SECRETARY OF DEFENSE

Washington

 

                                                        26 Feb 1953

 

MEMORANDUM FOR THE SECRETARY OF THE ARMY

                   SECRETARY OF THE NAVY

                   SECRETARY OF THE AIR FORCE

 

SUBJECT:  Use of Human Volunteers in Experimental Research

   

    1.  Based upon a recommendation of the Armed 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 and/or 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:

                      

        a.  The voluntary consent of the human subject is

absolutely essential.          

 

           (1) 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, overreaching, or other

           ulterior form of constraint or coercion; and should

           have sufficient knowledge and comprehension of the

           elements of the subject matter involved as to

           enable him 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

 

 

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