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 Adobe pdf documents is provided here [pdf].

Does My Project Need Review?

Exclusion Worksheet [pdf]
This decision tool must be filled out by all investigators before preparing an IRB application. Some activities do not require submission of an application to the IRB Office because they do not constitute research involving human subjects according to the federal definitions. Use this worksheet to learn whether an application package must be submitted for your project. The required IRB forms, outlined below, should only be submitted to the IRB Office if indicated by the instructions on the exclusion worksheet. This worksheet does not need to be submitted to our office.

Companion Document to Exclusion Worksheet [docx]
This companion document was created by the Doctor of Nursing Program to help nursing students navigate the exclusion worksheet. Investigators in other departments may find it a useful resource for understanding the difference between research designed to contribute to generalizable knowledge -- which requires submission of an application to the IRB -- and activities similar to research, such as quality improvement and program evaluations, which typically do not require submission of an application to the IRB.

Required Forms and Templates for New Study Submissions 

  1. IRB Assurance  [pdf]
    A faculty supervisor must sign this form if an IRB application is being submitted for review by a student. Likewise, faculty or staff must sign and submit this form with IRB application submissions for their own work as principal investigators. This form may not be filled out by student investigators. SJSU policy prohibits students from being principal investigators and requires faculty supervisors to act as PIs on student IRB submissions.

  2. IRB Application [docx]
    Provides a complete description of the methods and procedures of the proposed research.

  3. 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 [docx]
    Consent Notice Template [docx]
    Parent Permission Template [docx]

  4. Verification of Translation Accuracy Form [pdf]
    Must be included with any translated documents.

Submission Instructions

Please email your submission attachments to irb@sjsu.edu. 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.

Post-Approval Forms

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 irb@sjsu.edu, along with any accompanying documents that have changed. Include your IRB tracking number in the subject line.

Annual Status Report  [pdf]
If your study 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 irb@sjsu.edu. Include your IRB tracking number in the subject line. 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 study file after a period of three years from initial approval if we do not hear from you. 

Incident Report  [docx]
Principal 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 irb@sjsu.edu. Include your IRB tracking number in the subject line.

SJSU Investigator 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 external institution. For more information about this form and requirements, visit our collaborative and external studies page. The form and accompanying documents should be emailed to irb@sjsu.edu.

Informational Documents and Links

IRB Submission Checklist [pdf] 
Summarizes the documents needed for new protocol submissions.

Data Management Checklist [pdf]
A 2-page checklist based on our data management handbook that summarizes the most important points.

Data Management Handbook [pdf]
An educational resource intended to help researchers who want to conduct research with human participants construct an effective data management plan as part of their research proposals.

Data Management Excel Template
A spreadsheet template that investigators can use to manage their use of data throughout the lifecycle of the research.

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.

List of Expedited Review Categories