Reasons for Delay in IRB Approval

The principal reason for delays in Institutional Review Board (IRB) approval is incomplete study documentation. To assist Principal Investigators (PIs) and study personnel, we have specified below the kinds of documentation deficiencies we see most often.

  • Research team members have not completed required training – Human Research, Health Insurance Portability and Accountability Act (HIPAA) Research, and Good Clinical Practice (GCP), if applicable
  • Required signatures are missing (e.g., Department Chair, Principal Investigator, Faculty Sponsor)
  • Research is being conducted offsite and additional documentation is required (e.g., permission letter, IRB approval from other site)
  • The protocol requires review by another UT Southwestern Medical Center Committee (e.g., Cancer Center Protocol Review and Monitoring Committee, Radiation Safety)
  • Significant discrepancies exist between protocol summary and consent form (e.g., sample size, duration of research procedures)
  • Recruitment procedures and the informed consent process are not adequately explained in the protocol summary
  • Probable risks to the participants are not justified adequately and potential societal benefits are not mentioned
  • Safeguards to adequately protect data from a breach of confidentiality are insufficient (e.g., HIPAA waiver, HIPAA authorization, computer security provisions)
  • Consent form is deficient (missing required elements, includes objectionable exculpatory language and inappropriate compensation for injury language)
  • Scientific justification for exclusion of non-English speakers or provisions for responsible inclusion of non-English speaker is inadequate