Single IRB Review

Request Single IRB Review (Single IRB Review)

Investigators engaged in multi-site research can request a cede, or reliance, agreement when multiple Institutional Review Boards (IRB) are required. The term cede review refers to a reliance in which two or more institutions agree one institution will be designated as the Reviewing Institution/IRB for the study while the other institution(s) serve as the Relying Institution/IRB. The reviewing IRB would serve as the IRB of Record for the study.

The Reviewing Institution/IRB has jurisdiction and oversight over the ethical review and safety of the research for each Relying Institution/IRB.

Federal regulations require single-IRB review for federally funded, multi-site research. Investigators should consult with the funding agency to determine the appropriate IRB of record. 

Note: Exempt research is not eligible for single IRB review.

Single-IRB Request Process:

1. Create a new reliance request in COUHES Connect.
   • If MIT is the reviewing IRB: Follow the steps as described in the MIT as Reviewing IRB Guidance [PDF]. Investigators must list the engaged sites in the Engaged Institutions section of their existing protocol. This process can be done in parallel with the initial or amendment request. Relying sites must complete a Local Context Form, see Forms & Templates. 
   • If MIT is a relying site: Follow the guidance as described in the MIT as Relying Site Guidance [PDF]. Include any site-specific documents with your submission. 
2. Investigators are encouraged to contact collaborating sites to confirm single-IRB review process. MIT is a signatory of SMARTIRB (see participating institutions) and encourages the use of SMARTIRB when available. See guidance on SMARTIRB below.
3. For sites that are not members of SMARTIRB or prefer alternative routes, please refer them to the Points of Contact below. 

The SMART IRB Online Reliance System

The Reliance Request Process in the Online Reliance System must occur in addition to your submission for review by COUHES. The specific steps and requirements will depend on the reviewing IRB, but this is a general overview.

1. Lead PI creates a reliance request for the study in the Online Reliance System.
2. Lead PI requests the desired Reviewing IRB and lists the participating sites.
3. Participating site IRBs confirm their willingness to rely on the proposed reviewing IRB.
4. Proposed reviewing IRB confirms that they will be the reviewing IRB.
5. The Reliance Arrangement Determination is issued, which documents who will be the reviewing IRB.

For institutions not participating in the SMARTIRB Reliance Agreement, single-IRB is still applicable. Investigators should submit a request via COUHES Connect for further assistance.

For questions, please see our Single IRB FAQ page or contact the COUHES Office: couhes@mit.edu.