title: Attitudes about regulation among direct-to-consumer genetic testing customers.
abstract: BACKGROUND
  The first regulatory rulings by the U.S. Food and Drug Administration on direct-to-consumer (DTC) genetic testing services are expected soon. As the process of regulating these and other genetic tests moves ahead, it is important to understand the preferences of DTC genetic testing customers about the regulation of these products.
  
  
  METHODS
  An online survey of customers of three DTC genetic testing companies was conducted 2-8 months after they had received their results. Participants were asked about the importance of regulating the companies selling DTC genetic tests.
  
  
  RESULTS
  Most of the 1,046 respondents responded that it would be important to have a nongovernmental (84%) or governmental agency (73%) monitor DTC companies' claims to ensure the consistency with scientific evidence. However, 66% also felt that it was important that DTC tests be available without governmental oversight. Nearly, all customers favored a policy to ensure that insurers and law enforcement officials could not access their information.
  
  
  CONCLUSIONS
  Although many DTC customers want access to genetic testing services without restrictions imposed by the government regulation, most also favor an organization operating alongside DTC companies that will ensure that the claims made by the companies are consistent with sound scientific evidence. This seeming contradiction may indicate that DTC customers want to ensure that they have unfettered access to high-quality information. Additionally, policies to help ensure privacy of data would be welcomed by customers, despite relatively high confidence in the companies.
authors.affiliation: Genetics and Public Policy Center, Berman Institute of Bioethics, Johns Hopkins University, Washington, District of Columbia 20036, USA. jmurph46@jhu.edu
authors.forename: Juli Murphy
authors.initials: JM
authors.lastname: Bollinger
authors.forename: Robert C
authors.initials: RC
authors.lastname: Green
authors.forename: David
authors.initials: D
authors.lastname: Kaufman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001294:Attitude to Health; D003256:Community Participation; D003625:Data Collection; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005260:Female; D005820:Genetic Testing / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D014481:United States; D055815:Young Adult
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