prematurely.”

It is up to the OMB to formulate the exact wording of the new regulation mandated by Congress. Before imposing it, the OMB must draft proposed rules and request public comment on them. NCAB chair J. Michael Bishop, MD, of the University of California, San Francisco, named a five-member committee to develop an NCAB response for delivery to the OMB once it issues a request for comments. Dr. Schein will lead the group.

A brief commentary on the appropriations provision, written by NCI’s Office of Legislation and Congressional Activities, warned that, “taken literally, all data generated by research projects receiving support from federal funds would be considered public information and must be made available should a Freedom of Information Act request be submitted.”

Since the new regulation was ordered by Congress, it could be revoked by Congress. This is unlikely to happen—if it ever happens—before the OMB writes its new rules to implement the congressional order, said Marvin R. Kalt, PhD, director of NCI’s Division of Extramural Activities and NCAB’s executive secretary. “It is my judgment that these new rules are likely to be on the books long before any possible legislative relief could be obtained,” he said.

‘Data’ Not Defined

Nowhere in the legislation is the term “data” defined, and this is one important area that the OMB must address in writing its rules. Dr. Kalt gave three “extreme” scenarios of what could happen, if the congressional directive is implemented quite literally.

Participants in clinical trials could file Freedom of Information Act requests demanding study data. In studies with small numbers of patients, “even though we strip the personal identifiers, they could identify themselves easily from their age, zip code, or other things that would not be considered private,” he said.

An investigator participating in a clinical trial could demand to see data from a data or coordinating center prematurely.

Basic scientists might have to disclose the contents of their laboratory notebooks.

Under the Freedom of Information Act, federal agencies can charge a nominal fee to cover the costs of providing information. This money, however, goes to the US Treasury and not to the agency. “So we would incur costs, and, of course, awardees would incur costs,” Dr. Kalt noted.

In writing its rules, the Office of Management and Budget will have to balance the intent of Congress with existing laws, including provisions in the Freedom of Information Act designed to protect personal privacy and proprietaryy property.

This is why, Dr. Kalt stressed, it is important that the National Cancer Advisory Board and other scientific groups make comments and statements regarding such issues as patient privacy, how the word ‘data’ should be defined, who owns scientific data, and at what point they own it.