Does the HIPAA Privacy Rule require documentation of Institutional Review Board (IRB) or Privacy Board approval of an alteration or waiver of individual authorization before a covered entity may use or disclose protected health information for any of the following provisions: (1) for preparatory research at 45 CFR 164.512(i)(1)(ii), (2)for research on the protected health information of decedents at 45 CFR 164.512(i)(1)(iii), or (3) a limited data set with a data use agreement as stipulated at 45 CFR 164.51?
Answer:
No. Documentation of IRB or Privacy Board approval of an alteration or waiver of individual authorization is only needed before a covered entity may use or disclose protected health information under 45 CFR 164.512(i)(1)(i). See our research section and frequently asked questions about the research provisions for more information about Institutional Review and Privacy Boards.
Date Created: 12/20/2002
Last Updated: 11/21/2006
