Human Genomics in Global Health

Regulatory Bodies

Regulatory bodies, which today comprise national governmental entities, are responsible for formulating and enforcing laws that protect the safety of patients and set basic quality standards for genetic testing. The quality of a genetic test is contingent upon the many components of the genetic testing process, from sample collection to the communication of test results, so the responsibility of genetic test quality regulation is often divided amongst several organizations, which safeguard different elements of the testing process.

Laboratory Accreditation Bodies - The process of carrying out the genetic test is usually the responsibility of a clinical laboratory. Laboratory procedures, setup, and general quality assurance mechanisms may be held to standards, which are mandated and enforced by laboratory accreditation organizations. Although the statutory power of mandatory laboratory accreditation comes from the government, the process of laboratory accreditation may be outsourced to organizations external to the government. Additionally, these laboratories may be regulated in a more specific manner depending on the types of tests they perform. However specific regulations for laboratories performing genetic tests are not in place(in most countries).

Consumer Protection Agencies - Consumer protection agencies are responsible for maintaining legal quality and safety standards for products used by consumers. Genetic tests fall under this regulatory umbrella, and are subject to regulations mandated by these organizations, where they exist. Both the number and the types of genetic tests available are expanding, so regulation must ensure that tests that are offered to patient testing are of an acceptable efficacy. Tests that are marketed and distributed by private genetic test developers to laboratories in self-contained kits for use can be checked for their accuracy and reliability. However, most genetic tests are produced "in-house" by the clinical laboratory itself, so their quality cannot be as easily monitored. In reality, even when regulatory standards exist, these tests are rarely regulated very strictly.

Professional Licensing Organizations- Clinical geneticists, nurses, and lab workers are often required to have special training to properly perform required tasks pertaining to genetic testing. Professional licensing organizations uphold the quality of clinical staff, who play an important part in the delivery of genetic testing services, by licensing only those professionals who have been trained to perform required tasks. Certification of professionals may also require that those involved in genetic testing participate in continuing education to maintain and develop professional knowledge and certificates be revoked in light of inadequate performance.

Other Regulatory Bodies - Many other areas of regulatory need are emerging, and must be addressed by an array of actors. Protection of patient information and patient rights have implications for regulating the collection, management, and use of patients' genetic data, as well as access of that information by third parties. Direct-to-consumer tests, genetic biobanks and still other issues will need to be addressed within the national regulatory framework. They will likely need a response by several governmental agencies, and may require lawmakers to enact new laws or develop additional regulatory structures to address emerging challenges.