Monmouth Medical Center (MMC), a New Jersey hospital, received a warning letter from the U.S. Food and Drug Administration (FDA), after an inspection of its Institutional Review Board (IRB) found it failed to follow regulations meant to protect clinical trial participants, including for pediatric studies. In the warning letter, the FDA says the hospital’s IRB failed to document whether it reviewed certain studies involving children to ensure the studies provided additional safeguards for children in compliance with 21 CFR Part 50 Subpart D. The FDA further cited MMC for its IRB reviewing research proposals without a majority of its members present, and in instances when quorum was lost due to a member of the IRB having a conflict of interest. The FDA found studies in two instances when only 5 of the board’s 10 members were present and another two instances where only 6 of the 10 IRB Members were present and voted. In November, FDA issued a new draft guidance intended to clarify how IRBs should record their activities, including voting and other decisions related to FDA-regulated studies.
The attorneys at Frier Levitt advise hospitals and clinicians on issues related to clinical trials and research. The attorneys at Frier Levitt can review and update your hospital’s clinical research policies and procedures to ensure compliance with a vast array of federal law and requirements. If you need assistance, contact Frier Levitt today.
