the prospect of widespread genetic testing, the committee believes that effective oversight is essential to ensure that tests are validated before becoming standard medical practice and that such tests are used appropriately, with respect for the potential harms such testing may pose.

The committee believes that a national oversight body is needed to serve this function (see below). Such a body would help to bring order, over the coming years, to the continuing oversight of genetic testing and the evaluation of the readiness of new genetic tests for widespread use in medical practice, and to monitor professional practices. Such a body would collect and evaluate data on genetic testing, and advise state and federal agencies and other interested organizations with regulatory authority on establishing and enforcing standards for genetic tests. Among the organizations to whom this body could provide advice are the Human Genome Project (HGP), Health Care Financing Administration (HCFA), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Agency for Health Care Policy and Research (AHCPR), and the Congress, as well as legislatures, health agencies, and genetics advisory commissions at the state level.

Among genetics professionals, the American Society for Human Genetics (ASHG) has served some of the functions that the committee has in mind for the proposed National Advisory Committee on Genetic Testing and a Working Group on Genetic Testing (see below). ASHG has issued policy statements on maternal serum alpha-fetoprotein (MSAFP) screening; on cystic fibrosis (CF) testing and screening; on DNA banking, DNA data banking, and related confidentiality issues; and on freedom of choice related to prenatal diagnosis and to the selective abortion of fetuses diagnosed with, or at significant risk of, serious genetic disorders and birth defects. The National Society of Genetic Counselors (NSGC) has also developed a Code of Ethics and Guiding Principles that includes policy statements on access to care, nondiscrimination, and freedom of choice, as well as confidentiality of test results and informed consent. The Council of Regional Networks for Genetic Services (CORN) has developed policies and practices for laboratory quality assurance standards, proficiency testing programs, and essential data collection for newborn screening, cytogenetics, biochemical genetics, alpha-fetoprotein, and hemoglobinopathy screening; more recently, CORN has helped develop quality standards and proficiency testing for molecular genetics in conjunction with ASHG and the College of American Pathologists (CAP).

Many other professional groups also have an interest in genetic testing. The American Academy of Pediatrics (AAP) has issued a series of policy statements and fact sheets on newborn screening, including statements on screening for phenylketonuria and hypothyroidism, the subsequent use of newborn screening spots for DNA diagnosis, and the limits of consent in children and genetic testing in children. The American College of Obstetricians and Gynecologists (ACOG) has issued policy statements on MSAFP screening, prenatal diagnosis for advanced maternal age, and standards for the training of medical students and residents in

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement