FDA Warns IRB for Clinical Trial Without Patients’ Consent

The FDA has warned the IRB at a large Illinois healthcare system for enrolling emergency room patients in a clinical trial without their permission.

The trial at Advocate Christ Medical Center in Oak Lawn, Ill., involved ER patients who were given a sedative before undergoing intubation to open their airways.

The IRB originally approved the trial in December 2006 as a chart review study to evaluate the effectiveness of the sedative etomidate. The IRB waived patient consent because patients were treated before the study was conducted, and data was collected from medical records.
In 2007, the clinical investigator proposed that the study — which involved 122 patients during an 18-month period — be modified as a randomized, double-blind trial in which patients were given either etomidate or midazolam before intubation. The IRB did not lift the consent waiver after approving this modification.

In the June 1 warning letter posted recently online, the FDA notes the IRB’s approval of the randomized study made it “a clinical investigation subject to compliance with FDA regulations.” As such, the IRB was required “to determine that informed consent would be sought from each prospective subject or the subject’s legally authorized representative.”

The IRB’s failure to meet this responsibility “is particularly concerning because the concept of informed consent is fundamental to the conduct of ethical research,” the letter adds.

The warning resulted from a November 2011 FDA inspection that uncovered “objectionable conditions” at the IRB. The letter quoted the IRB as saying that until the inspection, it “did not make a connection” that FDA regulations applied to the study.

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