Complaint filed over ketamine research without prior consent

A consumer rights group has filed a complaint alleging a Minneapolis health care provider ignored ethical practices and federal safeguards when it researched the effect of the powerful sedative ketamine on more than 100 participants without their prior consent.

The Public Citizen complaint asks the Food and Drug Administration and the Office for Human Research Protection to investigate whether Hennepin Healthcare complied with federal regulations during clinical trials of ketamine . In the trials, paramedics sedated people before taking them to the hospital.

The federal complaint alleges researchers put patients at unnecessary risk and enrolled them in the study without their prior consent, The Star Tribune reported. The complaint also accuses the hospital's Institutional Review Board of failing to fulfill its duty by allowing researchers to enroll members of the public in the study without consent.

"The subjects deserve an apology for that failure," said Dr. Michael Carome, director of Public Citizen's Health Research Group. "And this could just be the tip of the iceberg."

The hospital accreditation ensures it follows "rigorous standards for ethics, quality, and protections for human research," said Hennepin Healthcare spokesman Thomas Hayes.

Dr. William Heegaard, the hospital's chief medical officer, has defended the research practices as ethical and in line with federal guidelines.

But the hospital has declined to release records that would show how they complied with the standards and what precautions researchers took to protect patients.

"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," Heegaard said.

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Information from: Star Tribune, http://www.startribune.com