March 29, 1948

         The Experimental Use of Radioactive materials in
               Human Subjects at AEC Establishments,
                          author unknown

     The Experimental Use of Radioactive materials in Human
Subjects at AEC Establishments.
     At the request of Dr. Shields Warren, Director, Division of
Biology and Medicine the Subcommittee on Human Application,
Committee on Isotope Distribution respectfully submits the
following recommendation:
     1.   Radioactive materials should be used in experiments
involving human subjects when information obtained will have
diagnostic value, therapeutic significance, or will contribute to
knowledge on radiation protection.
     2.   Radioactive materials may be used in normal human
subjects provided
          a.   The subject has full knowledge of the act and has
given his consent to the procedure.
          b.   Animal studies have established the assimilation,
distribution, selective localization and excretion of the
radioisotope or derivative in question.
     3.   Radioactive materials may be used in patients suffering
from diseased conditions of such a nature that there is no
reasonable probability of the radioactivity employed producing
manifest injury provided:
          a.   Animal studies have established the assimilation,
distribution, selective localization and excretion of the
radioisotope, or derivative, in question.

          b.   The subject is of sound mind, has full knowledge
of the act and has given his consent to the procedure.
          c.   Full description of experimental procedures and
calculated estimates radiation to be received by body structures
and organs are submitted.
     4.   Investigations are approved (1) by medical director or
his equivalent at the installation responsible for the
investigation, (2) by the Director, Division of Biology and
Medicine, and (3) full written descriptions of experimental
procedures and calculated estimates of radiation to be received
by body structure and organs must be submitted.
     5.   Radioisotopes and radiation doses are to be limited as
follows:
          1.   Tissue radiation dose at the site of greatest
concentration shall not initially be greater than 0.1 per day.
          2.   The effective net half-life which a combination of
the biological and physical half-life of radioisotope and/or its
derivative, shall not be greater than 20 days.
          3.   Administered material limited to those emitting
electrons and photons.