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How does the Rule help Institutional Review Boards (IRB) handle the additional responsibilities imposed by the HIPAA Privacy Rule?

Answer:

Recognizing that some institutions may not have Institutional Review Boards (IRBs), or that some IRBs may not have the expertise needed to review research that requires consideration of risks to privacy, the Privacy Rule permits the covered entity to accept documentation of waiver of authorization from an alternative body called a Privacy Board–which could have fewer members, and members with different expertise than IRBs. See the fact sheet and frequently asked questions about the research provisions on this web site for more information about Institutional Review and Privacy Boards.

In addition, the Rule allows an IRB to use expedited review procedures as permitted by the Common Rule to review and approve requests for waiver of authorizations. Similarly, the Rule permits Privacy Boards to use an expedited review process when the research involves no more than a minimal privacy risk to the individuals. An expedited review process permits covered entities to accept documentation of waiver of authorization when only one or more members of the IRB or Privacy Board have conducted the review.

See our research section and frequently asked questions about the research provisions for more information about the Common Rule.




Date Created: 12/20/2002
Last Updated: 03/14/2006