which it is to be conducted; all inconveniences
and hazards reasonably to
be expected; and the
effects upon his health
or person which may possibly
come from his
participation in the experiment.
(2) The concept of the human subject shall be in
writing, his signature
shall be affixed to a written
instrument setting forth
substantially the afore-
mentioned requirements
and shall be signed in the
presence of at least one
witness who shall attest to
such signature in
writing.
(a) In experiments where personnel from more
than one Service are
involved the Secretary of the
Service which is
exercising primary responsibility
for conducting the
experiment is designated to pre-
pare such an instrument
and coordinate it for use
by all the Services
having human volunteers involved
in the experiment.
(3) The duty and
responsibility for ascertaining
the quality of the
consent rests upon each individual
who initiates, directs or
engages in the experiment.
It is a personal duty and
responsibility which may
not be delegated to
another with impunity.
b. The experiment should be such as
to yield fruitful
results for the good of society, unprocurable by other methods
or means of study, and not random and unnecessary in nature.
c. The number of volunteers used
shall be kept at a
minimum consistent with item b., above.
d. The experiment should be so
designed and based on the
results of animal experimentation and a knowledge of the natural
history of the disease or other problem under study that the
anticipated results will justify the performance of the experiment.
e. The experiment should be so
conducted as to avoid all
unnecessary physical and mental suffering and injury.
f. No experiment should be conducted
where there is an
a priori reason to believe that death or disabling injury will
occur.
g. The degree of risk to be taken
should never exceed
that determined by the humanitarian importance of the problem
to be solved by the experiment.