IRB Forms

Forms and Templates to be Submitted to the IRB

Request for Not Human Subjects Research Determination

If you do NOT think your study is human subjects research, please submit the HRP-210 Request for Determination on IRBNet. Doing so allows the IRB to issue an official determination that your project is not human subjects research. This determination may be required for funding, access to certain data, or publication.

• HRP-210 Request for Determination

COMMON MISTAKE: If you think your study is NOT human subjects research, just submit the HRP-210 Request for Determination. Do NOT complete an Initial Review Application or submit any other forms.

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Protocol Templates

If a protocol was NOT provided by the study’s sponsor or lead site, then a completed HRP-503 Protocol Template must be included in your submission. Only one HRP-503 Protocol Template should be completed for each study.

• HRP-503 UCD Health Medical Record Review Template
• HRP-503 Record/Data/Specimen Secondary Analysis Review Template
• HRP-503 Surveys/Interviews and/or Focus Groups Review Template
• HRP-503 Drugs/Devices and/or Clinical Interventions
• HRP-503 General Template

Need help deciding which template to use? Refer to our Template Decision Tree.

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Consent Form Templates

• HRP-502 Template – Exempt Research
• HRP-502 Template for Minimal Risk Specimen Research
• HRP-502 Template for Survey/Interview Research
• HRP-502 Template – General (2018 Common Rule Compliant)
• HRP-502 Template- Consent Addendum: Submit this template for IRB review only if the research team is aware of new information (e.g., risks, COIs, procedures, etc.) which needs to be conveyed to subjects and documented in writing but the study is permanently closed to accrual.
• HRP-506 Consent Document – Expanded Access and Emergency Use

Need help deciding which template to use? Refer to our Template Decision Tree.

Consent Form Resources

• Glossary of Lay Terminology
• Consent Form Sample Risk Language
• GDPR Compliance: Notice and Informed Consent Language for EU/EEA Data Subjects
• Contraception Information Sheet (see instructions)

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Fee Forms

A fee is required for some new project and continuing review submissions to the IRB. To determine if fees apply to your research, please see the IRB Fees webpage.

• Sponsor Fee Form (Use for studies receiving any industry funding)
• Reliance Fee Form (Use for studies involving a reliance agreement)

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Post-Approval Submission Resources

• Response Memo Template: Complete this form if your application to the IRB has gone to the convened board and the IRB has requested modifications, justification, or clarification. See the Response to a Letter of Action page for guidance on completing a response memo.
• Project Events Summary Table Template: Complete this form when you submit a continuing review if reportable new information was submitted in the last approval period and/or if the study sponsor requires minor deviations to be reported to the IRB.
• Modification Summary Table Template: This optional form may be used when submitting a modification, but it is NOT required. If a Modification Summary Table is included in a submission, the Post-Approval Submission Form must still be included.

IRB TIP: The Modification Summary Table may be useful for communicating specific changes for more complicated modifications, especially in investigator-initiated clinical trials.

Forms and Templates to be Used in Research but NOT Submitted to the IRB

HIPAA Authorization Form (Version 2017)

HIPAA Authorization Version 2017 is required for studies initially approved on or after June 1, 2018. For questions regarding HIPAA Authorizations, please contact the Compliance Department.

• English
• Cambodian
• Farsi
• Mandarin
• Russian
• Spanish
• Vietnamese

COMMON MISTAKE: Do NOT submit any of the above HIPAA Authorization Forms to the IRB.

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HRP-507 Consent Document – Short Form

A Short Form Consent Document is an alternative to using a translated consent document when one is not available. For more information about when a short form may be used in research, please see the Overcoming Language Barriers section of our Consent Process page.

COMMON MISTAKE: Do NOT submit any of the Short Form Consent Documents below.

• Arabic
• Chinese
• English (Contact the IRB Prior to Using the English Short Form)
• Farsi*
• Hmong
• Ilocano*
• Korean
• Lao*
• Portuguese*
• Punjabi 
• Russian
• Spanish
• Urdu
• Vietnamese

* Not approved by the National Cancer Institute (NCI) IRB

Forms Used for Review

Below are the worksheets and checklists the IRB uses for review. These worksheets are for reference only.

COMMON MISTAKE: Do NOT include worksheets and checklists in submissions to the IRB.