Regulatory Open Forum

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  • 1.  specimens for DNA research

    Posted 31-May-2017 13:49
    One of my colleagues ( a university prof, not in a company) came up with an interesting comment on the recent Common Rule  discussion about informed consent and samples for research. She commented, "we are doing a lot of research into more accurate and faster DNA scans. Our scans are using human DNA samples, and while not completely whole genome, they are closer than anything currently on the market either RUO or  IVD. When does one consider the specimen needing patient consent, since we could easily identify any of these scans to an individual by comparing our results with another scan for DNA on the donor patient". My response was that since she didn't have that second scan, she didn't have to worry. But then I started to worry-anyone care to comment?

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    Anna Longwell JD RAC
    Principal
    Longwell and Associates
    Palo Alto CA
    United States
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  • 2.  RE: specimens for DNA research

    Posted 01-Jun-2017 08:20
    Hi Anna.

    I usually try to take a metered approach to such questions and in general I would agree that if she doesn't have the second scan to compare then she is probably not in a place where she would be required to get informed consent.  HOWEVER, if she is storing that data in any way that could be pulled, hacked, queried, etc. by someone outside her immediate organization then there might be a reason to at least inform the donor of the potential for that data to be collected and stored.  I think about things like the hacks of several major firms over the years and what sort of information the data in her dataset could reveal and what could be "held information-hostage".  I would suggest that if her only purpose is to scan, sequence and then store the sequence data, informed consent should not be too great an issue for donors (although I am sure you will have many who will not want that information collected).  So I would look to her purpose and her plan especially around storage of the data to determine what level of consent might be needed.

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    Victor Mencarelli
    Director - Regulatory Affairs
    Hain Celestial Group
    United States
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    Original Message


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