Institutional Review Board for Health Sciences Research (IRB-HSR)

Getting Started

Reliance on a Non- UVA IRB

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. UVA will only enter into an IRB Reliance Agreement for a study that requires expedited or full board review.

SMART IRB

SMART IRB is a nationwide platform designed to simplify the process to rely on another IRB.

UVA has an IRB Reliance Agreement with SMART IRB and is willing to rely on any non-UVA IRB that also has an IRB Reliance Agreement with SMART IRB (is a member of SMART IRB).

SMART IRB members are listed at SMART IRB Participating Institutions.

Relying on a Non-UVA IRB and opening the study to enrollment at UVA is a two-step process.

  1. Complete and submit the following form via email to CIRB@virginia.edu.
    IRB Reliance Agreement Request Form- non - UVA IRB as IRB of Record
  2. Enter Protocol Builder and submit an application to the UVA IRB-HSR. Even though the IRB-HSR will not serve as the IRB of Record (Reviewing IRB) the IRB-HSR maintains oversight of other UVA responsibilities including approvals of other compliance committees and training. Protocol Builder will create a separate application type for a study being submitted to a non-UVA IRB.

  3. NOTE: The turn-around time for each step is 10 working days.

Not a Member of SMART IRB
If the proposed IRB of Record (Reviewing IRB) is not a member of SMART IRB and is not an IRB listed below under “NON_UVA IRB’s with Established IRB Reliance Agreements with UVA” take the following steps:

  1. Complete and submit the IRB Reliance Agreement Request Form- non - UVA IRB as IRB of Record via email to CIRB@virginia.edu.
  2. If it is determined that UVA is willing to rely on the proposed IRB of Record, the UVA Researcher will then Enter Protocol Builder and submit an application to the UVA IRB-HSR. Even though the IRB-HSR will not serve as the IRB of Record (Reviewing IRB) the IRB-HSR maintains oversight of other UVA responsibilities including approvals of other compliance committees and training. Protocol Builder will create a separate application type for a study being submitted to a non-UVA IRB.

  3. NOTE: The turn-around time for each step is 10 working days.

Additional Information
For additional background information, definitions and scenarios please refer to IRB Reliance/Authorization Agreements
For procedures in working with a single or central IRB see CIRB Procedures

NON UVA IRB’s with Established IRB Reliance Agreements with UVA

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.

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.

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) :
Researchers may rely on WIRB for a multi-site study. The UVA PI will submit a CIRB application via Protocol Builder to the IRB-HSR. WIRB will also serve as the HIPAA Privacy Board.

Last Modified: Friday, 25-Aug-2017 10:32:16 EDT