Warning Letter Hits IRB Over Allegedly Poor Controls
In a rare warning letter to an institutional review board, CDER’s Office of Scientific Investigations contends that an IRB at Monmouth Medical Center was lax in supervising research at the facility.
According to the letter, Monmouth’s IRB did not provide sufficient scrutiny to pediatric research, conducted business without a quorum of members and failed to adequately track IRB activities, all of which violate federal rules.
The agency’s first complaint relates to the IRB’s handling of two clinical trials involving children. While the FD&C Act requires IRB’s overseeing pediatric trials to formally document that the research meets certain conditions of safety and data significance, Monmouth’s IRB purportedly had no records of such a determination. Details on the trials involved were redacted from the letter.
“Failure to determine that the additional safeguards for children in research are met may expose this vulnerable population to unnecessary risks, and may result in the child’s parent(s) or guardian(s) not being fully informed about the proposed research,” according to the letter.
The warning letter also contends that Monmouth’s IRB held four meetings between 2012 and 2014 without a quorum, rendering decisions made during those meetings suspect. According to the FDA, while one of the cited meetings had six members, the meeting covered research conducted by one of the board members, who should have recused himself or herself but failed to do so, thereby invalidating the quorum.
Lastly, the FDA identified apparent discrepancies with the IRB’s records. The FDA notes that the minutes from a February 2013 meeting show that one board member approved research discussed during the gathering, but a series of letters from 2015 state that this board member abstained from voting. Additionally, the FDA argues that several of the meetings involved board members participating in discussions of their own research prior to the IRB voting, which constitutes a conflict of interest.
All of the allegations stem from a check of the IRB’s records conducted in May, the letter states.
Monmouth officials told CTA that the FDA acknowledged the IRB’s response to the letter and its corrective action plan and said that no further response was required. Read the warning letter here: www.fdanews.com/02-02-16-WarningLetter.pdf. — Cameron Ayers
Subscribe to Clinical Trials Advisor NOW and save $200 off the regular one-year price of $645 — plus receive a FREE copy of our webinar CD, Electronic Informed Consent for Biobanks – a $287 value!
LINKS TO KEY DOCUMENTS — Need to read regulatory references, guidances, enforcement actions, and other documents? Simply click on the source documents in your electronic issue.
ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.
Copyright ©2018. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing