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  1. SMART IRB Support Center
  2. The SMART IRB Agreement
  3. Subject Complaints and Injuries

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?
SMART IRB Support Center