Is the continuation of a study (i.e. new grant funding) using the same protocol number considered a “new” study under HIPAA guidelines?
No. HIPAA does not address what would make a study a new study. If the study is a new study under JHM practices or the Common Rule, then both a new informed consent and privacy Authorization, or an IRB approved waiver of consent/privacy authorization, would be required. If the study is not a new study under these criteria, then no new informed consent/privacy Authorization would be required.
