Central Research Privacy Board (CRPB)

Overview | Memorandum of Understanding | Submission Processes & Documents | Administration

Purpose:

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 authorization 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 authorization for research purposes. ORD has established and provided the management of a centralized Privacy Board to facilitate VA research activities requiring a waiver of HIPAA authorization when the use of multiple IRBs would be required solely for granting waivers of HIPAA authorization or when an IRB does not review waivers of HIPAA authorization.

What is a Privacy Board?

Under the HIPAA Privacy Rule at 164.512(i)(1)(i), two types of committees/boards can grant a waiver of HIPAA authorization:

• Institutional Review Board (IRB)
• Privacy Board

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. 

What VA Research Studies are Eligible to be Submitted to the VA CRPB?

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:

• Any Office of Research Development (ORD) funded multi-site study with three or more VA participating sites that is exempt not requiring limited IRB review;
• Any National Cancer Institute (NCI) study overseen by the NCI IRB
• Exempt research protocols not requiring limited IRB review using the VA CIRB Individual Facility (single site IRB) panel;
• Other VA research studies as permitted/agreed to in advance by the VA CRPB Administrator, such as: (a) ORD-funded exempt studies involving only two VA participating sites; (b) Non-ORD multi-site funded studies that are exempt not requiring limited IRB review; (c) ORD or non-ORD funded non-exempt studies in which the reviewing IRB is unable to review waivers of HIPAA authorization for the VA human subjects research studies.

Please contact the CRPB Administrator for any questions regarding eligibility for submission of a study to the VA CRPB.

The VA CRPB will not:

• Review unfunded VA research studies.
• Review student research studies.

Consult with your local VA research office before submitting any applications for HIPAA waivers of authorization for CRPB review.

What is Required by VA Facilities to Use the VA CRPB?

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.

Contact Information: 

Michelle Christiano
VA CRPB Administrator/ORD Privacy Officer
Phone: 706-399-7980
Email: Michelle.Christiano@va.gov

VA CRPB Mailbox: vacrpb@va.gov