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Assessing Genetic Risks: Implications for Health and Social Policy
and standards for evaluating when genetic tests are ready for widespread use in medical practice and overseeing the use of such testing. The National Advisory Committee and its Working Group should be appointed by the Secretary of Health and Human Services to give advice to DHHS and to the Congress, including the Joint NIH-DOE Human Genome Project. Its policy recommendations must be directed wherever appropriate, however, including other NIH components, CDC, FDA, AHCPR, HCFA, DHHS, the Congress, and other public and professional bodies. This National Advisory Committee should consist of scientists and physicians with expertise in genetic tests, as well as consumers aware of the problems of genetic testing, including members of the genetics community (particularly the American College of Medical Genetics (ACMG), ASHG, CORN, CAP, and the Alliance of Genetic Support Groups), other professional societies (e.g., ACOG and AAP), as well as other interested parties from law, business, and ethics.
The majority of the committee urges DHHS to fund the proposed National Advisory Committee on Genetic Testing with its Working Group on Genetic Testing and to fund an adequate staff. The Advisory Committee should be appointed by the Secretary of Health and Human Services and funded independently in order to ensure oversight of the full range of federal agencies involved in genetic testing and to professional societies making ''standard of care" decisions. The Working Group should be capable of (1) collecting data on the validity and safety of tests already in use; (2) evaluating new tests by helping to design and evaluate pilot programs; and (3) measuring the performance of specific tests against the principles and criteria described in this report, and others that may be needed. The Advisory Committee would set priorities for which tests or types of tests should be evaluated and what additional data should be acquired by the Working Group. Based on the findings of the Working Group, the National Advisory Committee could make recommendations on altering current genetic testing practices, on when new tests are ready for widespread use, and on modifying or adding to this committee's principles and criteria for testing. The Advisory Committee should make reports as needed, but at least every two years, to the Secretary of Health and Human Services and the Congress. This policy mechanism should allow more comprehensive consensus and policy development, as well as the monitoring and oversight of professional practices related to genetic testing.
There have been discussions of and recommendations for a national commission on genetics to develop essential policy and provide oversight for this rapidly developing field, with its many scientific, ethical, legal, and social implications. The House Committee on Government Operations, Subcommittee on Information, Justice, and Agriculture (1992) issued a report recommending a national commission on genetic privacy at the level of the Secretary of Health and Human Services and the Secretary of Energy (Gellman, 1992; see Chapter 8). Issues in genetic privacy that are especially complex may warrant independent national review, depending in part on the outcome of the current round of health insurance reform at the national level. This will require careful monitoring over the next