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).
   • 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. 
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. 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

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.