Re: X-rays on Human Subjects for Research

[David Scherer <scherer@uiuc.edu>]

Michael Lemon wrote:
>
>	I am interested in your philosophies on giving x-rays to human subjects
>only for the purpose of research (development of athletic injuries,
>determination of visceral fat, etc.).   Would you consider these procedures
>preventative medicine?

I was involved with reviews of such studies several years ago.  As I
recall, it is not permissible to treat the results of the research as a
benefit to the patient.  (If you know the procedure or test is reliable,
you don't need to do research.)  The knowledge gained is a societal
benefit, of course.  At least this was the policy (law?) as it applied to
informed consent documents.  I assume the principle should hold true for
other purposes as well.

>  Does your Advisory Committee on Human Subjects
>submit these proposals to a Medical Committee or the Radiation Safety
>Committee for review.  What guidelines have been adopted by your
>institutions as acceptable?  What do you include in the consent form?  Do
>these experiments differ in your opinion from the radioactive materials
>experiments with human subjects years ago?   I would value your time, and
>welcome your personal replies.  Thank you!

The radiation safety section and committee began to review protocols for
machine-produced radiation under my watch.  There had always been RSC
review for nuclear medicine protocols.  It was my impression that most
other institutions did not have RSC review for x-rays, since there was no
regulatory requirement for it, but that was >10 y ago; practices may have
changed.  Any protocol meeting the FDA's standards for RDRC review were
approved pretty much as a matter of routine.  Larger doses were scrutinized
more carefully.  The only part of the informed consent document we looked
at was the statement of risks from the radiation.  We developed a general
statement that put the risk in perspective, i.e. usually minimal risk.  I
don't think the explanation used numbers, since it is supposed to be geared
toward a layman.

You should be able to get a lot of help on these legal/bioethical issues
from the executive officer of your human use committee.  There is nothing
fundamentally different about radiation exposures compared with the other
risks that might be incident to human experiments.  It's just a matter of
fitting this technology into their framework.

Regrds,
Dave Scherer
scherer@uiuc.edu