Independent ethics committee (IEC)

FDA uses this term mainly for studies outside the US, where an IEC plays the role an IRB plays in the US. An IRB under 21 CFR 56 is one kind of IEC.

Independent ethics committee (IEC) means an independent review panel that is responsible for ensuring the protection of the rights, safety, and well-being of subjects involved in a clinical investigation and is adequately constituted to ensure that protection. An institutional review board (IRB), as defined in paragraph (f) of this section and subject to the requirements of part 56 of this chapter, is one type of IEC.

21 CFR, 812.3