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U. of Michigan suspends a top researcher

The university's medical school is committed to ensuring patient safety in human subject clinical tests without creating a "regulatory nightmare" for clinical researchers.

By Andis Robeznieks, amednews staff. Sept. 24, 2001.

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Proving it's serious about protecting patients involved in clinical trials, the University of Michigan has more than quadrupled its budget for research oversight and suspended one of its most recognized cancer scientists for violating research protocols.

"It's not easy to do," said Allen Lichter, MD, dean of the University of Michigan Medical School in Ann Arbor. "But I think when this is done, we will be a better institution for taking a long, hard look at our processes."

The medical school is increasing its number of institutional review boards from one to four, and its IRB budget has grown from $250,000 to $1.1 million in two years, Dr. Lichter said.

While these moves are significant, it's the suspension of one of the school's top researchers -- Alfred E. Chang, MD -- that gained the most attention. Dr. Chang, a former investigator at the National Cancer Institute, was suspended from conducting research with human volunteers for three years.

The university charges that Dr. Chang violated protocol across five studies involving 94 research volunteers. Breaches in protocol included:

• Inadequate documentation of informed consent or informed consent obtained after the study began.
• Modifying protocol without notifying the IRB.
• Not reporting adverse events.

The research involved patients with advanced cancer, and Dr. Chang sought to alter study participants' immune systems to reject the cancer by using either gene transfer methods or vaccines generated by the patients' own tumors. [...]