Vanderbilt apology

["Gibbs, S Julian" <s.julian.gibbs@vanderbilt.edu>]

As a member of the Vanderbilt faculty who was heavily 
involved in preparation of data for the defense of the 
litigation in question, I feel compelled to comment on 
recent notes on RADSAFE.  Tracer doses of Fe-59 were 
administered to a group of pregnant women in the mid-1940s. 
A second group in the study got no Fe.  No informed consent 
was obtained--but that was consistent with practices at the 
time.  Doses of the tracer were small.  The apology was 
based neither on radiation risk nor lack of informed 
consent.  Instead, it was based principally on two factors:

1.  Records of the project have been lost.  Thus it is now 
impossible to determine which subjects got the tracer (and 
how much).

2.  No subjects were informed as to their participation in 
the project when epidemiologic and dosimetric followup 
studies were done in the late 1960s and published in 1969. 
The epidemiologic studies found 3 cases of cancer, reported 
as a statistically significant (p=0.03) elevation of 
incidence of childhood cancer in offspring of the 679 
subjects. No cancers were found in offspring of the control 
group of approximately equal size. Fetal doses of the 3 
cancer cases were reported as 0.036, 0.095, and 1.78 rad.  

It now appears that statistics of the epidemiologic studies 
were flawed, and calculated radiation doses were probably 
greater than actual doses.  Tracer doses were documented 
originally in milligrams of iron; one can only guess the 
specific activity.  Instrumentation at the time was crude 
and it was not possible to determine specific activity with 
any confidence.

I was at first categorically opposed to settling the 
litigation, since I felt there was no conclusive evidence 
of any harmful effect from the radiation (despite 
publications to the contrary), and informed consent was not 
an issue at the time. However, on further consideration of 
all factors, the settlement and apology seem justified.

Moral: When performing studies involving human subjects, 
retain all records with archival permanence.  If followup 
studies are done later, inform the subjects of the results. 
Obviously, current standards also require informed consent 
of all subjects.
***********************************************************
S. Julian Gibbs, DDS, PhD               Voice: 615-322-3190
Professor of Radiology                    FAX: 615-322-3764 
Dept. of Radiology & Radiological Sciences
Vanderbilt University Medical Center
Nashville TN 37232-2670 Email:s.julian.gibbs@Vanderbilt.Edu