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Research subject’s death prompts Johns Hopkins probe

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BALTIMORE — In another blow to human medical studies at Johns Hopkins University, a faculty member in India is being investigated for possible violations of the school's policies on research involving human subjects.

The investigation announced Monday comes a month following the death of a lab worker who was taking part in an asthma study at Hopkins' Bayview Medical Center, which is part of the university's medical school.

The Office for Human Research Protections, a division of the Department of Health and Human Services, temporarily shut down nearly all of Hopkins' federally funded research on human subjects because of the death.

In 1999 and 2000, the professor conducted a clinical trial of an experimental anticancer drug.

The researcher, whose name was not released, did not receive a Hopkins review board's approval for the study.

Hopkins spokesman Dennis O'Shea would not say how many people participated in the study at the Regional Cancer Centre in Kerala, India, or identify the drug used. The university said it did not know who paid for the project.

The university said Indian media reports cited concerns by doctors at the cancer center about the study. The doctors reportedly questioned whether the researchers received proper permission from patients, whether surgery or other treatments were delayed, and whether the drug had been screened for toxicity.

The researcher was ordered to stop working on it, the university said.

Estelle Fishbein, Hopkins' vice president and general counsel informed the Office for Human Research Protections.

"Please let me emphasize that we are not aware of any information that would lead us to believe that the university was either aware of, or otherwise condoned, any possible misconduct."

On the Net:

The Johns Hopkins University: www.jhu.edu

Regional Cancer Centre in Kerala, India: rcctvm.org/index.htm