Do I have to re-consent currently enrolled subjects with the new authorization after April 14, 2003?
Subjects that are already enrolled prior to April 14, 2003 are “grandfathered,” in that informed consent documents signed prior to this date and that do not contain the required HIPAA authorization elements remain valid for continued participation in the study after this date. However, if new information for the study requires re-consenting of already enrolled subjects on or after April 14, 2003, a HIPAA authorization must be obtained.
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- Do I have to re-consent currently enrolled subjects with the new authorization after April 14, 2003?
