Working with Commercial IRBs
UTHealth researchers may choose to rely on an independent or commercial IRB with which UTHealth has signed an IRB reliance agreement with the permission of UTHealth IRB. This option is available for industry sponsored multi-center clinical trials. Researchers may also request to use an independent or commercial IRB as the sIRB under the NIH sIRB mandate.
To request for UTHealth IRB permission to rely on a commercial IRB:
- Start a new study application in iRI
- On the panel “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 clinical trial 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 for signature.
If a study sponsor requires use of an IRB that UTHealth does not have an agreement with, please contact the IRB office to explore options.
To apply to the commercial IRB, first contact the Institutional Representative at the IRB to find out if the protocol has already been reviewed and approved by that commercial IRB. Register for access to the electronic IRB portal.
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. UTHealth has an arrangement with commercial IRBs to ensure that the UTHealth approved language for research related injury and HIPAA authorization is included in consent forms. If a sponsor does not agree to include the UTHealth injury language or makes changes to the HIPAA authorization section, contact a UTHealth IRB representative at firstname.lastname@example.org
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Institutional Accounts Manager