Single IRB Review for Multi-site Research
The Single IRB (sIRB) Policy at Columbia
The NIH Single IRB (sIRB) Policy is applicable to new and competing renewal applications/proposals for NIH funding that are due on or after January 25, 2018, and contract solicitations issued on or after January 25, 2018. It is applicable to NIH-funded multi-site domestic studies involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.
If you are preparing an NIH application, you should immediately complete the CU sIRB Survey Form if your application proposes to:
- Conduct non-exempt human subjects research; AND
- The same research protocol will be conducted at multiple domestic sites.
The Columbia University sIRB Request Process provides guidance in completing the request form, for when Columbia is the reviewing site AND when Columbia will be relying on another site for sIRB review.
What is the "same research protocol?" Protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes are considered to be the “same research protocol.” Additionally, sites that are accruing research participants for studies that are identical except for variations due to local context consideration would be considered to be conducting the “same research protocol.”
What is the difference between a central IRB and a single IRB? Both are designed to help streamline IRB review, and the terms are sometimes used interchangeably. In general:
- A Central IRB is the IRB of record that provides the ethical review for all sites participating in more than one multi-site study. The sites are usually in a network, consortium or particular program.
- A Single IRB is the IRB of record, selected on a study-by-study basis, which provides the ethical review for all sites participating in a multi-site study.
Note: At Columbia the same request form and process is used for requesting either a central IRB or a single IRB.