HUMAN RESEARCH SUBJECTS, INSTITUTIONAL REVIEW BOARDS, AND INFORMED CONSENT

The DTC genetic testing company Navigenics is collaborating with the Scripps Translational Science Institute in an ambitious study that will follow 10,000 participants for 20 years, researching the predictive value of genetic risk markers, looking at outcomes, and evaluating the effectiveness of behavior modification. Although the Scripps IRB reviewed and approved the collaboration—including Navigenics’ role—DTC genetic testing companies’ research is not necessarily overseen by IRBs.2

Whether a genetic test is provided direct-to-consumer or in a more traditional clinical setting, ensuring that the client fully understands the test’s risks as well as its benefits is critical. One potential risk, of course, is loss of genetic privacy and the many types of personal, emotional and financial harm that could ensue. A document designed to ensure that a client is giving free and informed consent must include an adequate description of the policies and procedures for securely handling the samples and the resulting data—including collecting, identifying and deidentifying, storing, using, sharing and destroying them. The factors and considerations that make up informed consent are many and complex. Is the customer, for example, merely consenting to have the DTC genetic testing done? Or is the individual also consenting to have the test results used for research? May a client consent to have the testing done without having his or her results used in research? 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. According to the director of the Chongqing Children’s Palace, “Nowadays, competition in the

2

 From the remarks of Elissa Levin, Director, Genetic Counseling Program, Navigenics, Inc.

3

 This sentence taken from the remarks of Scott Woodward, Director, Sorenson Molecular Genealogy Foundation.



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