DISCLAIMER

The following is a staff memorandum or other working document 
prepared for the members of the Advisory Committee on Human
Radiation Experiments.  It should not be construed as representing
the final conclusions of fact or interpretation of the issues. 
All staff memoranda are subject to revision based on further 
information and analysis.  For conclusions and recommendations of
the Advisory Committee, readers are advised to consult the Final
Report to be published in 1995.






				TAB I-5

þþþDRAFT þ FOR DISCUSSION PURPOSES ONLYþþþ

MEMORANDUM

TO:       Advisory Committee on Human Radiation Experiments

FROM:     Advisory Committee Staff

DATE:     January 13, 1995

RE:       New Ethics Documentation 

                                 

                                 
     The following recently retrieved documents should be inserted in 
the binders (provided in December) which include basic documentation 
on ethics policies.  Please note, we will send tab separators for 
these documents at a later time. 

Atomic Energy Commission

March 28,1948  Subcommittee on Human Applications document and a 
               related 1974 Shields Warren interview excerpt discussed 
               below.  These documents suggest that the Director of 
               the AEC's Division of Biology and Medicine may have 
               directed the Isotopes Division to respond to  concerns 
               about the plutonium injections by issuing a policy for 
               research ethics and consent.   (Discussed in Tab F)

September 1950 Carl J. Wiggers' medical school commencement address 
               published in the Alumni Bulletin, Western Reserve 
               University School of Medicine (September, 1950), 
               pp.60-65.  Dr. Wiggers was an eminent Case Western 
               physiologist.  His speech states that "voluntary 
               consent" was a long part of an "unwritten code" which 
               the Nuremberg Code codified.  
     
April 9, 1974  Excerpts from an Interview with Shields Warren that 
               provides some possible context for the March 28, 1948 
               document.  Warren's comments suggest that the Division 
               of Biology and Medicine, in the aftermath of the 
               plutonium injections, believed that the Isotopes 
               Division should develop guidelines to govern similar 
               experiments in the future. (Discussed in Tab F) 

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Department of Defense

March 12, 1954 Office of the Army Surgeon General guidance.  This 
               document, which in this iteration is addressed to 
               contractors, was found in the files of Yale University 
               researcher John Enders.  It embodies the policies 
               described in the Wilson Memorandum and the June 30, 
               1953 Army implementing directive, and  states that 
               these policies be used as a "non-mandatory guide" for 
               contract research. Additionally note that the document, 
               in contrast to the Wilson Memorandum, did not 
               specifically reference atomic, biological or chemical 
               warfare-related research.  Thus it might appear to 
               apply to "medical research" broadly.  See also the June 
               27, 1956 document discussed below.  (Discussed in Tab 
               F)

July 10, 1962  Army memorandum entitled "Use of Volunteers for Army 
               Medical Research."  This document reviews the history 
               of army research ethics policies and describes the use 
               of humans in army medical research.  It broadly states 
               that the Nuremberg Code and the March 12, 1954 SGO 
               document have governed Army research.  It further 
               states that a 1960 survey shows the application of 
               these principles to research with "students" and 
               "patients." (Discussed in Tab F)

August 27, 1951  Navy memorandum regarding the "Radioactive Isotopes 
                 Program" that indicates the need for a research ethics 
                 policy. Additionally, several documents attached to 
                 this memorandum demonstrate the requirment for consent 
                 forms for diagnostic and therapeutic uses of 
                 radioisotpes. (Discussed in Tab F)

November 5, 1953 Army memorandum on the "Use of Volunteers in Research" 
                 that indicates contractors should abide the same 
                 "principles and safeguards" as Army laboratories. 
                 (Discussed in Tab F)

June 27, 1956    Letter from a Tulane University researcher indicating 
		 the need to apply the March 1954 SGO guideline to 
		 contract research.  Note that the letter is addressed 
		 to the Armed Forces Epidemiological Board and 
		 apparently relates to research under its purview -- 
	         further suggesting that the 1954 SGO guidelines were 
		 not limited to atomic, biological, and chemical 
	         warfare-related research.  (Discussed in Tab F) 

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