Independent Ethics Committee [Food and Drugs] Law and Legal Definition
Pursuant to 21 CFR 312.3 [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter D Drugs for Human Use; Part 312 Investigational New Drug Application; Subpart A General Provisions], Independent Ethics Committee (IEC) means “a review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection. An institutional review board (IRB), as defined in § 56.102(g) of this chapter and subject to the requirements of part 56 of this chapter, is one type of IEC.”
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