IRB Reliance

IRB Reliance is when one IRB agrees to rely on another IRB for the review and approval of a non-exempt research project. IRB Reliance can be established between institutions or between an institution and an independent IRB, such as WCGIRB or the NCI Central IRB. A reliance arrangement is particularly useful when multiple study sites are following the same study protocol or procedures. Reliance arrangements can also be useful when some of the study sites or partners do not have their own IRB.

Reliance agreements may be put in place when:

  • UT Austin has agreed to be a reviewing IRB for one or more other institutions / organizations 
  • UT Austin has agreed to rely on the IRB of another institution or an independent IRB 

Anytime a researcher affiliated with UT Austin is engaged in the conduct of human subject research and wishes to rely on an IRB other than the UT Austin IRB, the Office of Research Support and Compliance must agree to the arrangement, and UT Austin must sign a reliance agreement with the reviewing IRB. Please note that the UT IRB typically will not enter into an authorization agreement for research determined to be exempt. Contact the UT IRB reliance team via email at for guidance.


IRB Reliance Documentation

In order to establish a reliance arrangement, the participating institutions or organizations must enter into a reliance agreement to document the arrangement. This agreement may be called a reliance agreement or an authorization agreement. These agreements are most often study specific; however, some master agreements exist to document the reliance arrangement between institutions for any study. Reliance agreements must be signed by an authorized institutional official since the agreement is between institutions and not between investigators.


Single IRB Review Requirement

The NIH has mandated that all domestic sites participating in a non-exempt, multi-site research study (where activities outlined in a single protocol are carried out at multiple institutions) use a single IRB (sIRB).

Effective January 20, 2020, the Common Rule requires a sIRB for all domestic sites participating in federally funded, non-exempt, cooperative research.

It is important to verify with the ORSC any plans for use of a single IRB before a grant proposal is submitted. Whether a grant proposes that the UT IRB or an external IRB will serve as the reviewing IRB, contact in plenty of time (at least two weeks before the proposal is due) to receive a response prior to the grant deadline.


Master Reliance Agreements

UT Austin has currently signed the following master agreement(s):

UT is able to utilize the SMART IRB agreement to facilitate reliance with most institutions and major independent IRBs.

Requesting Reliance Agreements

UT IRB Serving as Reviewing IRB for Participating Site(s)

To request a reliance arrangement where UT serves as the reviewing IRB, first contact the Office of Research Support Compliance (ORSC) to determine if UT is willing to serve as the IRB of Record (reviewing IRB) for other participating sites. Until further notice, the UT Austin IRB will consider serving as the IRB of Record when the study involves no more than four sites. If a study will involve more than four sites, contact the IRB reliance team at for consultation. 

When you are ready to submit your study for review, log in to UT Research Management Suite – IRB Module (UTRMS-IRB) with your UT EID and password to submit your application for IRB review.

Once the main study is reviewed and approved, add participating sites under the study.  Each relying site must complete the form “HRP-UT931 – Template Site Specific Request to Rely on UT IRB Form” found in UTRMS-IRB in the study workspace under IRB => Library => Template. This and any other supporting documentation should be uploaded into UTRMS when completing the “Add Participating Site” activity.

If the study is a multicenter study where all sites have their own PI and will follow a standardized protocol, UT IRB will approve the protocol and template forms, such as informed consent first. After the initial submission is approved, add participating sites in the system. This ensures that UT IRB approves template forms prior to the relying sites submitting these approved forms modified with their institution specific information.

Relying on an External IRB

First, contact before proceeding with any submission to ensure that UT is amenable to relying on the other IRB. Taking this step can save time in the long run. Once it has been determined that UT is willing to rely on the external IRB, submit an application in UTRMS-IRB.

Once logged in, create a new study online application and complete the HRP-UT930 Template Request to Rely on an External IRB Form found in UTRMS-IRB in the study workspace (under IRB => Library => Template) and upload it in the system.  Along with the HRP-UT930 Template Request to Rely on an External IRB Form, upload these documents: 

  1. Study protocol or IRB application approved or being reviewed by the external IRB
  2. Informed consent(s) and HIPAA authorizations that will be used by UT PI
  3. Approval letter for the study from the external IRB, if already approved
  4. Any local context form(s) required by the external IRB
  5. Verification of all applicable institutional approvals, such as IBC approval
  6. PI’s curriculum vitae (CV)

UT IRB will review the submission to assess local compliance with institutional policies and procedures, and other external IRB regulatory requirements including, but not limited to:

  • Determining if the PI is qualified and has appropriate credentials and privileges to conduct the research
  • Verifying that all research personnel have completed CITI human subjects training and GCP training, if applicable
  • Verifying that COI review has been completed, and sharing any COI management plan with the external IRB
  • Conducting HIPAA approvals for waiver of authorization, if applicable
  • Confirming that IBC approval is in place, if required

UT will correspond with the UT PI and/or the external IRB to finalize the reliance arrangement and document the agreement.

Responsibilities with the Reviewing (External IRB)

When a study is approved by an external IRB, the study PI is responsible for following all of the policies of the Reviewing IRB. These responsibilities may be outlined in the reliance agreement or the approval letter, but typically will include:

  • Adhering to the study procedures approved by the reviewing IRB
  • Submitting any changes for approval prior to implementation (amendments) including changes in study personnel
  • Reporting all unanticipated problems and noncompliance within deadlines established by the reviewing IRB
  • Reporting any changes in financial relationships that may be perceived as a COI
  • Cooperating with any post approval monitoring requests


Responsibilities with the UT IRB

After a study is approved by an external IRB, the study PI still has some responsibilities with the UT IRB. These include: 

  • Submitting amendments or modifications to the UT submission if there are PI or personnel changes, an addition of drugs or devices, or a change in research funding 
  • Submitting a report on the UT submission when an Unanticipated Problem occurs at the UT site (see the UT IRB Policies and Procedures Manual Section 9: Reporting Unanticipated Problems), if the reviewing IRB determines that an Unanticipated Problem occurred at the UT site, or if the reviewing IRB determines that Noncompliance occurred at the UT site  
  • Closing the study with the UT IRB when the reviewing IRB closes the UT Austin site