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)
Failure to maintain and operate as per written procedures required to perform proper functions of an IRB

  • A procedure for ensuring that the IRB reviews and approves proposed research

  • A procedure for reporting all IRB findings and actions to the investigator and the institution.

  • A procedure for ensuring that changes in approved research are reviewed by IRB before initiating those changes except where necessary to avoid immediate risk to the subjects.

  • A procedure for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any instance of serious or continuing noncompliance with the regulations or the requirements or determination of the IRB.

  • A procedure for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any suspension or termination of IRB approval.
    In this warning letter FDA asked for detail response from an IRB within 15 days. IRB should include all corrective and preventive actions to comply with applicable regulations.

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 info@mdiconsultants.com

Any questions on this new FDA rule please email us at info@mdiconsultants.com and Ref: Informed Consent requirements.