RE: Pediatric Volunteers

["David Scherer" <scherer@mirlink.wustl.edu>]

Several people have suggested applying the FDA's dose limits to clinical
studies involving machine produced radiation.  I questions whether this limit
is too restrictive.  The studies approved under the RDRC are intended to gain
purely physiological information, not directly address treatment of a disease
process.  I understand that the patient cannot be assured of any direct benefit
from clinical research, but the societal benefit may be greater in the latter
case.  Are there reasons for using the 3/5 rem standard (and 10 percent for
peds) or is this simply a number in print that can be used?

David Scherer