Attachment 10

Memorandum from Paul C. Aebersold, Chief of Isotopes Division to
A.H. Holland, Jr., Director of Research and Medicine, dated
October 5, 1949 regarding use of Radioisotopes in Human Subjects.

A. H. Holland, Jr., Director of Research
and Medicine
FROM: Paul C. Aebersold, Chief, Isotopes Division

SUBJECT: USE OF RADIOISOTOPES IN HUMAN SUBJECTS

IR: SAL

Reference is made to communication of August 11, 1949, sent to
you by Dr. Shields Warren, Director, Division of Biology and
Medicine, regarding allocation of radioisotopes to be used in
human subjects. It is noted that Dr. Warren instructed that such
allocations would be made by the Isotopes Division only after
review and approval by the Subcommittee on Human Applications of
the Committee on Isotope Distribution. It should be emphasized
that the instruction applies even though the radiomaterial is
produced in the laboratory where it is to be used.

Since this procedure has not been uniformly followed in the past,
we are writing to acquaint you with the appropriate details.
Enclosed is a copy of our latest catalog. On pages 30 and 31 are
presented the criteria governing the distribution of
radioisotopes when these substances are to be used in humans.
Enclosed also are six copies of Isotopes Division Circular D-4,
which contains the same statement, and which may prove convenient
to you in the process of acquainting members of your staff with
this procedure.

Obviously applicants for radioisotopes to be used in human
subjects will need to submit more information than has been
offered on previous applications submitted on Form AEC-558. For
the convenience of this office and of the Subcommittee on Human
Applications, applications should be submitted on Form AEC-313.
Special attention should be given to the information asked for on
pages 30 and 31 of the Catalog and Price List No 3, July 1949. We
shall assume, as in the past, that instrumentation, both for
measurement and for health physics purposes, is adequate at
Commission laboratories. It will not be necessary to use Part 2
of Form AEC-313. The Subcommittee has insisted that a physician
be connected with all projects in which human subjects are used,
so as to insure that the clinical care of the patients will be
provided for. It should be emphasized that each application
should be accompanied by a formal, written endorsement, signed by
the Chairman of the local "Isotopes Committee," the recommended
membership of which is outlined on pages 30 and 31 of the
catalog. Your special attention is called to the Subcommittee's
insistence that a complete dosage schedule be submitted with the
application.

Repository:    NARA Atlanta Archives

Citation:      RG 326, 68A1096
               OR Division of Research

Box No:        33

Folder:        ISOTOPES PROGRAM
               1 General Policy