A working group set up to advise the US National Institutes of Health (NIH) on the regulation of human gene therapy trials called for a greater involvement of the Recombinant DNA Advisory Committee (RAC), reports last week's Nature. The conduct of gene therapy trials in the US has been subject to scrutiny following the death of patient Jesse Gelsinger during a trial last year, and the subsequent report of hundreds of other 'adverse events'.
The latest advice contradicts former NIH policy which had sought to reduce the RAC's involvement. But under the new proposals, a trial could only start once the RAC accepted the scientists' protocols. Novel methods, for example new gene delivery systems, would have to be formally approved by the RAC, which meets four times a year.
In the past, new protocols were sometimes reviewed at the same time as the investigators were enrolling patients in the trial, a situation described as 'untenable' for former RAC chair, LeRoy Walters. 'That just promotes disrespect' he added. The new proposals await the approval of acting NIH director Ruth Kirchstein.
Meanwhile, the 'excessive secrecy' involved in the European procedures for approving gene therapy trials has been criticised by scientists attending a conference in Paris last week. The variety of national rules and committees is slowing down progress, and making it more difficult to organise large trials, said delegates. Ted Friedmann, a member of the US RAC, told the meeting that if there was a lesson for Europe from the US controversy, it was of the need for building 'openness' into regulatory structures.
Sources and References
NIH panel may increase gene-trial scrutiny...
...as Europe's 'excessive secrecy' is deplored