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Thread: Return of consent forms by post (CTIMP in rare disease area)

  1. #1
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    Question Return of consent forms by post (CTIMP in rare disease area)

    Hi everyone,

    I have been posed a question that I am struggling to answer effectively, so hoping someone can help!

    For a CTIMP that we will be coordinating, I have been told that (hypothetically) there could be a patient who did not enter the trial solely because they did not want to travel from their home to the site just to sign the ICF. The trial involves a rare disease so long distances can be involved.

    In this scenario, they would be provided with the PIS and have a discussion with the PI via phone to discuss the trial in detail and have their questions answered.

    Although I am aware that it is not good practice to do so (risk of falsification, etc), is there any regulatory/GCP reasoning to stop the patient signing the ICF at home and posting it back to the site, where the PI would then counter-sign?

    If the full process was covered in detail in the medical notes to explain the discrepancies in dates, and how the patient was provided with the PIS etc, does this sound acceptable?

    All thoughts are very welcome - many thanks in advance!

  2. #2
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    Actually there have been trials that involve electronic consent via the internet which have been approved by regulators and ethics. A risk assessment would document what the risks were, including the risk of inappropriate consent or even falsified consent. For instance, a low risk study that involved standard of care would have a low risk of the subject misunderstanding the trial and failing to give genuine informed consent. With a CTIMP the risks would be higher. Obviously you would need explicit approval from regulatory and ethics to your process including your safeguards against ineffective (and/or falsified) consent. If the patient is visiting the center would it not be possible to re-confirm consent at their first visit as a safeguarding process. The subject would then be identified and fully informed by staff, face to face and then confirm their consent in writing in front of the staff. What trial related processes does the subject have to perform before coming into the trial center? Could you do a risk assessment to see if that portion of the trial was very low risk (for instance questionnaires, routine blood test, etc.) and so the “remote” consent of the subject could cover this? The confirmation of consent would cover the rest of the trial.
    I would also be a good idea to look in the MHRA GCP Guide (2012) as there is a lot about consent.

  3. #3
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    Thanks for your response - the idea of re-confirming consent at the first visit is a very good one, and capturing the proposed process as part of the risk assessment is another very good suggestion. Lots of things to put into place I think, thanks again for taking the time to respond.

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