Community forum on Ketamine use raises issue of patient consent

- About two dozen community members gathered in Minneapolis Saturday to hear from a panel of professionals who have taken special interest in the use of Ketamine by Hennepin County first responders.

Communities United Against Police Brutality held the forum at their South Minneapolis office. The panel included University of Minnesota bioethics professor Carl Elliott, attorney with the Legal Rights Center Andrew Gordon, and civil rights attorney Zorislav Leyderman.

The panelists said they were extremely concerned with the study conducted by Hennepin Healthcare EMS, which aimed to look at whether Ketamine was a good sedative option when dealing with highly agitated patients at risk of hurting themselves or others.

“None of the subjects even agreed to be in the experiment,” said Elliott. “In fact they weren’t even told they were in an experiment until later.”

Gordon says he represents at least one client who believes he was dosed with Ketamine.

“Patients were supposed to get a paper saying they were involved in a ketamine study,” said Gordon. “We have yet to speak to anyone who has gotten one of those notices.”

Organizers asked attendees to contact Hennepin Healthcare and the city of Minneapolis and demand consent in such studies. They also encouraged individuals to contact the hospital and ask that the study never resume. The study was put on hold at the end of June.

In a statement, Minneapolis Police Spokesperson John Elder said, “For us to speak before the investigation is complete would be inappropriate… We look forward to the thorough, professional, and complete investigation that Ms. Yates will deliver,” referring to former U.S. Deputy Attorney General Sally Yates who the city hired to lead an external investigation into the matter.

Hennepin Healthcare said in a statement:

We are committed to transparency and retaining the public's trust and independent outside reviews help us to do that. To that end, we are participating in ongoing internal and independent external reviews. These include the Minnesota EMS Regulatory Board review, as well as two independent external reviews that are looking at our research and clinical protocols.    

In addition, our IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and has been since 2011. AAHRPP accreditation verifies that an organization follows rigorous standards for ethics, quality, and protections for human research. Our IRB is currently undergoing the usual reaccreditation review process by AAHRPP and we look forward to the results of the evaluation of our standards by this respected external peer review accreditation agency. 

To ensure that the external reviews are completed with integrity and independence, we will provide information requested by reviewers to help them complete their work. At the conclusion of these reviews, we expect that the Institutional Review Board data will be public and we also look forward to sharing conclusions of the independent outside reviews.

Hennepin Healthcare respects the important concerns regarding community awareness of medical studies and is committing to a higher level of transparency that goes beyond federal regulations to ensure greater community engagement in our work to improve patient care.

For more information about Ketamine, visit HCMC's web page

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