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Thread: Consent for possible future uses of data

  1. #1
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    Consent for possible future uses of data

    Dear Forum

    I would be interested to hear opinion on the use of consent for possible future use (secondary use) of data and/or samples. For example, sponsors often want to compare data between related trials to see whether more information about a drug can be revealed or pool data from many trials and perform further statistical analysis.

    Any advice or guidance on this matter would be helpful.
    Last edited by MHRA Moderator; 4th Nov 2011 at 11:15 AM. Reason: remove stars added incorrectly

  2. #2
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    Hi Catherine,

    Very interesting question. In my opinion, sponsor should make every effort to clarify why and how he is planning to use the data in the future. You may want to consider drafting a separate generic consent which details this process. It may present a challenge to the sponsor, as often it is not possible to decide all the comparison they want to undertake in future.

    As I said before, this is just my opinion.....

    I hope this helps.

  3. #3
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    Hi Catherine,

    If the patient information leaflet and ICD detail this I think it should be fine - as these documents will receive ethical approval, and the REC will raise any concerns they have with you. The key would be that the data or samples used should be anonymised for any future use and this should be explained to the volunteer. It's very unlikely that future use would receive ethical approval if patient identifiers were to be included without consent.
    A separate generic consent document isn't unworkable, but a simple paragraph in the ICD should suffice.

    Best wishes,

    Rob

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