- Request for Determination
- Protocol Templates
- Consent Form Templates
- Fee Forms
- Post-Approval Submission Resources
- HIPAA Authorization Form
- HRP-507 Consent Document – Short Form
Related Topics
- Does my Project Need Review by the IRB
- How to Submit to the IRB
Electronic Forms on IRBNet
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 “Form Complete” page of the Initial Review Application.
Post-Approval Submission Form
Any submissions to the UC Davis IRB after initial approval (i.e., modifications, reports of new information, continuing reviews, closures) should include a Post-Approval Submission Form, which is also an electronic form to be completed on IRBNet. For a complete list of documents to be included in your specific post-approval submission to the IRB, please see the “Form Complete” page of the Post-Approval Submission Form.
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.
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.
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.
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)
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)
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.
COMMON MISTAKE: Do NOT submit any of the above HIPAA Authorization Forms to the IRB.
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.
* 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.
- HRP-301
Review Materials - HRP-302
Calculation of Approval Intervals - HRP-303
Communication of Review Results - HRP-304
IRB Composition - HRP-305
Evaluation of Quorum and Expertise - HRP-306
Drugs - HRP-307
Devices - HRP-308
Pre-Review - HRP-309
Determining Common Rule Version - HRP-310
Human Research Determination - HRP-311
Engagement Determination - HRP-312
Exemption Determination - HRP-313
Eligibility for Review Using the Expedited Procedure - HRP-314
Criteria for Approval and Additional Considerations - HRP-314B
Requirements for Informed Consent - HRP-315
Advertisements - HRP-316
Payments - HRP-317
Short Form of Consent Documentation - HRP-318
Additional Federal Agency Criteria - HRP-319
Approval Periods - HRP-320
Scientific or Scholarly Review - HRP-321
Review of Information Items - HRP-322
Emergency Use - HRP-323
Criteria for Approval and Additional Considerations HUD - HRP-324
Contract Items Related to Human Subject Protections - HRP-325
Clinical Trials Contraception - HRP-331
FERPA Compliance - HRP-332
Review of Local Research Context - HRP-333
Research Involving Communities - HRP-334
Reliance Agreement
- HRP-401
Pre-Review - HRP-402
IRB Review - HRP-410
Waiver or Alteration of the Consent Process - HRP-411
Waiver of Written Documentation of Consent - HRP-412
Pregnant Women - HRP-413
Non-Viable Neonates - HRP-414
Neonates of Uncertain Viability - HRP-415
Prisoners - HRP-416
Children - HRP-417
Cognitively Impaired Adults - HRP-418
Non-Significant Risk Device - HRP-419
Waiver of the Consent Process for Emergency Research - HRP-430
Investigator Quality Improvement Assessment - HRP-431
Minutes Quality Improvement Assessment - HRP-441
HIPAA Waiver of Authorization - HRP-442
External IRB Review of UC Davis Human Subject Research
Additional Resources
- UC Davis Human Research Protection Plan
- UC Davis IRB Standard Operating Procedures
- Ancillary Reviews
- HRP-103 Investigator Manual
