Although injuries are not per se a reportable event (unless they also meet the definition of a unanticipated problem), the SMART IRB Agreement specifically calls out research-related injuries as needing to be reported to the Reviewing IRB because many institutions view injuries as inherently significant enough that the IRB should know about them and make the judgment call about whether they constitute unanticipated problems, rather than leaving sole judgment of whether an injury needs to be reported to the study investigator.
Articles in this section
- 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?
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