Re: x-rays, IRB, etc.

[psr@po.CWRU.Edu (P S. Rao)]

In our institution the Radiation Safety Committee (RSC) also wears a
Radioactive Drug Research Committee (RDRC) hat.  Investigative studies
involving x-rays are reviewed by the RSC/RDRC on their way to the
Institutional Review Board(IRB).  As far as possible, the same standards 
are used as those required of studies that involve only radioisotopes, ie, 
spelt out in 21 CFR 361.1.  The idea is to have a single set of standards
for all uses of ionizing radiation.

While on the subject, I have a question for Radsafers in a similar
situation:  How is the patient consent form worded to explain to lay
persons what the risks of radiation are?  I have discouraged the use of
passages like "... equivalent to 10 chest x-rays ...", and promoted
somewhat more honest comparisons to GI series, CT scans, etc., but have yet
to come with a wording that satisfies all the IRB committee members.

Reply by private e-mail is as welcome as postings on radsafe.  Thanks in
advance.

--
P. Sridhar Rao, Radiology, CWRU / Univ Hosp of Cleveland, Cleveland, Ohio.
Tel: 216-844-1295.    Fax: 216-844-5922.    E-mail: psr@po.cwru.edu