Home Challenged Sites Is Hennepin County Medical Health Center out of Control? FDA Findings are...

Is Hennepin County Medical Health Center out of Control? FDA Findings are Troubling

192
0
Research Ethics

In October 2018, TrialSite News placed Hennepin Healthcare (HCMC) on the “Site Watch Challenged” list. The great Minneapolis medical institution, founded originally in 1887, was discovered to be expediting research in disregard of fundamental patient protections established originally under the Declaration of Helsinki.

TrialSite News represents a global network of clinical trials experts, from regulatory specialists to expert clinical trial monitors. Top clinical monitors convey that violations of informed consent typically indicate other quality and safety issues with a clinical research site. HCMC got in deep water last year over injecting patients with ketamine without their informed consent.

Now HCMC is in the press again as the Minneapolis Star Tribune reports that medical professionals continued to administer ketamine to sedate people to collect data for a study months after the hospital’s leadership told elected officials they had voluntarily halted the research in in response to questions over ethics and safety.

A new inspection reports from federal regulators have brought to light that HCMC continues to fail to disclose incidents of patients suffering serious medical complications—e.g. high blood pressure, breathing challenges—to the committee in charge of keeping study participants safe. We include the FDA report here.

The Minneapolis Star Tribune reports that two FDA inspectors visited the Twin Cities hospital 17 times in April as part of a serious federal investigation into HCMC’s sedative research. Fresh questions have been raised about whether this health provider is in control of its clinical research operation.

The FDA’s Report

The FDA has filed a report summarizing at least one of their inspections of HCHC.  The FDA uncovered a number of significant findings at this clinical investigational site including:

  • Serious Adverse Events (SAE) were not reported to the IRB as required by IRB, GcP and law
  • New treatments included on subjects without IRB Approval
  • Hennepin treated 747 patients on a study a) over the 500 approved by the IRB and b) over the 737 reported as the total enrollment to the IRB
  • An IRB-required annual progress report was not submitted on the date required by the rules

The Public Should Keep an Eye on Hennepin’s Clinical Research Program

They remain on the “Site Watch Challenged” list. This means that we have uncovered adverse material data points that the public should be made aware of. Transparency helps, we hope, to correct wrongs and celebrate the rights. The hope is that the underlying problems—the root cause—will be systematically uncovered and addressed so that only the highest standards of clinical research occur at HCHC. TrialSite News will continue to monitor the situation.

 

LEAVE A REPLY

Please enter your comment!
Please enter your name here

This site uses Akismet to reduce spam. Learn how your comment data is processed.