Complaints, Concerns, Suggestions, Questions or Requests for Information Questions/Answers
Investigators respond to participant complaints or requests for information.
Who do you contact with a complaint, concern, or suggestions?
Concern regarding ORI and IRB administrative procedures -
ORI Director Helene Lake-Bullock
(859) 257-2978 or
Concern regarding an IRB Decision:
- Contact the applicable IRB Chair
- Submit a written appeal that includes a justification for changing the IRB decision. The convened IRB reviews the appeal. The appeal determination final.
What provisions do you have in place for receiving and handling a subject complaint of request for information?
- Your protocol-specific plan described in the IRB Research Description.
- The procedures to satisfy this should offer a safe, confidential, and reliable channel for current, prospective, or past research subjects (or their designated representative) allowing them to discuss problems, concerns and questions, or obtain information.
- For greater than minimal risks studies, the IRB recommends the consent document(s) include a reliable, dedicated pager or phone number for after-hours emergencies.