Letter to Chair of the Achre Stating Intent to Pursue Research Effort Re: DOD Human Radiation Experiments and Forwarding of Material Related to Achre Requests. Includes Compilation of Documents ...

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ASSISTANT TO THE SECRETARY OF DEFENSE Advisory Committee on Human Radiation Experiments 07 your recent letter and the appreciation that you expressed concerning discover and document the extent of its participation in human radiation experimentation. However, from another perspective, it also reflected the Department’s strong commitment to this task, and the dedication of those personnel, at numerous bases and installations throughout the Nation, who diligently made the search. Therefore, I am grateful for having the opportunity to appear before the Committee and represent the Department and its dedicated professionals. I also wish to express my appreciation for the kindness and consideration shown me by the Committee. ion at the Advisory Committee’s opening session on April 22, 1994. As you are aware,Fthe presentation summarized the Department of Defense’s (DoD’s) extensive efforts to The Department is eager to be of assistance to the Committee and its staff, and to provide you with the information available on the topics identified in your letter. Since January 1994 our efforts have been directed towards achieving the initial requirements established in the guidance promulgated by the Interagency Working Group. As such, information on some subjects of interest to the Committee may not be as extensive as in other areas. However, as we continue our search efforts, the Committee’s interest will be incorporated, which will fixther aid us in focusing our efforts. Regarding your letter, in addition to the four boxes of material provided to the Committee on 29 April 1994, I have enclosed additional material to address specific requests. A description of this material and its relation to your requests is enclosed. As additional information is found concerning these areas, it will also be forwarded for the Committee’s

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I hope that this information will assist the Committee in its tasks. The DoD is committed to achieving a full accounting of its involvement in human radiation experiments and welcomes the Committee’s efforts in helping us to attain this goal. On a personal note, I would like to commend you on the leadership and expertise that you, and the Committee, bring to this effort. I look forward to working with you.

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1. Ethical Standards and Regulations Tab A -- Memorandum for the Secretaries of the Military Departments from the Secretary of Defense, dated 26 February 1953, Subject: Use of Human Volunteers in Experimental Research. The Memorandum established DoD policy for the use of DoD volunteer personnel in experimental research in the fields of atomic, biological, and/or Tab B -- Department of the Army Memorandum, dated 7 January 1994, Subject: Historical Perspective on Informed Consent, with attached information paper. The information paper traces the evolution of the Army's policy on informed consent and human use review. A chronology is also included. Tab C -- Department of the Air Force Memorandum, dated 10 January 1994, Subject: History and Current Practice of Informed Consent in Clinical Practice and Clinical Research - INFORMATION MEMORANDUM. The memorandum is a chronology that traces the evolution of consent standards for human subjects from the 1940's to the present. It also incorporates the development of Air Force regulations relative to the subject. The Department of the Navy also researched its regulatory history for instructions governing human use. February 1994 the Navy stated, "The Navy Manual of the Medical Department in 1951 provided formal guidance for conducting experiments using human use test subjects. Further guidance was issued in DoD and BUMED [Bureau of Medicine] instructions in 1964, 1982, In a report on its review of human radiation experiments dated 28 2. Plutonium Injection, Green Run and Cincinnati Experiments. The available information was provided to the Committee staff on 29 April 1994. Our office has no information on plutonium injections (these experiments fall under the purview of the Department of Energy). Also, the material received from the University of Cincinnati contained duplicate copies of the same documents. To ensure the integrity of our search and that the Advisory Committee received a complete set, the documents were reproduced as is, with no attempt to remove duplicates. Tab D -- Additional information on the Green Run experiments received after 29 Tab E -- Secretary of Defense Memorandum, dated 7 January 1994, Subject: DoD Human Radiation Research Review. The memorandum published general record retention and

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Tab F -- Department of Defense Memorandum, dated January 3 1, 1994, Subject: Locating Records of DoD Human Radiation Experiments. This memorandum provides the Department’s components and agencies detailed guidance by which to conduct their document search. It also established reporting suspenses and formats in which the reports were to be Tab G -- Briefing vu-graphs, Department of Defense Human Radiation Experiments Review. The vu-graphs are copies of those that were used to brief the Committee on 22 April 1994 and contain information on the scope of the research effort and resources employed. Additional information on search techniques and resources are in the Phase I and Phase I1 reports contained in the boxes provided to the Committee staff on 29 April 1994.

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1. Dascd upon ci recommcmlntion of t h e Arnied Forces Medical Dcpar LmcriC of Defense in e::pci-imentaJ. rescarch i n the f ielii; of atomic,biological and / or chemical warfare. 2 . By reason of tlic basic rncc7icn.f. resp on si kili ty in connection a. The voluntary consent of Llic human - u b - ject is (1) This means that the pcrson invol.cd slimi'ld have lcgal capacity to give consent ; shoulr.: be s o ulterior form of constxainl: o r coerc4 on; .ar,d sno\:ld elements of the svbject matter involved asto the acceptance of an Gf fi kati ve decision by Ll;c experiinentnl suhject tlii?xa should be made knotin to him the nature,duration, and purpose of -- situated as to be able t o exercise f ce p o \ \ ( x of-_

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effects upon his health or ~ CPSOI ~whi.cli may possibly cone from his participation in the experiment. in stu ment setting forth su list anti ally the aforementioned requircrcicnts and shall be signed in the prcseiicc of n t least one witness who sli nll attest to such sign at urc in vr i tiny. (a) In cxpcrimcnts whcrc personnel from more than one Service arc iiivolvcd the Secretary of the Service which is cx er c ising primary responsibility for conduct in q the cxpariment is de sbn a ted to prep are such an instc ~ men tand coordinate it for USC by all the Services having human volunteers involved (3) The duty and responsibility for ascertaining the quality of thc consent rests upon each individual who initiates, directs o r engages inthe experiment. It is a personal duty and resp on sibi ; .ity which may not be delegated t o another with impunity. b. The experiment shoulci bc such as to yield fruitful results for the good of socj.et.y, un pro curable by other mcthocls o r means of sttidy, and not raiidoni and unneccafiary i n naturc?. c. The number of volunteers used sli ~ ' 1 2be kept at a d . The expcrirncrit should he so desi5:ne.d and based on the minimuin consistent with item b., above. results of animal ex per im cnt ation and a knowledge of the natural history of the disease or othcr problem under study that the antic ip at.cd results will justify the performance of the experiment. c . Thc experiment should be so conducted as to avoid all g. The degree of risk to 'be taken should never exceed that dctcrminccl by the humanitarian, importance of tho problem t o bo solvccl by tho oxporimont.

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evcn rcmotc possibilities of injury,disability, or death. i. The experiment should be co:iducted only by sci cnt if i shouLd bc rcquirccl through aJ.1 stages of t h e experiment of those who conduct o r engage i n the czperimcnt. j. During the course of tlic experiment the huiunii sub j cc rcachcd tiic physical or m cnt al state whzrc continuation of the experimcnt seems t o him to be impossible. k. During the coursc of the experiment the scientist in charge must be preparcd t o tc?rminakc thc experiment at any stage i f he has probable cause to bc li eve,inthe exercise of.the good faith, supcrior skill and careful judgment required of him that con-tinuation of the experir'ient is likely t o result in injury, di ability,or death t o the experimental subject. 1. The c stab li shed policy,which prohibits the use of prisoners of war i n human experimentation, is continued and they 3. The Secretaries of tlis Army, Wavy and Air Force are authorized to conduct experiments j ii connection with tli c - devclop of iicfciiscs of all.types against atomic, biological and/or chami warfare .al;c;its involving the use of iiwnan suij ect s within thc li mik s prescribed above. 4.In each instance in which a n experiment is proposed puxsunlit to this meirroranduin, the naturc and purpose of t h e proposcd such exparilncnt shall be subxlittcd for a px oval to the Secretary of the military clepartment i n which tiic proposcd experiment is 1: be conducted.No such expcriirient shall bc undertaken until such Secretary has approved in writing the experiment prcrbosed, the person who will be in charge of conducting it., as well as inform t h e Sccretclry of Defense. 5 . The addrcsses will be responsible for insuring eomplianc will not be used under any circumstances. ''1 \~expcriment and the name of the person who wi1.l be in charge of Research and Development Board

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DEPARTh!EHT OF THE ARMY II=XORANDUM THRU Commander, u . s , Army Kedical Research and FOR bput). Ch1ef of* - Staff, Regulatory Compliance and Quallty SUBJECT: HL at or ical Perspective on Informed Concenr: Reference telephone conversation barweem COL Erdtmann, SGPS2. Rocent rcvclatlcnt b y the Department of berw of " expr ~ ents " during the 19408 and 1950s involving axgosure of human subjects to radioactive macerials vith0u.t: their consent has caused the oepartnrent of Defense to begin sc rut ln lzh g its own procedures during that t h e . Requust you provide a two- to five-page information paper describing: the evolution of informed consent procedures used by tho Army, frum Ltmasdiately after w o r l d War I1 up to the presenr, and b. the procedures w h i c h the U.S.. Medical Research and 0eve l open - t Command (MRDC)has used, over time, to archive records will concribufo,significantly to the American people baing able to put t h e canduct of experiments in proper perspective. 4 - Request t h e information paper be provided by 1 4 Jan 9 4 . S. POC LEI COL 'Peter H. Xyers, OTSG Radiological Hygicne Director, Wofesslantil Servlcee

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Thc first formal authority to recruit and use volunteer subjcctx i n chemical wclrfara expcrlnents occurred i n 1942 whcn thc Acting Secretary of War approved arc quest to use anlistcd men for tenting for mustard type a gc nts(3,6),The initial statutory authority for the Secretary of the Army to Conduct research and dovelopment was t.ha Orqanization uf the my Act uf 10 July 1950, Sjootion 104 974Statute322 ; 5 USC 235a) (3). These action:, were followed by the egtabllshment of the Armcd Forces Medical Policy Council, I n i y 5 : ~ , the Secretary of Dcfcnse promulgated a policy governing ncldical cxparimanrs which also involving dcfrnae aya in ct atomic, biological and / o r chemical in 1953, which di rnc tcd that proposals using volunrcers fox irtornlc, chcmicnl, and bio lo q ical warfare ressarch be revi(%.wRdby The Surgeon Cc ncr al arid approvod by the Secretary of the Army ( 3 , 7 ) . Chemical weaporin dcfcnse research was conducted a t Edgewood Arsenal, both by thc Services and under contract. Most of this rese8rch was carried outin secrecy to protect national security Interests. In 1959, this research was presented by Major General Creasy, former Chiaf Chemical Officer, U.S. A r m y , to thc House Coxuxnittcs on Science and Astronautics, and also on several later occasions to other Congrescional committries (2,4). Documents Cor these years indicate that tests for mustard gas, phosgene, and o t h e r chcmicnl agents were conducrAid with volunteer cmployces of Edgewood Pusanal and military voluntears from several Army bases to include Navy and Air Force personnel (3,5). 7%e Army Chief of Staff published an implemenring memorandum In 1962, the thalidomidc incident prompted the Federal Covernuciit to revise the Food, Drug and Cosmetic Act, increasing the role of t h e Food and Drug Administration (FDA) in new drug approvals. This action prompted the establishment in 1964 o f DQD a Mcrnorandum of Understanding(MOW) batween tho Department or' y taff vith appropriate sjccuZit;y clc a ranc cn to allow thoir review rescarch4 Also, a t this time The Army Investigational Drug Review Board was established to evaluate the scaentrfic aGpects o f new -9 research protocols. The first Amy Regulation to regulate t h o use of human research voluntacrs, AR 7 0 - 2 5 , was published in 1362. This Ni placed responsibility for cesedrch involving life sciences under tho Army Research Office, Office of Research and Development. Revisions to this regulation in1974 placed there cp on bibi lit y for approval of all Army r(::iQnrch involving human subjects, except for nuclear and chemical agent studies, with The Surgeon General.Also in l g - ~ c ,with the issuance of OTSG Memorandun No. 10-7, the Em an tlse ~ i.evi ~ wnosrd Office was established under the supervision of the Assistant Surgeon General for Rescsrch and

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The Human Use Review Office was; charged with ndministerinq and coordinating the. activities of the U my Investigational Druq Review Doard, the (1,s. m y McdicaZ Research and Development General's Human use comit tec and Clinic.31 Investigation CommattRa to ensue the uniform application of ethical standards for h u m a n research studies conducted within or sponsotcd by the MWlD and other m y agencies (1). In 1975, The Human Subjects thrcc boards/committcec mentioned above. A l s o in 1975, the S uc rct aq of thamy ordered all human Lesting involving Army Health Care Stud186 and Clinical Studies Investiqutionnl. Activity was establishad to administer the review of clinical investigation protocols f o r Hoalth Services Command (HSC). since that tia e, a11 organizations in the Army thar conduct clinical investlqations or research, dovaloymcrit, test and evaluation ctudiec ate required to have thalr own Human Use C0rn mitt.e.e or to utilizc tha €Ism or its Sub comit t ce Lor protocol review. ARMY POLICY ON INFORMED CONSENT Several events occurred in the civilian and Federal communities which contributed to tho content of themy ' s in for ccd consent policy. In the Rur n mer of 1972, the Tuskeqee Syphilis Study, conducted by the Public Health Ser v ke fills d the American media reports. In October 1972, Conqress passed Public Low P92-570, which …