Do I need authorization if an IRB requires a new consent for a subject that consented before HIPAA?
Question: If research subjects’ consent was obtained before the compliance date, but the Institutional Review Board (IRB) subsequently modifies the informed consent document after the compliance date and requires that subjects be reconsented, is authorization now required from these previously enrolled research subjects under the HIPAA Privacy Rule? Answer: Yes. If informed consent or reconsent (ie., asked to sign a revised consent or another informed consent) is obtained from research subjects after the compliance date, the covered entity must obtain individual authorization as required at 45 CFR 164.508 for the use or disclosure of protected health information once the consent obtained before the compliance date is no longer valid for the research. The revised informed consent document may be combined with the authorization elements required by 45 CFR 164.508. See the fact sheet and frequently asked questions about the research provisions on this web site for more information about I
Related Questions
- The sample consent form supplied by my clinical trial sponsor includes HIPAA language. Do I still need to use the HIPAA authorization form?
- Must the IRB approve the separate authorization form or is the new HIPAA language included in the new consent form template?
- Do I need authorization if an IRB requires a new consent for a subject that consented before HIPAA?
