Update on VA Human Research Protection Program (HRPP) Accreditation Contract
As we announced previously, the new Veterans Affairs (VA) contract for accrediting VA Human Research Protection Programs (HRPP) has been awarded to Alion Science and Technology Corporation. The VA contract with the Association for the Accreditation of Human Research Protection Programs, Inc. ® (AAHRPP) expired on March 31, 2012.
Veterans Health Administration (VHA) Handbook 1200.05 Paragraph 64 on Accreditation of HRPPs has been amended to take into account the transition to the new vendor. The new VHA Handbook 1200.05 Paragraph 64 is as follows,
"64. ACCREDITATION OF HUMAN RESEARCH PROTECTION PROGRAMS
Any VA facility with a Federalwide Assurance must obtain accreditation of its HRPP by the Accrediting Organization under contract with VA. This HRPP accreditation must be obtained in accordance with a schedule to be determined by the ORD based on the facility's HRPP accreditation status and history. Maintenance of HRPP accreditation must be in accordance with ORD HRPP accreditation requirements including those relating to academic affiliates providing IRB services to the VA facility. Academic affiliates may be required to cooperate with the Accrediting Organization under contract with VA or to maintain their own accreditation with another accrediting organization recognized by VA. NOTE: The HRPP accreditation requirements are posted on the ORD web site at: http://www.research.va.gov/pride/accreditation/default.cfm"
The new VA HRPP accreditation policy and requirements do the following:
They provide flexibility for ORD to determine a reasonable schedule for HRPP accreditation of VA facilities by the new vendor based on their HRPP accreditation status and history, allowing time for transition to the new system.
They take into account the loss of accreditation from AAHRPP during the transition to the new vendor. This will keep VA facilities from falling out of compliance with prior VHA policy on maintaining HRPP accreditation. This means you do not need to report loss of your HRPP accreditation to the VHA Office of Research Oversight (ORO) if the loss of accreditation is due to the transition to the new vendor.
- They provide ORD flexibility to recognize the academic affiliate's HRPP accreditation status if the affiliate's HRPP is accredited by an organization that is not under contract with VA. As of May 2, 2012, ORD recognizes affiliate HRPP accreditation by AAHRPP. This means that if you use your affiliate's IRB and your affiliate's HRPP has AAHRPP accreditation, there is nothing it needs to do during your VA facility's HRPP accreditation process.
The transition to the new vendor will take place over the next several months. There is nothing you need to do now. The plan is to pick up the schedule where AAHRPP left off. In other words, if your facility recently achieved accreditation for 5 years, you will not come up for re-accreditation until you were due to come up for AAHRPP reaccreditation. For facilities in the middle of the accreditation process, the schedule will be pushed back to allow for the transition and then we will pick up where AAHRPP left off. To ensure the least possible disruption, we will work with you and the new vendor to see that you do not have to start all over again in the application process. The new schedule will be released in a few weeks.
We are working with the Office of General Counsel on the letter AAHRPP sent to accredited VA facilities indicating its intention to revoke their HRPP accreditation, and the communication from AAHRPP revoking accreditation. We will provide more information as it becomes available. In the meantime, since AAHRPP is no longer under contract with VA, there is no requirement for your facility to pay AAHRPP to maintain its HRPP accreditation. Please note your facility's maintaining AAHRPP accreditation will not exempt your facility from obtaining HRPP accreditation from the new vendor under contract with VA.
VA and ORD are very proud of your accomplishments with HRPP accreditation and remain committed to protecting the rights and welfare of human research subjects. If you have questions, please contact Lynn Cates at Lynn.Cates@va.gov.
On behalf of
Joel Kupersmith, M.D.
Chief Research & Development Officer
U.S. Department of Veterans Affairs