Office of Research & Development |
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Overview | Memorandum of Understanding | Submission Processes & Documents | Administration
The purpose of the VA Central Research Privacy Board (CRPB) is to review and approve waivers of HIPAA authorization for VA research studies that are eligible to be submitted to it. The VHA Office of Research and Development (ORD) has established the CRPB with the intent of enhancing the efficiency of these reviews across participating sites.
HIPAA requires specific reviews and documentation by an IRB or Privacy Board (PB) when a waiver of HIPAA authorization is approved. While the HIPAA Privacy Rule allows for an IRB or PB to approve a waiver or alteration of HIPAA for research provided that the research meets the criteria outlined in 45 CFR 164.512 (i) (2) (ii), VA does not permit alterations of HIPAA for research purposes. ORD has established and provided the management of a centralized Privacy Board to facilitate VA research activities requiring a waiver of authorization when the use of multiple IRBs would be required solely for granting waivers of authorization or when an IRB does not review waivers of authorization.
Under the HIPAA Privacy Rule at 164.512(i)(1)(i), two types of committees/boards can grant a waiver of HIPAA authorization:
The HIPAA Privacy Rule describes how a Privacy Board must be constituted and permits a Privacy Board or IRB the authority to grant a waiver of HIPAA authorization. However, the HIPAA Privacy Rule does not grant a Privacy Board any other powers or authority granted to IRBs under the Common Rule (38 CFR Part 16) or the U.S. Food and Drug Administration (FDA) human subject protection regulations in 21 CFR Parts 50 and 56 for IRB approval of human subject research activities. A Privacy Board is not an IRB. The VA CRPB does not grant IRB approval for any VA research activities, nor can both the VA CRPB and another IRB or Privacy Board both grant a waiver of HIPAA authorization for the same VA research study.
The VA Central Research Privacy Board (CRPB) is authorized to review and approve waivers of HIPAA authorization for VA research projects that meet one or more of the following requirements for submission:
Please contact the CRPB Administrator for any questions regarding eligibility for submission of a study to the VA CRPB.
The VA CRPB will not:
Consult with your local VA research office before submitting any applications for HIPAA Waivers for CRPB review.
Each VA facility that plans to use the VA CRPB must sign a Memorandum of Understanding (MOU) with ORD. VA Nonprofit Corporations (NPCs) do not sign the CRPB MOUs. The CRPB MOU clearly delineates the respective roles and responsibilities of each entity. Please note that the VA CRPB does not provide the privacy reviews conducted by privacy officers. There is no requirement to use the VA CRPB, nor is there a cost to VA Facilities using the VA CRPB. Please refer to the VA CRPB MOU.
Investigators whose requests for waivers of HIPAA authorization will be reviewed by the VA CRPB should contact the VA CRPB Administration, whose contact information is available below, as far in advance of the planned submission as possible to obtain the most current information about submission procedures. Application forms for the VA CRPB can also be found on this website under the Important Links box on the right-hand side of this page.
Michelle Christiano
VA CRPB Administrator/ORD Privacy Officer
Phone: 706-399-7980
Email: Michelle.Christiano@va.gov
VA CRPB Mailbox: vacrpb@va.gov