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U of Minnesota's Human Research Program Could Get Jacked Over Ethics Violations

Dan Markingson and his mother before he died by suicide in 2004.

Dan Markingson and his mother before he died by suicide in 2004.

Ten years ago, Dan Markingson, a mentally ill man, was recruited for a University of Minnesota medical experiment as an alternative to forced commitment in an asylum. He killed himself after months of taking a new anti-psychotic drug.

At the time, Markingson's mother blamed the university for exploiting him when he wasn't in the right state of mind to make decisions for his personal safety. U officials dismissed her complaints, citing their own internal investigations into the medical center's ethical standards for human research, which found the university to be above reproach.

See also: U of M's Human Experimentation Program Hasn't Learned Much from Dan Markingson's Suicide

But earlier this month, the Association for the Accreditation of Human Research Protection Programs (AAHRPP) released the first substantive external review of U of M's human experiments. It was a full-scale indictment of the university's methods, and captured the attention of federal agencies with the power to completely shut down its research programs.

AAHRPP is an accreditation agency that vouches for the standards of research institutions. Its report on the U found that clinical research proposals were being approved after lightning fast reviews. Psychiatric clinical trials were being approved by people with no background in psychiatry. Junior researchers were evaluating department chairs' protocols.

Yet the AAHRPP doesn't have real power to stall the university's research. That authority falls to the U.S. Department of Health and Human Services' Office for Human Research Protections (OHRP), which can suspend a research institution's license to receive federal dollars.

Dr. Michael Carome, the former deputy director of OHRP and current director of consumer rights group Public Citizen's health research group, wants OHRP to come down hard on the U.

"The OHRP has certainly, in the past two decades... where equally serious problems with the human protection program at major universities, taken action to suspend research," Carome says.

In 1999, the OHRP pulled federal support for Duke University's medical center. In 2001, it chopped funds for Johns Hopkins. About a dozen other university research programs have gotten the axe after scathing investigations into their ethics.

"For the most part, universities are trusted to do the right thing," Carome says. "How did we get here? It's inexplicable. The university over 10 years has repeatedly denied that it did anything wrong regarding the Dan Markinson case. They've sort of been in a state of denial."

Professor Leigh Turner, an associate professor in the U of M's bioethics department, has been speaking out against the university's treatment of human research subjects for the past five years. He and another whistleblower, Professor Carl Elliott, urged the university's Board of Regents to investigate what happened to Dan Markingson back in 2010.

Turner says he didn't have high hopes for the AAHRPP report to tell the truth, so he was surprised to see his fears validated on paper.

"They found pretty significant violations of federal law," Turner says. "The findings are so serious that there's a role for a federal agency to come in and do an investigation that doesn't serve the university's interests, but serves the interest of research subjects."

Turner says he's experienced bullying in the workplace as a result of publicly slamming the university. Just recently another bioethicist professor shouted at him that if he disagreed with how the university is handling itself, he should just resign.

"You can let it roll off, or you could take it personally," Turner says. He's looking forward to OHRP launching its own investigation to confirm the findings of the last external review. After that, he says the OHRP will have every right to suspend federal funding.

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