Attachment 16

     Minutes of the Meeting of the Committee on Human Studies
            2nd Floor Conference Room, Medical Division

                         January 31, 1972

The meeting convened at 9:30 a.m. and adjourned at 12:00 noon. 
Those present were:

     Committee
     G.A. Andrews
     A.B. Brill
     C.L. Edwards
     Melvin Koons
     Robert D. Lange
     T.A. Lincoln
     Bill Nelson
     John B. Storer

     Visiting Investigators
     J. Grant Brewen
     R.L. Hayes
     Helen Vodopick

Item I.

Consideration of proposal:  "Cytogenetic Analysis of Primary
Spermatocytes of Irradiated Individuals," J. Grant Brewen and R.
Julian Preston (Identification No. ORNL 2).

This proposal had previously been presented to the committee by
mail and a questionnaire had been sent with it to obtain a
response.  Of those responding four said that they believed that
the proposal required further discussion at a meeting, and two
said that they would agree by mail to approve it with certain
reservations, including a statement that the radiations and
biopsies were not being done specifically for the research in Oak
Ridge.  In view of this response, we asked Dr. Brewen to obtain
further information, which he had done, and which had been mailed
out to the committee members.  This included a statement from Dr.
Carl Heller stating that the irradiations were all completed and
that the biopsies would be done anyway, and not specifically for
the project in Oak Ridge.  There were also copies of previous
committee actions on this research project.

The members of our committee discussed Dr. Brewen's proposal at
considerable length.  Some of the committee believe that the
original experiment would not be approved by our committee if
presented at this time.  All agreed, however, to approve of the
proposed participation by Drs. Brewen and Preston in view of the
fact that they will simply be getting additional information from
procedures that will be done anyway.  We recognize that by
participating in this way we take some responsibility, and that
there is a possibility that criticism will be directed toward 
ORNL if the whole project ever becomes a subject for public
discussion.  Outweighing this, in the opinion of all members of

the committee, was the opportunity to obtain valuable information
without any additional stress or potential injury to the subjects
in the study.

Item 2.

Discussion of proposal No. 18: "Scandium-Augmented Gallium
Localization in Tumors - Phase I and Phase II Studies," by R.L.
Hayes, C.L. Edwards, Bill Nelson.

The committee engaged in a fairly extended discussion of this
proposal.  They felt that the form of approval, to be signed by
the patients, might not be ideal, but eventually did not
recommend any specific change in it.  Instead, they recommended
that an additional type of note should be made and put on the
patient's record indicating the information included in the
discussion with each patient.  Dr. Edwards, during the meeting,
had prepared a brief note indicating the topics to be covered. 
These are as follows:

     1.   The patient may have his 67Ga scan, whether or not he
          agrees to participate in the scandium study.

     2.   No toxic effects are known or expected at the proposed
          doses.

     3.   In much higher doses (more than 10 times the maximum
          proposed dose) in animals it has produced a mild
          reversible anemia thought to be due to interference
          with the utilization of iron.

     4.   In animals, much of the scandium is sequestered in
          macrophages of the liver, spleen, and bone marrow where
          it apparently remains for long periods of time.

There was considerable discussion about the question of whether
any specific risk could be described to the patient, since the
doses of scandium that are intended are believed to be far below
minimal toxic doses.  The investigators are quite certain that no
untoward effects will be encountered.  On the other hand, there
is a remote possibility that human beings will exhibit a bizarre
species response which may lead to some type of toxic effect.  If
so, it is unlikely that the animal experiments will be a very
good guide in suggesting the nature of the toxicity that may be
encountered.  One thing that has been clearly seen in animals is
a mild anemia produced by very large amounts of scandium citrate. 
Other complications involving effects upon the coagulation
mechanism and vascular disturbances have not been clearly
verified in animals at our laboratories, and may not be
pertinent.  The committee felt that the patient should be made
aware of the fact that the scandium may stay in the phagocytic
cells for long periods of time.