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Reporting Rules for Gene Therapy Experiments to be Loosened

Genetic Crossroads
August 4th, 2000


Washington Post writer Rick Weiss reports that the National
Institutes of


Health Recombinant DNA Advisory Committee (RAC), which oversees
human gene

therapy experiments, has endorsed easing rules that require
investigators

to immediately report serious illnesses or deaths among participants.

("NIH Panel Backs Easing Of Gene Therapy Rules," June
30, 2000.)


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
revelations

that "gene therapy researchers had in recent years failed
to report

promptly, as required, more than 650 serious adverse events
among

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."
The lawyer

representing Paul Gelsinger, Jesse's father, also criticized
the move.


See <http://www.washingtonpost.com/wp-dyn/articles/A23297-2000Jun29.html>.



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