Introduction: Privacy Issues in Research

In January 1996 the journal Science reported a dilemma plaguing the Centers for Disease Control and Prevention (CDC) in Atlanta. For a decade a group of biologists there had been collecting blood samples from people for eventual use in genetic research, and by 1996 they had some 17,000 samples of DNA, an invaluable archive that could help researchers understand the connection between genetics and the development of various diseases. But no one was allowed to use the archive. As Science reported, the CDC was ''concerned that its original procedures for obtaining consent fall short of today's standards.''

If it were an isolated event, the CDC's predicament would be unfortunate but not particularly worrisome to anyone outside the small group of scientists involved. But the situation is not unique. In labs around the country genetic researchers find themselves face to face with ethical and legal quandaries concerning the collection, analysis, and dissemination of genetic information. As the potential benefits of genetic science have grown, particularly in the diagnosis and treatment of disease, so have the worries about possible abuse, and Congress and a number of state legislatures have begun looking into regulating the flow of genetic information.

To date, much of the discussion has been driven by people concerned about genetic discrimination—the misuse of genetic information by insurance companies, employers, and others to make decisions based on a person's DNA—and so most of the policy debates have centered on how to ensure the privacy of genetic information in medical records and to protect people from such discrimination. But there are other issues as well. In particular, biomedical researchers—not insurance companies or employers—are by far the biggest consumers of genetic information, but relatively little attention has been paid to them and to the sorts of



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--> Introduction: Privacy Issues in Research In January 1996 the journal Science reported a dilemma plaguing the Centers for Disease Control and Prevention (CDC) in Atlanta. For a decade a group of biologists there had been collecting blood samples from people for eventual use in genetic research, and by 1996 they had some 17,000 samples of DNA, an invaluable archive that could help researchers understand the connection between genetics and the development of various diseases. But no one was allowed to use the archive. As Science reported, the CDC was ''concerned that its original procedures for obtaining consent fall short of today's standards.'' If it were an isolated event, the CDC's predicament would be unfortunate but not particularly worrisome to anyone outside the small group of scientists involved. But the situation is not unique. In labs around the country genetic researchers find themselves face to face with ethical and legal quandaries concerning the collection, analysis, and dissemination of genetic information. As the potential benefits of genetic science have grown, particularly in the diagnosis and treatment of disease, so have the worries about possible abuse, and Congress and a number of state legislatures have begun looking into regulating the flow of genetic information. To date, much of the discussion has been driven by people concerned about genetic discrimination—the misuse of genetic information by insurance companies, employers, and others to make decisions based on a person's DNA—and so most of the policy debates have centered on how to ensure the privacy of genetic information in medical records and to protect people from such discrimination. But there are other issues as well. In particular, biomedical researchers—not insurance companies or employers—are by far the biggest consumers of genetic information, but relatively little attention has been paid to them and to the sorts of

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--> policies that should be put into place to regulate research that involves human genetic information. On November 1, 1997, the National Research Council's Board on Biology brought together a group of scientists and other experts to discuss the policy issues raised by the ongoing revolution in genetic science. The primary reason for the workshop, called "Privacy Issues in Biomedical and Clinical Research," was the worry that federal legislation intended to ensure the privacy of genetic information in medical records could have unanticipated—and damaging—consequences for research. But the discussions at the workshop also identified a number of other problems and potential problems concerning genetic research. For example, in universities and research hospitals an important safeguard against the misuse of genetic information generated by research is the institutional review board (IRB), which must review and approve all research affecting humans; workshop participants identified weaknesses that hamper IRB review of genetic research protocols. The following is a synopsis and synthesis of the workshop's proceedings. It identifies the main concerns of scientists and others involved with genetic research, it pinpoints particular pitfalls that policy makers should be aware of, and it offers suggestions for the sorts of policies that would allow biomedicine to continue its recent history of dramatic advances.