UTHealth may rely on IRB review of another organization or may serve as the IRB for another organization under a written IRB authorization agreement. These agreements are also called IRB reciprocity agreement or IRB reliance agreements. About 12% of studies approved by CPHS in 2017, were reviewed by an outside IRB.
Resources
NIH Mandated sIRB: 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 submission date on or after Jan 25, 2018. For more information on the NIH sIRB mandate.
Relying on Outside IRB: When UTHealth is the Relying Institution, the UTHealth PI must submit an application in iRIS to request for permission to rely on the outside IRB. Instructions on the process to apply for permission to rely.
UTHealth IRB as Reviewing IRB: When the UTHealth PI is the lead PI of a multi-site study or a collaborative study, UTHealth IRB may be willing and able to be the reviewing IRB. Instructions on the process to request for UTHealth IRB to be the reviewing IRB.
List of Commercial IRBs: UTHealth has offered the option to rely on a commercial IRB for multi-site clinical trials since 2012. Guidance on working with a commercial IRB.
Key Terms: There are some new terms that are used in the IRB reliance context, such as relying institution and reviewing IRB. Definitions of key terms.
List of UTHealth Reliance Agreements
UTHealth has signed several IRB Authorization Agreements. Many of these agreements are individual IRB Authorization Agreements or reliance agreements signed for a particular research study. UTHealth also has signed multi-study agreements for studies done under the auspices of a consortium or network. Negotiating IRB reliance agreements takes time and effort, UTHealth IRB encourages researchers to use the SMART IRB Agreement.
SMART IRB Agreement: SMART IRB is a platform designed to ease common challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy (effective date: January 25, 2018). The SMART IRB is an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status. More than 350 institutions have signed the SMART IRB reliance agreement. UTHealth and Memorial Hermann Health System are participating institutions. When you have a new multi-site study and would like to use the SMART IRB reliance platform, check to see if all the sites in your study are participants in SMART IRB platform by visiting the SMART IRB website .
State of Texas Master IRB Reciprocity Agreement: UTHealth has signed the State of Texas Master IRB Reciprocity Agreement, which serves to reduce duplicative IRB reviews. Multi-site studies involving more than one of the participating institutions (listed below) may request to rely on one IRB. Consider using this agreement any time you are conducting research with institutions in Texas. Participants:
- Baylor College of Medicine (contact reliance@bcm.edu)
- Rice University (contact 713-348-3586)
- Texas Tech University
- The Methodist Hospital System (contact 713-441-7887)
- The Texas A&M University System (contact irb@tamu.edu)
- The University of Houston (contact cphs@central.uh.edu)
- The University of North Texas Health Science Center Fort Worth
- University of Texas System components (all 14 components)
Commercial IRBs: UTHealth has offered the option to rely on commercial IRBs for multi-center industry sponsored trials since 2012. Currently, UTHealth has agreements with several commercial IRBs:
- Advarra IRB (including Schulman IRB and Chesapeake IRB)
- BRANY IRB
- Quorum IRB
- Sterling IRB
- WIRB (or Western IRB or WCG IRB – including Copernicus IRB)
More information can be found in the guidance on working with a commercial IRB. Commercial IRBs may be used as the sIRB for NIH funded multi-site studies. For more information on commercial IRBs as sIRB.
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
IRB OFFICE HOURS Thursdays from 1 to 4pm, via the Teams Room at this link
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