Work

The Current Landscape for Direct-to-Consumer Genetic Testing: Legal, Ethical, and Policy Issues

Year: 2008

Type: review

Abstract: This review surveys the developing market for direct-to-consumer (DTC) genetic tests and examines the range of companies and tests available, the regulatory landscape, the concerns raised about DTC testing, and the calls for enhanced oversight. We provide a comparative overview of the situation, particularly in the United States and Europe, by exploring the regulatory frameworks for medical devices and clinical laboratories. We also discuss a variety of other mechanisms such as general controls on advertising and consumer law mechanisms.

Source: Annual Review of Genomics and Human Genetics

DOI: 10.1146/annurev.genom.9.081307.164319

Authors: Stuart Hogarth, Gail Javitt, David Melzer

Institutions: Loughborough University, Johns Hopkins University, University of Exeter

Language: English

Topic: Biomedical Ethics and Regulation

Subfield: Issues, ethics and legal aspects

Field: Nursing

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: bronze

Funders: Pew Charitable Trusts, Johns Hopkins University, Wellcome Trust, National Human Genome Research Institute