IRB Fails to Get Informed Consent

IRB Fails to Get Informed Consent

June 14th, 2012 // 1:33 pm @


One of the largest health systems in the US may have a little trouble connecting the dots. Specifically, the Advocate Health Care institutional review board was conducting a clinical trial of an intravenous anesthetic, but failed to ensure that informed consent was sought from participants. Why? Initially, the IRB was running a chart review study, but later amended the effort to randomize subjects. Hence, its study 4257 became a clinical trial.

As you know, clinical trials require informed consent. But it was not until after FDA inspectors last November reviewed operations – and issued a 483 report – that the IRB realized informed consent was lacking. “We note that in your December 19, 2011, written response to the Form FDA 483, you stated that, until FDA’s November 2011 inspection, the IRB did not ‘make a connection’ that FDA’s regulations applied to Study 4257,” the FDA writes in a June 1 warning letter.

“In order to approve research subject to FDA’s regulations, an IRB must determine that all of the requirements listed under 21 CFR 56.111 are satisfied. Among other things, the IRB must determine that informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with and to the extent required by 21 CFR Part 50 [21 CFR 56.111(a)(4)],” the agency continues.

To make amends, the clinical investigator sent letters to participants after the study was completed, but the FDA also found this lacking. Why? The IRB did not review the letter to determine whether appropriate information was provided about the study before being sent to the participants. Moreover, the letter did not inform subjects “unambiguously” that they were enrolled in a research study or “include details of the study and other information that should have been contained in the informed consent document, including information about risk to the subject,” the FDA writes.

The agency knows all this because Advocate last month submitted a response that included a protocol deviation form for study 4257 and a copy of a letter that the clinical investigator mailed to subjects. “The IRB’s failure to meet this responsibility (to ensure informed consent is pursued) is particularly concerning because the concept of informed consent is fundamental to the conduct of ethical research,” the FDA admonishes

For those unfamiliar, Advocate bills itself as one of the nation’s top 10 health systems, based on clinical performance, the largest health system in Illinois and one of the largest health care providers in the Midwest. The system operates more than 250 care sites, including 10 acute care hospitals, two integrated children’s hospitals, five Level I trauma centers (the highest designation in the state), and one of the largest home health care companies and medical groups in the region (read more here). We asked an Advocate spokesman for comment and will update you accordingly.

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