Protocol Preparation Checklist


Please review this checklist to ensure that your human subjects application packet is complete before you submit the application and protocol to the IRB for review.

  • All applicable sections of the IRB application and Protocol Narrative should be completed.
  • The Lead Researcher has either a paid UCI faculty appointment greater than or equal to 50% or a Faculty Sponsor.
  • The Lead Researcher must complete and sign the Disclosure of Investigators' Financial Interest, and Investigator's Assurance form.
  • The Faculty Sponsor, if required, should sign the Investigator's Assurance form.
  • All Departmental and/or Research Unit approvals should be secured.
  • If using an experimental drug/device, the IND or IDE number and filing date are provided in the IRB Application.
  • All potential co-investigators and research personnel have been listed as appropriate (in application and protocol narrative, on consent if involved in the informed consent process). Each research team member's role on the project is clearly defined in the narrative.
  • The purpose of the research is explained adequately.
  • The subject population and size is justified in the context of the proposed research (Consider providing a power analysis, if appropriate).
  • Equitable inclusion of women and minorities has been assured.
  • The proposed recruitment and consent methods guarantee voluntary participation. If the proposed subject population may be vulnerable to coercion, explain how this will be minimized.
  • Subject inclusion/exclusion criteria explained in sufficient detail.
  • Adverse event reporting and treatment is addressed.
  • All activities involving subjects are thoroughly explained.
  • Probable risks to participants and potential benefits to participant and society are explained adequately.
  • The consent form addresses all areas required by federal regulations and is written at the eighth-grade level or lower.
  • Data collection instruments and/or citations are provided.
  • If research will take place off site, proper documentation (permission letter, Federalwide Assurance for off-site entity, off-site research agreement, etc.) has been obtained or is in progress.
  • If research will be funded by an external sponsor (grant, contract, or gift), proposal paperwork has been filed with Sponsored Projects.
  • All applicable approvals for other committee reviews have been obtained or are in process.
  • Recommended Reading, "Common IRB Submission Errors."
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