Direct-to-Consumer Genetic Testing: Summary of a Workshop by National Research Council, Institute of Medicine, Board on

By National Research Council, Institute of Medicine, Board on Health Care Services, National Cancer Policy Forum, Board on Health Sciences Policy, Roundtable on Translating Genomic-Based Research for Health, Development, and Translation Forum on Drug Discov

This present day, ratings of businesses, essentially within the usa and Europe, are supplying entire genome scanning prone on to the general public. The proliferation of those businesses and the providers they provide reveal a public urge for food for this knowledge and the place the way forward for genetics will be headed; additionally they show the necessity for severe dialogue in regards to the regulatory surroundings, sufferer privateness, and different coverage implications of direct-to-consumer (DTC) genetic checking out. swift advances in genetic learn have already got began to rework medical perform and our figuring out of ailment development. current study has published a genetic foundation or part for varied illnesses, together with Parkinson's ailment, Alzheimer's disorder, diabetes, middle disorder, and a number of other different types of melanoma. the provision of the human genome series and the HapMap, plummeting charges of high-throughput screening, and more and more refined computational analyses have ended in an explosion of discoveries of linkages among styles of genetic edition and illness susceptibility. whereas this examine is not at all a directly direction towards higher public healthiness, superior wisdom of the genetic linkages has the capability to alter essentially the way in which future health pros and public healthiness practitioners process the prevention and remedy of illness. knowing this strength would require larger sophistication within the interpretation of genetic assessments, new education for physicians and different diagnosticians, and new techniques to speaking findings to the general public. As this quickly becoming box matures, all of those questions require cognizance from a number of views. to debate the various foregoing matters, numerous devices of the nationwide Academies held a workshop on August 31 and September 1, 2009, to assemble a still-developing group of execs from quite a few correct disciplines, to coach the general public and policy-makers approximately this rising box, and to spot concerns for destiny examine. The assembly featured numerous invited displays and discussions at the many technical, felony, coverage, and moral questions that such DTC trying out increases, together with: (1) evaluate of the present kingdom of information and the longer term study trajectory; (2) shared genes and rising concerns in privateness; (3) the regulatory framework; and (4) schooling of the general public and the scientific group.

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Pdf, Accessed: March 29, 2010. ContentId=816, Accessed: March 29, 2010. The HGC subsequently released its final report on August 4, 2010. hgc. DocId=280&CAtegoryId=10, Accessed August 18, 2010. Copyright © National Academy of Sciences. All rights reserved. html 49 APPENDIX B • Test providers need to provide a high-quality service that both meets client expectations and safeguards their interests; • Tests for inherited diseases should be provided only with individualized pre- and post-test counseling; • Providers should comply with local, national or international advertising guidelines, and promotional claims should describe tests accurately and without bias; • Providers should supply clients with easily understood information, including likely outcomes of the test; • Tests should be carried out only with clients’ free and informed consent; and • Unless there is a clinically important reason to do so, individuals should not be tested until they have reached the age of consent.

Although the FDA has primary oversight of genetic testing, other agencies occasionally become involved. The Federal Trade Commission (FTC) has jurisdiction over claims made in the advertising and promotion of any commercial product, genetic tests included. In 2006, the Senate Special Committee on Aging asked the Government Accountability Office (GAO) to investigate and report on so-called “nutrigenetic” testing web sites. S. S. pdf, Accessed: March 29, 2010. S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services, Report of the Secretary’s Advisory Committee on Genetics, Health, and Society, April 2008.

Genome-wide association study. genotype. An individual organism’s entire, exact genetic makeup, including all its alleles—regardless of whether or not those alleles are expressed. HIPAA. Health Insurance Portability and Accountability Act of 1996. haplotype. A set of alleles on a chromosome that tend to be inherited together. HapMap. A haplotype map of a consensus human genome. The HapMap is a catalog of common genetic variants that occur in human beings. It describes what these variants are, where they occur in human DNA, and how they are distributed among people within populations and among populations in different parts of the world.

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