Humans Subjects Research - Institutional Review Board (IRB)

Important Announcement
Cayuse Implementation Suspended 

With great regret, the Office of Research has decided to terminate its contract with Cayuse IRB and revert back to the pre-Cayuse email submission system for IRB applications. Concerns about the long-term stability of the Cayuse product and barriers to access are the primary reasons for this decision. Access to the system will end on May 1, 2021.

The following instructions are provided for applicants who have interacted with the Cayuse system.

Investigators with a Cayuse application in the draft phase
You may choose to complete the submission and approval process via Cayuse or you may choose to abandon your Cayuse application and submit your protocol using our pre-Cayuse forms to irb@sjsu.edu.

We strongly recommend that you submit your application via email instead of Cayuse, especially if you are in the beginning stages of your draft. If you choose to move forward within Cayuse, please be aware that access will terminate on 5/1, and you will need to take into account the review and approval process so that your submission is approved before 5/1. Our office cannot guarantee approval by the termination date for submissions that require extensive revisions or that do not qualify for exempt review. Once your application is approved, make sure to download a pdf of your approved application for your records and take note of the Cayuse tracking number; further requests (e.g., modifications, status reports) will be submitted via email (irb@sjsu.edu) using the forms posted here.

Investigators with a Cayuse application in the revisions phase
Please complete your revisions as soon as possible so that you get approval before the access termination date on 5/1. Once your application is approved, make sure to download a pdf of your approved application for your records and take note of the Cayuse tracking number; further requests (e.g., modifications, status reports) will be submitted via email (irb@sjsu.edu) using the forms posted here.

Investigators with a Cayuse application – initial, modification, renewal, external registration  – that has been approved
We have saved a pdf of your application and attachments outside of the system, including any approved modifications to an initial submission. We recommend that you download a pdf of your approved application for your records before 5/1 and take note of the Cayuse tracking number, as further requests (e.g., modifications, status reports) will be submitted via email (irb@sjsu.edu) using the forms posted here. You will need to continue submitting an annual status report for your approved study outside of the system.

SJSU investigators who submitted a request to add a pre-Cayuse study to the system
We continue to retain your past submissions outside of the system and you may continue to submit future requests via email (irb@sjsu.edu) using the pre-Cayuse forms posted here.

We sincerely apologize for the disruption and inconvenience this may cause some researchers.  

SJSU Researchers: Getting Started

  1. Do I Need IRB Approval? Fill out the exclusion 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.

  2. View our submission help page to understand the various review types and associated timelines. This page also lists common application issues and ways to troubleshoot submission problems.

  3. Visit our forms and documents page to understand the types of documents you will need to prepare.

  4. Make sure you have completed a preliminary 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.

Submitting Documents for a New Study

Researchers may not begin ANY recruitment or data collection until a formal approval letter from the SJSU IRB has been received. If 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 application refer to the IRB checklist [pdf] for a summary of required documents, and fill out the required forms. Be sure to access forms directly from our website for each new submission, as we may update them periodically.

  2. If you’re a student submitting a new study, you will need a faculty supervisor to review the submission and provide a signature on an assurance form [pdf]. Faculty and staff submitting their own applications must also sign the assurance form.

  3. The application and accompanying documents should be submitted to irb@sjsu.edu.

  4. Await a screening email from the Human Protections Analyst confirming that your submission was received and containing information about how it will be reviewed (allow 3-5 business days).

  5. Once your submission has been reviewed, further instructions will be emailed to you by the Human Protections Analyst. Depending on the nature of the revisions, you may be asked to submit a new application or only the revised documents. If you are a student and only have minor revisions to submit, your professor’s signature is not required.

  6. Once you have obtained IRB approval, follow the instructions below for reporting modifications and problems.

Post-Approval Guidance

Modifications 

To report changes to your research methods and procedures, design, data instruments, personnel, type or number of subjects, consent process, or location, please fill out the Modification Request Form [docx] and email it to irb@sjsu.edu, along with any accompanying documents that have changed. 

Annual Status Reports

If your application was approved under an exempt or expedited IRB review category, as indicated on your approval notification, you must file an
annual status report [pdf] with the IRB so that we may keep track of active research. The form should be emailed to irb@sjsu.edu. No review is associated with submission of this form. However, failure to provide this form annually may result in closure and deletion of your IRB file after a period of three years from initial approval if we do not hear from you.

Extensions/Renewals

Federal regulations no longer require IRBs to conduct a continuing review of research that was approved under the exempt or expedited review process. Renewal requests need only be submitted for studies that were reviewed by the full/convened IRB or under special circumstances, as noted in the study approval letter. Researchers whose applications were evaluated by full review should contact us to obtain a renewal form at least one month prior to the expiration date indicated on their approval notification.

Reporting Unanticipated Problems, Adverse Events, or Injuries

Primary Investigators must file an incident report [docx] within 7 calendar days upon discovery of an unanticipated problem, adverse event, or injury affecting human subjects. This form should be emailed to irb@sjsu.edu.

Registering External IRB Approvals

SJSU researchers with an external IRB approval, as well as external researchers with IRB approval should visit our collaborative and external studies page for details on how to register their IRB approvals with the SJSU IRB Office.