Introducing a New Application Form for New Human Subject Research Protocols – the IRBNet Wizard (SMART) Application Form

Over the last few months, the North Texas Regional Institutional Review Board (NTR IRB) has been diligently working on a special project meant to enhance the submission process for our researchers and we are pleased to announce its launch! Drum roll, please…

Based on feedback from our investigators and research community, the NTR IRB will be implementing an electronic-based Application Form for NEW projects / protocols, known as the IRBNet Wizard (SMART) Application form. The Wizard Application form will go live (in IRBNet) on Wednesday, May 1, 2019.

The IRBNet Wizard Application form will replace our current, traditional Exempt, Expedited and Full Board IRB Application forms. Researchers will now only need to fill out the IRBNet Wizard Application form, regardless of the category of review being sought (Exempt, Expedited or Full Board). No more trying to figure out which application form to use!

Because the IRBNet Wizard Application form uses a logic-tree (“smart”) design, it guides researchers to enter information that is relevant/pertinent to their specific study and needed to facilitate the IRB review process. For example, if researchers indicate their project is a pharmaceutical study, the system will prompt researchers to complete a series of pharmaceutical-related questions (in addition to other IRB-required information, such as key personnel and contact information). (For this reason, you may often hear this application be fondly referred to as the “smart” form).

The Wizard Application form will be embedded within IRBNet as an electronic form. There will be no need to download a separate application form from the IRB website, or from the “Forms and Template” section of IRBNet. When you are creating a new project in IRBNet, and you want to open/fill out this “smart” form, simply click on “Start a Wizard” and select “North Texas Regional IRB – New Protocol Application Form” from the drop-down menu. Then, you go from there! Based on the information entered, IRBNet will generate (at the end of the application form) a list of items and documents that researchers will need to attach/include in their package for IRB review. Once the electronic application form is completed by the investigator, the application form itself will become a new, separate document within the submission package.

The North Texas Regional IRB will be launching guidance material (or a “How To” Manual) to help researchers navigate this new application form. The guidance material will be available starting May 1st on the NTR IRB website (under “IRB Forms”) and IRBNet (under “Forms and Templates”).

Important notes to highlight with this new process for submitting NEW projects / protocols:

(1) Researchers must still upload and submit a study-related Protocol Synopsis (e.g., Site-Specific Protocol for Sponsored-Initiated projects, Protocol Synopsis for Chart Review studies, Protocol Synopsis for Survey Research, etc.). The IRBNet Wizard (SMART) Application form does NOT replace the Protocol Synopsis or any other study document. The Wizard Application form is the general application that is submitted with any new protocol.

(2) Given this new electronic application form, there is no longer a traditional place for the Principal Investigator to provide a physical signature. Therefore, the Principal Investigator (PI) must electronically sign the submission package in IRBNet before the project is formally submitted to the North Texas Regional IRB. This will require the PI to log into IRBNet and sign the package.

(3) Researchers do NOT need to fill out the IRBNet Wizard Application form for projects that have already been approved by the IRB (i.e. existing projects). Researchers are only required to use the IRBNet Wizard Application form for any NEW projects being submitted as of, or after May 1, 2019.

(4) Post-IRB Approval: If you request an amendment/modification to the protocol, and the proposed amendment/modification will affect critical information found in the Wizard Application form, then you will need to update/modify the information in the Wizard Application form. Please note that the “track changes” / redline feature is not available within the Wizard Application form; therefore, you will need to describe the modifications (that you make to the Wizard Application form) in the Amendment/Modification Memo.

The North Texas Regional IRB appreciates your patience as we embark on this new electronic system and hope this additional resource facilitates and streamlines the submission process. We are here not only to ensure subject safety but to enhance the research enterprise.

Finally, feel free to contact Itzel Peña Pérez (, 817-735-0673) or Tania Ghani (, 817-735-2081) if you have any questions regarding the rollout of this new application.