IRB Lands Warning Letter Over 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 — which was issued in November but not made public until last week — 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.

Monmouth officials said 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.