IRB Forms and Documents
Technical Note: Some forms may not look complete or may not be visible if you preview them on your
web-browser. Please be sure to download, view, and fill out forms on your computer rather than
on your web-browser. Information on how to configure a digital ID for signature lines in pdf documents
is provided here.
Does My Project Need Review?
This decision tool must be filled out by all investigators before preparing an IRB protocol. Some activities do not require submission of an IRB protocol to the Office of Research for review because they do not constitute research involving human subjects according to the federal definitions. Use this worksheet to learn whether a protocol package must be submitted for your project. The required IRB forms, outlined below, should only be submitted to the Office of Research if indicated by the instructions on the exclusion worksheet. This worksheet does not need to be submitted to our office.
Required Forms and Templates for New IRB Protocol Submissions (Updated January 2018)
- IRB Assurance (pdf)
A faculty supervisor must sign this form if an IRB protocol is being submitted for review by a student. Likewise, faculty or staff must sign and submit this form with IRB protocol submissions for their own work as primary investigators. This form may not be filled out by student investigators. SJSU policy prohibits students from being primary investigators and requires faculty supervisors to act as PIs on student IRB protocols.
- IRB Application (docx)
Provides a complete description of the methods and procedures of the proposed research.
- Informed Consent Handbook (pdf)
Includes comprehensive instructions for preparing consent and assent documents for different kinds of research. You may also download the following modifiable (docx) templates to work with:
Standard Consent Template
Consent Notice Template
Parent Permission Template
- Verification of Translation Accuracy Form (pdf)
Must be included with any translated documents.
Please email your submission attachments to firstname.lastname@example.org. There are no specific requirements for the subject line and body of the email. Please
be sure to include all your documents in one email. You will receive a confirmation
response once your submission has been screened within 5 business days. Paper submissions will no longer be accepted beginning January 2018.
Request for Modifications to Approved Research Form (docx)
Use this form 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 and email this form to email@example.com, along with any accompanying documents that have changed.
Annual Status Report (pdf)
If your protocol was approved under an exempt or expedited IRB review category, as indicated on your approval notification, you must file this form with the IRB so that we may keep track of active research. The form should be emailed to firstname.lastname@example.org. No review is associated with submission of this form. However, failure to provide this form annually will result in closure and deletion of your IRB protocol file after a period of three years from initial approval if we do not hear from you.
Incident Report (docx)
Primary investigators must file this form within 7 calendar days upon discovery of an unanticipated problem, adverse event, or injury affecting human subjects. This form should be emailed to email@example.com.
External IRB Approval Registration Form (docx)
This form is intended to document SJSU’s acceptance and reliance on an external IRB review in place of a review conducted by the SJSU IRB. This form should only be used if you are an SJSU investigator that has IRB approval from an outside institution to conduct your research elsewhere, or if you are an outside investigator that already has IRB approval from another institution to conduct your research at SJSU. The form and accompanying documents should be emailed to firstname.lastname@example.org.
Informational Documents and Links
IRB Checklist (pdf)
Summarizes the documents needed for new protocol submissions.
Table of Exemption Categories (pdf)
A list of the exemption review categories, how they apply to vulnerable groups, and the SJSU-specific consent requirements for each category.