Subject Complaints and Injuries
- What constitutes a significant subject complaint that must be reported to the Reviewing IRB?
- Who is responsible for addressing a subject's complaint?
- Why does the SMART IRB Agreement require Relying Institutions to report research-related injuries if the events do not also represent unanticipated problems?
- Why is the Relying Institution responsible for ensuring consistency in financial coverage for research-related injuries between the approved protocol and consent form and the provisions of a grant or contract?
- Why does the SMART IRB Agreement require Site Investigators to notify the Reviewing IRB of any subject complaints and any subject injuries?
- What is a "significant" subject complaint as contemplated by the Agreement?