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Re: Pediatric volunteers
On Wed, 14 Jun 1995, Huda Walter wrote:
>
> 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
0.006 Sv is not a particularly large dose equivalent, but it would seem
from the radiation protection philosophy standpoint that the "volunteers"
would have to receive some benefit from the procedure, such as a more
accurate diagnosis, for this to be acceptable.
There is also the question of whether "informed consent" can be obtained
from a child. Suggest you see a lawyer who specializes in probable
causation;-)
Regards,
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* Rich Oesterling, CHP ogr@twinpeak.inel.gov *
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