IRB Review Process | External IRB Review Process | Consent Process | Protocol Modifications | Reportable Events | Human Subject Educational Training Requirement | IRB Submission | IRB Submission Deadline
What if I am involved in a research study subject to multi-site IRB review (i.e. JPS as well as UNTHSC)?
If you are newly submitting a protocol for review and also require review from another IRB, OReC recommends you submit first your protocol to UNTHSC IRB. OReC Policy, guided by federal regulations, states those involved in human subject research and working for UNTHSC (or will be presenting the research under the UNTHSC name) are subject to UNTHSC IRB review. Once the protocol has been reviewed and approved here, it can be submitted for IRB review elsewhere.
OReC will work with the investigator and other participating IRBs (when needed) during the process of a multi-site review. In particularly, address any modifications to the protocol. If an investigator needs to amend their protocol upon request of another IRB, submit a request for modifications with the appropriate documents. If the information conflicts with UNTHSC IRB standard language or policy, please contact OReC staff for assistance.
In some cases you may need to get the approval of the outside IRB first before submitting to us. We recommend this if the majority of the research is being conducted at that institution and UNTHSC employees are involved in a smaller role (for example, data analysis). OReC staff can help you decide which approach will be best. In all cases, UNTHSC faculty and staff should not participate in any research activities related to the project until it is approved by the UNTHSC IRB.
Do I need UNTHSC IRB approval if my project has received approval at another IRB where I am conducting some of my research?
Under federal regulations and guidance, UNTHSC IRB policy states investigators working for UNTHSC or publishing using the UNTHSC name are required to submit research involving human subjects for UNTHSC IRB review. Submission is particularly important if the majority or some of the research elements will be conducted at UNTHSC or UNT Health.
What type of documentation do you need from me related to an external IRB’s review and approval?
If approval has been granted at another IRB, please submit IRB category determination and approval from that institution. For Expedited or Full Board category research, submit a protocol synopsis along with the appropriate research-related documents (e.g. questionnaire) for proper UNTHSC IRB review and determination. For Exempt category research, fill out and submit the Exempt application form available at our website.
On a case-by-case basis, UNTHSC IRB may acknowledge and accept other IRB determination of research originally approved elsewhere.
For ongoing studies subject to multi-site review and approval, please submit a copy of each IRB stamped consent document (if differ from UNTHSC) to have on file.