Radiation Exposure Limits for Research Subjects

[ehsnet!hps (HPS)]

Reply-to: Wes.Dunn@p2.f13.n233.z1.fidonet.org (Wes Dunn)
Fido-To: steve kasten

In a message of <02 Jun 94  10:06:21>, Steve Kastin writes:

 >We are currently working on a research protocol involving multiple brain
 >SPECT studies (with HMPAO) as well as PET scans (F-18 FDG).  The question
 >is: What, if any, are the exposure limits applied to research volunteers?
 >Are they considered patients?  Radiation workers?  Members of the general
 >public?

The last three questions are the easiest: No.  They aren't patients, rad
workers or the general public.  They are research subjects.  When I last
tried to get an answer (about 5 years ago), I was informed there are no
regulatory limits.  I've seen some numbers, but I believe those were only
advisory for tracer studies (as opposed to imaging studies).  I doubt FDA
has since imposed any limits, and I know the radiation regulatory agencies 
(NRC, etc...) certainly haven't.

What it appears to boil down to is that's why such studies have to be
approved by the Institutional Review Board (IRB), the Radioactive Drug 
Review Committee (well, RDRC, I'm not sure that's the real title), and 
(of course) the Radiation Safety Committee (RSC).  They are supposed
to ensure the cost/benefit is thoroughly reviewed.  FDA requires the
first two, and radiation regulatory agencies require the third.  

Wes 

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