Analysis of Perceived Benefits and Potential Harms of Direct-to-Consumer Genetic Testing with Regard to Improving Regulation
Direct-to-Consumer (DTC) genetic testing has been historically under-regulated. Since the development of DTC genetic testing in 2002, regulations have been slowly accumulating with the creation of legislation such as the Genetic Nondiscrimination Act of 2008 and the FDA’s 2010 decision to deem DTC genetic tests as medical devices requiring FDA approval and regulation. There are still gaps left by current regulations that must be filled through improving upon current regulations and establishing new legislation. When considering the need for improved regulations, it is important to recognize the reason consumers pursue such testing. Understanding consumer motivations helps to create regulation that avoids impeding benefits received from testing and ensures consumer protection by mitigating potential harm and risks from DTC genetic testing. This thesis provides a history of DTC genetic testing and analyzes consumer motivations, risks, and benefits to be taken into consideration for future regulations.