IRB Reliance Agreements
The University of Houston Institutional Review Board (IRB) may rely on the review of another institution’s IRB, or may serve as the reviewing IRB for another institution under what is called an IRB reliance agreement. Whether UH serves as the reviewing or relying IRB, specific procedures apply at each institution prior to the initiation of research.
When may an IRB Reliance Agreement be used?
UH researchers may request to rely on an external IRB for the review of a project involving human subjects. This is usually appropriate when a collaborating institution is the primary recipient of award funds with a subcontract to UH, or otherwise serve as the “lead” institution directing the research, especially when the research measures performed by the institutions are the same, or UH is involved primarily in data analysis. Likewise, if UH is the primary/ lead institution, UH will typically serve as the reviewing IRB. UH strongly encourages reliance on a commercial IRB (Sterling IRB) for industry-sponsored clinical trials, and JAEB Center IRB may be utilized as the IRB of record for certain pediatric optometry trials. It is important to note that an IRB reliance agreement does not cover other regulatory oversight requirements of the research, such as safety reviews, conflict of interest, or required clinic/hospital approvals. Training requirements for UH investigators and study team members still apply and will be reviewed by the UH IRB office prior to finalizing a reliance agreement.
How is an IRB reliance requested?
The UH PI must request permission from the UH IRB office to set up an IRB reliance. UH IRB staff will work with the non-UH IRB office to determine if reliance is appropriate for the project in general. If so, the IRB sites will agree on which IRB will serve as the reviewing IRB.
If UH will rely on another IRB:
The UH investigator must submit an “external” protocol within the IRB module of the ICON online system. An abbreviated external protocol application is activated when Question #7 on the SmartForm (“Will an external IRB act as the IRB of record for this study?”) is answered “yes.” Prior to formal acknowledgment, a copy of the full external site IRB protocol, the associated approval letter, and the IRB reliance agreement signed by both institutions must be attached. Studies created with the intent of relying on a non-UH IRB’s review will receive a reliance acknowledgment letter in ICON in lieu of a traditional IRB approval letter. This letter must be received by the UH PI prior to the initiation of any research procedures (including advertisement/recruitment) at the UH site.
If the other site(s) will rely on the UH IRB:
If another site or sites will rely on the UH IRB, a full protocol must be submitted by the UH investigator, to include procedures and personnel at all sites. The answer to Smartform Question #8 must be either “Multisite Study” or “Collaborative Study,” which will open up a new Question #9, where the request for one or more IRBs to rely will be initiated.
Detailed instructions for both situations are provided in the information below and hyperlinked attachments.
In either case, a formal document solidifying the agreement between the two IRB is signed by senior leadership in the research offices of both institutions for the specific project; this process is facilitated by the respective IRB offices. For questions about this process, please contact the UH IRB Office.
Please note: the timing and processing of these submissions can sometimes be confusing to investigators, however, the IRB office can help with questions and will keep you updated with the progress. The investigator should keep in contact with the IRB office; we will work with you to ensure the smoothest process possible.
When is IRB reliance required?
Certain projects may require that one participating institution serves as the IRB of record. For example:
NIH-funded multi-site studies: Effective January 25, 2018, NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program, must use a single Institutional Review Board (sIRB). This requirement applies to all competing NIH grant applications (new, renewal, revision or re-submission) with a submission date on or after Jan 25, 2018. Visit here for more information on the NIH sIRB mandate.
Other Department of Health and Human Services (DHHS) funded cooperative research: Although currently an acceptable option, the new Common Rule regulations at 45 CFR Part 46.114 will soon require that any institution located in the United States that is engaged in cooperative research use approval by a single IRB for that portion of the research that is conducted in the United States. The effective date for this single IRB compliance is 1/20/2020.
Can the collaborating investigators decide which IRB will be the reviewing IRB?
While some cases are clear cut, others are not. In certain situations, UH reliance on a non-UH IRB may not be appropriate, for example, when UH is the prime recipient of award funding and the UH PI will conduct the majority of the interaction with research subjects. Additionally, there may be times when UH reliance on an external institution is most appropriate, for example, if the external site PI will conduct the majority of interaction with research subjects or the external institution’s IRB is more specialized in the review of the type of research being conducted. The IRB office will take the investigators’ requests under consideration, but the decision is ultimately up to the institutions signing the agreement. The direction of the reliance may often be negotiated prior to the submission of a proposal for funding; please contact the UH IRB Office for more details.
What are the options available for UH to rely on an external IRB?
There are four options for UH to rely on an external IRB:
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- UT System/TMC Reciprocity Agreement
UH has signed a reciprocity agreement with the following 24 institutions. This allows the standardization of reliance agreements and streamlined processing among these member institutions:UT Arlington UT Austin UT Dallas UT El Paso UT Permian Basin UT Rio Grande Valley UT San Antonio UT Tyler UT Southwestern Medical Center UT Health UT Medical Branch UT Health Science Center San Antonio UT MD Anderson UT Health Science Center Tyler Baylor College of Medicine Texas Tech University Texas Tech University Health Sciences Center Texas Tech University Health Sciences Center El Paso Angelo State University University of North Texas University of North Texas Health Science Center Rice University The Methodist Hospital System Texas A&M University University of Houston - Industry-sponsored multisite clinical trials
UH investigators are strongly encouraged to rely on Sterling IRB (a commercial IRB) with whom UH has signed an IRB reliance agreement for industry sponsored multi-site clinical trials (this will likely become a requirement for these types of studies as we obtain more industry sponsored research). The UH IRB office works closely with the UH PI to gather required documentation; the UH IRB makes the submission to Sterling on the PI’s behalf. If the parent/sponsor study is already approved by Sterling, adding UH as a site typically offers a quick turnaround time.
Please click here for a list of documents required for requesting reliance under this agreement, as well as instructions for completing your ICON external IRB submission. - Multi-center research protocols coordinated by the Jaeb Center for Health Research
UH investigators may request to rely on the Jaeb IRB for these studies. For more Jaeb resources, visit here. - Requesting reliance on an institution not named above:
If you would like the UH IRB to rely on any other external institution’s IRB for the review of a collaborative project, you will need to confer with the UH IRB Office. If it is determined to be appropriate for UH to rely on the external institution, the UH IRB office will work directly with the IRB office in that external institution. For more information, visit here.
Please note that in all of the above cases, an abbreviated external study protocol must be submitted and formally acknowledged in ICON prior to the initiation of the work at the UH site.
What are the options available for an external institution to rely on the UH IRB?
One of two situations will apply to your research protocol:
- UH and the relying external institution are members of the UT System/TMC Reciprocity agreement
UH has signed a reciprocity agreement with the following 24 institutions. This allows the standardization of reliance agreements and streamlined processing among these member institutions:
Please click here for instructions to request reliance under this agreement. - You wish to request for an external institution’s IRB to rely on UH; the external institution is not a member of the UT System/TMC Reciprocity agreement described above
If you would like an external institution’s IRB to rely on UH’s IRB review for a collaborative project, and the institution is not part of the UT/TMC reciprocity agreement, you will need to confer with the UH IRB Office. If it is determined to be appropriate for the external institution to rely on the UH IRB, our IRB office will work directly with the external IRB office.
Please click here for more information.
- UT System/TMC Reciprocity Agreement