FDAs recognition of IRB https://www.fda.gov/dow
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Posted On: 03/09/2017 10:30:54 PM
FDAs recognition of IRB
https://www.fda.gov/downloads/RegulatoryInfor...294729.pdf
As defined at 21 CFR 312.3(b), an IEC is “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.” We consider an IEC to be “adequately constituted” if it includes a
reasonable number of members with the qualifications and experience to perform the
IEC’s functions. One type of IEC is an institutional review board (IRB) as defined in 21
CFR 56.102(g) and subject to the requirements of 21 CFR part 56. Another type of IEC
is one that adheres to section 3.2.1 of ICH E6. Compliance with 21 CFR part 56 or ICH
E6 is not required, however, for an IEC to be considered “adequately constituted” under
21 CFR 312.120. We have expressly allowed for flexibility in how to meet the
requirements of this regulation in recognition that the organization and membership of
IECs may differ among countries because of local needs.18 For more information on IEC
membership, see Section III.B.6 of this guidance document, below.
https://www.fda.gov/downloads/RegulatoryInfor...294729.pdf
As defined at 21 CFR 312.3(b), an IEC is “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.” We consider an IEC to be “adequately constituted” if it includes a
reasonable number of members with the qualifications and experience to perform the
IEC’s functions. One type of IEC is an institutional review board (IRB) as defined in 21
CFR 56.102(g) and subject to the requirements of 21 CFR part 56. Another type of IEC
is one that adheres to section 3.2.1 of ICH E6. Compliance with 21 CFR part 56 or ICH
E6 is not required, however, for an IEC to be considered “adequately constituted” under
21 CFR 312.120. We have expressly allowed for flexibility in how to meet the
requirements of this regulation in recognition that the organization and membership of
IECs may differ among countries because of local needs.18 For more information on IEC
membership, see Section III.B.6 of this guidance document, below.
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