IRB Forms and Documents
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Does My Project Need Review?
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
Note: email or fax submissions are not accepted.
IRB Application (pdf)
Must be submitted as part of a complete protocol package. Provides basic info about the research team and methods.
Protocol Narrative (doc)
Must be submitted as part of a complete protocol package. Provides a complete description of the methods and procedures of the proposed research.
Informed Consent Handbook (pdf)
Includes comprehensive instructions for preparing consent forms; templates for adults and parents of minors; and examples of adult, parental, and minor assent documents.
You may also download this modifiable word version (docx) of the templates only.
Verification of Translation Accuracy Form (pdf)
Must be included with any translated documents.
Follow-up and Registration Forms
Extension Request (pdf)
Researchers who wish to collect data beyond the IRB approval expiration date must file an extension request before the approval period expires. NOTE: if you fail to submit the request before your protocol expires, you will need to submit a new protocol with all of the required documents included to resume data collection. Data collected outside of the IRB approval period cannot be used for research purposes.
IRB Registration - Intent to Conduct Human Subjects Research (pdf)
This form should only be used if a) you are an outside investigator that already has IRB approval from another institution to conduct your research at SJSU, or b) if you are an SJSU investigator that has IRB approval from an outside institution to conduct your research elsewhere, or c) if you are an SJSU investigator awaiting approval of a grant proposal and will submit a complete IRB protocol to the SJSU IRB prior to the initiation of the research activities.
IRB Checklist (pdf)
Summarizes the documents needed for IRB review.
IRB FAQs (pdf)
Describes everything researchers need to know about the IRB process, including when IRB approval is needed and how long it takes to get approval for different kinds of research. You can also learn this information by viewing our video tutorials.
IRB Process Flow Charts (pdf)
Provides a visual overview of the IRB process.
Samples of IRB Protocols
Sample documents are for educational purposes only. Our forms and documents may be updated from time to time and they should be downloaded directly from this page. Please do not copy text from the sample protocols. IRB protocols should be written in your own words. Some information may be redacted from the samples to protect the privacy of the researchers.