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Research and Medical Issues
Pages 19-22

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From page 19...
... DTC companies maintain that it is not their intent to practice medicine or to enter into a therapeutic relationship with their clients, and they do not consider themselves to be doing so.1 Are the companies' customers de facto human research subjects? What are customers' rights with respect to their samples, data, and any benefits of the research conducted using them?
From page 20...
... One DTC company, in trying to streamline and clarify its informed consent document without weakening its protections, has so far managed to reduce the document to "only" six pages.3 A complicating factor relates to individuals who are unable to give informed consent -- either test subjects who are minors, or a test subject's relatives -- but whose lives could nevertheless be affected by the results. In China, for approximately $900, parents in Chongqing, PRC, can send their children -- ages three to 12 years old -- to a five-day camp for DNA testing to identify their gifts and talents, so they can focus on those strengths from an early age.
From page 21...
... Vice Provost for Research Harvard University world is about who has the most talent. We can give Chinese children an effective, scientific plan at an early age."4 In contrast, the framework of principles developed by the United Kingdom recommends that genetic testing of minors should only be carried out if there is a specific medical indication and if delaying the test till the age of consent might adversely affect that individual's medical care.5 A similar view seems to be the norm in the United States.
From page 22...
... • How can immediate or extended family members of tested individuals be protected from learning their genetic information if they choose not to, or from the effects of others' learning about it? • Are DTC genetic testing companies subject to CLIA, HIPAA, and various state laws regulating clinical laboratories or the practice of medicine or not?


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