Alternative IRB of Record –Existing IRB Reliance Agreements
UVa researchers are often engaged in non- exempt human subject research that may involve collaborators and/or human subjects at other institutions. In accordance with 45CFR46.114, UVa may rely upon the review of another qualified IRB. This is done through a Reliance Agreement, also referred to as an IRB Authorization Agreement. The scope of the Reliance Agreement may be limited to a specific protocol on a case-by-case basis or to any group of protocol agreed upon by both parties.
IRB Reliance Agreements have already been established with several Non- UVa IRB’s.
If the non- UVa IRB you wish to serve as the IRB of Record is not listed below see IRB Reliance/Authorization Agreements to determine if a non UVa IRB may serve as the IRB of record.
Procedures to follow when working with a Non- UVa IRB for which an IRB Reliance Agreement is already established.
NON_UVA IRB’s with Established IRB Reliance Agreements with the IRB-HSR
Fred Hutchinson Cancer Research Center IRB: Central IRB for Cancer Immunotherapy Trials Network (CITN) Protocols (CITN CIRB)
Researchers doing research within the CITN NIH consortium may use the Fred Hutchinson Cancer Research Center IRB. The IRB-HSR will serve as the HIPAA Privacy Board.
National Cancer Institute IRB: CIRB for NCI Protocols (NCI CIRB)
Researchers wishing to open cooperative group oncology trials that have been approved by the National Cancer Institute Central Institutional Review Board (NCI CIRB) may submit the appropriate paperwork to the IRB-HSR. The NCI CIRB does not oversee research involving prisoners.
The IRB-HSR will serve as the HIPAA Privacy Board. Use the HIPAA Authorization forms found below.
Use the Consent Short Forms found below.
- Consent Short Forms for non-English Speaking Subjects
Partners IRB: Central IRB for NeuroNEXT Protocols
NeuroNEXT: “NINDS Network for Excellence in Neuroscience Clinical Trials”
Partners Healthcare System, Inc. (“Partners”) is made up of Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital, Inc. (BWH) and is collectively known as “Partners Human Research Committee” (Partners).
Partners has been selected by the National Institute of Neurological Disorders and Stroke (“NINDS”) to serve as the Central IRB for the NINDS Network for Excellence in Neuroscience Clinical Trials (“NeuroNEXT”). NeuroNEXT is a network of academic institutions (each a “NeuroNEXT Network Clinical Study Site” or “CSS”) established by NINDS to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. MGH is the Clinical Coordinating Center for NeuroNEXT (the “NeuroNEXT CCC”). UVa is a NeuroNEXT Clinical Study Site. The University of Iowa will serve as the Data Coordinating Center. (NeuroNEXT DCC).
Researchers doing research within the NeuroNEXT NIH consortium may use the Partners IRB. Partners IRB will also serve as the HIPAA Privacy Board. Consent short forms may be used for either IRB. If using forms from the IRB-HSR use forms located on the IRB-HSR Website under Forms/ Consent Short Forms
Vanderbilt IRB: Central IRB for PETAL Protocols
PETAL: Prevention and Treatment of Acute Lung Injury
Researchers doing research within the PETAL consortium may use the Vanderbilt IRB. The Vanderbilt IRB will also serve as the HIPAA Privacy Board. Consent Short Forms may be obtained from the Vanderbilt IRB.
Western IRB-(WIRB) : Oncology Cooperative Group Trials /Expanded Access Protools
Researchers wishing to open any of the following types of protocols may use the Western Institutional Review Board (WIRB) as the IRB of record for the protocol.
- Phase 1 or 2 adult cooperative group oncology trials or Phase 3 trials or a pediatric cooperative group oncology trial which cannot be opened through the NCI CIRB
- Continued/expanded access protocol.
- Protocols through ORIEN(Oncology Research Information Exchange Network)
- Protocols through CTTI (Clinical Trials Transformation Initiative)
The PI will submit the appropriate paperwork to WIRB and the IRB-HSR. The IRB-HSR will serve as the HIPAA Privacy Board. Study teams should use the UVa HIPAA Authorization forms found below