NCAB Urges Repeal of Law Requiring Research Data Disclosure

BETHESDA, Md—The National Cancer Advisory Board (NCAB) has urged Congress to repeal legacislation that some scientists fear will have a paralyzing impact on clinical research. NCAB also made recommendations to the White House Office of Management and Budget (OMB) aimed at reducing the feared threats posed by the legislation.

Damaging to Research

In a resolution urging that the legislation be rescinded, NCAB warned that it could be damaging to scientific research by negatively affecting the voluntary participation of human subjects, compromising the confidentiality of medical information, causing premature disclosure of incomplete and possibly contradictory data, and undermining protections for intellectual property rights.

NCAB is a presidentially appointed panel that advises the National Cancer Institute and the White House on the National Cancer Program.

The Omnibus Supplemental Appropriations Act, which was enacted in the closing days of the last Congress, contains wording that makes research data obtained from federally funded projects publicly available under the Freedom of Information Act (FOIA). The legislation directs OMB to write regulations implementing the change. Because it seems unlikely Congress would repeal the new law before it goes into force, NCAB and many others with a stake in clinical research have urged OMB to craft its wording to have the least onerous effect.

OMB released its proposed rules for implementing the law in early February and opened a 60-day period for public comment. In response, NCAB sent a three-page, single-spaced letter outlining its concern and views regarding the proposed regulatory language.

“While we recognize the responsibilities of investigators and the National Cancer Institute to disclose important research findings to the public in a timely manner, the undefined scope and ambiguities of the statute’s language could result in serious and unintended consequences,” the board said. “The result, in our judgment, would be a critical negative impact on our country’s 27-year commitment to programs of cancer prevention, diagnosis, and treatment—a national priority.”

NCAB members expressed particular concern about the law’s impact on patients’ rights and their willingness to take part in clinical trials. If not limited, “the provision could pose a significant deterrent to future patient participation in such research and thus to medical progress itself,” the letter said. “People being treated for life-threatening diseases such as cancer are seriously concerned about issues of privacy that relate to both their medical conditions and their involvement in research studies.”

The panel emphasized that disclosure of medical data can adversely affect a person’s ability to obtain or retain employment and health insurance coverage.

“While usual procedures under FOIA would delete names of specific patients from any response to requests for records, privacy experts believe that complicated research records may nevertheless contain sufficient information to enable one to identify individual patients without much difficulty,” the panel said. “This concern is especially applicable for those subjects residing in small communities or with rare diseases.”

NCAB noted that language in FOIA states that the act does not apply to matters related to medical files and similar files, “the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.” It urged OMB to recognize that “the risk of disclosure of patient-specific medical information is substantial” and to grant “a broad exemption for medical research involving patients.” Such a “blanket exemption” may be “the only way to preserve the government’s compelling interest in maintaining the confidentiality of patient medical records,” panel members said.

Among its other concerns, the board noted that the statute’s language says it applies to all data developed with federal support, but fails to specify any time limitations on the release of data. As a result, this might mean that data would have to be made available to the public at any time during a study. This, NCAB said, represents a major departure from current policy.

‘Data Can Take Many Forms’

“‘Data’ can take many forms, such as information in laboratory notebooks, entries in confidential medical records as well as computerized databases,” the board wrote. Premature disclosure of such data “carries with it substantial risks, including the potential release of misleading and erroneous information. . . . Unplanned examinations of interim data can place an entire study at risk.”

The NCAB said that the law’s language ignores the joint funding and collaborative nature of many research projects today. Given that studies often involve researchers from a number of academic institutions and private companies, data ownership becomes a complex issue.

“Because of the increasing complexity of cancer research and need to expedite the flow of new products to the American public, private-public partnerships are often required, and indeed encouraged by other federal legislation,” the panel stated. If partial federal support were interpreted to mean a study would be subject to full disclosure, “this would have a chilling effect on the willingness of the private sector to participate in programs that are critical to our national effort to control cancer, especially since such research often uses unpatented trade secrets in its conduct.”

As premature disclosure would threaten securing the protection of patents and copyrights, “this would compromise both the rights of research institutions and the public benefit that would accompany full development and marketing of the new discovery,” the panel added.