IRB — Appeals, Problems, and Non-Compliance

Appeals

  • The Institutional Review Board will deny a research application if they believe the risks outweigh the benefits of the research. If the investigator disagrees with the Board's disapproval decision, the researcher may make an appeal. The researcher may re-submit the same application form, a letter of appeal presenting the researcher's arguments for approval, and any other pertinent information in support of the appeal
  • The appeal application may be submitted via email or as a hard copy and should be directed to the Chair of the IRB. Applications submitted for appeal are considered by the entire board. The decision of the IRB is delivered in writing and via email to the investigator. If the appeal application is not approved, the research cannot be conducted
  • If a researcher questions the conduct of the IRB or feels that his/her appeal was unfairly denied, he/she may make an appeal directly to the vice president for academic affairs


Reporting of Unanticipated Problems, Serious or Continuing Non-Compliance, and Suspensions or Terminations of IRB Approval

  • Investigators must immediately report to the IRB any adverse effects, events, or unanticipated problems involving risks to subjects or others. The IRB chair must report such events to the vice president for academic affairs, the sponsors of the research, and OHRP
  • Upon receiving knowledge of adverse effects, events, other unanticipated problems involving risks to subjects, or serious non-compliance, the IRB chair will inform the vice president of academic affairs, who will determine the next immediate course of action
  • In cases where there is significant risk of injury to participants, the IRB chair has the authority to suspend the research until a more thorough review can take place. The vice president for academic affairs will notify OHRP as soon as possible after the verification of a report of adverse event or non-compliance
  • Following the immediate response to reports of adverse effects, events, serious non-compliance, or other unanticipated problems involving risks to subjects noted above, the IRB may take one or more of the following actions:

      1. Suspend the study pending further investigation

      2. Terminate IRB approval and require the study to be closed (with appropriate protections for avoiding harm to enrolled participants)

      3. Require further training for the investigator as a condition of review for future research

IRB Resources