Re Pediatric Volunteers

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

Regarding the question about the research study in which pediatric
volunteers may receive about 600 mrem:

Our committee has struggled with the same type of question, and has found
the answer in the regulations that govern a Radioactive Drug Research
Committee, contained in 21 CFR 361.1.  Although those regs are for
"radioactive drugs", we have adopted them as a standard for all research,
including x-rays.

For an adult subject, the limits are:

        Per study - 3 rems whole body (EDE), 5 rems any organ.
        Annual -    5    "                 , 15     "        .

For a minor (under 18), the limits are exactly 10% of the above.

In the example you gave, the study might be approved, subject to the
condition that the dosage be decreased to meet the 0.5 rem limit.

--
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