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Pediatric volunteers




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