Draft Final Report of the Advisory Committee on Human Radiation Experiments: Discussion of Applicability of 1953 Wilson Memorandum Standards to Research in Contractor Facilities in the 1950'S a ...

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OFFlCE OF GENERAL COUNSEL MEMORANDUM FOR THE ASSISTANT TO THE SECRETARY OF DEFENSE SUSJZCT: Draft Final Report of t h e Advisory Committee on Human Radiation Experiments - - Discussion of Applicability of 1953 Wilson Memorandum Standards to Research in Thank you f o r the opportunity to review and comment on chapters of the ACHRE draft final report.I am aware that others are commenting on a wide range of issues In this important report. I wish to comment on a single issue, t h e draft report's discussion of che applicability of the 1953 SECDEF policy on protecting human subjects in atomic, biological, and chemical warfare defense research to research conducted in concraccor facilities. This will be a critical issue in ongoing litigation, where the establishment of'a clear factual record w i l l be a major challenge f o r the courts. In brief, I believe'the impressive factual record compiled by the ACHRE shows that although there were some pwponents within DoD for che early extension of the 1953 SECDEF memorandum procedures to research in contractor facilities, no s u c h genera3 requirements were established until many years later. Further, I think a number of fact-relaced characterizations made in the aratt suggesting that such requirements on contractor facilities were established in the early implementation or' the 1953 memorandum are not well supported by t h e factual record. characcerizations are identified below, with my suggestions on revisionscthat I believe would be more consistent' with the The draft states (lines 15-21): Secreta,? Wilson's policy is a landmark tnat invites axd deeerves continued study. Having determined to

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recognize international principles of human rights, w h y , or how, could the Secretary have limiced its a-pplrcation to some, but not all human experiments? Why was the policy directed solely to experiments related t o "atomic, biological, and chemical warfare"? Moreover, was the policy, as is not completely clear from its face, to govern such research wherever it was conducted; for example, when it was performed by private.contractor investigators, as well as intramural researchers? How was a directive issued First, because this paragraph makes an observation on what is "not complerely clear from i t s face," the relevant facial text should be quoted. I suggest adding a t the end of line2 (following armther quote from.the text) the following new. on d u t y a;z' installations engayed in such r-%search shall be permitted t o actively participate in al.1- phases -of rhe is t h e same as cited in-the previous footnote.),] Second, based on -the text's expression of the policy. civilians OR ? duty at installations engaged in such research" page 26, lines 14-16) of t h e policy it presented to t h e Secretary for his signatire as a policy "for t h e use of 3uman volunteers (military and civilian) in experimental research ac.Armed Forces t h e memo.!s applicahility to contractors "is not completely clear offer commentary on the limitations of t h e Wilson memo, I suggest that the "Moreover, ,.. sentence (beginning 02 line 19) be replaced by the following: Moreover, why was t h e policy apparently lirnited to DoD installations, racher than also expressly applying to research performed by private contraccor Investigators?

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The draft cracks the Army's early implementation of the Wilson memo by referring to the ' Army Chief of Staff memorandum of 3 0 J u n e 19S3 and the Army Surgeon General's policy of March 12, 1954. On the issue of contractor resedrch, the draft states . Moreover, while the J u n e 1953 Army memo did not state directly whether ic applied to contract .researchers,.. the 1954 OSG policy was transmit-ced to s o m e univer6iC.y applicable as a non-rnandato.ry-gUidef o r planning and . While the AFEa's invocatibn-of the 1954 OSG policy makes clea? chat the policy extienbed-to*concractors and was not: limited to itABCi4 research, the extent to which i t [A 1 9 6 2 A r m y memorandum that reviewed past Army research) has been conducted in strict accordance-with t h e Nuremberg Code." The Nuremberg Code was said to have applied to There are several factuai disparities in :his excerpc. First,tk ' June 1953 Army memo employs language almost identical to Chat quoted above in the Wilson memorandum-: After a lengthy discussion of legal issues regarding acceptance of voluntary services, claims against t h e government for injuries, and life insurance,the Army memo staces: Subject: to the above conditions, A,med Forces personnel and/or crvrllans on duty at if is tall at ions engaged in research i n subject fields shall be permir,:ea to actively participate in all phases of the program.

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Second, the documents cited in footnotes 8 3 through 85 do not support t h e statement that mandatory requirements were incorporated into AFEB contraccs. I have noc seen any copies of contracts awarded by the AFEB or any o t h e r DoD component during this time period that included requirements similar to those in the Wilson memo. The documents ciced in these footnotes are correspondence showing AFEBIs implementation of the 'Inonmandatoryt1policy, but they do not reflect a conversion of the policy to a mandatory one applicable to contractors. In addition, to the extent t h e draft seeks to suggest that t h e AFEB materials represenr the norm for all Army research or fox Army , radiation research, there is no evidence offered to support such Third, the summary of the 1962 Army- memorandum that reviewed past Army research is misleading. memorandum, Lt. Col. Donald Howie, says regarding contract What- the author of the Contract-use of volunteers: A complete survey of research contracts i n which volunteers were us-ed-was conducted in 1960 p r i o r to prelirninarjl'drafting of AR 7 0 - 2 5 , 2 6 March 1962. A t that time, a total of 21 contracts were -active- Approxirhately 3,000 students; 250 patients, and 300 - prisoners were participants. The general picture today 1s essentially unchanged; 'Investigators have utilized the 12 March,.1954 SGO Directive-as a guide and have had prior approval of protocols by their own institutions, the project officer, the AFEB when applicable and appropriate Advisory ' Committees to t h e Surgeon General. I C is cigar that Lt. Col. Howie was talking about implementation contract research,.not asserting some new declaration about t h e applicability of the Nuremberg Code to contract research. i suggest the above excerpt be revised to read as follows: memorandum appeared to be limited to research at DoD installations. However, the 1954 OSG policy was transmitted used as far as applicable as a non-mandatory guide for

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clearly "non-mandatory,"evidence shows that t h e policy was taken very seriously by, at least, the Armed .Forces While the AFEB-'s invocation of the 1954 OSG policy makes clear that the policy, as a non-mandatory guide, extended to contractors and was n o t limited to'-"ABC" research, t h e extent to which it extended to research with that reviewed past Army research] expressed the view chat conducted in strict accordance with the Nuremberg tode." This observation reflected the wriEer'S view khat the SGO's non-mandatory guide was being followed by-Afmy contractors. The draft states (lines 14-17): In sum, t h e evidence shows that a military tradition of requiring some form ' o f consent from'healthy volunteers was in existence in 1944, and was reiterated thereafter. A t - least asa matter of rule, this craditioii was aqlicable whether research was done "in-service" o r by contractors. If the phrase + @ a sa matter of rule" is synonymous w i t h -':asa matter of mandatory policy," this dentence is a birecr: contradi&ion of the historical record. directives, regulations o r other mandatory policy this The following is a applicable to research a c DoD installacions; 5. t h e 1953 Army Chief of Staff memo, by I t s cerms, also apparently only applicable to research. at A-my

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the 1'954 Amy Surgeon General memo, applicable to no Navy mandate purporting to apply Wilson memorandum requirements to contractor facilities; no Air Force mandate purporting t o apply Wilson memorandum requirements to contractor facilities; no mandates established by any Defense agencies (such as the Defense Atomic Support Agency) purporting to apply such requirements to contractor facilities; and no acquisitions regulations or procurement manuals direccing contracting activities purporting to incorporate such requirements in research contracts. - In t h e context of the 19506, it is not surprising that a federal agency would establish a set of standards for in-houseresearch, but not impose the same requirements to extramural programs. As discussed in pages 3 3 - 3 6 of the draft, this is exactly whar. the National Institutes of Health did. An explanation for this NIX policy has been offered by Professors Faden and Beauchamp as involving both a hope that the NIH Clinical Center would set an example for other institutions and a view that !'judged the scientist-and local institutions to be the responsible parties."l Perhaps the same observation would apply toa prevailing DoD viewpoint of the time period, and help explain why the Wilson memorandum requirements-were not "as a matter of rule" made applicable to contractor -installations. Based-on this, I suggest that the "matter of ruleiisentence be replaced with the following: As a matter of rule, regulation, o r directive, :his :radition was not made the subject of mandatory policy f o r research a t contractor facilities, aithoush it was in some instances encouraged upon contractors. Informed Consent, Oxford University Press 1986, p.202.

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The draft report's chapter 3 discussion of government standards f o r human experimentation i n the 1960's and 1 9 7 0 ' s describes the 1962 Army Regulacion 7 0 - 2 5 . It s t a t e s (page 9 , In 1962 the Army, for the first time,issued the1953 policy embodied i n the Wilson memorandum as a formal regulation, Army Regulation (AR) 70-25. The regulation crystallized, as the 1953 DoD and Army policies had lefc implicit, hasic questions about the-scope of DoD's rules. Unlike t h e Wilson memorandum, the new regulation applied to all types of research, iricluding atomic, biological, ~ chemical and others. However, the regulations specifically excluded clinical research, that is, research likely to be performed with patients at the many Army hospitals. In 1963, an ad hoc committee concluded thar the rule did apply when research was done by contractors; however, tracer Despite the comrnitte'e"~recommendations, however, no immediate changes were made to t h e rkgulation. There are several factual problems with che excerpt. First, the discussion of t h e comments of the ad hoc commictee (which seems t o have been formed for the purpose of a one time session) is incomplete. The ad hoc committee, among ocher things, expressed t h e view t h a t AR 7 0 - 2 5 applied "to Army supporcea contracts and grants as well as indhouse research programs. ' ' The committee recommended igsuance by t h e Surgeon General of irnplernencing instructions to govern all reseazch nnder t h e juris dic - tion of the-Surgeon General, includins thar conducted by contractors and grantees. ?he proposal was made to che Army Research and Development Command, which had organized t h e ad hoc committee's session. I n reviewing chrs aroposai, the Command Judge Advocate said: The committee apparently takes the view thac AR 7 0 - 2 5 applies to A m y contracts and grants a s well as in-house projeccs, and i t is understood c hatch is 1s consiscent wlth Surgeon General for Research and Development]. Since AE? 7 0 -

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2 5 could also be interpreted oppositely, consideration should be given to clarifying AR 70-25 in this respect.2 The Command Judge Advocate recommended against issuance of the proposed implementation memorandum, suggesting instead that: AR 7 0 - 2 5 be revised to address a number of issues. Apparently, t h e implementation memorandum was not issued, nor was there any action on revising AR 7 0 - 2 5 . As a result, apparently the 1 9 5 4 Second, in the context of t h e ongoing research program of 1962, the failure of AR 7 0 - 2 5 to specifically state that it applied to contractors might support the inference chat it did not apply. It might be guessed that in the 1953 time frame, primary attention was on in-house research activities, possibly explaining why the 1953 policy issuances failed to expressly address research at contractor facilities. But by 1962, the issue of human subjects protection standards for research at -contractor facilities was clearly on the table. In additLon t o being the subject of the 1954 "non-mandatoryguide" &licy, the Army Medical Research and Development Command-conducteda survey of research pr0jects;apparently in connection with the discussed above). The survey identified 21.active contracts, involving as human subjects approximately 3 ; O O O students, 2 5 0 patients, and 300 prisoners. An appendix to A R 70-25 discusses legal implications relating to various categories of subjects, military personnel, civilian employees, private citizen's, contractor's employees, and irregular or fee-basis employees. The appendix concludes that subject to a number of conditions staced in the discussion, "Armed Fsrces personnel and/or civilians on duty at installations engaged in research in subject fields w i J l be permitted to actively participate in all phases of the program" - - which is the same language that appeared in the 1953 Army Chief of Staff memorandum. With the attention that had Memorandum from Col. Maurice Levin and Alexander Naimon, "Use of Volunteers as Subjects of ?.esearch," 2 3 March 1964. As an additional comment, che draft should identify the documents relied upon for the discussion of the ad hoc committee.

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policy and the identification of more than 3,500 students, patients and prisoners involved in ongoing projects, it would appear reasonable to assume that: i f the Army leadership intended to establish standards for research at contractor facilities, AR 7 0 - 2 5 would have said something a b o u t students, patients, prisoners, or contract facilities. This, of coufge, 1s not conclusive, but it should cast serious doubt on the supposition reflected in the draft t h a t AR 70-25 applied to research in Based on these points, I suggest the last two sentences of c h e above excerpt be replaced with the following: Tracer research (which arguably posed minimal risk) was excluded. In 1963, an ad hoc committee advising the Surgeon General on implementation of AR 70-25 concluded that it did apply to research done by contractors and recommended t h a t this position be reflected in the Surgeon General's implementation requirements. However, the Judge Advocate of the Research and Development Command s a i d AR 7 0 - 2 5 could be incerpreted oppositely and suggested consideration of revision to …