IRB Forms
In This Section
Related Topics
For Researchers
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.
IRBNet – Online Submission Process
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
Forms are also located in IRBNet within the “Forms and Templates” section.- HRP-210 Request for Determination
- HRP-212 Continuing Review Progress Report (11/06/19)
- HRP-212 Continuing Review Relying sIRB Site (11/22/19)
- Sample Reportable New Information Summary Table (12/02/13)
- HRP-213 Modification (03/10/16)
- HRP-214 Reportable New Information (11/06/19)
- HRP-226 Administrative Approvals (06/03/15)
- Sponsor Fee Form
- Sponsor Fee Form-Reliance-UCD IRB Relying
- Sponsor Fee Form-Reliance-UCD IRB of Record
- Response Memo
- Project Events Summary Table
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.
- HIPAA Authorization for Research (Version 2017)
Templates
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.
- HRP-503 Protocol Templates
- HRP-504
Letter – School Permission to Conduct Research (08/27/14) - HRP-506
Consent Document – Emergency Use (06/01/15) - HRP-507
Consent Document – Short Form (07/01/14)
For IRB Administration
NOTE: 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
Non-Committee 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