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Thread: Reconsenting due to change of PI

  1. #1

    Reconsenting due to change of PI

    Hello All,

    I hope you find this question really interesting.

    What are recommendation in case of change of PI and ICF. Is it required or recommended to do reconsenting when the version is not changed? The only information changed is PI name. When above is not required, is patient notification enough?

    Please share your thoughts


  2. #2
    Forum Member
    Join Date
    Nov 2011
    Obviously there are lots of considerations regarding changing PIs and the MHRA GCP Guide (2012) is a useful guide. GCP Compliance is essential to maintain the safety, wellbeing, rights and privacy of subjects and ensure the integrity and robustness of data. Your IEC/IRB and NHS Health Research Authority would be a useful source of information as to how to inform subjects and document this.

    The Research Quality Association (RQA) GCP Committee had a similar question regarding similar changes.
    The consent form identifies the PI, so a new ethics approved consent form is required because a new PI represents a substantial amendment.
    Subjects will need to be informed about the change of PI and consent to this. The PI may be a relevant factor for the patientís initial decision to participate in the trial and affect their continued participation in the trial.
    Before getting ethics approval of the amended consent form, it would be permissible to tell the subjects of this change and document this communication. One way to ensure that subjects' are fully informed and to document their written consent, is to re-consent subjects when the ethics approved consent form is available. As this is a non-safety related change, there may be no need to take expeditious steps to re-consent current subjects. The subjects could be asked to sign the consent form, when they are next in the research center for their routine study visit. Subjects should be given the opportunity to question staff about this change (and anything else) and they should be given a copy of the new consent form for their reference. By their signature on the consent form, subjects confirm their continued consent to participate in the trial, and their awareness that the PI has changed. Just informing the patients of a change in PI of the clinical trial may not be adequate. Your Ethics Committee may have an opinion on what is appropriate or risk proportionate.
    It would be useful if the inspectorate could give an opinion

  3. #3
    Thanks for sharing your opinion. I will check in details above mentioned source. I agree PI change is a substantial amendment, however in this case there was no submission of consent to EC due to PI change. The ICF version remains the same. Basically, CRO has a master copy for all sites and then it is being adapted with site specific details (PI name, site address,emergency contact, etc). I do agree ongoing patients have to be informed about this change and have to be provided with new emergency cards. I am just wondering if reconsenting in this particular case is something recommended/required or it is being done just in case. I do agree the PI may be relevant factor for the patient's participants, however I do believe they should be just informed about it and asked if they are willing to participate.

  4. #4
    Forum Member
    Join Date
    Nov 2011
    "... informed about it and asked if they are willing to participate". This sounds a lot like "Consent" to me, but under another guise. Why not use the IEC/IRB approved updated ICF that has all the changes on it and document the subjects consent?

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