Harvard quizzed on research ethics

May 28, 2004

Boston

The US government has cited Harvard University for ethical lapses in research experiments involving human subjects, including some in China and Tanzania.

One-third of Harvard research projects investigated by the government turned out to have problems, generally involving a failure to provide complete information to the people involved. One scientist began an experiment using human subjects without approval.

While no one was hurt as a result, the lapses came despite intense scrutiny of human-subject research by US universities following several deaths.

A teenage research subject at the University of Pennsylvania died during a genetics experiment. Another subject died at Johns Hopkins University. And a healthy young woman committed suicide in February during clinical trials at Indiana University of a compound meant to treat depression.

The government is threatening disciplinary action against a clinical investigator at the University of California, San Francisco for failing to report several patient deaths associated with his studies of an experimental medical device.

Harvard was accused two years ago of failing to protect patients during genetic research experiments in China.

Other universities have also been accused of ignoring rules requiring that human-subject research is peer reviewed. They include Duke University and the universities of Alabama, Colorado, Illinois and Texas.

The University of Chicago faces a lawsuit alleging that doctors there failed to disclose all the risks of a clinical trial involving high-dose chemotherapy and experimental stem-cell transplants.

Investigators conducting a random audit of 25 experiments at Harvard over the past four years found that in six projects, patients were given confusing information about the risks of the experiments, but the work was allowed to proceed by the university's institutional review board. One research study never went before the board, contrary to regulations.

The Harvard experiments included a study of depression in Shanghai, which was allowed to proceed even before researchers had shown how they would deal with pregnant women and people who might be at risk of commiting suicide. In a study into the effects of HIV on villages in Tanzania, the consent forms were written at a reading level the participants probably did not understand, according to the government investigators.

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