IRBs, informed consent

[LEIDHOLDT.EDWIN@forum.va.gov]

     Two references of interest regarding informed
consent statements for research involving the administration of
ionizing radiation to human subjects are:
(1) Federal Policy for the Protection of Human Subjects
published in the Federal Register on June 18, 1991
(2) ICRP Publication 62, Radiological Protection in Biomedical
 Research
     The Federal Policy, which is binding on research performed
in federal institutions (e.g., the Department of Veterans Affairs)
or supported by federal institutions (e.g., the NIH), requires the
informed consent to include "A description of any reasonably
foreseeable risks or discomforts to the subject."  My interpretation
of this is that the consent statement should mention that the study
might slightly increase the subject's risk of developing cancer.
It amazes me that most of the consent statements I have seen fail
to mention the "C" word.
     Also, I have reservations regarding the comparison of
exposures of the subjects to the 5 rem annual dose limit for
workers.  Although technically correct, it can leave the subject
with the incorrect impression that X-ray techs, radiologists, and 
others routinely receive annual doses of this magnitude.
Ed Leidholdt
U.S. Department of Veterans Affairs
San Francisco
The opinions expressed above are my own and do not necessarily
reflect the policy of the U.S. Department of Veterans Affairs.