Re: Pediatric volunteers

["Dale E. Boyce" <dale@radpro.uchicago.edu>]

An additional consideration for the nuclear medicine aspects of
the protocol is it being done under an IND?  If so that
constitutes FDA approval and the 361.1 regs don't apply.
If it is being done under the RDRC and is limited to
physiological research 361.1 should probably be followed.
There is some debate over what is covered under 361.1
which is a very narrowly worded regulation.  Much of these
types of protocols have been performed under state
pharmacy and practice of medicine laws and not under FDA
committees.  FDA has become interested in regulating
these types of protocols so I would recommend consulting
your legal counsel if the protocol is not under an IND.

Dale E. Boyce
dale@radpro.uchicago.edu