Policy and Ethics Issues
The growing availability and use of genetic testing in the clinical setting raises a number of ethical, legal and social issues and questions that healthcare providers should become familiar with. For example, how should such tests be regulated? Should "home brew" tests be regulated by the FDA just like diagnostic devices? What level of analytical validity (accuracy of the test result), clinical validity (use of the test as a diagnostic tool), or clinical utility (use of test result for treatment) should be required for tests offered to the public? What counseling should be provided for recipients of test results, and who should provide that guidance? How can the public be protected from discrimination?
This section provides healthcare professionals with links to more detailed information about the ethical, legal and social challenges that accompany genetic testing.
- Coverage and Reimbursement of Genetic Tests
Who will pay for genetic tests?
- Genetic Discrimination
Protection for personal genetic information.
- Informed Consent for Genomic Research
Information to assist the development of informed consent materials for genomics-related research projects.
- Intellectual Property
In a landmark decision in June 2013, the Supreme Court determined that DNA in its natural form cannot be patented.
- Privacy in Genomics
Privacy in research, in the clinic in society and protections
- Regulation of Genetic Tests
Issues, questions, legislation and policies.
Last Reviewed: August 21, 2014