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/ Request to Rely on an External IRB Cover Sheet
Version 04.17.2019
Section A. Study Information
Protocol Title: / Click or tap here to enter text. /
Principal Investigator Name, Email, Phone: / Enter the name of UC Davis PI and contact information. /
Primary Contact Name, Email, Phone: / Provide the UC Davis Contact Information if different than above. /
Section B. Eligibility Considerations
1. / ☐ Yes☐No / This project is eligible for exemption determination or is not human subjects research (NHSR).
  • If the answer is “Yes” – STOP. This project is not eligible for a reliance request. Submit an application for review or request for “NHSR” determination to UC Davis IRB via IRBNet.
  • If the answer is “No”, complete this form and submit it with required documentation as noted in Section C. UC Davis may rely on an external IRB on a case-by-case basis. The IRB will review the request and inform you of the determination.
  • If you are unsure, contact the IRB Education Team at .

2. / The proposed IRB of Record is:
☐ Advarra IRB☐ Western IRB (WIRB)
☐ Other UC Campus: Click or tap here to enter text.
☐ Other IRB (name and contact information): Provide the name of the external IRB and their contact information.
3. / ☐ Yes☐No
☐Yes☐No
☐Yes☐No / The study is funded.
  1. By: If funded, enter the name of the funding source(s) here.
  2. If federal, name the primary grantee: Click or tap here to enter text.
The funding source will pay external IRB fees.
The funding source will pay UC Davis Administration fees.
4. / ☐ Yes☐No / The proposed IRB of Record is identified as the central IRB by the Sponsor or Grant.
5. / ☐ Yes☐No / The study has current approval by the proposed IRB of Record.
If yes, provide basic review information.
  1. The IRB determined the study to be: ☐ Minimal Risk ☐ Greater Than Minimal Risk
  2. The Initial Review was conducted by: ☐ Expedited Procedure☐ Full Board

6. ☐ Yes ☐No / PI Assurance: I attest, as the UC Davis PI, that all UC Davis personnel assigned to this study are qualified to perform the protocol procedures assigned to them, have completed required CITI/NIH training, have reported any and all conflicts of interest to the UC Davis Conflict of Interest Committee, and will receive appropriate training on the protocol prior to engaging in research activities.
7. / UCD personnel will: (select all that apply)
☐ Access medical records for recruitment purposes
☐ Access medical records and/or private identifiable information for purposes of the study
☐ Recruit subjects and/or answer questions about the study before consent is obtained
☐ Be involved in the consent process (conduct the consent process or answer questions)
☐ Communicate or interact with subjects for research purposes
☐ Observe subjects without interacting or communicating with the subjects
☐ Alter or manipulate the subjects’ environment or administer research related procedures
☐ Be involved in activities not listed in the protocol
☐ Other: Briefly describe the activities: Briefly describe the activities here.
8. / ☐ Yes☐No Do any personnel involved in the design, conduct or reporting of the protocol have a
related financial interest in this research?
  1. If yes, briefly describe the activities: Briefly describe the nature of the related financial interest here

Section C. UC Davis IRB Submission Checklist
Submit to UC Davis IRB via IRBNet the following documents listed below. For documents requiring IRB approval, submit the document that has approved by or will be submitted to the external IRB:
  • This completed Cover Sheet
  • The Initial Approval Document from the proposed IRB of Record
☐ N/A – the study has not been approved by the proposed IRB of Record yet
  • HRP-226 Administrative Approvals
  • Online Initial Review Application
  • Protocol
  • Consent Document(s)
  • Recruitment Materials
  • Investigator Brochure / Product Insert
  • UC Davis Ancillary Approvals, when applicable
See information at http://research.ucdavis.edu/policiescompliance/irb-admin/researchers/ancillary-revs/
  • Sponsor Fee Form (when applicable)

Section D. Determination
If this study qualifies for External IRB oversight.
UC Davis IRB will seek to secure an agreement with the proposed IRB of record and provide further instructions via IRBNet. / If this study does not qualify for External IRB oversight.
The IRB Reliance Team will contact the PI and the listed contact person with the determination and provide further instructions for moving forward.