On this page, you will find hyperlinks to download forms and templates that may be used in the course of conducting human subjects research at UC Davis.
Need help deciding which protocol or consent template to use?
- Electronic Forms on IRBNet
- Forms and Templates to be Submitted to the IRB
- Forms and Templates to be Used in Research, but not Submitted to the IRB
- Forms Used for Review
- Additional Resources
The IRB has adopted the IRBNet suite of tools, accessible via the internet, bringing electronic protocol management, online submission, and many other important research oversight features to the UC Davis research community. For more information visit our IRBNet webpage.
Initial Review Application
All New Project submissions, except requests for a “Not Human Subjects Research” determination, to the UC Davis IRB must include an Initial Review Application, which is an electronic form to be completed on IRBNet. For a complete list of documents to be included in your specific New Project submission, please see the “Additional Documents and Requirements” page of the Post-Approval Submission Form.
Post-Approval Submission Form
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.
- 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.
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 General Template
- 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 – General (Not 2018 Common Rule Compliant)
- HRP-502 Template – Consent Pregnant Partner: Submit this template for IRB review only if the research team has identified a pregnant partner of an individual enrolled in a clinical investigation of a medical drug or device.
- 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 – Emergency Use
Resources for Consent Form Language
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 page.
- Sponsor Fee Form (Use for studies receiving any industry funding)
- Reliance Fee Form (Use for studies involving a reliance agreement)
- 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.
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.
- COMMON MISTAKE: Do NOT submit any of the above HIPAA Authorization Forms to the IRB.
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.
- English (Contact the IRB Prior to Using the English Short Form)
* Not approved by the National Cancer Institute (NCI) IRB
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.
Calculation of Approval Intervals
Communication of Review Results
Evaluation of Quorum and Expertise
Determining Common Rule Version
Human Research Determination
Eligibility for Review Using the Expedited Procedure
Criteria for Approval and Additional Considerations
Requirements for Informed Consent
- HRP-316 Payments
Short Form of Consent Documentation
Additional Federal Agency Criteria
Scientific or Scholarly Review
Review of Information Items
Criteria for Approval and Additional Considerations HUD
Contract Items Related to Human Subject Protections
Clinical Trials Contraception
Review of Local Research Context
Research Involving Communities
Waiver or Alteration of the Consent Process
Waiver of Written Documentation of Consent
Neonates of Uncertain Viability
Cognitively Impaired Adults
Non-Significant Risk Device
Waiver of the Consent Process for Emergency Research
Investigator Quality Improvement Assessment
Minutes Quality Improvement Assessment
HIPAA Waiver of Authorization
External IRB Review of UC Davis Human Subject Research
- UC Davis Human Research Protection Plan
- UC Davis IRB Standard Operating Procedures
- Ancillary Reviews
- HRP-103 Investigator Manual
- IRB TIP: The IRB requires that all principal investigators review and agree to comply with the Investigator Manual before and during their research.