Re: Radiation tests at VA hospital questioned

["JERRY ROSEN" <rosen@rso.radsafe.pitt.edu>]

I think we are missing the point.  Who are we to question the 
credentials of the individuals involved, when we are operating out of 
ignorance?

I am not familiar with the regulations of the State of California or 
whether the VA must follow those regulations. At the Federal level 
the research falls under the guidance of the Office of Protection 
from Radiation Risks (OPRR) of DHHS.  The FDA is mute on this issue 
since it appears that common x ray modalities were used. OPRR 
requires approval by a valid local IRB staffed by representatives of 
appropriate professions; medicine, surgery, radiology, ethics, a 
member of the general public, etc.

Assuming that there was a qualified radiologist on the local IRB, 
then the approval would meet Federal requirements, at least in terms 
of evaluating radiation risk.  However, the either the news paper 
reports or Otto's note indicate that the protocol's were subject to 
review by the RSO.  It appears that someone in the VA screwed up by 
not following procedure.

This issue should have been settled as part of their IRB process, not 
in the press and after the fact.  The RSO's concerns may or may not 
be valid but without all of the facts, what do we have to discuss?


Jerry Rosen

University of Pittsburgh
Phone:  412-624-2728
Fax:    412-624-3562
Email:  Rosen@radsafe.pitt.edu