What do you do if a study procedure is in the HREC approved protocol but not in the HREC approved Informed consent form?  You may think this will never happen but this is a real life scenario.

We all know to comply with GCP no study procedures can be performed without informed consent.  However, we also know that to comply with GCP we must not deviate from the protocol unless it is for patient safety reasons.  When these two core principles conflict which one wins?  In this case, the procedure should not be performed without written consent.

The Sponsor and the HREC should be notified immediately.  An amended Informed Consent form should be drafted and submitted to the HREC for urgent review.  The patient should sign as soon as possible after HREC approval and then undergo the study procedure if it is still possible/practical.

And double check all your informed consent forms thoroughly.



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