C O N F I D E N T I A L                         

 

                                Item 3247

 

                         DEPARTMENT OF THE ARMY

                      Office of the Chief of Staff

                           Washington 25, D. C.

 

CS: 385 (30 Jun 53)                                         30 June 1953   

 

MEMORANDUM THRU:  ASSISTANT CHIEF OF STAFF, G-4

 

            FOR:  CHIEF CHEMICAL OFFICER

                  THE SURGEON GENERAL

 

SUBJECT:  Use of Volunteers in Research

 

     1.  This directive prescribes policies and procedures governing the

use of volunteers in research in defense against atomic, biological and

chemical warfare.  The purpose of this research is to permit a realistic

evaluation and/or development of effective preventive measures of    defense against atomic, biological or chemical agents.

 

     2.  Certain basic principles must be observed in order to satisfy

moral, ethical and legal concepts.  These basic principles are:

 

         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, over-reaching, or ether 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 under-

standing and enlightened decision. This latter element required that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and pur- pose of the experiment; the method and means by which it is to be con-ducted;  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 substan- tially the aforementioned 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 prepare such an instrument and coordinate it for use by all the Services having human volunteers involved in the experiment.

ATTACHMENT TO CBC 200/15, 12 June 56
as per. 4.               C O N F I D E N T I A L
                                   270                                 5 

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