Friday, February 7, 2014

The IRB as a Tool to Hide Research Abuse

Reporting on the Markingson case in the Journal of Bioethical Inquiry, Trudo Lemmens writes:

"Remarkably, the university never even conceded that enrolling patients like Markingson in the context of a stay of commitment could have been a problematic practice or that the recruitment pressures and financial incentives as they existed in that trial could raise serious concerns. Instead, the university insisted misleadingly that several institutional bodies, external agencies, and the courts had all cleared the university and researchers from any wrongdoing or errors. University administrators and the general counsel repeatedly suggested that detailed reviews by the institution’s research ethics committee, a U.S. Food and Drug Administration (FDA) investigator, the court, and professional disciplinary bodies cleared them from any wrongdoing. A careful review of these claims, however, raises additional concerns, not only about the failure of regulatory and legal structures to respond when things have gone wrong in medical research but also about the disingenuous use of flawed procedures to shield institutions from their moral responsibility."

And:

"Recent testimony of another patient who claims to have been coerced into participating in clinical trials at the same psychiatric research unit further suggests that the Markingson case was not unique."

And:

"Many of our existing research ethics review procedures may result in superficial assessments that institutions can easily employ as a protective shield. Instead of promoting better ethical standards in research, they may sometimes become tools to hide abuse."

1 comment:

  1. For all the U-MN "observers" that like to keep tabs on what Carl posts, here's something for you to ponder. It's been a few months now since Stephen Olson, MD, showed up uninvited to the Senate Faculty hearing and vote, and egotistically and looking quite disheveled, pushed himself into the speakers line (uninvited) and attempted to abolish himself from any wrongdoing in the Markingson case (actually tried saying Carl was unjustly attacking him) and proceeded to say that cancer patients die so why not mentally ill. So, there was no need for an investigation. And then it got comical- the idiot forgot why he was even there, and told the press he would welcome an investigation, hell, he's done nothing wrong. So, you U-MN observers...do you see the problem with credibility. This article is exceedingly accurate, right up there with Carl's Mother Jones piece, you know, the one you tried to squash.

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