In This Section
The IRB has created an Investigator Manual that outlines the duties and responsibilities of investigators engaged in human subjects research at the University of California, Davis. The IRB requires that all first time and current principal investigators review and comply with this manual before and during their research. UC Davis has adopted a Human Research Protection Program Plan that outlines our responsibility to the UC Davis research community. View our Standard Operating Procedures here.
The IRB has adopted the IRBNet suite of tools, accessible via the internet, bringing electronic protocol management, on-line submission and many other important research oversight features to the University of California, Davis research community. For more information visit our IRBNet webpage.Forms are also located in IRBNet within the “Forms and Templates” section.
- HRP-210 Request for Determination
- Fee Forms:
- Modification Summary Table
- Response Memo
- Project Events Summary Table
- HIPAA Authorization for Research (Version 2017)
HIPAA Authorization Version 2017 is required for studies initially approved on or after June 1, 2018
NOTE: Do not include the HIPAA Authorization in Submissions to the IRB. For questions regarding HIPAA Authorizations, please contact the Compliance Department.
Templates are also located in IRBNet within the “Forms and Templates” section.
- HRP-502 Consent Form (12/04/18 Removed Clinical Trials Consent Template and added General Consent Template compliant with 2018 Common Rule)
- HRP-502 Template – General
- HRP-502 Template – General (2018 Common Rule Compliant)
- HRP-502 Template for Minimal Risk Specimen Research (2018 Common Rule Compliant)
- HRP-502 Template for Survey/Interview Research (2018 Common Rule Compliant)
- HRP-502 Template – Exempt Research (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.
- Surrogate Consent
- HRP-503 Protocol Templates
Letter – School Permission to Conduct Research (08/27/14)
Consent Document – Emergency Use (06/01/15)
Consent Document – Short Form (07/01/14)
NOTE: 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