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.. Due to recent regulatory changes at the National Institutes of Health (NIH) and Office of Human Research Protections (OHRP), the single IRB model has become more prevalent (additional background below).

 When preparing submissions for funding from NIH or one of the Common Rule Agencies, the following steps will help ensure a smooth IRB review process when UAB is the prime awardee of funding:

1.       Propose a Single IRB: Identify an IRB of record and ensure that the chosen IRB is willing and able to serve as the reviewing IRB for the research (i.e., obtain a letter of support from the Office of the IRB identified as the reviewing IRB for the cooperative research project).

 

a.       If the proposed IRB of record will be the UAB IRB, click here for instructions on how to obtain a letter of support from the Office of the IRB.

b.       Alternative options include relying on an external IRB from one of the participating institutions that has an AHRPP-accredited Human Research Protections Program (HRPP);

c.       Requesting IRB services from the Trial Innovation Network at no cost; or

d.       Contracting an independent IRB (e.g., WIRB, Advarra, etc.) to serve as the reviewing IRB. 

2.    ​   Budget Accordingly: Assess any costs associated with using the single IRB, such as fees for UAB to serve as the single IRB (see below), commercial IRB fees, monitoring fees, translation fees for consent forms and other materials, etc. Include these costs in the budget accordingly.

3.       Budget Justification: Provide adequate budget justification for the costs associated with the use of a single IRB (an example of budget justification language is included below).

4.       Single IRB Plan: Develop a single IRB plan to provide the name of the reviewing IRB, indicate that all sites have agreed to rely on the proposed single IRB (include letters of support from external participating sites), describe the reliance arrangements (e.g., IRB authorization agreements, use of the SMART IRB agreement, etc.), along with a communication plan to outline expectations for communication between the lead site and participating sites. 

Click here for the appropriate type of content to include in the communication plan. 

5.      ​Pre-Submission Consultation: Upon receiving a favorable score for funding, it is advisable to request a consultation with the Office of the IRB prior to submission. During this consultation meeting, representatives will assist in proactively identifying any potential regulatory challenges, help develop a plan to ensure turnaround time requirements, etc. Click here​ to request a pre-submission consultation.

 

Background

The National Institutes of Health (NIH) policy requiring single IRB review for multi-site studies went 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.


The Department of Health & Human Services (DHHS) Office of Human Research Protections (OHRP) implemented revisions to the regulations governing human subjects research (45 CFR 46 or the Common Rule) effective January 21, 2019. The revisions, also referred to as the 2018 requirements, included a mandate that new cooperative research projects subject to the 2018 requirements approved on or after January 20, 2020 require review by a single IRB. Cooperative research is defined as research projects that involve more than one institution…​



UAB Single IRB Guidance

UAB IRB may agree to serve as the single IRB in the following scenarios:
  • Legacy arrangements where the UAB IRB already serves as the single IRB.
  • The sponsor requires the prime awardee institution’s IRB to serve as the single IRB.
  • UAB is the prime awardee and a letter of support is obtained from the UAB Office of the Institutional Review Board prior to submission of the application for funding.
  • 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:

​Single IRB Review When UAB is Prime

Considerations during Grant Preparation:​

Identifying the Reviewing IRB

Establishing Reliance Agreements

The Reviewing IRB and the Relying Sites are responsible for working together to identify 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. When the UAB IRB will be the reviewing IRB, the SMART IRB agreement will be utilized, unless extenuating circumstances prevent its use. This will avoid negotiating the terms of the agreement for each study with every participating site, and managing the study according to different terms for each 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

The table below outlines the IRB fee schedule that must be built build these fees into your budget. 
 
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 site for external sites

Single IRB Support Costs

Once the UAB Office of the IRB has agreed to serve as the reviewing IRB and provided a letter of support, the following is an example of budget justification language that may be included in applications for funding to justify IRB costs associated with single IRB review:

 

The Institutional Review Board (IRB) at the prime institution (UAB) will serve as the IRB of record for this project and will be responsible for overseeing the human subjects protections for this multi-site study, which involves xxx institutions (in addition to UAB*).  Funding will enable required activities associated with the review of site-specific considerations for all of the participating sites.  This includes an assessment of local context requirements such as institutional requirements, state/local regulatory requirements. 

 

In addition to the initial approval, as part of its oversight responsibilities, funding will support activities associated the continuing review and assessment of reportable events (unanticipated problems, protocol deviations, notices of complaint, issues of non-compliance and all other determinations) from all participating sites, and other post approval monitoring activities.  When necessary, UAB’s IRB will be responsible for any related reporting to the Office for Human Research Protections (OHRP), the Food and Drug Administration (FDA), and other regulatory agencies or sponsors as applicable. 

 

*The current single IRB fee schedule for UAB to serve as the IRB of record is accessible online: https://go.uab.edu/sIRB​. As per NOT-OD-16-109, costs for activities associated with the ethical review of the proposed research protocol and the review of the template informed consent document describing the study will be charged as indirect costs and are not reflected in this direct cost request.

Protocol Develop​ment:

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 plans. The investigators should also consider standard of care procedures that may differ from one institution to another, and how this may affect the conduct of the research. 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

​​​​​​​​​