Common IRB Submission Errors


The UCI IRB application, the protocol narrative and consent documentation are designed to obtain information necessary for compliance with federal regulations, state statutes, and UC and UCI Policy regarding the protection of human subjects in research. The IRB Committees evaluate the application, protocol narrative, and consent document, when applicable, to assure that all procedures are adequately described and documented. The following is a list of common errors that may contribute to a delay in IRB review:

  1. The protocol requires the approval of another UCI Committee, prior to the release of final IRB approval. See Other Required UCI Review Committees.
  2. Research is to be conducted at a non-UCI site. Additional documentation is required for research conducted at a non-UCI site. (e.g., letter of cooperation, letter of approval from other site’s IRB). See Human Research Activities Performed at Other Institutions.
  3. Submission of wrong versions of narrative or consent (e.g., old version of protocol narrative, consent form for a different research study). Always provide the most recent IRB-approved versions. See Lead Researcher Recordkeeping Responsibilities.
  4. The application is incomplete; requires completion of additional documentation (e.g., complete Appendix P when requesting a waiver of written (signed) informed consent).
  5. Documentation concerns:
    1. Not addressing all Protocol Narrative instructions – for each section.
    2. Non-technical summary is overly scientific – not written in lay language.
    3. Significant discrepancies exist between the protocol narrative and consent form (e.g., sample size, duration of research procedures, description of risks).
    4. The consent form is deficient (e.g. missing required elements of consent, includes exculpatory language and inappropriate compensation for injury language).
    5. Recruitment and the informed consent process are not adequately explained in the protocol narrative.
    6. In the protocol narrative, probable risks to the participants are not adequately justified and potential societal benefits are not mentioned.
    7. Safeguards to protect personal health information and research data from an erroneous breach of confidentiality are inadequate (e.g., investigator stores personal information and research data on portable device). See Application and Forms Instructions.
  6. Research team members have not completed the required tutorials – the CITI Human Research Tutorial (required) and the UCI or CITI HIPAA Research Tutorial (required if accessing, creating, or disclosing PHI). See Electronic Research Tutorials and Videos.
suggestions and comments