Healthcare experts have called for a federal investigation into a Minnesota hospital's clinical trials, which sedated patients with different drugs without their consent, according to The Washington Post.
Here are five things to know:
1. Minneapolis-based Hennepin Healthcare has conducted several studies on the use of ketamine, a powerful sedative used by paramedics when responding to calls of severely agitated or aggressive individuals, according to the report. The health system's most recent study, which began in August 2017, did not require patients' or caregivers' consent to be involved in the research. Patients were reportedly told after the fact that they had become part of the experiment.
2. Hennepin suspended the clinical trial in June after Star Tribune reported on the trials earlier the same month, drawing attention and criticism. Federal laws require that patients consent before participating in research trials and be informed of all possible risks and benefits before enrollment. Exceptions are made in specific circumstances after an institutional review board determines the process may be waived.
3. Bioethicists, led by consumer advocacy group Public Citizen, recently sent a letter to the FDA and the HHS' Office for Human Research Protections regarding Hennepin Healthcare's trials, stating the health system's research efforts did not meet the criteria for patients' consent to be waived, The Washington Post reports.
4. A spokesperson for the health system told the publication Hennepin is "committed to transparency and retaining the public's trust and independent outside reviews help us to do that."
5. An FDA spokesperson told The Washington Post the agency does not comment on specific clinical trials, but stated: "With few exceptions, patients have a right to informed consent before participating in a clinical trial. The FDA takes seriously reports of possible violations of the laws in place to protect human participants and will take action where warranted."
To access The Washington Post's report, click here.