Update – February 4, 2011
Warning letter to Institutional Review Board (IRB)
The role of IRB is to review, to approve the initiation of and to conduct periodic review of biomedical research involving human subjects. IRB should safeguard the rights, safety and well-being of all trial subjects. To perform all functions of IRB, IRB should be must comply with all applicable provisions of the 21 CFR Part 56. FDA inspects IRB to confirm that IRB is performing its functions and also to ensure compliance with 21 CFR Part 56.
FDA recently (August 24, 2010 to September 24, 2010) conducted an inspection of an IRB located in California. It was conducted in response to the data submitted in applications such as Investigational Device Exemptions (IDE), Premarket Approval (PMA) applications, and Premarket Notification submissions (510(k). Another intention of an inspection is to ensure that IRB is performing its function of safeguarding rights, safety and well-being of the subjects under clinical investigations.
During this Inspection FDA investigator issued FDA form 483 and listed various violations as follows:
1. Noncompliance with 21 CFR 56.107(a), (c), and (e)Failure to ensure that the IRB is composed of at least five members; at least one IRB member is from nonscientific background; and no IRB member participates in the initial or continuing review of any projects in which the member has a conflict of interest.
2. Failure to comply with 21 CFR 56.108(a),
(b), and (c)
For more information on this issue you can go to the following link: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm240960.htm or contact mdi at firstname.lastname@example.org
Any questions on this new FDA rule please email us at email@example.com and Ref: Informed Consent requirements.
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