Home Challenged Sites Site Watch: FDA Inspection Finds Hennepin Violated Informed Consent Rules

Site Watch: FDA Inspection Finds Hennepin Violated Informed Consent Rules


Michael Mezher writing for RAPS’ Regulatory Focus reports on a troubling report of informed consent and IRB rule violations involving Hennepin County Medical Center. TrialSite News covered the news a couple months ago where Hennepin was dosing emergency patients with ketamine and other sedatives without the patients consent—see TrialSite News link: https://www.trialsitenews.com/more-news-on-the-hennepin-ketamine-study/

The whole incident started back in July 2018 when the Star Tribune reported on disturbing information involving ketamine and emergency room patients lack informed consent; Public Citizen around that time reported the incidents to the Department of Health and Human Services Office for Human Research Protections (OHRP) to investigate the hospital’s ongoing activities.  In August the FDA conducted an inspection. The study centered on the evaluation of safety and effectiveness of ketamine compared to either haloperidol or midazolam to manage pre-hospital agitation. Public Watch was quoted “the medical center’s IRB appears to lack even a basic understanding of federal regulations for protection of human subjects and is clearly incapable of fulfilling its obligation to protect the rights and welfare of human subjects.”  See the link for the Public Citizen letter and FDA Form 483 https://www.citizen.org/sites/default/files/2453.pdf

Read Mr. Mezher’s article in Regulatory Focus for further details.


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