Rad Risk Wording for Informed Consent Statements

[Mack Richard <MRICHAR%INDYCMS.bitnet@vmd.cso.uiuc.edu>]

Here at Ind. Univ. Med. Cntr., the following standard radiation risk
statements were developed by the RS Staff and approved by the RSC
and the IRB:

"Your participation in this research study involves exposure to
radiation.  We are exposed to radiation every day of our lives from
both natural and manmade sources.  The average whole body radiation
exposure to a member of the U.S. from these sources is about 360
millirem per year.  By comparison, the amount of radiation exposure
which you receive when participating in the research study is about
(fill in %) of the annual amount listed above.  This amount of
radiation exposure is well below the levels that are thought to
result in a significant risk of harmful effects."


For effective doses of greater than 360 mrem, the first three
sentences are the same.  The remainder of the paragraph is as
follows:


"For comparison, individuals who use radiation in their work (for
example, x-ray technicians, radiologists, etc.) may legally receive
up to 5000 millirem per year.  The amount of radiation exposure
which you will receive in the study is greater than your average
exposure from natural and manmade background, but less than the
limit for occupationally exposure individuals.  This amount of
radiation exposure is well below the levels that are thought to
result in signficant risk of harmful effects."


IRB guidelines indicate that wording must be understandable to an
individual with an 8th grade education.  We also have standard risk
statements regarding pregnancy.  Will be happy to forward them to
anyone interested or on radsafe.