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:
- 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).
- 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.
- Alternative options include relying on an external IRB from one of the participating institutions that has an AHRPP-accredited Human Research Protections Program (HRPP);
- Requesting IRB services from the Trial Innovation Network at no cost; or
- Contracting an independent IRB (e.g., WIRB, Advarra, etc.) to serve as the reviewing IRB.
- 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.
- 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).
- 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.
- 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.
This email address is being protected from spambots. You need JavaScript enabled to view it. 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
- 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.
- An independent IRB (e.g., WIRB, Advarra, etc.), or
- A Trial Innovation Network (TIN) central IRB, when applicable.
Fees for Independent IRB as Single IRBIt 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 IRBThe 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://www.uab.edu/research/home/single-irb/. 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 Development:
- Information about review by independent IRBs
- Information about review by the UAB IRB
- Information about relying on an external IRB when UAB is a participating site
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- Revision: Notice of Extension of Effective Date for Final NIH Policy on the Use of Single Institution Review Board for Multi-Site Research
- Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research
- NIH Frequently Asked Questions Single IRB Policy for Multi-site Research
- SMART IRB
- SMART IRB Exchange
- IRB Reliance Exchange (IREx)