UPDATE: The SMART IRB Reliance Agreement has reached 1,000 signatories, making it one of the largest medical research study reliance agreements in the United States. Learn more about the milestone.
Through its Clinical and Translational Science Awards (CTSA) Program, NCATS is developing a single institutional review board (IRB) platform for multisite clinical studies: the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform. The goal is to provide flexible resources that investigators nationwide can use to harmonize and streamline IRB review for their own multisite studies.
The process of obtaining ethical approval by multiple IRBs is a longstanding challenge that can lead to significant delays in study activation. One way to streamline the IRB review process and provide more consistent, high-quality reviews is for all sites participating in a multisite clinical study to rely on the ethical review of a single IRB. This concept is called a single IRB reliance model.
NCATS intends for its SMART IRB Platform to serve as a roadmap to help implement the NIH policy originally released on June 21, 2016, that requires all NIH-funded multisite clinical studies to use a single IRB.
There are different types of single IRB models, including the following:
- Central IRB: The same IRB of record (also known as the reviewing IRB) provides the ethical review for all sites participating in more than one multisite study. The sites are usually in a network, consortium or particular program.
- Single IRB: One IRB of record (or reviewing IRB), selected on a study-by-study basis, provides the ethical review for all sites participating in that multisite study.
The NCATS SMART IRB Platform was developed with input from experts across the nation, including several CTSA Program representatives who are recognized authorities on IRBs. The platform is based on the successful experiences of NIH central IRB initiatives and on a CTSA Program demonstration project using a single IRB reliance model. Building on the IRBrely model, the NCATS SMART IRB Platform is designed to be a flexible option that can be used to set up a central IRB for a network of many studies or a single IRB for one multisite study.
The NCATS SMART IRB Platform will provide the following harmonized (i.e., consistent) approach, so that the platform can easily be used by any clinical research network or even a single investigator wishing to conduct a multisite clinical study:
- Authorization and joinder agreements:
- Authorization agreement: An umbrella agreement that establishes a harmonized approach for roles and responsibilities of the single IRB (also known as the reviewing IRB or IRB of record) and the participating sites (also known as the relying institutions). The authorization agreement is also known as a reliance agreement.
- Joinder agreement: An agreement that enables institutions to sign on to or join the SMART IRB Platform authorization agreement.
- Guidance documents: Documents that describe how to use the authorization and joinder agreements and further describe how the single (reviewing) IRB, study team and sites (relying institutions) work together. There also will be best practices for implementing the NCATS SMART IRB Platform.
The NCATS SMART IRB Platform involves two steps:
- The first step is signing on to the NCATS SMART IRB Platform authorization agreement. Institutions sign the joinder, which documents their agreement with the roles established in the authorization agreement. This is done once. CTSA Program hubs and affiliates can visit SMARTIRB.org to learn more and join.
- The second step is designating an IRB to be the single IRB (the reviewing IRB) and identifying the participating sites that will rely on the IRB for the review of a multisite study. The platform is flexible and can be used for one investigator-initiated multisite study or for a network conducting many multisite studies.