FDA allows involuntary research on patients Rules apply to gravely ill who are unable to consent


For the first time in a half-century, new federal regulations allow investigators to enroll patients in some medical research studies without their consent.

The Food and Drug Administration regulations, which took effect Friday, apply only in carefully circumscribed situations.

The patients must have a life-threatening condition, such as a severe head injury, and must be unable to say whether they want to be part of a study. They would be selected only if it was not feasible to obtain consent from a relative.

Furthermore, the community in which the research is done must be notified about the study, and the research design must have been reviewed and approved by the FDA.

Even the most ardent supporters of the new regulations say they understand the seriousness of what they have done. They have repealed a principle that dates back to the Nuremberg trials of Nazi doctors after World War II, when American judges were agonizing over rules that might prevent doctors from ever again using human subjects in horrendous experiments. The judges wrote a code of ethics, the Nuremberg Code, whose first principle was that no one should ever be forced to take part in a medical experiment.

"It's a tremendous philosophical change," said Dr. Norman Fost, director of the Center for Clinical Ethics at the University of Wisconsin, who lobbied for the change.

Bonnie Lee, a senior policy analyst at the drug agency who wrote the regulations, said: "This is not something we did lightly."

But supporters of the regulations say patients will benefit. The requirement for informed consent, they say, was hobbling research that could save lives.

Fost said the regulations would liberate researchers to study treatments that were desperately needed. Until now, he said, "research was not moving forward." The harm would be greater if patients were kept out of such studies, he argued, than if they were entered without their consent.

Others, however, are gravely concerned. "It's a fateful step," said Jay Katz, an ethicist and lawyer at Yale University.

The new rules arose out of the frustration of some ethicists and medical researchers. The problem, said Fost, was that the previous rules were making it virtually impossible to study treatments that must be provided to patients who are gravely ill or injured.

Pub Date: 11/05/96

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