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Genomic Research, Personal Genomics Require New Ethical and Regulatory Guidelines, Experts Say

NEW YORK (GenomeWeb News) – Informed consent and regulation need re-thinking in the genomic research context, according to a pair of policy papers published today in Nature.
In the first of these, Patrick Taylor, deputy general counsel at the Children’s Hospital Boston and lecturer at Harvard Medical School, argued that mandating informed consent for genomic research is not necessarily the best way to protect individuals' privacy. And, he said, traditional informed consent measures may hamper genetic and genomic research and its translation into healthcare settings.
“Mandating consent increases the burden and biases research,” Taylor wrote, citing a Taiwan study suggesting that several populations, including the elderly, low income individuals, and Taiwan aborigines, were likely to refuse consent for research. “Even if large cohorts muffle consent bias, consent issues will endanger research into rare diseases, including those that cause childhood death,” he wrote.
Researchers need to connect genetic information with medical information in order to improve healthcare, Taylor noted. But requiring patient consent for use of electronic medical records would be a mistake, he argued, adding that Microsoft, patient activists, and others are currently lobbying Congress for such legislation based on a need for individual autonomy.
“For sound reasons, some research, particularly that involving interventions on the body requires consent altruistically given,” Taylor wrote. “But other research rightly proceeds on different ethical grounds. For good cause, where the primary potential harm is loss of privacy, ethics permits waiving consent given reasonable privacy protection.”
Taylor also argued that consent cannot ensure privacy and suggested that autonomy is just a small part of a much larger picture. He suggested that some ethical principles call for individuals to participate in low-risk research in order to benefit society as a whole. And, he added, beneficence and justice should also be taken into consideration when considering healthcare and genomic research.
“Protection of privacy is critical,” Taylor concluded, “but consent alone is the wrong means to protect it. Working with the public, we must preserve and explore ethical alternatives.”
In a second commentary paper in Nature, an international team of researchers from the UK, US, Australia, Austria, and the Netherlands argued that direct-to-consumer whole-genome tests, such as those offered by 23andMe, Decode Genetics, and Navigenics, should not necessarily be evaluated under the same regulatory frameworks used for traditional genetics.
“We believe that anticipatory governance is premature without a better understanding of how SNP-based whole-genome information is used by, and what it means to, a wide range of users,” lead authors Barbara Prainsack, a biomedicine and society researcher at King’s College London, and Jenny Reardon, a sociologist at the University of California at Santa Cruz, wrote.
Although they did not advocate an unregulated genomics market, the authors urged regulators to wait until information is available on the effects of such tests before introducing regulation. For instance, the team noted that personal genomics is “pushing the individualization of responsibility for health one step further,” without necessarily providing clear information about how genetics ties into health and individual choices.
“Regulation will be effective only if it is informed by the results of a systematic examination of these issues,” they wrote. “We recommend that public authorities make it a priority to fund empirical research exploring what individuals expect from personal genomics, and in what way genetic-susceptibility information is likely to affect practices and lifestyle choices.”
On that front, the authors lauded efforts by New Jersey's Coriell Institute for Medical Research and California’s Scripps Translational Research Institute, Navigenics, and Microsoft for undertaking research to determine how personal genetic tests affect individuals.
The researchers also noted that genomics is blurring the lines between medical tests and genealogical or recreational information — particularly since consumers often play a larger role in interpreting the information than physicians.
“Effective responses to this situation require clarification of the novel issues created by the convergence of information about health, consumer and lifestyle choices, and genealogy; novel relationships between geneticists, patients, consumers and corporate executives; and the continued intensification of collaboration, on both the research and the patient/consumer sides,” the authors wrote.

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