In order to reduce duplicative IRB reviews, UT Houston has signed the UT System IRB Agreement that allows researchers in UT Houston to seek approval from any IRB within the UT System. You should investigate the possibility of using this agreement any time you are conducting research with any sister UT institution, either as a consultant or as a full satellite site.
If you wish to rely on the IRB from another UT Institution:
If a PI from another UT institution (also called Site PI for the purpose of this policy) wishes to rely on UT Houston CPHS
Links to SOPs related to reciprocity below:
As of February 2012, researchers may choose to obtain IRB review and approval for industry sponsored, multi-site clinical trials from Chesapeake IRB. Researchers may choose to continue to apply to UT Houston CPHS for review and approval. Researchers must obtain written CPHS permission before applying for Chesapeake IRB review and approval. Written permission must be sought via an iRIS application.
Process to Obtain Permission from CPHS:
a. Create a new study in the iRIS application. In the panel on Reciprocity Agreement, choose the option
"Chesapeake IRB Review”.
b. Upload sponsor protocol and sponsor consent document.
c. If the clinical trial will be conducted at a Memorial Hermann site, complete
the Memorial Hermann Application Form.
d. If the application is being prepared by anyone other than the Principal Investigator, route to the Principal Investigator
e. Route to the Department Representative for signature.
f. Await written permission from CPHS office.
Applying for Chesapeake IRB Review and Approval
a. In order to be able to submit research applications to Chesapeake IRB the user
must first register in their electronic system, CIRBI.
b. Any member of the study team may create and submit the application. We
encourage research teams to ensure that the Principal Investigator has reviewed
the application before submitting.
c. If the study will be conducted at a MHH site, please include Cassandra Varacalli
as a study contact on the CIRBI application.
d. Chesapeake IRB will issue a written approval letter via their electronic system.
e. Chesapeake IRB will be responsible for continuing review, change requests and
Research teams seeking approval from Chesapeake IRB must familiarize themselves
with Chesapeake Investigator Handbook for reporting requirements and other
Research Conflicts of Interest (RCOI) - In order to make sure all research personnel on the study have completed the appropriate research conflict of interest form, all key study personnel should be added to the original CPHS submission so that it can be routed for electronic signature and RCOI sign-off. If key study personnel are added at a later date, the site is required to submit a personnel change request through CPHS as well as Chesapeake to insure RCOI is completed.
Consent documents and HIPAA Authorization – Only consent documents that have been approved by Chesapeake IRB must be used during the course of the clinical trial. If HIPAA authorization has not been waived, the research team must obtain authorization from the participants.
Fees – It is preferable for the industry sponsor to pay Chesapeake directly for the IRB review services. In addition to the Chesapeake fees (fee schedule available in iRIS-My Assistant-Operating Procedures), CPHS will invoice an administrative fee for maintaining compliance oversight at UT Houston. CPHS administrative fee will be $1300 for initial review and no charge for continuing reviews.
All communication regarding the research must be directed to the Chesapeake IRB representative. However, researchers may contact CPHS Office for assistance or clarification. Representatives from CPHS Office will have access to all UT Houston research on the Chesapeake electronic IRB system.
If UT PI wishes to rely on Baylor College of Medicine (BCM) IRB
If BCM PI wishes to rely on UT CPHS
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
IRIS Support 713.500.7960