Minneapolis-based Hennepin Healthcare on June 25 shared plans to halt a clinical trial on ketamine after being criticized for allegedly enrolling patients before getting their consent, according to the StarTribune.
Here are six things to know:
1. Ketamine is a sedative paramedics often use to calm agitated patients. The study, which Hennepin Healthcare launched in August 2017, does not require patients given ketamine to consent to their information being used for research. Instead, the study allows individuals to retroactively opt out, according to a seperate StarTribune report.
2. State Sen. Jeff Hayden (DFL, District 62) and Hennepin County Commissioner Peter McLaughlin called the hospital's clinical trial "unconscionable and unethical," in a June 25 statement cited by StarTribune.
3. However, Hennepin Healthcare believes it has followed federal research procedures.
"Hennepin Healthcare would never conduct research without appropriate consent from patients involved," hospital spokesperson Christine Hill said in a June 25 statement cited by StarTribune. "However, due to the concerns that have been expressed we have decided to put the study on hold at this time. In addition, we are committed to a much higher level of transparency and community dialogue, well beyond the federal regulations."
4. Hennepin Healthcare appeared before the Hennepin County Board June 26 to present a report of their ketamine study.
5. Much of the controversy surrounding the study stems from a draft police oversight report the StarTribune cited in a June 15 article, which questioned some paramedics' use of ketamine in emergency situations. In one case, a paramedic administered an injection of ketamine to a woman begging for an asthma pump after being maced by a police officer.
6. Hennepin Healthcare physicians defended the hospital's use of ketamine and said the study's consent procedures are both legal and ethical.
“Anytime that we interact with EMS about this, we emphasize to them, crystal clear: In no way is the study ever to increase the number of sedations,” Jon Cole, MD, an emergency physician and toxicologist at Hennepin Healthcare told StarTribune.
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