'Minimal risk of harm' to unwitting participants in its ketamine study, Hennepin Healthcare says

Three reviews that Minneapolis-based Hennepin Healthcare commissioned found its paramedics and research staff acted appropriately in its ketamine study of agitated patients, which drew criticism last year, according to the Star Tribune.

The study, which Hennepin Healthcare launched in August 2017, looked at the use of ketamine — a sedative paramedics often use to calm agitated patients.

Hospital leaders asked for reviews of the study to be conducted last year after community criticism surfaced about the role of police in paramedics' sedation of patients in the field and the hospital's enrollment of those patients in a study.

The drug trial did not require patients' consent, which two Twin Cities elected officials called unethical and unconscionable. On June 25, Hennepin Healthcare suspended the study.

In the reviews, investigators found the paramedics who administered the sedatives in emergency scenarios were consistent with national standards and appeared to be well-trained. They concluded that the paramedics "demonstrated independent and appropriate clinical decision," and did not sedate patients at the direction of police officers.

The reviews said the hospital made mistakes in its description of studies and its Institutional Review Board, which is tasked with protecting patients in research, but "did not increase the risks of research participation, nor did they cause any participant to be exposed to more than a minimal risk of harm."

But Michael Carome, MD, director of the health research group for medical watchdog Public Citizen, said the review's findings are unsatisfactory and biased. He said the review findings don't comport with findings from the Minneapolis police oversight office or the FDA.

"These so-called 'independent' reviews conducted by individuals hired by Hennepin County predictably resulted in the whitewash desperately sought by the county's healthcare system," Dr. Carome told the Star Tribune. "Further action by the [FDA] and the Office for Human Research Protections is urgently needed to ensure the protection of human subjects in research conducted by Hennepin Healthcare."

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