UTHealth as Reviewing IRB
UTHealth IRB may be the reviewing IRB for a multi-site study. CPHS has been the IRB of record for several Clinical Trial Xpress trials. CPHS has also been the reviewing IRB when a research study involves other investigators in other institutions in collaborating roles e.g. samples are sent to another institution for analysis as part of a research study.
For multi-site studies, before agreeing to be the IRB of record, ensure that UTHealth IRB is wiling and able to be the Reviewing IRB.
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 choosing an sIRB and budgeting requirements, please visit here. (go to sIRB page)
A request for UTHealth IRB to be the reviewing IRB must be made via iRIS. The request may be made at the time of initial submission or later as a change request. The submission packet for requesting UTHealth IRB to be the reviewing IRB should include, for each relying site:
- Permission letter from the relying institution
- Completed Addition of PI form for each relying institution
- Consent forms with local PI information (if applicable)
- Local context information (if requested by UTHealth IRB)
The IRB staff will check whether UTHealth has an agreement with the relying institution(s). If not, the IRB staff will work with the relying institution to enter into an IRB reliance agreement. UTHealth IRB will issue a letter that indicates that the addition of the relying institution is approved. With this approval, UTHealth IRB will assume IRB oversight for the research study at the relying institution. The requirements for submission and review may also vary depending on the terms of the agreement between UTHealth IRB and the relying institution.
For more detailed guidance on managing IRB communication the UTHealth PI is the lead PI and the UTHealth IRB is the reviewing IRB, please click here.