How to Respond

Human Subject Research

During the IRB preliminary review, each research application is evaluated for completeness by an IRB designated reviewer. If a submission is incomplete, the PI will receive an email through the IRBNet Project Mail feature outlining what documents, forms, or training requirements are missing, or what revisions and/or clarifications are needed in order to conduct a thorough review and issue an approval or exemption certification.

  • Stipulation Letter Issued

    For Expedited and Exempt Project Reviews:

    If a research project meets the regulatory criteria to be reviewed by expedited or exempt review, the IRBNet package is initially reviewed by an IRB administrator or other designated reviewer appointed by the IRB Chair. If the IRB reviewer has identified during the preliminary review that the investigator needs to provide more information, attach additional documents, or obtain electronic signatures, the reviewer will generate a Project Mail to the investigator outlining what needs to be modified or added in order to issue a final review.

    For Full Board Review Projects Requiring Modifications:

    If a research project is reviewed by the Full Board and modifications are required before the project can be issued full approval, an IRB Administrator will generate a stipulation letter within IRBNet based on the reviews and requests from the convened meeting. The letter will be sent directly to the Principal Investigator, and to the Faculty sponsor if the investigator is a student, providing an itemized review of the protocol, consent, or any other documents that were submitted for IRB review. In addition, the letter may outline whether additional documents or information were requested by the convened board.

  • IRBNet Package Unlocked

    Once a preliminary review has been conducted on an expedited or exempt review project and a stipulation email through Project Mail is issued to the investigator, the IRBNet package will be UNLOCKED by the IRB to allow the investigator to respond to the items. Through the "unlocking" procedure, the investigator has the ability to modify any document that was posted initially in their IRBNet package, add or remove documents, and provide a letter to the IRB outlining the changes that were made to the research project. If your IRBNet package status is unlocked, the investigator should NOT create a new package in IRBNet when responding to a stipulation email issued through Project Mail.

  • Relocking Your IRBNet Package

    For Expedited and Exempt Projects ONLY:

    Once an investigator has addressed the requested clarifications or modifications to their expedited or exempt review project, and all documents and revisions are complete, the investigator is responsible for RE-LOCKING their IRBNet package. By re-locking your package, the IRB will be automatically alerted that revisions have been completed and your project is ready for re-review. If your IRBNet package is NOT RE-LOCKED, the IRB will not know that your project is ready for re-review and the final IRB review will be delayed.

    NOTE: If an investigator re-locks their package and, after doing so, realizes that additional documents need to be added, the IRB must be contacted to administratively UNLOCK the package. Unlocking a package within IRBNet can only be done by the IRB Administrators.

  • Creating a New Package in Response to an IRB Review

    For Full Board Review Projects ONLY:

    Once an investigator has reviewed and addressed any clarifications or modifications requested by the Full Board, the investigator is responsible for CREATING A NEW PACKAGE in IRBNet to post their responses. This process is different from responding to an expedited or exempt review. When a full board review is issued, your IRBNet package remains LOCKED, and only through CREATING A NEW PACKAGE, allows for clarifications or documents to be posted for IRB review.