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Incidental Findings via Next Gen Sequencing in Human Subject Research



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  • Incidental Findings via Next Gen Sequencing in Human Subject Research

    In a recent New York Times article by science writer Gina Kolata,

    "Genes now tell secrets they can't utter"


    the ease and affordability of human genome sequencing is targeted as the source of growing ethical quandries. One such trouble is what to do about significant incidental findings. It is my opinion that the blame can be placed on investigators relying on human subject consent forms from another era as well as Institutional Review Boards that continue to maintain technology-blind approaches ill serving genomic advances in the clinic.

    My suggestions to deal with the ethical issues of significant incidental findings center on reporting back results to a patient's referring primary care physician (many studies gain subjects through a referring physician whom the patients trusts). For those entering studies without a primary or referring physician, each study program should provide for an "incidental findings primary care doctor" who would meet with the subject to deliver and discuss findings of note.

    Yes, both my proposals involve communicating genetic findings back to a research subject through a doctor--not in line with the do-it-yourself, over the counter movement, I'm afraid. But human subject clinical research is not a population field-study project, however genetic the research question may be. Relying on subject anonymity (however this is stated or consented to by the subject) is an unacceptable ethical short cut and a detriment to the obligations involved in human subject research under ethical conditions.

  • #2
    Thee is no substitute for asking the research subject on their consent form what they might want back


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