IRB: Submit Your Protocol

IRB Mentor is an interactive web application that uses smart forms. You do not need to identify whether your submission qualifies for exemption [pdf], expedited review, or full review. SJSU does not use different applications for different review types. Instead, different sections and questions are made visible based on how you respond to questions as you move along in the application. The routing of your submission and the type of review it undergoes will be determined when it is screened by the IRB office.

Starting June 1st 2023 new study applications must be submitted via IRB Mentor. New study submissions will no longer be accepted via email after this date. 

IRB Mentor Login

LOGIN: SJSU students and employees have automatic access to IRB Mentor via SJSU single sign-on at the following link: https://www.axiommentor.com/login/shibLogin.cfm?i=sjsu

IMPORTANT NOTE: The Mentor system is set up to send notifications to the email address that you identified as your preferred email address in Peoplesoft (mySJSU). If you do not receive communication from us when expected, please check your preferred email address or spam folder.

If you are an employee of the SJSU Research Foundation only, please contact our office for a login link.

Basic Steps for an Initial Submission

1. Create the protocol in Mentor following our User Guide for Initial Submissions [pdf].
   
   
2. Fill out the application sections and attach any files where prompted, following our User Guide for File Requirements [pdf].
   
   
3. Electronically sign by clicking the button next to your name on the protocol information page. This will deliver the protocol to the IRB office if you are a faculty or staff member. If you are a student, this will deliver the protocol to your faculty supervisor, who should follow our User Guide for Faculty Supervisors [pdf]. Do not forget this step – your submission will not be delivered to the IRB if you have not signed your submission! Faculty supervisors should receive an email confirmation both when their student has signed the submission and it is ready for the supervisor to review/accept as well as upon delivery to the IRB when the faculty supervisor accepts the submission.

User Guides for Navigating IRB Mentor

The following user guides are required reading. Please take 15-20 minutes to read the user guides relevant to your submission type – reading this information prior to accessing the IRB Mentor system will save you time in the long run.

Initial Submission [pdf]
Outlines steps and guidance for creating a new protocol, submitting requested revisions, approval durations, and submitting study status check-ins.

Faculty Supervisors [pdf]
Provides information on how to navigate your review and acceptance of student submissions within IRB Mentor.

File Requirements [pdf]
Outlines required naming and formatting conventions for files uploaded to IRB Mentor as well as how to use Mentor’s organization and management features for files.

Post-Approval Study Status Check-ins or Continuing Reviews [pdf]
Provides information on approval durations and instructions for submitting either a study status check-in or a continuing review request (depending on the review type of the approved protocol).

Post-Approval Reporting: Modifications, Incident Reports, Deviations [pdf]
Provides information on how to navigate submission of modification requests, reporting of incidents and unanticipated problems, and reporting of study deviations/protocol violations.

External IRB Approval Registration and Reliance Agreements [pdf]
Provides navigation instructions for SJSU investigators who intend to rely on an external IRB approval for their research. Please also refer to our Collaborative and External Studies page for preliminary information so that you understand what is required to establish a reliance agreement between SJSU and the external reviewing IRB before initiating the process in IRB mentor.

IRB Members

Visit our reviewer training page for a list of steps and training requirements for IRB members, including a reviewer user guide for navigating your review of protocols in IRB Mentor.

IRB Mentor Smart Form Application

For a PDF preview of the smart form application in IRB Mentor, visit our forms and documents page.

Managing Pre-IRB Mentor Submissions

While new submissions will not be accepted via email after June 1st 2023, the SJSU IRB will continue to accept modification requests [docx], status reports [pdf], and incident reports [docx] via email at irb@sjsu.edu for IRB protocols approved prior to the implementation of IRB Mentor until April 1, 2024. After April 1, 2024, you must submit a new protocol via the IRB Mentor system if you wish to modify a previously approved pre-IRB Mentor study. We will not be adding pre-Mentor protocols to the system.

If no modifications are anticipated, investigators may continue to submit status reports for their pre-IRB Mentor approved studies to irb@sjsu.edu. Pre-IRB Mentor studies will be maintained outside of the system, so long as no modifications are requested, for three years after the last status report was received by the IRB office or three years after an investigator communicates that a study is complete on their status report (whichever comes first). 

To access our pre-IRB Mentor forms, visit our forms and documents page.