What is the difference between emergency use and compassionate use?
While the term emergency use refers to the immediate need for an investigational agent to be used in a person with a life threatening situation, compassionate use refers to the use of investigational agents in patients who would otherwise not qualify for enrollment into a clinical trial or who are otherwise not eligible to participate in existing research trials. Although the two terms are often misused interchangeably, they refer to very different courses of action and require completely different IRB review. Most notably, although emergency use can commence immediately, with a five day grace period of IRB notification, compassionate use requires the prospective full Board review and approval of the requested use before the patient can be treated. Compassionate Use is a special type of research activity and therefore mirrors the requirements of a typical research study: It requires a principal investigator, a protocol, permission and distribution of the agent by the manufacturer/spons
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