Humans Subjects Research - Institutional Review Board (IRB)

SJSU uses a cloud-based submission and review system for IRB applications called IRB Mentor.

For IRB Mentor submission information, including how to manage pre-IRB Mentor approved studies, please visit our submission page. View the information under the "Managing Pre-Mentor IRB Submissions" heading at the bottom of the page for information on your pre-Mentor IRB protocol.

SJSU Researchers: Getting Started

• Does My Project Need Review? Use our exclusion decision worksheet [pdf] to determine whether your work needs to be submitted to the IRB Office for review. This involves determining whether the work meets the federal definitions for "research" and "human subjects." If, after using this worksheet, you determine that your work does not need to be submitted for review, please keep the worksheet for your records. This worksheet does not need to be submitted to our office and you do not need confirmation from our office to proceed with work that is excluded.
  
  
• Access our help and guidance pages for videos and related educational documents, to understand review types and associated timelines, and to familiarize yourself with common application problems and ways to avoid them.
  
  
• Visit our forms and documents page to download informed consent templates and other forms or informational documents.
  
  
• Make sure you have completed a training course if you are a faculty or staff member submitting your own protocol or supervising student research. The training is also recommended but not mandatory for students. Refresher training courses are currently required every five years.
  
  
• View our submission page to get acquainted with the IRB Mentor submission system and to access user guides on how to accomplish various submissions in Mentor. 

Steps for Submitting Your Protocol for IRB Review

You may not begin ANY recruitment, enrollment, or data collection until you have received a formal approval letter from the SJSU IRB, regardless of the review type associated with the submission. This includes submitting any formal requests for the use and analysis of secondary data. If research data are collected prior to receiving IRB approval, you may not use that data in your research. The IRB does not retroactively issue approval.

1. When submitting a new study refer to our IRB Submission Checklist [pdf] for a summary of required items.
   
   
2. Go to our submission page for instructions on how to access IRB Mentor. Make sure to read the relevant user guides for navigating the Mentor system before you log in.
   
   
3. Once you have completed your IRB application within IRB Mentor and uploaded all required documentation, you will submit your study by electronically signing the submission. If you are a student, you will be prompted to identify your faculty supervisor as part of the submission process. Once you sign your submission, your faculty supervisor will be notified by an automated email to review and approve your submission before it is delivered to the IRB. Your faculty supervisor may require edits before accepting the application. If your faculty supervisor does not accept the submission, it will not be delivered to the IRB office.
   
   
4. Check IRB Mentor for any status updates.
   
   The IRB Office will contact you with any questions, comments, request for revisions, or concerns about your submission. Once a study has been determined to meet federal, state, and institutional criteria for approval, you will receive an approval letter via email. The research team will then be able to begin subject recruitment, enrollment, and data collection.

Registering External IRB Approvals

SJSU investigators with an external IRB approval should visit our Collaborative and External Studies page for details on what will be needed to register their external IRB approval within the IRB Mentor system in order to allow the IRB office to initiate a reliance agreement with the reviewing IRB.

Post-Approval Guidance

All post approval reporting is handled via the IRB Mentor system. This includes: requesting modifications to an approved protocol, reporting incidents and study deviations, continuing review renewals or study status check-ins, and study closures.

For information on how to file these post approval reports please visit our submission page and review our IRB Mentor User Guide for Post-Approval Reporting [pdf].