Are there special IRB procedures required to address complaints or concerns?
YES! The Informed Consent process MUST provide prospective participants with contact information for a research team in the event they want to ask questions and voice concerns or complaints to the investigator. The Informed Consent process MUST also provide prospective participants with contact information for the Campus IRB, as a person independent of the research team, in the event the research staff can’t be reached; or the participant wishes to speak with someone other than the research team about question/concern/or complaints about the research team.
