A subject has lodged a complaint related to a study for which IRB review has been ceded to another Participating Institution. Who is responsible for addressing the subject's complaint?
The Relying Institution still retains responsibility for receiving and addressing subject complaints. Significant subject complaints must be reported to the Reviewing IRB. The Reviewing IRB, in consultation with the Relying Institution at which the complaint was received, will assess the impact of the complaint on the research study and can determine if any additional action to ensure the protection of subjects' rights and welfare would be required.