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x-rays, IRB, rad-safty, consents, regs




Hi RADSAFERs:

I have a regulatory question and would like to know how is this is done at 
your location.  At the university hospital we generate about 5 research 
projects reviewed by the IRB every months that have some form radiation 
exposure. Of course all radiopharmaceutical applications are reviewed by the 
Radiation Safety Comm. But x-rays are not. For instance some require extra 
fluoroscopy time, 3 minutes, 5 min ... or an unspecified time, the surface 
entry dose is around 1-2 rads/min. Also some include  CT scans at 1 
rad/slice.  A brain CT scan has 10-20 slices.

Should the use of x-ray, fluoroscopy for research be regulated? Research 
projects require patient consenting.  The risk section should give a 
quantitative risk, compare it to other common sources of radiation, use lay 
language and give a quantitative estimate of  an increase in cancer risk. 
 If we regulate, who should do it?  The IRB or the Rad Safety Comittee? Or, 
we already regulate too many things, we should leave this one alone?.

Thanks . . .enjoy the summer

. . .  J Villanueva-Meyer
. . .  UTMB
. . . jvillanu@ancillary.utmrad1.utmb.edu