RE: Pediatric Volunteers

[psr@po.CWRU.Edu (P S. Rao)]

>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


I believe the answer is the latter.  Given the sensitivity surrounding
radiation and human experimentation, any body (eg RSC, IRB) that has to
judge such experiments must apply some set of criteria, and the FDA's is
the only official one around.

Personally, I would support the idea of increasing the limits when there is
a tangible chance of benefit to the patient or research subject, as opposed
to pure experiments on normal volunteers.  It will, however, be impossible
or extremely difficult to specify those new limits.  If anything, the furor
over the supposed mishandling of human experimentation by DOE will likely
spawn regulations with even more restrictive limits.

--
P. Sridhar Rao, Radiology, CWRU / Univ Hosp of Cleveland, Cleveland, Ohio.
Tel: 216-844-1295.    Fax: 216-844-5922.    E-mail: psr@po.cwru.edu