IRB Reliance

Smart IRB Learning Center

Recent changes to the Common Rule and NIH Policy on the Use of a Single IRB (sIRB) for Multi-Site research have mandated the use of a single IRB for cooperative or multi-site research. The goal of this policy to eliminate duplicate IRB review is to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible.

Federal regulations (45 CFR 46.114) allow reliance agreements between institutions when the institutions are engaged in cooperative research projects in order to avoid duplication of effort.

When utilizing a reliance agreement:

  • The Single (sIRB) or Central IRB (cIRB) is responsible for conducting the ethical review of multi-site studies for participating sites.
  • The PI is responsible for ensuring that authorization agreements are in place, copies of authorization agreements are maintained, and ensuring the channel(s) for communication between the sIRB and participating sites are established.

 When requesting TAMU-CC to rely on another IRB:

  • TAMU-CC Investigators are responsible for submitting a “Request to Rely.”
  • The TAMU-CC Office of Research Compliance is responsible for providing the local context review, communicating to TAMU-CC Investigators, and maintaining documentation of research studies which utilize a sIRB.
  • The TAMU-CC Office of Sponsored Contracts is responsible for obtaining an executed IRB reliance agreement.

Timing: Investigators must submit and receive approval to rely on another IRB before beginning research at TAMU-CC.

How do I start a Request to Rely on an External IRB?

Login into iRIS. To begin this process, click Create a New Protocol on the Study Assistant Workspace

When you get to Section 4.0 to select the submission type, select the type “Application for an External IRB Review”.

The smartform will generate questions applicable to your research. This type of submission goes through an abbreviated administrative review.


1400.01 Template-IRB reliance agreement