It is common for investigators from two or more institutions to partner to conduct human subjects research or be involved in multi-site research studies. To conserve resources and enhance and streamline the institutional review board (IRB) review process when such collaborations occur, regulations allow institutions to “enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort” (45 CFR 46.114). In other words, regulations allow research partners to agree to rely on a single IRB for review and approval of their non-Exempt study. If a non-Rutgers owned IRB is chosen as the reviewing IRB, it is called an ‘External IRB’, as it is external to our organization. Here are a couple of different types of external IRB models:
- Central IRB: A reviewing IRB provides the ethical review for all sites participating in more than one multi-site study. The relying sites are usually in a network, consortium or particular program, such as the Children’s Oncology Group.
- Single Independent or Commercial IRB: The IRB is independent, established for commercial purposes, developing products and services to support the research industry. Pharmaceutical companies conducting multi-site studies usually rely on ‘Single Independent (Commercial) IRBs’ to coordinate IRB review services (e.g. WIRB).
- Single IRB, or sIRB: A reviewing IRB, selected on a study-by-study basis by partner institutions, provides the ethical review for all relying sites participating in that multi-site study (2 or more sites). Rutgers IRB may choose to rely on another IRB or it may be chosen as the reviewing IRB, or IRB-of-Record, on which partners will rely for review.
For each model, the Rutgers IRB enters into a ‘reliance agreement’ with the Reviewing IRB. A reliance agreement is a formal, written document that provides a mechanism for institutions partnering in research to rely on one IRB to be responsible for multi-site IRB review. ** Funded and unfunded multi-site studies may enter into reliance agreements.
Contact your IRB to request additional information or to request a reliance agreement template.