The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Monmouth Medical Center, a New Jersey hospital, 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.
Specifically, the IRB failed to adequately document whether clinical investigations involving pediatric subjects were in compliance with FDA regulations, or document why IRB members failed to recuse themselves from deliberation and voting when they had a clear conflict of interest.
These issues raise "concerns about the adequacy of the IRB's review process," the letter states.
When reached for comment, Elizabeth Brennan, regional director of marketing and public relations at Barnabas Health, Monmouth's parent company, said the hospital had already taken actions to correct the issues cited in the letter.
"This week, Monmouth Medical Center received a response from the FDA in which the Agency acknowledged Monmouth's response and corrective action plan and noted that no further response is required," Brennan told Focus via email.
In November, FDA issued a new draft guidance intended to clarify how IRBs should record their activities, including voting and other decisions related to FDA-regulated studies.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 warning letter, dated 10 November, was sent following an inspection that took place over 20 days last April as part of FDA's Bioresearch Monitoring Program, which reviews clinical studies to ensure they are accurate and adequately protect the rights and safety of participants.
First, 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.
According to the letter, the hospital said the IRB would review one of the study protocols, identify any groups of vulnerable subjects in the study and review and revise its standard operating procedures and IRB checklist for studies involving children.
Second, FDA says the IRB reviewed 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 inspection found Monmouth's IRB voted on studies in two instances when only five of the board's 10 members were present.
In two other cases, six of 10 IRB members were present and voted. In each of these cases one of the six members was the principal investigator on the research being reviewed and should not have counted toward the votes.
Lastly, FDA said it found discrepancies between the IRB's meeting minutes and documents the IRB sent in response to a Form 483 that preceded the warning letter. According to FDA, minutes from a February 2013 meeting showed that an IRB member involved with three studies voted in their review, though letters from the hospital later stated that member abstained.