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  • 1.  Informed Consent

    This message was posted by a user wishing to remain anonymous
    Posted 09-May-2018 10:51
    This message was posted by a user wishing to remain anonymous

    Hello Members, 

    Is it mandatory to file provide the informed consent template with the initial IND application, even though we are agreeing in the protocol that the Informed consent will be obtained from all participants and the PI will take full responsibility to obtain the same. 

    Does the FDA need to see the informed consent with the initial application iteself?

    Thanks


  • 2.  RE: Informed Consent

    Posted 09-May-2018 11:06
    I can answer from a medical device trial side - the IC form is required for an IDE application.

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    Michael Nilo
    Network Regulatory Partners
    Portland OR
    United States
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    Original Message


  • 3.  RE: Informed Consent

    Posted 10-May-2018 06:17
    Dear Anonymous,

    FDA regulations don't require that Informed Consent template be included in an IND. However, the Agency may request this document post-IND filing.

    Sincerely yours, Suzanne

    ------------------------------
    Suzanne M. Sensabaugh, MS, MBA
    President and Principal Consultant
    HartmannWillner LLC
    100 M Street SE
    Suite 600
    Washington, DC 20003
    Phone: 202-749-8616

    www.hw-fda.com
    ------------------------------

    Original Message


  • 4.  RE: Informed Consent

    Posted 10-May-2018 10:14
    I agree with Suzanne.
    Initial IND applications do not require ICF submission.
    We still include it just to cut it short.

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    Artur Shchukin
    New York NY
    United States
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    Original Message


  • 5.  RE: Informed Consent

    Posted 10-May-2018 08:23
    I am not aware of a regulation stating that the informed consent is required to be submitted in an original IND or amendment. I have not always submitted an informed consent document when submitting a new protocol. However, it could be considered a best practice to do so and FDA can request that it be submitted, particularly for studies that involve significant risk or vulnerable populations.

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    Glen Park
    Jersey City NJ
    United States
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    Original Message


  • 6.  RE: Informed Consent

    This message was posted by a user wishing to remain anonymous
    Posted 10-May-2018 12:51
    This message was posted by a user wishing to remain anonymous

    My experience is with IDEs, not INDs. For devices, FDA wants to see the Informed Consent document in the IDE submission. Recently I submitted a draft version and FDA came back and asked for the final. I would think the requirement would be the same for INDs.
    Original Message


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