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-3

            þþþDRAFT þ FOR DISCUSSION PURPOSES ONLYþþþ

			MEMORANDUM

TO:       Members of the Advisory Committee on Human Radiation 
	  Experiments

FROM:     Advisory Committee Staff

DATE:     January 10, 1995

RE:       Legal Protection of Military Research & Development (R&D) 
          Contractors 



     With a tradition that dates at least to Dr. Walter Reed's turn 
of the century yellow fever research, the Army has long sponsored 
research and human subject volunteer experimentation relating to 
infectious diseases.  This research was centrally coordinated by the 
Army Epidemiological Board (AEB) from 1941 to 1949, and thereafter by 
its successor, the Armed Forces Epidemiological Board (AFEB).  While 
the AFEB does not appear to have been a significant sponsor of 
radiation experimentation, the research rules and practices of the 
AFEB may well shed significant light on the rules and practices of 
radiation experimentation. Staff has therefore been reviewing 
National Archives collections related to the AFEB.

     This memorandum discusses some of the materials retrieved from 
the archives. The sample does not focus on particular experiments 
sponsored by the AFEB, but on the relationship between the AFEB and 
private research contractors. As shown by the documents, it appears 
that:

     1.   A 1943 law authorized indemnification of Office of 
          Scientific Research and Development (OSRD1 [OSRD coordinated 
	  World War II military research & development.]) contractors 
	  against claims for property damage or personal injuries 
          brought by third parties.  It is not known whether any OSRD 
          medical research contractors were indemnified under this 
          law.  In any event, the law expired with the 
          disestablishment of the OSRD in 1945.

     2.   In the late 1940s, certain university researchers who 
	  wanted to resume hepatitis studies involving federal and 
	  state prisoners expressed their concern over potential 
	  legal liability to the AEB.  Army lawyers responding to 
	  these inquiries stated that the Army could not pay the 
	  premiums on third party liability policies and, without 
	  specific Congressional authorization, could not indemnify

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          contractors.  The Army lawyers recommended use of waiver 
	  forms signed by the subjects, but at the same time 
	  expressed uncertainty over their effectiveness.


     3.   The Army was of the view that waiver forms would not be 
          sufficient to protect the private researchers from 
          liability, and that specific Congresssional authorization 
          was needed if the Army were to indemnify its contract 
          researchers.  There was concern, however, that an approach 
          to Congress on behalf of human experimentation could result 
          in negative publicity that would set back research.

     4.   During the same time period, the Senate passed a bill 
          authorizing the Department of Defense (DOD) to indemnify its 
          R&D contractors against claims for property damage or 
          personal injuries.  There was no mention in either the 
          committee hearings or report of the need to protect medical 
          R&D contractors.  Although the bill had the full support of 
          DOD, for some unknown reason the House of Representatives 
          took no action on it.

     5.   There was an awareness by some researchers at this time 
          that, in light of the Nuremberg Code, new rules would be 
          required to govern human experimentation.

     6.   In 1952 Congress enacted legislation authorizing DOD to 
          indemnify its R&D contractors against third party claims.  
          The only hearing mention of potential its applicability to 
          medical research was when an Army officer testified that the 
          indemnification provision would be relevant to work such as 
          that done by Dr. Walter Reed.

     7.   Responding to an AFEB inquiry, Army lawyers stated that the 
          law would cover outside researchers using prisoners and 
          other subjects and recommended inclusion of an 
          indemnification clause in all pertinent AFEB contracts.  
          This response also noted that, as a technical matter, the 
          contractor would be indemnified but the result would inure 
          to the benefit of the "human guinea pig".

     These documents shed further light on the June 1953 Secretary of 
the Army directive which implemented the Secretary of Defense's 
Nuremberg Code policy (sometimes referred to as the "Wilson 
Memorandum").  As previously discussed, that directive, drawing on 
underlying legal analysis from the Judge Advocate General's office, 
focused with legal precision on the questions of (l) the statutory 
basis for the Army's performance of human experimentation in the first 
place; and (2) the statutory basis for the selection of subjects. In 
addressing the second question it focused on the issue of whether or 
not the government could pay death or disability benefits in case of 
mishap. The answer to this question, the analysis indicated, depended 
upon whether or not there was clear Congressional authorization for 
the expenditures of funds for this purpose. In sum, the AFEB documents 
indicate that the 1953 Army

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memorandum embodied continued and serious legal analysis of the 
relation between the use of human volunteers and the obligation to 
provide compensation for risks that might result in harm.

     It is not known how many AFEB and other DOD medical research 
contracts provided for indemnification; however, such contracts as the 
initial one with the University of Cincinnati for whole body radiation 
had such a clause.

The documents include:

Attachment 1:  October 23, 1947 Memorandum from the Robert J. 
               O'Connor, Chief, Legal Office, to Col. Frank L. Bauer, 
               Army Medical Research and Development: Re: Protection 
               of Research Project Volunteers

     In this memorandum the Army Legal Office advises that there is 
nothing in the standard research and development contract "which would 
require the Government to reimburse the contractor for payment to a 
prisoner as compensation for injury resulting from participation in a 
research project."

     The memorandum states that the Contract Insurance Branch had been 
consulted, and advised that "there was no authority for taking out 
such a policy [disability policy covering prisoners] and it would not 
be approved." This office reported that it had been advised by private 
underwriters that "the cost would be prohibitive."

     The Legal Office therefore urged that the University of 
Pennsylvania's Dr. Stokes be told to "protect himself, the State of 
New Jersey, and the Government, by means of the usual waiver. . . 
.This office will supply the necessary form upon request."

Attachment 2:  October 27, 1947 letter from William S. Stone, Colonel, 
               Medical Corps, Chairman Medical Research and 
               Development Board to Dr. Joseph Stokes, Jr., University 
               of Pennsylvania

     In response to Dr. Stokes' inquiry regarding compensation of 
research subjects, Col. Stone encloses the above memorandum and 
responds that "there seems to be no real answer except requesting 
special legislation for cases as they arise." Col. Stone further notes 
that a proposal for compensating volunteers "when they are not on 
military status" will be presented to the services in an effort to see 
if legislation can be forwarded.

Attachment 3:  February 18, 1948 letter from John R. Paul, M.D., 
               Commission on Virus and Rickettsial Diseases, to Dr. 
               Stokes

     In this letter, which appears to respond to a request for comment 
on Dr. Stokes letter of February 11 to Dr. McLeod (Attachment 3A may 
be this document), Dr. Paul addresses Dr. Stokes request for

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compensation for prisoners "who may be sufficiently disabled as a 
result of their acquiring experimental hepatitis to prevent their 
full return to gainful occupation."


     Dr. Paul comments: 

          As to the second question relating to studies on humans 
          which as you say raises a point of 'ethics', I agree with 
          your principles but believe the timing is not as opportune 
          as it should be. Namely, at this stage in the world 
          situation one should proceed cautiously, until whatever 
          standards are set up by what ever body is in 'authority.' I 
          am not sure just what the rules are but I understand that 
          Dr. Ivy [expert witness of what became the Nuremberg Code at 
          the international trial] at the University of Illinois has 
          been on some type of vigilance committee which has laid down 
          certain principles about volunteers in order to protect this 
          country from criticisms brought up by Germany during the 
          Nuremberg trials. The Russians in Japan have also accused 
          U.S. scientists of experimenting on humans. During the war 
          we more or less made our own policies on this, but I am not 
          sure that is possible today and if there are to be official 
          policies, I believe, we have to know them before any 
          official statements should be made.  (emphasis added)

     The Nazi medical defendants at Nuremberg did launch criticisms of 
American prison research as part of their defense.  They claimed that 
the Nazi concentration camp experiments were not significantly 
different from the experiments conducted in American state and federal 
prisons during the war.  Andrew Ivy was appointed chair of a committee 
by the Governor of Illinois (hundreds of Illinois prisoners served as 
subjects in wartime tropical disease research).  The report of the 
committee pronounced that prison experimentation, as generally 
conducted in America, was ethically acceptable (actually, the report 
used the word "ideal").  The report appeared in JAMA vol 136 (14 Feb. 
1948): 457-458 (Advisory Committee members were presented with a copy 
in conjunction with an earlier staff report on the Heller/Paulsen 
prison experiments).

Attachment 4:       April 5, 1948 letter from C.J. Watson, M.D., 
                    Commission on Liver Disease to Dr. McLeod, with a 
                    copy to Dr. Stokes and others

     In this letter Dr. Watson explains that a survey of academic 
experts has indicated that the use of a waiver is not likely to 
provide much protection for the private contract experimenters. "I 
have concluded that any human experimentation must be carried out in 
the future as in the past, on the basis

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of the sole liability of the individual experimenter."

     In a further comment Dr. Watson offers:

          I have given considerable thought to the matter of whether 
          it would be advisable to approach individuals or groups in 
          Congress with the idea of having laws passed relating either 
          to payment of compensation for disability or release of the 
          experimenter from liability. I am afraid that this would be 
          a dangerous course, and that it might in fact, injure 
          clinical investigations generally. There is a very real 
          possibility that unfavorable publicity  would quickly 
          result. Dean Fraser [a law professor who had been consulted] 
          and his colleagues were in thorough agreement on this point.

Attachment 5:  April 12, 1948 letter from Dr. Watson to Lt. Col. 
               Bauer, Office of the Army Surgeon General

     In this letter Dr. Watson recounts his finding that law 
professors were "inclined to doubt the value" of a waiver, and asks 
Dr. Bauer if he can request an opinion from Army lawyers.

Attachment 6:  April 20 and 23, 1948 Exchange between the Army 
               Epidemiological Board and the Legal Office, Re: Human 
               Volunteers for Research Investigations

     In this exchange the Legal Office advises, among other things, 
that (l) it cannot give an opinion on the efficacy of a waiver in the 
absence of recorded cases; (2) the Army cannot obligate itself to the 
protection of investigators; and (3) "no branch of the Department of 
the Army should under any circumstances write any letters to any state 
offices concerning this subject." 

Attachment 7:       October 14, 1952 Memorandum from Col. Rapalski, 
                    AFEB, to Chief, Legal Office, Re: Applicability of 
                    Section 5, Public Law 557-82d Congress, and 
                    related Memorandum from Col. Rapalski to the 
                    "Members of the Armed Forces Epidemiological 
                    Board; Directors of All Commissions."

     In the October 14 Memorandum, Col. Rapalski asks for legal 
opinion regarding a recently passed law. That law provides (the 
relevant portion of the law appears as Attachment 8) DOD with the 
authority to indemnify contractors against liability and loss from 
injuries to third parties arising out of the direct performance of a 
research and development contract.

     Col. Rapalski's memorandum stated:

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          l.  The Armed Forces Epidemiological Board has raised the 
          question as to a practical problem in conjunction with 
          Public Law 557-82d Congress. Under its sponsorship, the 
          Armed Forces are supporting crucial medical research in 
          which human volunteers in Federal and State prisons are 
          involved.

          2.  The particular question that has been raised is whether 
          Section 5. . .is applicable to afford relief to the 
          immediate dependents of such prisoner volunteers when as a 
          result of these experiment [sic] they should die.

     In his attached Memorandum to the AFEB, Colonel Rapalski reported 
that the legal office had advised:

          From the wording of the law, and from the above quoted 
          legislative history [which does not expressly refer to human 
          experimentation], it can be determined that this provision 
          was aimed at private contractors as distinguished from 
          Government agencies. It is aimed at those functions or 
          experiments which are unusually hazardous for which the 
          contractor cannot obtain liability insurance, and it is a 
          direct indemnification to the contractor and not to the 
          human guinea pig. The charge of claims, therefore, would be 
          for the next of kin of the deceased person to make a claim 
          against the contractor.

Attachment 8:  Public Law 557 - 82nd Congress
				

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