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Re: Pediatric volunteers



                      RE>Pediatric volunteers                      6/14/95
21 CFR 361.1 deals with radioactive drugs for research uses.  Although the
intent deals with RDRC compounds, dose limits are set for subjects under 18
years old at 10% of adult limits.  Under this reg. and applying to only the
specific conditions it references, these limits would be 300 mrem for a single
dose and 500 mrem annually for the under 18 group.  

I believe approved FDA drugs are without such limits and up to the discretion
of the IRB.  Proper parental consent is a must and is still a scary issue.  The
benefit to the kids then is an important determining factor in deciding whether
to proceed.

Rob Forrest
UPENN
--------------------------------------
Date: 6/14/95 2:59 PM
To: ROB FORREST
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From: Huda Walter <hudaw@xray1.xray.ufl.edu>
To: Multiple recipients of list <radsafe@romulus.ehs.uiuc.edu>
Subject: Pediatric volunteers
X-Listserver-Version: 6.0 -- UNIX ListServer by Anastasios Kotsikonas
X-Comment:  Radiation Safety Distribution List 


We've recently received a research proposal to review for the radiation 
protection aspects of an IRB proposal. Volunteer children (with an 
identified disease) are to be asked to undergo Nuclear Medicine and CT 
examinations of the head - the estimated values of the effective dose 
equivalents to these volunteers is about 600 mrem (6 mSv). The pilot study 
is an attempt to measure the sensitivity/specificity of diagnostic tests to 
detect this disease; the next step would be use these diagnostic tests in 
children who do not have the disease.

The question that our committee is trying to address is whether such doses 
to "volunteer" children are "acceptable". Is there any guidance available as 
to the acceptability of such doses to children? Anyone have any thoughts or 
comments as to whether this research proposal should be approved from the 
radiation protection point of view, assuming the research protocol is deemed 
to be well designed and worth pursuing?

Walter Huda PhD               Phone (904) 395 0293
Department of Radiology       FAX   (904) 395 0279
University of Florida
Gainesville, FL 32610         Email  hudaw@xray.ufl.edu