Another $.02 on MIT and Informed Consent

[VERNIG.PETER@FORUM.VA.GOV]

I agree with Sandy Perle and Ruth Weiner, dose and the risk from it were
not the issue withholding information was.  I appreciate Dr. Gibbs' per-
spective on consenting practices at that time.  I would like to point out
a distinction that I think is important and is in todays regulatory climate
That is, the study differs from one where say a plane film x-ray of similar
dose might be used or even a Nuc Med study using an approved [NDA] radio-
active drug.  Plane film x-rays and Nuc Med studies are widely used in 
medical diagnosis.  The radioactive iron [Fe-55 ?] was not.  It was a 
research "drug".  Today such a study would require scrutiny by an RDRC
{Radioactive Drug Research Committee].
 
Some of the comments on this string, regarding not consenting plane film
x-rays and such appeared to miss the distinction between a patient and a
research subjects.  A patient is expected to derive benefit from a proceed-
ure, a research subject may derive none or may have some potential benefit.
A blood draw is not consented for a patient but often is for a subject,
as subjects must [todays standards] be informed of any risk to health or
possibility of discomfort.  The situation today becomes a little murky with
the debate over the validity of the LNT and discussion if there really is
any risk at all, at very small doses, in dealing with routine x-rays and
NM studies in research.  From the lawyers perspective, it's a no brainer,
consent any and everything dealing with radiation and radioactive material
s.