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JANUARY 18, 2001

The Food and Drug Administration on Wednesday proposed a new rule that would require immediate disclosure of clinical study data taken from human gene therapy tests.

Gene therapy research is controversial and an experiment in 1999 led to the death of a teenager at the University of Pennsylvania. Researchers there apparently hadn't disclosed full details to the FDA regarding its study and the new rules would alleviate fears about such tests.

But some said they would put unncessary strains on researchers and could unfairly bias the public because data could be misinterpreted before it is fully understood.

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New Rule for Gene Therapy Tests Proposed (The Washington Post 1/18)