UTHealth as Relying Institution
UTHealth researchers may choose to rely on an approved outside IRB with which UTHealth has signed an IRB reciprocity agreement. The UTHealth PI must seek permission from the UTHealth IRB to rely on an outside IRB via iRIS.
- Start a new study application in iRIS
- In the pane “Determining Review Type” select the option “Request for permission to rely on IRB approval from an IRB with whom UTHealth has a reliance Agreement.”
- On the next panel if you do not find the IRB that you with to rely on for this particular research study, choose “Other” and enter the name of the Reviewing IRB.
- On the next panel, upload protocol and consent form (if there is one).
- If the research study will be conducted at a Memorial Hermann site, complete the Memorial Hermann Application Form.
- If the application is being prepared by anyone other than the Principal Investigator, route to the Principal Investigator and co-investigators for signature.
- The Reviewing IRB may require each relying site to submit a site for. . Many institutions use the SMART IRB Relying Site Study Team Survey.
In some agreements, the reviewing IRB may request for “local context” issues such as institutional requirements for informed consent language (e.g., compensation for injury language), attesting to the adequacy of research team training,/cphs/irb-reciprocity/Reciprocity.htm qualifications of the research team and resources available to conduct the study, and providing any relevant conflict of interest management plans. UTHealth IRB staff will provide this information to the reviewing IRB.
The IRB staff will review the request to ensure that UTHealth has an agreement with the Reviewing IRB institution. IRB staff will also review adequacy of research team training, qualifications of the research team, resources available to conduct the study, check whether any related significant financial interests have been disclosed. If all the requirements for relying on the outside IRB are met, the IRB staff will issue a ‘permission to rely’ letter to the UTHealth PI via iRIS.
Consent Template when UTHealth is Relying on Outside IRB
UTHealth IRB has published a template consent document on the UTHealth IRB website. We highly encourage researchers and research teams to use this template consent to ensure all the necessary elements of consent are included in the consent document. Addition of local information in the consent form may depend on the reviewing IRB.
Commercial IRBs – Most of the commercial IRBs that UTHealth works with will revise the sponsor consent template to add the UTHealth mandatory language (injury, local contact, HIPAA authorization language.
Academic Center IRBs – When UTHealth relies on an IRB of an academic center, the consent form is approved reviewing IRB and only certain sections may be edited for local context issues. The UTHealth study team must ensure this language is added to the consent and submitted to the Reviewing IRB.
Researchers and Research staff are reminded that there are several other institutional approvals that may be required for a research study to be conducted at UTHealth. It is the responsibility of the UTHealth PI to ensure that all these approvals have been obtained before the research is initiated at UTHealth.
- Memorial Hermann CIRI approval
- Harris Health System approval
- Conflict of Interest Management Plan
- Execution of Contract/Clinical Trial Agreement
- Safety Committee approvals
A checklist of Relying Institution PI responsibilities can be found online.