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.




Who may a subject call, outside of the study personnel, about their rights and welfare?

Each IRB approved informed consent document should include the ORI toll-free phone number (1-866-400-9428) as a subject's primary contact point about their rights and welfare.