BETHESDA, MdThe 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In a resolution urging that the legislation be rescinded, NCAB warned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
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 statutes language could result in serious and unintended
consequences, the board said. The result, in our
judgment, would be a critical negative impact on our countrys
27-year commitment to programs of cancer prevention, diagnosis, and
treatmenta national priority.
NCAB members expressed particular concern about the laws 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
The panel emphasized that disclosure of medical data can adversely
affect a persons 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
governments compelling interest in maintaining the
confidentiality of patient medical records, panel members said.
Among its other concerns, the board noted that the statutes
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 laws 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
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