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for the use or disclosure of protected health information once the consent obtained before the compliance date is no longer valid for the research.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 Privacy Rule and Research and other frequently asked questions about research for more information about Institutional Review Boards and privacy.
Learn More:
-
When is a researcher a covered health care provider under HIPAA?
- What does the HIPAA Privacy Rule say about a research participant's right of access to research records or results?
Date Created: 12/20/2002
Last Updated: 03/14/2006