Single IRB

Single IRB

Single IRB

​The basis for the single IRB model is to allow multiple sites that are conducting the same protocol to use a single IRB for review, instead of using multiple IRBs to review the research at the sites individually. The single IRB model has been in use for many years, across a wide variety of studies and circumstances.

The National Institutes of Health (NIH) policy requiring single IRB review for multi-site studies goes into effect on January 25, 2018. This policy applies to “the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training, or fellowship awards. This policy applies to domestic awardees and participating domestic sites. Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.”

In response to this policy, the UAB Human Research Protection Program (HRPP) has developed the UAB Single IRB Guidance that provides information on scenarios when (1) UAB is the prime site for a study and is responsible for coordinating or providing the single IRB review, as well as when (2) UAB is a participating site and will rely on the single IRB identified by the prime site for a study.

Educational sessions will be held to provide details on the single IRB review process for the UAB research community. See the IRB Presentations page of the IRB website for dates/times of these sessions.

UAB Single IRB Guidance

UAB IRB will agree to serve as the single IRB in the following scenarios:
  • Legacy arrangements where the UAB IRB already serves as the single IRB.
  • When the sponsor requires the prime awardee institution’s IRB to serve as the single IRB.
  • Other extenuating circumstances considered on a case by case basis. The complexity of the protocol and the number of sites will factor into this decision.
All other scenarios will be referred to:
  • An independent IRB (e.g., Quorum, Schulman, WIRB), or
  • A Trial Innovation Network (TIN)​ central IRB, when applicable.
    • Because UAB is a Clinical & Translational Science Award (CTSA) institution and part of the CTSA’s Trial Innovation Network, the use of the Trial Innovation Network Central IRBs (Johns Hopkins University School of Medicine, the University of Utah, or Vanderbilt University Medical Center) may be available for studies. Additional information on use of the TIN Central IRB is accessible on the TIN website.

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UAB is Prime

(UAB is responsible for arranging single IRB review)

Sponsor requires single IRB
  • UAB IRB will be the single IRB, rely on one of the selected independent IRBs, or rely on the Trial Innovation Network Central IRBs.
  • SMART IRB reliance agreement will be used whenever possible.
  • P​I will work with reviewing IRB to develop a budget to include in the proposal.

UAB is a Participating Site

(the main site is responsible for arranging the single IRB review)

  • ​The main site is responsible for selecting the single IRB, reliance mechanism, and costs. UAB will rely on the single IRB as long as the IRB is (1) accredited by AAHRPP or (2) can demonstrate that it has equivalent policies and procedures that comply with regulatory requirements.​
Sponsor does not require single IRB

UAB is Prime

(UAB is responsible for arranging single IRB review)

  • UAB IRB will not be the single IRB.
  • PI may use the Trial Innovation Network Central IRBs.
  • PI may contract with one of the selected independent IRBs.
  • SMART IRB reliance agreement will be used whenever possible.
  • ​PI will work with reviewing IRB to develop a budget to include in the proposal.

UAB is a Participating Site

(the main site is responsible for arranging the single IRB review)

  • If the main site uses a single IRB, UAB will rely as long as the IRB is (1) accredited by AAHRPP or (2) can demonstrate that it has equivalent policies and procedures that comply with regulatory requirements.

​​​​​​​​Additional Information

Reliance Agreement
  • UAB, Quorum, and Schulman have signed the SMART IRB agreement.
  • The Trial Innovation Network Central IRBs have signed SMART IRB agreement.
  • ​Investigators may use WIRB if desired. UAB already has an agreement with WIRB. Other sites would have to enter into an agreement with WIRB unless they already have one.

​Single IRB Review When UAB is Prime

Considerations during Grant Preparation:​

Determining who will be the Single IRB - 

If UAB is prime and your study will involve a single IRB, it is imperative to contact the UAB Office of the IRB for consultation as early as possible during the planning stage. Please complete a Reliance Consultation Request (forthcoming) to initiate this conversation.

The single IRB and the Relying Sites are responsible for working together to come to a decision about relying on the single IRB for any given study. This decision must be documented in writing via an IRB Authorization Agreement, also called a Reliance Agreement. The Reliance Agreement outlines the obligations and responsibilities of both parties. It is preferable to utilize the SMART IRB agreement with all participating sites to avoid negotiating the terms of the agreement for each study with every participating site.

Costs of Single IRB Review - 

The costs for IRB review at a single institution by that institution’s IRB have typically been considered an indirect cost covered under an institution’s Facilities and Administration (F&A) rate (except for industry-initiated-and-sponsored studies).

However, NIH expects that many single IRBs will charge fees to review other sites and these can be part of the direct costs. The fees are the responsibility of the prime site and should be included in the grant budget.

Fees for Independent IRB as Single IRB

It is the responsibility of the Principal Investigator (PI) to contact the independent IRB and get an estimate of fees to include in the budget.

Fees for UAB IRB as Single IRB

Effective immediately, IRB fees will be charged for non-UAB sites that rely on the UAB IRB as the IRB of record. The new fees also apply to new or competing grants or contracts submitted on or after January 25, 2018 that are subject to the NIH policy, including competing continuations of studies or networks for which the UAB IRB has previously served as the single IRB.

Please build these fees into your budget. See the Office of Spo​nsored Programs page for additional information on this (forthcoming).
 
Service Provided
UAB IRB Fee
Initial review (full or expedited)
​$0 for protocol and UAB site
$1,500 per site for external sites
Continuing review (full or expedited) – required at least annually, but may be required more frequently
$0 for UAB site
$1,000 per external sites

Protocol Development:

As with any study, the protocol must be developed and finalized. This is primarily the responsibility of the Lead Study Team, although the Participating PIs and Study Teams may also provide input as part of a collaborative effort.

When using single IRB review, it is important to ensure that the protocol includes a detailed recruitment plan, consent process, and data and safety monitoring plan. These details will not only help the single IRB to have complete information for their review, but will also ensure that the Relying Sites have enough information to determine if the study meets local requirements. The Participating PIs and Study Teams may need to provide information about their local requirements, such that the protocol can address the needs at each site.

It is also valuable for the Lead Study Team to develop a consent document that can be used for the study. Each Participating Study Team may need to make minor changes to the consent document to accommodate local consent language requirements. The single IRB will generally approve a consent document version for each Relying Site.

General Steps For Single IRB Review

The steps for single IRB review will vary greatly depending on the IRB reviewing the study.
UAB Single IRB Team
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