UPDATE on Internet IRB submissions for the North Texas Regional IRB

Dear Colleagues,

As you now know, the North Texas Regional IRB has adopted IRBNet as our electronic software system for management, submission, review and oversight of human subject research protocols.

Some target dates and information to keep in mind:

• Right now, you may access IRBNet from virtually any computer using a web browser by visiting www.irbnet.org. At this site, you may then self-register and create your own User ID and Password, as part of the JPS and UNTHSC research community, and immediately begin using these exciting new tools.

• Beginning on September 1, 2018, all NEW protocols (Exempt, Expedited and Convened [Full Board] protocols) must be submitted electronically via IRBNet, and all review decision letters will be issued electronically via IRBNet.

• For existing projects…to assist in a smooth transition, all Modifications (Amendments), and Continuing Reviews (Progress Reports, and Close-outs*), will transition from “paper-based” to electronic beginning October 1, 2018.

*Please Note: If you will be closing your existing study prior to transitioning it to IRBNet, please submit the appropriate closure form (“Sponsored Clinical Trials – Final Report (Close-out Form)” or “Investigator-Initiated Projects – Final Report (Close-out Form)”) to the North Texas Regional IRB in paper. Studies that will be closed prior to their next continuing review (and that will not be amended) will be closed out in paper, and will not need to be transitioned to IRBNet.

• After October 1, submit all requests for protocol modifications (amendments to protocol), Continuing Reviews, and Final Reports* (please see above) via IRBNet. When submitting a package via IRBNet, it is critical that all of the current documents for your study are uploaded into IRBNet. Such documents include, but are not limited to: protocol synopsis, consent form(s), questionnaires, investigator brochures, sponsor protocols, DSMB reports, etc. This will help to ensure that all appropriate documents for the study are electronically accessible (to both the study team and the IRB) for the life of the study. (Please note that if you are submitting an amendment you will still need to submit a “track changes” copy of the revised documents). Consult the many tools, pdf files and videos provided on the IRBNet site for how these processes work.


o Do not contact IRBNet directly for any issue or question about process, procedure, forms, or documentation…contact our office instead.

o All PIs, investigators, and pertinent research personnel will need to register for an IRBNet account in order to be granted access to a study. Without access, key personnel on a study will not be able to view or make any necessary revisions to the protocol, and will not receive correspondence from the IRB regarding a protocol. In addition, please be sure to grant pertinent research personnel the appropriate level of permission access (full, write, read and no access).

NOTE: Please note that if your studies involve CDC and commercial IRBs, guidance on how to enter the information into IRBNet is forthcoming. In addition, for SAE and UAP reports, and protocol violations, please contact the IRB office on the process for submitting these during this transition.

As usual, for assistance and information please contact the following persons who can assist you with any questions you may have as we move forward with this important initiative.

Tania Ghani, MS, CIP                 Itzel Peña Pérez, MS, CIP
Tania.Ghani@unthsc.edu         Itzel.Pena@unthsc.edu
(817) 735-2038                              (817) 735-0673

Once again, the North Texas Regional IRB is pleased to bring these robust new tools to our research community.