FDA Inspection Finds Minnesota Hospital Violated Informed Consent, IRB Rules

Regulatory NewsRegulatory News | 29 October 2018 |  By 

In an inspection report obtained by Public Citizen, the US Food and Drug Administration (FDA) cites the Hennepin County Medical Center over its institutional review board’s (IRB) oversight of clinical trials that involved dosing emergency patients with ketamine and other sedatives without the patients’ consent.
The inspection, which ran from 7-24 August, came after the Star Tribune reported on clinical trials conducted by the hospital and just weeks after Public Citizen called on the agency and the Department of Health and Human Services’ Office for Human Research Protections (OHRP) to investigate the hospital’s ongoing studies.
Two of the hospital’s studies sought to evaluate the safety and effectiveness of ketamine compared to either haloperidol or midazolam to manage pre-hospital agitation.
The first of those studies concluded in September 2016 and found that ketamine was much more likely than haloperidol to cause serious adverse events. The second study, which began in August 2017, was halted by the hospital in June following the Star Tribune’s reporting. In both studies, participants were not informed of their participation in a clinical trial prior to being injected with the drugs.
In light of the issues cited in the inspection report, Public Citizen is calling on FDA and OHRP to suspend the hospital’s IRB and its Federalwide Assurance approval until the hospital takes corrective steps to ensure adequate protections for research participants going forward.
“The medical center’s IRB appears to lack even a basic understanding of federal regulations for the protection of human subjects and is clearly incapable of fulfilling its obligation to protect the rights and welfare of human subjects,” Public Citizen writes in a follow-up letter to FDA and OHRP.
According to FDA, the hospital’s IRB appears to have violated federal clinical trial regulations by approving four clinical trials for waiver of informed consent without determining that the trials met the criteria for exemption from informed consent or emergency research.
FDA also says the IRB approved research involving vulnerable patients without assessing whether additional safeguards were included in the study to protect those patients.
Additionally, FDA says the IRB approved at least five studies using an expedited review process intended for research involving “no more than minimal risk to human subjects” that did not meet the criteria for expedited review.
Public Citizen Letter & FDA Form 483


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