By establishing new waiver criteria and authorization requirements, hasnt the HIPAA Privacy Rule, in effect, modified the Common Rule?
No. Where both the Privacy Rule and the Common Rule apply, both regulations must be followed. The Privacy Rule regulates only the content and conditions of the documentation that covered entities must obtain before using or disclosing protected health information for research purposes. See the fact sheet and frequently asked questions about the research provisions on this web site for more information about the Common Rule. 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? Yes. If informed consent or reconsent (i.e., 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 requ
Related Questions
- By establishing new waiver criteria and authorization requirements, hasn t the HIPAA Privacy Rule, in effect, modified the Common Rule?
- By establishing new waiver criteria and authorization requirements, hasn the HIPAA Privacy Rule, in effect, modified the Common Rule?
- By establishing new waiver criteria and authorization requirements, hasn ’t the HIPAA Privacy Rule, in effect, modified the Common Rule?
