Re: X-rays on Human Subjects for Research

[Chris Hawkins <chawkins@inet.guthrie.org>]

When I sat on an IRB at a medical school, the philosophy was that if the
risks are thoroughly (and accurately) explained to the subject, and
there was no possible coercive relationship (e.g., researchers could not
use their employees, graduate students, medical students they were
supervising, etc., or the remuneration appeared excessive0 [this once
led to a lengthy discussion on the going price for bone marrow
donation]) then an informed subject could agree to accept a risk for the
altruistic reason of advancement of human knowledge, possible medical
benefit to others in future, etc.  Pains were taken to review the
science behind the research proposal.  The Board's philosophy was that
if the science was faulty, then any risks the subject was willing to
take would not provide the societal benefit the investigator thought it
might.  Applications were modified or rejected if the science was found
to be faulty.  Sometimes it was a question of the investigator
explaining things better, sometimes it was just plain lousy science.

Research protocols involving radionuclide doses were also sent to the
Radiation Safety Committee for their inpout to the IRB, and the IRB
deferred to the Radiation Safety Committtee's judgement.  Protocols
involving external beam therapy or diagnostic x-ray exposure were
handled by the IRB.  I and a radiologist always had input.

Our IRB reviewed about 250 - 350 proposals/yr, and had about 20 members.
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