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OCR for page 88
Appendix D
SECRETARY OF DE"NSE
Washington
MEMORANDUM FOR THE SECRETARY OF THE ARMY
SECRETARY OF THE NAVY
SECRETARY OF THE AIR FORCE
SUBlECT: Use of Human Volunteers in Experimental Research
26 Feb 1953
Based upon a recommendation of the Anned Forces Medical Policy Council that
human subjects be employed, under recognized safeguards, as the only feasible means for
realistic evaluation and/or development of effective preventive measures of defense against
atomic, biological or chemical agents, the policy set forth below will govern the use of human
volunteers by the Department of Defense in experimental research in the fields of atomic,
biological and/or chemical warfare.
2. By reason of the basic medical responsibility in connection with the development
of defense of all types against atomic, biological andJor chemical warfare agents, Armed
Services personnel and/or civilians on duty at installations engaged in such research shall be
permitted to actively participate in all phases of the program, such participation shall be subject
to the following conditions:
The voluntary consent of the human subject is absolutely essential.
(~) This means that the person involved should have legal capacity to
give consent; should be so situated as to be able to exercise free power of choice,
without the intervention of any element of force, fraud, deceit, duress, over-
reaching, or other ulterior form of constraint or coercion; and should have
88
1 Retyped for this report from illegible copy.
OCR for page 89
Appendix D
89
sufficient knowledge and comprehension of the elements of the subject matter
involved as to enable hun to make an understanding and enlightened decision.
This latter element requires that before the acceptance of an affirmative decision
by the experimental subject there should be made known to him the nature,
duration, and purpose of the experiment; the method and means by 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 consent of the human subject shall be in writing, his signature
shall be affixed to a written instrument setting forth substantially the
aforementioned requirements and shall be signed in the presence of at least one
witness who shall attest to such signature in writing.
(a)
are involved the Secretary of the Service which is exercising primary
responsibility for conducting the experiment is designated to prepare such
an instrument and coordinate it for use by all the Services having human
volunteers involved in the experiment.
In experiments where personnel from more than one Service
(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 experunentation and a knowledge of the natural history
of the disease or other problem under study that the anticipated results will
justify the perfonnance of the experiments.
e. The experiment should be so conducted as to avoid all
unnecessary physical and mental suffering and injury.
Downgraded to UNCLASSIFIED 22 August '75 per
S. Clemenis
OCR for page 90
9o
The ALL Thyroid Function Study
f. No experiment should be so 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.
h. Proper preparation should be made and adequate facilities
provided to protect the experimental subject against even remote
possibilities of injury, disability, or death.
i. The experiment should be conducted only by scientifically
qualified persons. The highest degree of skill and care should be required
through all stages of the experiment of those who conduct or engage in the
experiment.
j. During the course of the experiment the human subject
should be at liberty to bring the experiment to an end if he has reached the
physical or mental state where continuation of the experiment seems to
him to be impossible.
k. During the course of the experunent the scientist in charge
must be prepared to terminate the experiment at any stage, if he has
probable cause to believe, in the exercise of the good faith, superior skill
and careful judgment required of him that a continuation of the experiment
is likely to result in injury, disability, or death to the experimental subject.
I. The established policy, which prohibits the use of prisoners
of war in human experimentation, is continued and they will not be used
under any circumstances.
3. The Secretaries of the Army, Navy and Air Force are authorized to conduct
experunents in connection with the development of defenses of all types against atomic,
biological and/or chemical warfare agents involving the use of human subjects within the limits
prescribed above.
4. In each instance in which an experiment is proposed pursuant to this
memorandum, the nature and purpose of the proposed experiment and the name of the person
who will be in charge of such experiment shall be submitted for approval to the Secretary of the
military department in which the proposed experiment is to be conducted. No such experiment
Downgraded lo UNCLASSIFIED 22 August '75 per
5. Clemerlis
OCR for page 91
Appendix D
91
shall be undertaken until such Secretary has approved in writing the experiment proposed, the
person who wile} be in charge of conducting it; as well as informing the Secretary of Defense.
5. The addressees will be responsible for insuring compliance with the provisions
of this memorandum within their respective Services.
/signed/
C. E. Wilson
Copies furnished:
Joint Chiefs of Staff
Research and Development Board
Downgraded to UNCLASSIFIED 22 August '75 per
S. Clements
Representative terms from entire chapter:
experimental subject
