Minneapolis hospital enrolled ER patients in ketamine studies without consent, FDA finds

Federal inspectors found Minneapolis-based Hennepin County Medical Center tested antipsychotics and ketamine on emergency room patients without their consent, which violates human research regulations, according to STAT.

Here are five things to know:

1. In July 2018, Public Citizen and 64 bioethicists, physicians and medical scholars submitted a complaint about two of Hennepin's ketamine studies to the FDA and HHS.

2. FDA inspectors visited the hospital in August and found Hennepin's institutional review board "did not determine that informed consent would be sought from each prospective subject," in four studies. The IRB also offered fast-track review for five other studies that did not qualify for it. At least three of the studies involved people brought into the ER with severe agitation. Study leaders allegedly persuaded the IRB that these patients could not provide informed consent and therefore included them as unknowing clinical trial participants, according to the FDA's report, which Public Citizen obtained through a public records request and shared with STAT.

3. Public Citizen and two professors from Minneapolis-based University of Minnesota wrote a letter to the FDA and HHS Oct. 29 after the report was released, urging the agencies to suspend all clinical trials at the hospital. IRB, which is legally responsible for protecting research participants, "appears to lack even a basic understanding of federal regulations for the protection of human subjects and is clearly incapable of fulfilling its obligation," the letter read.

4. The letter also calls for Hennepin to replace its current IRB with a newly trained group, retrain researchers involved with clinical trials at the hospital and inform past trial participants of their unknown involvement.

"[The hospital put patients in danger] including by waiving the requirement for informed consent in situations where that is not allowed," Michael Carome, MD, director of Public Citizen's Health Research Group and the letter's organizer, told STAT.

5. A spokesperson for Hennepin County Medical Center said the FDA's findings were not formal or conclusory.

"[Hennepin] has provided formal written responses to each of the inspectors' findings and has undertaken several reviews by independent experts to evaluate its research and emergency medical practices with the intent to improve our processes. …We understand our mission includes providing the highest standards of medical care, and also conducting studies that help to continuously improve the health and wellness of our patients," the hospital said in a statement to STAT.

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