fied, there is growing pressure to broaden existing screening programs, and otherwise increase both the number of available genetic tests and the volume of genetic information they generate.

The rapidly changing science and practice of genetic testing raise a number of scientific, ethical, legal, and social issues. The national investment in the Human Genome Project will greatly increase the capacity to detect genes leading to disease susceptibility. It will also greatly increase the availability of genetic testing over the next 5 to 10 years, identifying the genetic basis for diseases—even some newly discovered to be genetic—and increasing the number of tests for detecting them. The emergence of the biotechnology industry increases the likelihood that these findings will be rapidly translated into widely available test kits and diagnostic products. Entrepreneurial pressure may also lead to the development of commercial and academic "genetic testing services" that would not be regulated under current Food and Drug Administration (FDA) procedures. Problems of laboratory quality control would be heightened by the introduction of "multiplex" tests that detect the presence of numerous genetic markers—for disease, carrier status, and susceptibility alike—at the same time. And the potential for generating all of this genetic information about individuals raises serious questions of informed consent, confidentiality, and discrimination. Over the next five to ten years, there will be an increasing number of personal and public policy decisions related to genetic testing; well-trained health professionals and an interested and informed public will both be key to that decision making.

As genetic screening becomes more widespread, these issues threaten to outrun current ethical and regulatory standards, as well as the training of health professionals. There will be a need for greater numbers of genetics specialists, but genetic testing is no longer just for specialists. Increasingly, primary care providers will be called upon to administer tests, counsel patients, and protect their privacy. Government officials and the broader public will also be called upon to participate in setting public policy for genetic testing and in making difficult decisions, public and private, based on the results of genetic tests. Consequently, there must be a significant increase in genetics education, both in the medical curriculum and for all Americans. Finally, there will be a need for centralized oversight to ensure that new genetic tests are accurate and effective, that they are performed and interpreted with close to "zero-error" tolerance, and that the results of genetic testing are not used to discriminate against individuals in employment or health insurance.

COMMITTEE ON ASSESSING GENETIC RISKS

This study of the scientific, ethical, legal, and social issues implicit in the field of genetic diagnosis, testing, and screening was supported jointly by the National Center for Human Genome Research at the National Institutes of Health and the Department of Energy's Health Effects and Life Sciences Research Of-



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