Unanticipated Problems: Information and Guidance
Information
Historically, federal regulations have required research teams to report all adverse events to the Institutional Review Board (IRB); however, the regulations for the protection of human subjects only require require that there be:
"written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head any unanticipated problems involving risks to subjects."
OHSU has developed written policies and procedures in accordance with this federal requirement to support a more appropriate monitoring and reporting sytem.
Background: Why the Change?
OHSU's Policies
Unanticipated ProblemsData and Safety Monitoring
Helpful Documents
OHRP Analysis of On Protocol Events
PowerPoint Presentations from Educational Launch Session
Frequently Asked Questions (FAQs)
