A bill designed to protect the privacy of genetic information
of individual citizens was introduced in the U.S. Senate last
spring. Sponsored by Sens. Pete Domenici, R-N.M., and Paul Simon,
D-Ill., S 1898 or the "Genetic Confidentiality and
Nondiscrimination Act of 1996," addresses an appropriate concern.
But it fails to recognize that its provisions would have an
overwhelmingly detrimental effect on genetic research.
Genetic research has progressed at an astonishing pace during
the past two decades in a largely unregulated environment. It holds
great promise in diagnosis and treatment of a variety of
genetically related diseases. Included are inherited disorders for
which specific genetic explanations have been or are being
identified. These include fibrocystic disease, sickle cell disease,
Alzheimer's disease, diabetes, leukemia and cancer.
Although many people would benefit from this progress, only a
very few would be harmed by breaks in confidentiality of genetic
information. The Domenici-Simon bill seeks to protect these very
few while creating a serous hazard to benefits that would flow to
the very many.
The prologue to the bill focuses entirely on potential negative
aspects of obtaining human genetic information. It fails to point
out the many benefits of genetic studies.
The bill, which exceeds the U.S. Constitution in length,
attempts to micromanage procedures for confidentiality and
disclosure, records and tissue-sample storage. The bill would
create a morass of legal interpretation.
Provisions of the bill - some clearly specified and some that
are likely to arise from court interpretations - would essentially
bring human genetic research to a halt in this country because:
(1) High administrative expenses will be caused by the need to
acquire consent of source individuals for any studies involving
genetic information. These will restrict study of archival
specimens on which much progress in genetic understanding of cancer
has been based to date.
(2) The bill would create a daunting potential for liability
for researchers. Strong penalties are specified for studies of
specimens that currently can be studied without permission of the
donors; these are acquired by sampling of blood, other body fluids
or by surgical operations. In the vast majority of studies, the
information obtained can be safeguarded by conventions already in
place. I know of no harm done to individuals by inappropriate
release of genetic information in the many studies with which I
have some familiarity.
(3) Expenses of research would be increased by an inappropriate
requirement of informed consent for study of archival specimens,
and the broad rights to genetic and psychological counseling
specified by the bill. …