Washington Post writer Rick Weiss reports that the National
Health Recombinant DNA Advisory Committee (RAC), which oversees
therapy experiments, has endorsed easing rules that require
to immediately report serious illnesses or deaths among participants.
("NIH Panel Backs Easing Of Gene Therapy Rules," June
The recommended rule change "would allow researchers to
wait as long as a
year before reporting…all such `adverse events.'"
The move comes less
than a year after the death of Jesse Gelsinger and subsequent
that "gene therapy researchers had in recent years failed
promptly, as required, more than 650 serious adverse events
volunteers in gene therapy experiments."
Some patient advocates "lambasted" the plan "as
a case of bringing lax
researchers into compliance by merely loosening the rules."
representing Paul Gelsinger, Jesse's father, also criticized