Hi. As a person who served as a member of an IRB for several years in a prior job, I would actually not generally expect you to re-consent all of cohort 1 unless you were going to involve them in the study in a manner that did not appear or apply to the original consent. If your IRB has approved the increased payment and they have no requirements/instructions for your to complete before they finalize their approval, then your issue is a "cohort 2 only" issue in my mind.
Obviously I am a single voice on this but this would be my interpretation. So unless you are going to do something different with the samples from cohort 1 or you are going to require them to become part of the test set for additional data or sampling, I would say that you only need to worry about cohort 2 in your scenario. I will be interested to see if any other colleagues have a different opinion on this point.
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Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
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Original Message:
Sent: 05-Feb-2017 19:06
From: Anonymous Member
Subject: Re-consenting subjects from previous cohorts
This message was posted by a user wishing to remain anonymous
Hello: If the ICF was revised to include higher dose and higher payment for cohort 2 (for example), do subjects in cohort 1 need to be re-consented? Cohort 1 was complete prior to revising the ICF. The reason for increasing the payment was due to difficulty in recruitment. The IRB does not provide specifics regarding this topic.
Thanks a lot.