RE: x-rays, IRB, etc.

["Barry Siegel" <siegelb@mirlink.wustl.edu>]

At Washington University School of Medicine, we have developed standard consent
form language.  The investigator is required to compute an effective dose for
the experimental procedures (radioactive drug studies and/or radiologic
studies).  Then the effective dose is related either to natural background (if
<300 mrem) or to occupational exposure (for doses between 300 and 5000 mrem). 
We also have developed a more comprehensive Radiation Fact Sheet for
distribution by investigators to research subjects.  It is almost never
requested. 

Examples of the consent language are as follows:

     "This study involves exposure to radiation from the radioactive drug.  The
amount of radiation received from this procedure is equivalent to a uniform
whole body dose of 150 mrems.  This is equivalent to 50% of the amount of
natural background radiation exposure all people in St. Louis receive each
year.  It is also equivalent to about 3% of the allowable annual dose to
radiation workers (for example, x-ray technicians).  The risks from the amount
of radiation in the study is too small to be measured.  It is of little, if
any, consequence when compared to other everyday risks.  If you would like more
information about radiation exposure, I can provide you with a radiation fact
sheet.
                                  OR
      "This study involves exposure to radiation from the radioactive drug. 
The maximum amount of radiation you will receive from this procedure is
equivalent to a uniform whole-body dose of 2.6 rems.  This is equivalent to
approximately half of the allowable annual radiation dose to radiation workers
(e.g., x-ray technicians).  The risk from this amount of radiation is too small
to measure directly and is small when compared with other every day risks
(e.g., driving a car).  If you would like more information about radiation
exposure, I can provide you with a "Radiation Fact Sheet."

This approach has been well accepted by our RSC, RDRC, and IRB.  It also was
highly ranked in a formal study of consent form language (see Castonovo FP. An
attempt to standardize the radiodiagnostic risk statement in an institutional
review board consent form.  Invest Radiol 1993; 28:533-538).

Barry A. Siegel, M.D.
Chairman, RDRC
Washington University School of Medicine
_______________________________________________________________________________
From: radsafe@romulus.ehs.uiuc.edu on 23 May 1995  13:24
Subject: Re: x-rays, IRB, etc.
To: Multiple recipients of list

In our institution the Radiation Safety Committee (RSC) also wears a
Radioactive Drug Research Committee (RDRC) hat.  Investigative studies
involving x-rays are reviewed by the RSC/RDRC on their way to the
Institutional Review Board(IRB).  As far as possible, the same standards 
are used as those required of studies that involve only radioisotopes, ie, 
spelt out in 21 CFR 361.1.  The idea is to have a single set of standards
for all uses of ionizing radiation.

While on the subject, I have a question for Radsafers in a similar
situation:  How is the patient consent form worded to explain to lay
persons what the risks of radiation are?  I have discouraged the use of
passages like "... equivalent to 10 chest x-rays ...", and promoted
somewhat more honest comparisons to GI series, CT scans, etc., but have yet
to come with a wording that satisfies all the IRB committee members.

Reply by private e-mail is as welcome as postings on radsafe.  Thanks in
advance.

--
P. Sridhar Rao, Radiology, CWRU / Univ Hosp of Cleveland, Cleveland, Ohio.
Tel: 216-844-1295.    Fax: 216-844-5922.    E-mail: psr@po.cwru.edu

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From: psr@po.CWRU.Edu (P S. Rao)
To: Multiple recipients of list <radsafe@romulus.ehs.uiuc.edu>
Subject: Re: x-rays, IRB, etc.
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