November 30, 2001
NIH Issues New Rules on Reporting Safety Problems in Gene-Therapy Trials
The National Institutes of Health issued new rules last week aimed at improving oversight and public disclosure of safety problems in gene-therapy trials. The changes follow criticism that inadequacies in safety oversight contributed to the 1999 death of Jesse Gelsinger, a research volunteer in an experiment at the University of Pennsylvania.
In a key change, the agency will establish a national committee to review the safety of gene-therapy experiments. Those studies involve inserting
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