.: Task Force Reports on Genetic Testing
By:Aaron Hall
Genetic Test: The analysis of human DNA, RNA, chromosomes, proteins, and certain metabolites to detect heritable disease-related genotypes, mutations, phenotypes, or karyotypes for clinical purposes. Such purposes include predicting risk of disease, identifying carriers, establishing prenatal and clinical diagnosis or prognosis, monitoring, and screening prenatally and in newborns, but they exclude tests conducted purely for research.
The Task Force on Genetic Testing, chaired by Neil Holtzman (Johns Hopkins University), was formed in 1994 by the NIH-DOE Working Group on Ethical, Legal, and Social Implications of Human Genome Research. The working group asked the task force to review genetic testing in the United States and make recommendations to ensure the development of safe and effective genetic tests to be delivered in high-quality laboratories and used appropriately by healthcare providers and consumers. The working group took this action after considering the imperfect predictability of tests, quality of laboratories providing clinical genetic tests, lack of proven interventions for many disorders, and the questionable ability of many healthcare providers to explain genetic tests accurately and nondirectively to patients.
In 1995, the task force undertook a survey of organizations likely to be engaged in genetic testing and conducted in-depth interviews at 29 of the 463 organizations. From respondents whose organizations performed genetic tests, the task force collected informational materials distributed to providers and patients. The task force then commissioned papers on some of the widely used genetic-screening programs in the United States. Individuals, both professionals and consumers, also were asked to report their experiences with various aspects of genetic testing.
Halfway through its deliberations, the task force published interim principles, held a public hearing on them, and invited public comments. Taking these comments into consideration, the task force developed recommendations on which the public was again invited to comment. Final principles and recommendations were presented to the joint working group on May 9, 1997, and the final report was submitted in September (http://www.hopkinsmedicine.org/tfgtelsi/).
Summary of Recommendations
* The Secretary of Health and Human Services should appoint an advisory committee on genetic testing to be instrumental in implementing the task force's recommendations. The advisory committee or its designate should establish a system for determining which genetic tests require stringent scrutiny.
* Protocols for developing genetic tests that can be used predictively must receive the approval of an institutional review board if subject identifiers are retained and if the test is expected to be readily available for clinical use.
* To permit informed decisions about routine use, test developers must submit their validation and clinical data to external review and to interested professional organizations.
* The task force urges the newly created genetics subcommittee of the Clinical Laboratory Improvement Advisory Committee to consider creating a genetics specialty to ensure that problems specific to genetic testing are addressed in assessments of laboratory quality. If only a subspecialty is feasible for DNA- and RNA-based tests, the subcommittee should then address how to ensure the quality of laboratories performing non-DNA and non-RNA predictive genetic tests.
* The task force encourages the expansion and strengthening of genetics curricula in medical school, residency, and specialty training and the development and improvement of genetics programs by schools of nursing, public health, and social work.
* Hospitals and managed-care organizations should require evidence of competency before permitting providers to order predictive genetic tests that require stringent scrutiny or to counsel about them.
* Physicians who encounter patients with symptoms and signs of rare genetic diseases should have access to accurate information that will enable them to include such diseases in their differential diagnosis, to know where to turn for assistance in clinical and laboratory diagnosis, and to locate laboratories that test for rare diseases. The quality of laboratories providing tests for rare diseases must be ensured, and a comprehensive system must be established to collect data on rare diseases.
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