IEC

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 of this chapter and subject to the requirements of part 56 of this chapter, is one type of IEC.

Source

21 CFR § 312.3


Scoping language

The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this part:

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