RCC2.950201.002 8

U. S. A!!! !GDIC.iL RESrRCH INSTITLTE OF IXFECTIOUS DISEASES

PROJECT i,NITZCOAT: A EISTOKY

.. 14 February 1974

rt TABLE OF COdTENTS

PACE

SEC'IIOX I. Authorization and Establishment. 1

NOTE: Some of the information presented in Sections I and I1 was obtained from historical files acd binders ic the Editor's Office. Source documents are not available for zll of the drafts, however, inasmuch as the notes, memos, etc. were derived from first hand observations, they are considered as such in this document. i I I SECTION 11. Unit Expansion and Progress. 3 i NOTE: Some of the information presented in Sections I and 11 was obtained fron historical files and binders in the Editor's Office. Source documents are not available for all of the drafts, however, inasmuch 3s the notes, memos, etc. were derived fron first hand observation, they are considered as such in.. this docuzenr. SECTIOE: 111. Projcct Whitecoat. 5 I I SECTION IV. Sample Project Synopsis. a 1

- NOTE: A waalth of supplemectary material 13 the fom of I moffical notes, drafts and memoranduns can be located in the Editor's Office. Included is a Project Whitecoat binder arranged by a former Whitecoat which contains several docrnents prepared by che Seventh Day Adventist i Church, professional articles by former key USXNRIID personnel and observztions by the news media. These articles, too numerous and diversified to acknowledge indivi&J:l1y, provide significant background information essential to the total comprehension of Project Whitecoat.

APPENDICES

APPEYDIX 1. Staff Study; pre?ared by OTSG for the Arned Forces Xedical Policy Council; subjcct: Parcicipatior. of rh~-3Ldical Services in Siological !;aifare Resszrzn (VI; dated 9 Sep 52. (CONFIDENTIAL)

XTE: Appendices 1 - 6 are filcd in the Sffice of cha Cax~xd?~. USAXXIID, , !li. 2li31. 'QPE~IX2. Xemcrandum for Chief Chemical Officer and The Surseon General (CS: 385); prepared by the Army Chief of Staff; subject: Use of Volunteers in iiesearch (E); dated 30 Jun 53. (CONFIDENTIAL.)

APPENDIX 3. DF fron the Chief Chemical Officer tc tlhe Acting Chief Chemical Officer/FW; subject: ?rocurement of Extrapolation Data (U); dated 21 Oct 54. (C0EiOENTLJ-L)- APPENDIX 4. Minutes of a meeting of the Conmission on Epidemio- logical Survey (18 Oct 54); undated. (CONFIDEXITI&)

APPENDIX 5. Letter €ut the President, hmed Forces Epidenio- logical Board (XFEB: to the Chief C!iemical Officer; subject: Findings of the Board (U); dated 1: Dec 5s. (COhTIDENTLAL)

AWENIMX 6. Letter from the Chief Officer to the Secretary of the Army; subject: Use of Vo1untee:s-b iesearch (U); dated 10 Jan 55. (CONFIDENTIAL)

WPENDIX 7. Memorandum for the Amy Chief of Staff; prepared by the Acting Secrccary of the Ary;; subject: Use of Voiunteers in Research; dated 14 Jan 55.

APPE%IX 8. GO 37, IXV.lC; Organization of Xedical Unit, KWCYC: dated 20 Jun 56.

APPENDIX 9. Joint Xedical Service - Chemical'Corpa AgreeKent on Responsibilities for the Ccnduct of Xcsesrch acd Development in Dcfensive aioloeical L'arfare; dated 21 Feb 56.

APPENDIX 10. GO 7, 'URWC, Organization of '&Vi (extract); dated 1 Aug 57 escabiished Ward 203, !,RUiC at USA'W.

APPEXDIX 11. 1957 USA!! Annual Report

AlPEKDIX 12. GO 9, OTSG, kited 29 Sep 5; (extract).

MPESDIX 13. Organization Chart, 1 Apr 63.

APPEXDIX 14. GO 6, OTZG, Fiedesignation of Units/Activities, dated 27 Jan 59.

APPEXDIX 15. Xcnorandun for !X Amstrong, The Surgeon General; prepared by Li'C Tiger::; c3;2c! 14 Oct 54 re: :!eeting with Dr. Theodore D. Tkiz. APPENDIX 16. Letter to MG Armstrong, with attached Statement of Attitude. from Dr. Flaiz; dated 19 Oct 54. 4 APPENDIX 17. Letter from MG Hays, The Surgeon General, to Hr. G. '4. Chambers; dated 27 Oct 55 with attached published article.

APPENDIX 18. Minutes of Heeting, USASIRM:, dated 17 ?far 59.

APPENDIX 19. DF From Enlisted Braxh, Personnel and Training Division to CG, USLXlUC, dated 27 Jun 60, subject: Whitecoat Volunteers.

APPENDIX 20. USAMRIID Table of Distribution and Allowances. Document can be located in the 3udget and Fiscal Off ice, USAEIRIID.

UPENDIX 21. AR 70-25, 26 Mar 62, Use of Volunteers as Subjects of Research.

APPENDIX 22. Letter from U.S. Army Medical Training Cecter to CG, CONARC (undated; but attached to TI. dated 23 Feb 673; subject: Imunitacion of Potential Volunteers for Stdies of Tnfactiotis Diseases at U.S. Army Hedical Unit, Fort Detrick, Xazyland. Entire appendix attached to Appendix 22.

APPENDIX 23. DA Message 767602, 1 Jun 66; subjecc: Immunization for Class I-A-0 Fetsonnel.

APPENDIX 24. Final article on Project Whitecoat submitted by Thomas Green and forwarded by Clark Snith, Sirector, Sevencn Day Adveacist National Service Organization; xdated.

APPENDIX 25. Article in the National Examiner, dated 1 Dec 69, subject: Ccnscientious Objector Experience. Subject matter along with official U.S. Army rebuttai cm be .- - -. located in the Office of the Comandsr.

APPENDIX 26. Fact Sheet - Project Whitecoat. dated 28 Nov 69.

APPEh'DIX 27. Duties of Secretary, Xedical Division.

APPENDIX 28. Resume Research Projects Involving Volunteers and Others (Iy5S-73).

SPEIUDIS 29. Resune k%itecoat Volunteer Rccruitnnext Procecure. SECTION I

AUTHORIZATION AND ESTABLIS- I

Ever since and the intrpduction of mustard gas into military Inventories, the use of chemical and biological agents in open warfare has been addressed as a moral, social and tactical issue at military conferences as well as a mtter for open public cotxern. Although the use of biological agents in the military armamentarium was not a universally accepted proposal, the reqciremeot to investigate the effects of such a weapon if applied by a hostile element against the United States received attention from the highest levels of the military establishment. This concern engendered coordination between the Chemical and Medical elements of the Army and invclved the supervision of the Secretary of the Army, Army Chief of Staff, and the Secretary of Defense. Coordination effected by MG W.M. Creasy, Chief, Chnical Officer (CCO) and MG C. E. Armstrong in conjunction with an ex:ensive legal review, culminated in the authority to conduct research investigation utilizing volunteers in defense against . This - - authority was granted by the Acting Secretary of the Army on 14 January - 1955. \

The authorization added a nev dimension to the biological warfare (Bk') research then being coriducted at Camp Detrick, Frederick, , in that effective research leading to the development of a defense egriinst the .Lse nf zicrcbii-lcg5c-l -0-*ezts cn-12 be ccier!tificzl>; conducted and evaluated without relying upon extrapolated data obtained from_animal studies. Approximately two years prior, an Ad UDC Camittee was established to investigate the feasibility of obtaining dose-response data on and/or Q Frver in hurrans. The comittee chcse to investigate by the experhental inoculation of volunteers with a Coxiella burnetii. This project, known as the CD-22 progras, terminated its initial research effort ir 1956 after yielding the first scientific data of its kind, gathered by U.S. military investigations from experiments conducted on human volunteer subjects. >.reas of interest concerning the project were: the vulnerability of ran to biological agents; prevention and treatment of BW casualties; 2nd identification of biological agents. Information such as the minimum infectious dosage, effectiveness of prophykctic and therapeutic measures, serologic responses to infectian 2nd the effects of various doses of inoculum, eventually provided answers to most initial questions contained within the researcn objectives.-. The entire progrm %as monitored by 52Csx.issisn 211 ;?iceniolo~ical 5iir\-ey (C5.r: of the fumed Forces Epideniological iSoara (AFEB) wnich provided tschnical assistance of a consultory nature to the research teams.

The responsibility to provide a defense >Fainst t;iologicai wzrfare .-- vris assigzed tn .!.zzy ?!-.'ic=l S=-ic=-, ::n?cr tb.: pzr*.ris: cf che Scrr;e02 _-- - General. .U:houEh the origin of the tern ":?itrcoat" is not dx.;-entcd here, its use to descriire research invslving vclunt.cers is found in correspondence dating back to October 1954. "OPERATION WHITECOAT" vas the code name for the plan to use human volunteers in field experiments concerning the effect of certain biologicdl upon humans (bbjective of program in 1955). Thorough legal investigation and moral consideration was rendered. yielding a group of conditions under which volunteers may be used in research, to wit: a. Voluntary consent is required. Vritten consent must be witnessed, and signed by the individual concerned.

b. No experimentation which could predictably lead to death or permanent disabling injury will be investigated with the use of human volunteers.

c. Proper medical supervision and treatment capability will be imediately available to the subjects.

d. Experfmentation must be expected to yield fruitful results for the good of society, not available by other means. e. Experimentation should avoid all unnecessary physical and mental suffering.

f. The degree of risk taken should never exceed the hportance of the experiment or tho expectable benefits from It.

g. The volunteer may remove himself from the experbent at any stage if he feels thtt he has reached the limits of his physical or mental endurance. The authorization to use volunteers, success of the two-year research project Cn-22, the definition of responsibilities concerning research into BW defense, and the legal requirements essential to OPERATION WiIITEC0.4T culminated in the organization of the Medical Unit (USAXLJ) and its activation at Camp Detritk, Frederick, Maryland cm 20 June 1956. US.LW was assigned the research responsibilities of the Army Medical 3rpartment's requirement to provide a defense against EX. W.D. Tigertt, M.C. assumed command of US.LW end occqied that position until 1961; during his tenure as Concander, Colonel Tigertt established the ground wcrk for an effective, ongoing recruiting progrzm aimed at continuing tke supply of volunteer personnel for Project Whiteccat.

2 SECTION I1

UNIT EXPANSION &?ID PROGRESS

' .The first significant action to have a direct bearing upon USAMU was a revised Agreement on Responsibilities for the Conduct of Research and Development for Defense Against Biological Warfare, signed by MG S. B. Hays, The Surgeon General and NG W. M. Creasy, Chief Chemical Officer, on 21 February, 1956. This document in conjunctioa with the policies of the Secretary of the Army, governed the research re- sponsibilities of the Comander, USAMU until 1963, when revised agreements . were signed. The revised agreements did not change the status of BW medical defense research but added chemical warfare (CW) defense to the Army Medical Departments',tasked responsibilities. CW defense work was never assigned to USA, or its successor, US&%IID.

During the CD-22 project, personnel concerned with research at Ft. Detrick were assigned to CIRAMC. Even though personnel were assigned to USAMU after its establishment, WRAMC remained as the next higher headquarters until 1958, when USAMU was assigned to the United States Army tledical Research and Development Command (USAXRDC). In 1962, authority was granted to suspend , cholera, plague, typhus and shots for personnel earmzrkc? for Project Whitecoat in order to allow their participation in research without irmnur?ological bias. In 1963, USAW was internally reorganized to reflect the unit divisional structure which remains essentially the same today.

In August, 1957, Ward 200, bR4X. was established at ESAIIIJ to provide a medical treatment facility for all xilicary personnel and to--satisfy the requirement for an inpatient facility for conducting research studies in Project !Jhitecoat volunteers. By Oeceolber, 1957, 110 Project Whitecoat volunteers were actively participating in research programs. T>e CES of the AFEB continued to nonitor the overall effort. During the period 1957-1960, provision for Fort Detricks logistical support for USA?"N Iias icplemented. Although considerable effort was expended to construct and adapt buildings identified for use by USMU, two major research projects, which would utimately yield significant data, were initiated. The first project, designed to identify the infectious dosage of P. tularensis organism, began in Ff 58 and was recorded as the fTrst research project involving humn volunteers (WHITECOAT) performed at USAWJ.

Venezuelan Equine Encephelitis (WE), the second mjor project was conducted by USxW in conjcEccion with the Allied Sciences Division, Biological Kdrfare Lzborstorics. Animals infected intraprlconeaily showed no symptoms of disease except a diphasic frver curve vhich was detected 24-72 hours subsequent to onset in 752 of the animsls tested. ALthough attenuation of the Trinidad strak was achieved in tissue culture, potentially hazariccs reactiors occurred, precluaing definitive prophylaxis ZchieveTent. VEZ :?search c@n:inwd until 1962, when responsible investigators published a research paper

3 the comparative pathology of the disease as e.xperimentally introduced into various animals. This project did not initially involve the uJe of, WHITECOAT designated volunteers, however, sevecal professional members of the USAMU staff actively participated aa volunteers in the studies

Work continued and during 1964, the immunization requirements were reasonably established for VEE and tularemia. The research findings pertaining to VEE and tularemia were followed with the preparation of industrial sized lots of immunizing vaccines against these diseases. Since that rime, several publications have been prepared in these area8 as significant findings such as the effects of aerosol age on the infectivity of airborne P. tularensis, effects of respiratory acquired x. tularensis on blzod chemistry, and the effects of live attenuated VEE vaccine on immune status. The use this vaccine with at risk personnel proved to be completely successful in preventing laboratory acquired VEE infections of symptsmatic nature.

In 1969, USAMU was redesignated the United Stetes Army Medical Research Institute of Infectious Diseases (USAXRIID) and although the mission was generally the same, the motivating purpose was altered to reflect current DA policies and strategic plans. The continuing search for chemoprophylactis,t vaccines and improved methods for their utilization was no longer structured to meet the requirements for BW defeaze, hut 33s directed tnwnrd the attenuation of comunicable disease in man vnich couid be expeccad to be contracted-in time of peace. In November, 1969, Preseident Nixon announced several najor decisions concerning the use of biological weaponry, research and stockpiles. Although BW defense (immunization and protective measures) research is still authorized, all offensive EN activities were tednated. This decision cane approximately at the time of the USLXRIID redesignation, USAEIRIID research objectives and ultimate goals are oriented and planned with the reasonable expectations, therefore, that they will benefit the civilian community as well as fulfill a military objective.

4 SECTION 111

PROJECT WHITECOAT I

I The profound decision tt alltv human volunteers to participate actively as research test subjects resulted in a meeting between LTC W. D. Tigerett and Dr. Theordore R. Raiz at which preliminary plans were made to establish the Seventh Day Adventist (SDA) Church membership as a potential resource for Project Whitecoat volunteers. This meeting which took place in October 1954, initiated the project that has afforded 60me 2200 Seventh Day Adventists the opportunity to participate in continuing research at 'J'SAXRIID, ana an additional 800 to function as laboratory technicians, ward attendants and at several other significant positions. A stateaent of attitude was rendered by Dr. Haiz to LTC Tigertt indicating that SDA official approval of the project as planned. The SDA General Conference as well as the Surgeon General, regarded the services rendered by the volunteers in such a light that a commendatory .article, published in the official church newspaper on 3 November 1955, openly indorsed the program by both parties. The article colorfully described the contribution of each 'VHITECOAT" with particular reference to their service of the country and individual standards of fortitude. This article, as much as any single action, influenced the theme of the volunteer mission as it relates to USAWIID. The SDA Project Whitecoat volunteers have provided the Army Medical Department with an extremely valuable.. and irreplaceable resource and have performed, without question, "tlevona the Call of Duty".

Project Whitecoat volunteers are selected from personnel classified as-noncombatants (formerly idectif ied by a I-A-0 draft status) during their training at . Twice annually, the Commander. and Executive Officer, USA?!RIID, along with the Director, National Service Organization for the SDA Church interviewed potential Project Whitecoat volunteers at Fort San Houston to select from those interested to volunteer, a group of men to be assigned to the unit. ?ersonnel were oriented as a group in order that a comon understanding of the general provisions of the program is insured. Potential participants were then interviewed izdividually to detennine the compatibility of their needs of conscience and the requirements of Project Vhitecoat. If an individual was selected, his reassignnent orders 3re annotated as "earmarked for W/C Project ISC" and personnel reports were similarly modified. Coordination between the Comander, USitMID and Comander, Medical Training Center (:.!TC) advises the latter of the impending visit and reqnJested permission for group presentation and perSOna1 interviews.

The above procedure proved effective as long as selective service classification (1-A-0) vas proiinent data in military records and the special provisions of conscientious objector status rfnained in effect. Coincidcnt viti the ternination st the draft, vas ciie absence Of the requirecent to provide identification of conscientious objeccors since the theory attendant to a voli,nteer military force presumed -1.':.

5 unrestricted assignment policies. The position of the SDA Church concerning the volunteer Army is consistpnt with their statenents ,of attitude in the past a noncombatant status must pe guaranteed their personnel prior to entry into military service. To date, a 3 year enlistment program as a "Volunteer" has been approved by the Department of the Army; this program is now being implemented by the Selective Service System and does include provisions for classify in all interested candidates as 1-A-Os. So Project Whitecoat recruiting has been effected since the discontinuance of the draft.

During the early stages of Project Whitecoat, (circa 1959). volunteers participated in several projects and for the purpose of cornnand and control, the volunteers were assigned to USAMJ'S enlisted detachment. Two hundred spaces were authorized by the Surgeon General to perpetuate Project Whitecoat. This authorization does appear on the TDA. In that all Project Whitecoat personnel are required to complete 9U- ATT Training, the spaces appear as 3 line items on the TDA: E-5, E-4, E-3 9lA's. The number of volunteers required were reduced to 172 during 1964. Volunteer projects generally required approximately two monthslyear of a mitecoat's time. During non-project intervals the volunteers performed mission work as laboratory technicians, ward attendants, building systems monitors, and administrative assistants in such a manner that the Institute relied upon their resources for continuity and perpetuatiod' of functions.

The De?art-%t nf the -4m.y nfficidly $et forth the specific regulations for the conduct of research studies in subjecc volunteers with the publication of AR 70-25, in 1962. Use of volunteers as Subject ofResearch, the provisions of which were outlined in Section I. The true significance of this regulation is manifested in thrae areas: levels of authority at which prcj xi approval is maintained. Considering the first item, it is important to note that withdrawal from any particular project and, if the individual so desires, from the entire program, is guaranteed upon request. The success of any endeavor pursuant to such strict regulation and procedural discipline depends largely upon the morale of the volunteers and their respect for the progras and the organization. The second item of interest interfances with the first in that it is impossible to achieve research goals without preparing the protocol with the utnost diligence. Desired projects are reviewed thoroughly by the Commander and his staff and forwarded to Commander, USA?PLlC as appropriate, for final approval. The required involvement of high level personnel insures the proper conduct of experinenis administered to huEan research test subjects.

Inherent in the nature of human volunteer research, conditions exist which, when misunderstood, may appear to reflect unfavorably upon the organization conducting the research. 'iiih reference to Preject Gihiternnt, allegations as to an ulterior purpose and nndesirable

6 consequences of research at USAMRIID hav,e been made by individuals ,associated with the news media. Two of the more abrasive articles are retained in permanent historical files in the Otfice of the Cormnander, USAMRIID. Both of the articles pertain to alleged undue suffering and death of one or more Whitecoat volunteers as a direct result of participation in research testing. Official U.S. Army information sources as well as The Surgeon Grnerai have flatly denied any allegation pertaining to the death of a Project Whitecoat volunteer during, or as a result of, any experiment. One article alleged the death of three enlisted men as related by a fourth (the sole survivor) who ' was never assigned to Project Whitecoat. Similar newspaper and magazine articles addressed the more general area of BW or CW as a whole, referencing Ft. Detrick and USrL%IID (or USAXU) as the proponent unit for their discussion of BW/CW topics. To date there have been no deaths and only one documented complaints of undue suffering concerning Project Whitecoat volunteers. There have been no instances involving violation of a volunteer's rigk to withdraw from a project or to exempt himself from a specific experiment.

Of all agencies concerned about the welfare of Project Whitecoat volunteers, it would be reasonable to assume that the Seventh Day Adventist Church would head the list since the overwhelming majority of Project Whitecoat volunteers are members of the SDA Church. Since the initial attitude statement rendered by the Secretary, General Cozferexz a: Seventh 3qA&-cr,t5s:s, ths pssitisn of the S2.A C!xzrch has remained in favor of Project Whitecoat and the voluntary participation of Adventist inductees. Several papers and items of official correspondence hav2 originated froa various levels in the SDA hierachy unequivocable supporting the research conducted at USAMRIID. In light of the Adventist doctrine that prescribes the stric: manner in which the human body should maintained. the absence of derogatory correspondence from the SDA Church indicates that few conplaints have been forwarded to church officials. Occurrences such as those purported in some periodicals would certainly have had a deleterious effect upin the strengch of Whitecoat volunteers assigned to USA'RIID if .any creedence were given them.

7 SECTION IV I SAMPLE PROJECT SYNOPSIS '

The procedures used to initiate and control the experiments involving human volunteers are organized and disseminated by the Secretary, EIedical Division and ultimately become the Standing Operating Procedures which the Comander, USAZEIID will administer throughout the course of an experiment. The objective, scope, anticipated risk, and special circumstznces surrounding a project are prepared by the originating division 2nd Medical Division secretary and are collectively referred to as the protocol of the project. A master bleeding schedule is included as a record of hematological data accumulated during the experiment since variations in blood chemistry are important in final evaluations. The protocol is reviewed and analyzed at a conference attended by the Commander, Scientific Advisor, and Research Division Chiefs to refine procedure 2nd determine the potent;al, foreseeable benefits expected from the research. Once a protocol is accepted by the conference medoers and signed by the Commander, it is forwarded to higher headquarters for final approval. A comprehensive distributicn list insures maximum utilization of research data and proapt ioplementatim of the findins by the responsible divisions. After the approved protocol is dfstributed, individual volmteers are selected, notified and interviewed. The eulti- purpose inteiview provides the volunteers with pertinent and required protocol informatlnn, nbtains his consenr, cornpieces the administration necessary for admission, and consolidates health historical records lor review. A-final selection process based upcn scrutinization of individual medical histories regults in the identification of primary and alternate test subjects. This information is provided the Adjutant, USAMRIID in order to require project films, change mail distrfbutions and rJintain a quick reference record of project data in the Adrdnistrative Division. Once the health records are screened by the intervievers, they are returned to the Kard Secretary for' filing. Master laboratory slips are prepared in dupliczte for printary and alternate test subjects and forwarded to the Clinicai Laboratory, PatkOlOgY Division for record administration.

On the day of admission, admission sheets 2re forwarded to Walter Reed Army Medical Center, Registrar Division. Telephonic cancellation of eech primary and alternate test subject is provided, as appropriate, the WFAXC Registrar in exchange far the Registrar Members pertaining to the rezaining test subjects. P.egistrar numbers are then forwarded to the liard Secretary. As the admission sheets are returned bv kXG!C, they Rre incorporated into the patient Clinical ?.?cord folder alc?ig with the adnission card, consent statement, and other pertiaent project data.

a Half-way through the project, the Cpmmander and Chief, Hedical Division ,determine the convalescent leave and blood compensafion to be awarded to each. test subject. Coordination with the Adjutant and Budget and Fiscal Officer will effect the necessary documentation for convalescent leave, "blood money" and separate rations recoupment.

Some projects have year long bleeding schedules and require the maintenance of suspense files and preparation of bleeding dates at least one week in advance. As the project is completed, narrative summaries are prepared, signed and returned, along with the project charts, to the ?ledical Division Secretary who transmits a copy of the cover sheet to the Hedical Records Library, Registrar Division, WYC. Project charts, when completed, are filed in a records area, building 1412. blaster folders, containing 211 project infomation, are prepared and reflect the names of participating Volunteers, a copy of the protocol, publications referenced, smmaries of findings by all investigators, narrative summaries pertaininc to each individual and copies of infornation included in the USAt!ZIID Annual Report. W project infomation is ultimately summarized and arranged by the Chief, Medical Division. The Secretary, ?!edical Division extracts Sescriptive project information from the cover sheets and transcribes it mto the permanent, continuing list of USPNRIID research projects iavoliring human volunteers. ..

9 .. APPENDIX 7 ;/

14 Jan 55

MEXORAVDIM FOR: Ti% CHIEF OF ST.AFF I

I SUBJECT: 17% of Volunteers in Rer:lrch

1. Approval is granted for :he conduct of research investi- gations utilizing -?olunreers, in defense against biological war- fare, as outlined in the proposed pkn, subject as above, dated 10 January 1955, subaitted by the Chief Chemical Officer and rc- viewed by The Surgeon General, U.S. Army (copy of plan a:t&ched, HV-9W-3/10 Jan 55).

2. Special care and attention will be given to those por- tions of the approved investigations which are to be acconplished by contract, to insure that the sane basic principles and safe- guards applicable to Departzcnt of the Amy laboratories arc ob- served by the contracror.

3. Reference Plan iiV-B[+-3/1C Jan 55 refers to the use of enlisted volunteers. It is understcod that the Chief Chenicai Officer desires to use officer volunteers as well. The reference ?la is amended accordingly to fnc.iude officer volunteers.

(Signed) F. H. Higgir;s 1-incl Frank H. Higgins 1. CmlC Proposed Plan, Acting Secretary of t5e Arzy W-Blr'-3/10 Jan 55, copy #1 ..., APPENDIX a

ICDFC

1. Effective 20 June 1956 the followhg S1h-Y2bie of Distribution Unit is established as a separate Clas:; 11 nctivitjr of the '*alter Heed Amy :?edical Cmxr (9901) xith station at Fort Oetrick, Naiyland: Unit Desienztion Table of Di stri-brition

Medical Unit, :.'?AX 8-9901.07 (99O1.07) Fort Detdck, Narylacd .....

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i. APPEhQIX 10

GENERAL ORDERS NO. 7. Valtcr Reed Army Medical Center, 1 August 1957.

Extract: Organization of Walter Reed Army Hospital.

I ' 1. Effective this date, so much of paragraph 1% General Orders KO. 11, dated 29 June 1956, this headquarters, is amended to add 1.1. as follows:

j. Ft. netrick Annex

(1) Comand and Administration. These elements will be recognized as sub-activities of ;heir counterparts at Walter Reed Army Hospital.

(a) Office of the Commanding General

(b) Registrar Division

-1 Medical Records and Reports -2 Admission and Disposition -3 Hospital Treasurer (c) Medical.. Holding Detacbent -1 Patients Baggage acd Supply (2) Professional and Nursing Care. These elements will :unction un&r the jurisdiction of the Officer-in-Charge, Ft Detrick Annex, Walter 2ee.t

Army ifospital. .

(a) Professiocal Services -1 Medical -2 Ward 200 (b) Nursing Senices

(3) AI1 other norm1 hospitai scpport functions (adninistrs:i-e, food service, and logistical) required of th- Fc Petrick Annex will be furnished by Ft Detrick end the Waiter Reed ?ledical Center consistent wi:h the agreement approved by the Surgeon General and Chief Chezical OffiCcr, iu support the research oission of the kkdical Unit, ',G.MC (9501.07) ?t Dctrick. c - ..-. .

APPENDIX 11

U.S. ARMY UED1C.U UNkT FORT DETRICK, WLRYLAND ANNUAL REPORT 1957

1. General:

This unit was activated 20 June 1956 (WRAMC General Orders 37) at Fort Detrick, Maryland. It functions conjointly with the Division of Special Operations of the Walter Reed Army Institute of Research and, with this latter unit, has the responsibility for the conduct of research aimed toward deternin- fng and meeting the problems incident to the defensive aspects of biological warfare. Its establishment was a direct outgrowth of the Joint Medical Service- Cheniirnl Corps agreement on this subject, dated 21 February 1956. There has been no change in mission since submission af last annual report. r'unds for the operation of the unit are provided to the Surgeon General by the Chief Chemical Officer.

Throughout most of this report period'the Medical Unit had the frustra- ting experience of having an assesbled research team without aioquate lakora- tories and supporting facilities, Investigative programs had to 50- tailore? '7 the pattern af the limited facilities. The several infectious diseases &oratory Suil5iil;s at Fnrr Detrick spccifieci for Xedica: :zit "s'. 256 YO? become available until midyear, and some were still not available at the end of the year. This deviation frcm originally planned schedules delayed or prevented initiation of programs planned for 1957.

Buildings selected for the Medical. Unit were built in 1943-44 2s "five year temporary buildings". Considerable rehabilitation was necessary to equip the temporary structures as laboratories for the ?!edical Vnit. Unexpected . delays were encountered. For euanpple, Building SP-427 for :he Xiczobiology Branch was not vacated and available to the contractor until 1 December 1956, 8nd rehabilitation was not started until 18 February 1957. Work was not cmpleted at the end .Jf 1957, and occupancy for laboratory type work Is not expected until March 1958.

Similar problems were encountered in Suilding SP-522 for the Animal Assessment Branch, although part of this building was occupied by July 1957. However, laboratory space fcr this Brmch was restricred during mosc of the year by the requirenenc to furnish tempnrar:fl quarters fcr the ;ICspital I diagnostic laboratorias and the Xicrobioiogy 3rsnch while kborzcories for ! those activities were being rehabilitated. The only senijemment buildings in the hospital area was occupied by patients at the beginning of the year, but

1 rehabilitation of the central material, operating room, and X-ray suites was oot finished until September 1957. I 1 2. Personnel:

All key administrative, technical and professional personnel were on duty at the beginning of the year, in accordance with the Medical Service- Joint Agreement setting 1 January 1957 as the target date for initiating Medical Unit research programs In the Fort Detrick buildings. Additional personnel in all categories were added during the year as facilities became available to inaugurate planned programs. There is an authorized overstrength of 200 enlisted men for individuals who volunteer to participate as subjects in the research program; at the end of the year 110 volunteers were on duty.

Personnel Summary.

Officers E.M. Civilians Total 1 January 19 22 20 61

31 December 25(10 MC, 7 VC, 4 MSC, 4 ANC) 20 48 93

Representatives of other services assigned for duty are: .. USN - 1 LT., MSC (reported 10 September) 3 enlistad GCC (rqmr-tP-2 ?!zch)

USAF - 1 Captain, MSC (reported 12 July) USPHS - 1 Lt. Cmdr, MSC (reported 16 December 1956) 3. Programs: -

No change was made in the primary mission: "To determine the risk to the U.S. Armed Forces of biological protective xeasures". Personnel of the Commission on Epidemiological Survey of the Armed Forces Epidemiological Board have participated actively in developing the research program.

Several projects directly applicable to the mission were initiated despite disappointing delays in acquiring work space and facilities. Sorre of this work was done in laboratories made available before the end of the year, but most of the projects were started as joint programs with Fort netrick persc or with other organizatiom having established facilities: e.g., Arned Forces Institute of Pathology, blter Reed An:; Institute of Research, Dusaj. Drovin;

2 .. . -.rLL..~ .. ApPrnIx 11

Ground. Considerable progress was made in a urn er of these ivestigations but none,had progressed fir enough at the end of the year to warrant a formal report. 1

Suprmary of Principal Projects.

a. Venezuelan Equine Encephalitis (VEE).

A study of VEE in rhesus monkeys infected by aerosol exposure was initiated in cooperation with Aerobiology Branch, Allied Sciences Division, Biological Warfare Laboratories, and continued in the Medical Unit using animals infected by intraperitoneal infection. Significant results were: failure to detect clinically any signs of infection except a daphasic fever curve in approximately 75 per cent of animals, with an initial temperature spike in 24-72 hours, and a secondary fever of 2-7 days duration beginning at 4-6 days post-infection: demonstrably viremia 4-6 days post-infection; which generally disappreared with onset of secondary temperature elevation; perivascular cuffing and nodular glial proliferations In brains of monkeys sacrificed 2-3 veeks posc- infection.

Behavior of the virus of VEE was studied also in snall laboratory animals and in tissue culture systems. Vaccines were prepared from infected mouse brains, FeLa cell cultures and chick embryo tissue for evaluation. Test- ing of vaccines will be a part of the 1958 program. Two workers at Fort Detrick became infected with the WE virus in laboratories. Clinical and laboratory study of these cases, review of the medical- literature, and careful review of clinical records from numzrous other cases of VEE at Fort Detrick and elsewhere afforded the opportunity to define characteristics of the diseases in man as clearly as can be done without exposing volunteers. The program on VEE will continue next year.

b. . Respiratory anthrax was studied in three species (sheep, pig and dog) at , Utah, in September and.0ctober. Animals were challenged with a large dose of spores by means of a wind tunnel. Sheep dis- played a marked febrile through the seventh post-exposure, but appeared clir.icaily well until a few hours before death at 48-72 hours -- except one animal that survived though febrile through the sevench post-infection day. Swine and dogs remained clinically vel1 throughout the period af observation, though - half the pigs and 3 of the 14 dogs became febrile for short periods during the first week post-exposure. Elood cultures were all neg:;tive in piss .znA dogs; in sheep bacteremia appearcd with onset of fever snd increases until

3 APPENDIX 11

death. Cultures taken at autopsy of sacrificed animals disclosed organisms on19 in.the lungs and their regional nodes, except for sheep sacrificed shortly before anticipated time of death. Pathological examination disclosed lesions only in the lungs and pulmonary lymph nodes in swine and dogs. In sheep. there were hemorrhagic mediastinitis, lymph node and tonsillar en- largement. but splenic involvement and generalized hemorrhages were not seen. Lesions in swine and dogs were confined to lungs and pulmonary lymph nodes; discrete unencapsulated pulmonary lesions were noted in animals sacrificed at 8-10 days. An anthrax therapy evaluation was conducted in two groups of sheep with a combination of anthrax vaccine and penicillin. Treatment was started at 6 hours post-exposure in one group and at 18 hours in the other. All animals survived, although 2 of 4 animals in the second group had bacteremia at time of starting therapy.

C. Tularemia.

Studies were designed primarily to evaluate the prophylactic and therapeutic effects of different vaccines and antibiotics, and to clarify some of the problems with this disease that are directly related to our mission.

First-hand experience was afforded by meticulous study of patients who acquired laboratory infections. Additional pertinent clinical information was obtained by analysis of regords on patients previously treated for tularemia it Fort Detrick (1957 cases bring total to approximately 100) and by review of 36 clinical records obtsfmd :hrough :.mid Forces Instirut= of .D-cL-'-r**L.L.,'"*"*, L."".'..-- files of the Surgeons General and the Veterans Administration. A study now in progress on 120 monkeys challenged by aerosol exposure to 8. tularense will furnish supplementary fundamental information.

A contract wit5 Ohio State University provides for study of tularemia 'in volunteers. Exposures of men by subcutaneous challenge had already been . accomplished. Experience now in hand warrants aerosol exposure of volunteers in 1958.

Current programs have progressed sufficiently to permit several per- tinent conclusions: (I) Tularemia in inununized laboratory workers exposed to small doses of organisms by either cutaneous routes or by aerosols is a relatively mild diseases.

(2) Foshay vaccine has little or no effect in preventing infection but may moZify the disease in man.

4 APPENDIX 11

(3) Early and adequate streptohycin or broad spectrum antibiotic therapy' promptly controls infections and prevents compfications.

d. Volunteers.

No studies with -?olunteers were conducted at Fort Detrick this year. During the Spring 140 volunteers were interviewed and examined at Brooks Army Medical Center and 124 were accepted for the Medical Unit program. At the end of the year 110 of the authorized volunteers were assigned.

e. Rapid Identification Methods.

Preliminary results are encouraging in several investigations of methods to shorten the time required for definitive clinical diagnosis and for specific identification of microorganisms. Various clinical and autopsy speclaens have been examined by fluorescent labeled antibody technics in a joint study with the Armed Forces Institute of Pathology. In current studies these methods are being utilized in conjunction with tissue culture technics. Investigations are directed toward improved methods of obtaining, handling and preparing specimens. These studies will be expanded in 1958.

4. Hospitalization. .. The hospital facilitv for Fort Detrick was operated throuzhout the year by ihe I4edical Unit. On i Augusi 1957 it was designated as Ward ZGG, Xaiter Reed Amy Hospital. Of the 277 patients admitted during the year, 21 were occupational infectious diseases in Fort Detrick personnel. Supporting diagnostic laboratories performed a total of 48,500 tests and procedures.

,S. Training: .

Mandatory military training programs are supplercented by formal and on-the-job instruction. Professional staff members attend weekly staff Conferences, Journal Club meetings and tape recorded review of current medical literature. Staff members participate in training programs of Walter Reed Army Xedical Center and the John Hopkins Hospital. A course on "Statistics in the Xedical Sciences" vas conducted 14-25 January by Dr. H. G. Batson, visiting consultant from Department of Public Health, College of Medicine, University of Illinois.

Military and civilian technicians receive on-the-job training supplecented by form31 classes. Three technicians have been sent to Amed Forces Instlture of Pathology far periods of 2-4 noaths for training in fluorescent antibody and

5 APPENDIX 11

and histopathology technics; three technicians have been assigned to Walter Reed Army Medical Center for 1-4 week periods for specialized training in Parasitology and Biochemistry. I 6. Supplies and Equipment:

Logistics support is provided by both Walter Reed Army Medical Center and by Fort Detrick. Satisfactory policies have been developed for joint operations. Establishment of new laboratories necessitated an active procure- ment program throughout the year, but at the end of the year 95 per cent of required equipment and supplies were on hand.

7. Construction and Facilities:

In addition to the previously mentioned rehabilitation of buildings, plans were completed for several projects in 1958:

a. An addition to the Animal Assessment Branch Building SP-522 will provide additional holding areas for convalescent animals. Estimated cost: $25,000; estimated completion date: August 1958.

b. An addition to the hospital Building T-60, to house a 1000 L?rp Medical X-ray Unit, will be started early in 1958. Estizated cost: $125,000; the x-ray machine is scheduled’for delivery and installation in July 1958.

0. Summary:

The-entire year hac been reminiscent of time spent in a war-time staging area.

6 GENERAL ORDERS KO. 9, Office of the Surgeon General, 29 September 1958 I~ Extract: I. Change of Table of Distribytion Nunbers of Medical Activities. 1. Effective 3 October 1958, the following Tablk of Distribution Numbzrs of activities, uder the jurisdiction of The Surgeon General, are changed as fndfcated:

DESIGXATION Ah?) OLD TC NUNRER DESIGNATION AED MEU TD NWER

U. S. Army Medical Unit, Fort U. S. Amy Kedical Unit, Fort Detrick (08-9901.07) Detrick (08-9906.05)

2. There is no change in location, mission or authorized strength as a result of this action.

3. Appropriate entries will be made in the record of events se:tion of the final and initial 14ornir.g Reports in accordance with paragraph 92b and c, AR 335-60. .. 4. Authority: AR 220-5 and AR 310-41

VI. Assigno-ent of U. S. Army Medical Unic, Zort Detricic. ._ 1. Effective 3 October 1958 the U. S. Army Mediczl Unit, Fort Detricic,

(TD Number 58-9906.05) is assigred to Xeadquarters, U. 5. Arny I!ediczl Research and Development Command.

2. Effective 3 October 1958 the U. S. ).my Medical Unit, Fort Detricic is attached to Headquarters, 'halter Reed P.rmy Medical Cecter for adzzicistraticn and logistical supper:./$/

/S/ T. B. Drotnina, Xajor, MSC, Adjutant .n

I . APPENDIX 14

DEPARTMENT OF SiiE /CMY GO 6 OFFICE OF THE SilXGEON GENERAL Washington, D. c. 20315 .:. GENERAL ORDERS 27 January 1969 NUME3 6 ...... REDSIGNATICN 07 UNIIITS/ACTIVITIES

TC 010. iollowir,j Units/ActivitIes XEDESIGSATED.

EfF date: 15 January 1969 Auth: DA Letter, AGSD-C (M) (10 Jan 69), ACSFOR, 10 Janucry 1969,,subject: "Redesignation of Units. ." ...... '. .. .. Fund oblg: .IAW curr fiscal 'Socedures: .. .. Presest dsg: New dsg: Asg to: -stc: United S:atcs Army Medico1 United Stotes Army Mcdical USAMRDC Frederick, Unit, Fort Derrick Research Institute of In- Maryland ..fectious Diseoses * Cnltei ktc: Axy Surgi- %:d S!^tc: !c- U5.AJAP.X 5.4M.C ,Fer! cal Research Unit stitute of Surgiccl Re- Som Houston, .- search Texas

United States Army Aero- United 5:ctes Army Aero- USAhr,RDC ioi: Rvcker, medico1 Research Unit rredical Reseorcn Lobo- Alobcma, rotory

United States Army bLedical Letternan Army Institute USAhkRDC Scn Frar.cisco, Rereaich Unit, Presidio of of Reseaich California Son Francisco

Files/rec: WEcontinued without cutoff (AX 245-210). MR: Ea:ry WE mc2a in :he rccoid cf events rec of :hc? h4R prepcrec Tor the eff lo:e (para 4.3, AR 335-60).

MEDDD-OH (17 Jan 69)

.-

I

1 -.- . APPENDIX 14 i

I

, .,

DISiRIBUT!ON: A6 plus TAGO, DA, \A'XX, 9. C. 20310, ATTN: AGSD 20). Copy Fur.:isi,cd: IISAMIDA, AiTN: AVXMI-RA.

......

., ., .._. . .. ' . . ..-..

.. . .,A,,

.. ;. ., .

2 2 APPENDIX 15

EDEC-ZA I 14 October 1954 9

METiRANDUX FOR: Major General George E. Armstrong, HC The Surgeon Szmzal Department of the Army Wzshington 25, D.C.

Several days ago, I contacted Dr. Theodore R. Flaiz, Secretary, Medical Department, General Conference of Seventh-Day Adventists, to ascertain the views of his church organization as they relate to the us.. of volunteers in lredical research.

After I had explained in general teras the ty?e of study which was contemplated, Dr. Flaiz proposed that it should be considered by a small group of the Conference Cfficers and agreed to bring such a group together during the veek of 18 Dctober.

Dr. Flaiz appeared to Je'cxtremely interested and to consider that It vas a re21 opportunity for members of the Seventh-Day Adventist * group to assist in the riaLioiial defense. I; is p053ily:~ that. tk Ch:& will actively support &he project and assist in obtaining the necessary voIiiinteers.

If you consider the attached letter to be appropriate, we believe that it would strengthen OUT approach to this grcup materially. I would like to deliver it to Dr. Flaiz at :he tizc of the conference.

1 Incl W. D. TIGERTT Draft of Ltr Lt Colonel, PIC to DK. Flaiz

1 APPENDIX 15

Theodore R. Fliaz. M.D. Secretary, Medical Department General Conference of Seventh-Day Adventists 6840 Eastern Avenue, N.W. Washington 12, D.C.

Dear Doctor Flaiz:

I have been advised by Lieutenant Colonel W.D. Tigertt, MC, that you have arranged for him to present to representatives of the Seventh-Day Adventist Conference a request for their assistance in the conduct of a study of the highest importance to our nation's health. Only through the use of volunteers can the necessary information be obtained.

Colonel Tigertt will explain to you in considerable detail the reasons for and the aims of the prograQ. I wmt to enphasize, however, that we have sought and received tne advice of the. leading physicians of the United States in reaching this decision. k'e have their assurance that they will continue to advise us and, indeed, will directly essist us in this project. The program has the full concurrence of our highest military and governmentai officers.

---It is my earnest hope that your Conference will consider that partici- pation of your young men in this progran is appropriate. You can thereby make yet another significant contribution to our h'ation's health and to our national security.

If during your deliberations questtons arisc that you feel should Se directed to me, I will be glad to meet with you.

with highest personal regards, I am,

Sincerely yours,

2 MEDICAL DEPARTMENT GENERAL CONFERENCE OF SEVENTH-OAY ADVENTISTS 4840 EASTLRH AVtNU5. HW. WAShlNGiON 12. D. C.

ICh T. a. . '. .. I I October 19, 19%

Major C-eneral Cecrg- E. Amstrong The Surgeon C-eneral Deprtment of tle Amy Washington 25, 3.C.

Dear General hmstrcng: Tiroc,-? the ccL-tepj cf Colonel :!. D. Tigertt, XC, I have Just received your letter of October le,. :.:e hzve a?prsclated v?~rxn Colrs?l Ti,-ort.t,'s cle;: and aatient deiinlcation of t5.e ;i~? Tor the nzdical resaarcli pxject :Liic;? :.vu hae under xay. '.le feel tnat if arq one shoold reccgrize a debt of loyalty and service for the r.my courtesies ?xd ccmidoraticns recci-..cd frcn the 2e3artner.t cf 3eZense,.. ice, as .i.+.vontists, are in a position to feel a doL.t 6: Gr'ALiLuie Icr insss icma cmsi.cPrPt.lons. .-The type of vclan*aTf service which is bcirz offered to vir boys in this research ?roble? offers an excellent ongo~vm?b; r'cr these young men to rer.6ei a sert-ice :.:hick ;rill be of vslw not cnpj to nilitxy r.ediclna '5-1: tn 7u5lic heaith gerxrailj. Ibelieve J saeak . ,.. not orlly the xmti-.er.;s cl' o~na&:.Lm.-?lstrative group -n znis c:'flse, but alzo ol' cxAc..-??5sc ~.II?C ca 5~ the zervicas in cbsel-rLi,?l: that it shollld h regardzd as a nri-rilege to be identified with this signifi- cant ad-mncedsiea in slinical research.

As ire ha-re +.dic;ted tc Colonel Tigerti, ::e trill trj ts have an appropriate stztexeni of our attihce tc;;ard this matter in ycxr hmds qdithb a fex days.

Very skceyeu pxs, - APPESDIX lo %--.. <- >?, \.,,. :, '..1'.- I vrould likz to makc mcntion of a particular Ledical Service

t . activity in Fhich various mcmbcrs cf your grouR now in service have

pcrticlpattd. This 1s the mcdicnl study on (1 fever in human voluntccre.

Certain aqxcts have bccn described in your denominational papr

(Review & E!crald, 3 Kov 1955) and I prirnarlly want to brine you up

to date ad thio particular study is now cosentially completed.

The aimo cnd hazzrds of the projcct were presented to Seventh-Day

Advcntiat solCicre at t!!$ ?,fedical Service School at Fort Sam Houston

by rcp,refie-:=:ivcs cf my ofiicc adby EXcr G. W. Charnbzrs. The

rcspoasr rstc VX.J extremely f;i;h. Of this orizical Gror?? 120 adticrs

from 33 states and the District.. of Columbia have completed the entire

FrC,"PIZ'. There hZV:! 35 CZS=J Cf C!k!C2.?!3' 2??2Ze=t 0 fE'.Z?.

.-All recponded promptly to the antibiotic. terramgcin, rcgardless of thc

oize of thc infectin; dose of Co:riz!!a ixrnctii. Those who did not - bncorre ill fc?Icwir= exposure hxvc 2:rrccstrctd t::z cffec;ivesc:3 cf

vaccinzticn or ckl-.-mopro$qlz&s, or a combinatioa therecf, in Freventiz:

clinical evidznce of disease.

OmFarticularly ctrikiq findin2 has kad to do with thc iaportaxlce

of the time of initiation cf chzmo?rophylwie. Terramycin, ,oiven

sooa :;ftcr exposGre (LxGirmi::z wittiin 2.5 hours) for n period ir: d:ys,

does not prevcnt the di~caoe. An i6cnticol achcdul: of the antijiotic

be$tninz 0-10 da;r~post e::?scure has invariably rcwiteci in t;:e

3 APPESDIX 16

prcveztfc:: of c1izi:d il1:;ioo.

I Fill nckc co cffort to Cive yo3 more th-n thio Gricf review, ? A prclininary XFO~~of the findiny was made at thc Asmociation of

Amcricen ~Lhy;ici~n03 Lky lot this ycar, and a detailed report is noa bci3,o wrfttzn.

You ohouid underctand L\at the prticipnnto have served as co1;licrs volwtccro withoat: any additional compcaoation. We intcnd to rccoznfze their acto in an zpprapriztn faohion. However, their grcatcot aatisfacticn rnwt core from the real;--iion tkt they have each coiitributcd ia J. ~ziqwf-ziliczi to c fczd ef kzs~L2;e v:tic!i can be uscd to aid ia t\e ccntrol.. of disease. TJx results to date are of conoiderable irqort to military adcivflizn irrdicinc in this particular dicczsc. Similz: studkg in c:her dizc-zc enti:icc \-rill be n:c=cxirg if v;c are to I-30r-r C;e sco?: of our problems in th: area of co=:r?..uScablc

(?iaeat.> ad det-rmizc our ca;.rcify to zcet tic;= tkc~:s.I czn ansure you that thi3 cssea;fsl informaiicx can bo obtaimd in no cther famkion that by the nnselfiok psrticipatioa of voluntccrs.

4 APPEhiIX li

I 27 October 1955 1

... ..

1 APPENDIX 17

Beyon The Call of Duty! :

ItThis letter concerns a number of Adventist young men who have participated voluntarily in a military nedical research program and who, by their acts, have contribute2 materially to the development of knowledge essential . . . to the advancement of medical science. Only through the use of such volunteers could the necessary information have been obtained." These words, written by Maj, Gen. S. B. Hays, The Surgeon General of the United States Amy, to Elder A. V. Olson, Chaiman of the committee that guides the War Service Commission, introduce a story of heroism. Last fall Maj. Gen. George E. .h-rastrong, then Surgeon Ge-era1 of the U.S. Army, wrote to Dr. T. R. Flaiz, Secretary of the General Conference Medical Department, concerning the possibility of securing permission froa the General Conference to contact its men in uciform about participation in a special medical study. In.. response to this initial contact a committee of our General Conference Officers met with Lt. Col. W. D. Tiggert, of Wdter Reed !.r=;. Updiczl Czttcr to stiiiiy tho question. After careful consideration, the committee voted to give support to the proposed study. .- Writing for the cornittee, Elder W. R. Beach made the foilowing statement: "Seventh-day Adventists are well aware of the exploits of Pasteur, Corgas, Reed, and their associates by which many of the dangerous and epidemic diseases have been robbed of their terror. Progress in the knowledge of these diseases and the development of techniques for their control vas often achieved through deliberate risk to themselves personally. It is through the risks and dangers which they accepted in line with and beyond the call of duty that we are now comparatively safe from plagues which a

2 APPEND;)! 17

Beyond The Call of Duty 1 2 : Page

generation or two ago claimed their victims in large numbers. We honor these men for their courage and sacrificial devotion to the betternent of the lot of their fellow pen.

I, There are still conspicuous blank spaces in our knowledge of disease and its treatment. Research in these areas calls for some of the same self- less devotion in the search for lifesaving knowledge as was manifest by the pioneers of modem medicine.

"It is the attitude of Seventh-day Adventists that any service rendere6 voluntarily by whomsoever in the useful necessary research into the cause and the treatment of disabling disease is a legitimate and laudable contribution to the success..of our nation and to the health arid comfort of our fellow men.

I* .- So far as Seventh-day Adventist personnel is concerned, %e would earnestly request that the conscientious 2rinciples by which ow young men live might be respected and gurantced by the Armed Services in the - project the same as it is now in their regulnr line of military duty."

Elder G. W. Chambers, War Service Comission Secretary of the General Conference, was asked to work with Col. Tiggert on this project. X number of trips were made to Fort Sam Houston, Texas by these two men. Or each of these trips our S. D. A. men were told of the proposed medical study, and were given a number of hours, usually over night, :o consider it before reach- ing a decision. Each man vas intcrviired se?arately by Col. TCgzerz 2nd Elder Chambers. Each made his ova person21 decision whether oi ilot to volunteer for the project. All that was prmised them was an cnuort-ni' LY to save the lives of others, and to add to the kncvledge of medical science,

3 ! .

APPPENDIX 17

I beyond The Call of Duty ! Page 3

by their own participation and probable suffering. Most of the young men thus contacted volunteered. Not all of the volunteers were accepted, for each volunteer was given a most rigid physical examination. No cne who failed to pass this examination was accepted for the project. Only Seventh-day . Adventists were considered.

About one hundred seventy of our young men passed the test arid came to Washington D. C. Most of them are here yet. Many of them have passed through all stages of the test. Some have been sick, but all are fully recovered now. Some showed no reaction whatever to the disease agent to which they were subjected.

After referring to the .. objectives of the study, Gen. Hays states in his letter:

"While it will be some months yet before all of the medical data can be evaluated, it is completely clear now that, in the Q fever project, in which group has participated, most of the objectives noted above have been met. For the benefit of non-medical readers I perhaps should explain, as has been explained in detail to each of the volunteers, that Q fever is not a code designation but the accepted medical name of a diseases having a world-wide distribution, and one which was the cause of considerable difficulty to us in World War 11. It also occurs in our om country, particularly in the Western States.

"It is our belief that each volunteer in this progrzm h2s been fully

aware of the potential hazards of the diseases t.3 which he was exposed and we know that in each instance their participations was withofit pronice of rewrd

or materiai gain. T'ne courage shorn by rhese men is oi pariicuiar ~ir~nd,

4 APPENDIX li

Beyond the Call of Duty I Page 4 3 while this letter to you is a form of recognition of the contribution of the group, there will also be recognition of each participant in accordance with military practices.

"Although we have had the active support of several members of the General Conference, I would like to make particular mention of the time and energy devoted to this program by the General Secretary of the War Service Commission, Elder G. W. Chambers. In this, as in our numerous other contacts with him, he has shown a broad appreciation of :he aims of the Medical Service and of the other participating agencies. He has made himself constantly available, serving as a spiritual leader and as an administrator . .. It is with pride in the courage and unselfish davotion of the men who participated in this projzit that ue indicat;: that they pi-cgerlp belong in the ranks of those who have gone "above aad beyond the call of duty." Sustain these men with your letter and your prayers as they carry for God and country. '.

Signed, A. V. Olson Vice President of General Conference of Seventh-day Adventists

5 APPENDIX 17 Houston, Texas, by these two men. Beyond the C3l of Duty! On each of tlie,e trips our bcvciitli- day .itlveiitist men were told of tlie p~opodnleilical studv. 2nd IWW By A. 1'. Olwn. Ckninnnir, IVnr Servire Conimissioii given a nutiibcr of hours. usua1l.i

I ing a &cision. hcli man was inter- viewed scpmtely Iiy Col. Tiqxert 2nd "This letter conceiiis a number of Adventists that any service rendered Elilcr Ch;luiIiers. Exh ninde Iils own Adventist young iiirn who have par- voluntarily by whomsoerer in the use. persoid decision whcther or nor to ticipated iuluntsrilv iii a rnilitaq Iul necessary research into tlie cause volunteer for the project. .\I1 that was medicil mearch propin and who, and the trcatnicnt of disabliri; diseare proniised them W:IS an opportunity to by their acts. have cuiitributcd ni:itcri. is a legitiin:ire and I~uILIIJI~:contri- save the lives 0: others. 2nd to add ally to the develo!imeiit of knowledge butioii to the success of our nation to thc knowled!$ of mcdicsl science, essential . . . to the advancement of and to the lienlth 2nd con:iort of our by their own participalion and prob- medial science. Only tlirouyli tlic I'elloiv inen. able suffering. Most of the youn,n nieii ux of such voluntecrs could tlie ncc- "So far as Seieiitli.day .\liventist volunteered. Sot all of the volunteers usary inforination have been ob- penonriel is concerned, we would were acce ted tor each was ;ken a tained." earnestly request that the conscien most ri:if ph;*sicnl examinntion. So 7-hae words, writtcn by Maj. Gen. tiour princi~ilesby which our tounq one c,ho failed to pars this esaniina- S. B. Hays. the Surgeon General of men live mizht be respected and tion 1v35 accepted for he project. che United Stares .\my. to .A. V. paranteed bv the Armed Services in Only Sei-enth-day.idventisis were con. Olsooli. chairman of the committee the project the same as it is iioiv in sidercd. chat guides the l\'x Service Coinmis- their regular line of niilitsrv duty." ;\bout I 70 of vounq lion. intrmlur- a ,tory ot heroism. G. I\'.CliamLers. I\'x .>el\ice Coni- the te,t and came to iVasliiii;ton. 1) C. Last I:111 Maj, GKII.Gcorqe E. .Arm. mission jecretarv of the Gener:il Cori- JIost of them are here ret. ?.lsiiv qf strons. then 5ur:cou C;ener;ll of the ference. was asked to iroi k with Co!. them have parsed r1iroii;h all sts;es Unitcd States .\riiiv, i>iote to Dr. T. Ti2;ert on this project. .A riirriilier of the test. Some twve lierii sick. hit R Fkiiz. ,ecretarv ot die Genenl of trip were nintie to tort S:m all are fully recovered noit'. Some Conference Medical Dcpartiiient. coli. cerning the possibility ot muriii; per- mission from the Gt.ncr.il Coiifeience .- to contact the Sc\entli-dno .\ilventirt .. I '- L:y*-- e I L... . I] uniform abour p:irticipntinu -# I ,.' . [. .\ j...% -. ,- 7, '. .~!# * iir ., ., :ci:t: iiicZ;~aIGU~:. lii ~cslioi::~ - I-. -. to this initial coiitart I miiiiiittee -. .-. 7. of .. .- . L our Ceiieral Conferelice oliicerr mer h - .- -. with Lt. Col. D. -1i;:ert. 01 1V:iI. I * .'._ .* ...+ : .- n'. .-. -. . .. ---. ,. - - I .,'. .. .I tcr Red ;\riny Meclicnl Ceiiter. to ~:. .. ..:. i' ij I. - < study the question. Atter cxeful COII- , .. ..- ,,..-= .; i sideration, the commirtce voted to I* ! I I .a', . '1 support to the piopo~edstiidv. -, ,/ gve , I . t,.,. I.- ...... tt'ritin; lor tlie cniiiiiiiiwe. \\'. 1:. i 1 . i.\ Beach iiiade the folloi\ iiis st:iteinenr: "Seventh-day Adventirts sic well 1, aware ot tlie ex >loit>of F;i\reur. Cor- gar, Red, anA their asocintes bv 9.. I_ which m:my of thc dnii;erous and .. .,. .. - . .. *i. epicleniic diseases Iim i' Lccii rohlictl ! ;*'-I,. I of their tenor. Pro;ic,j iii tile L.iiun!- : .' cdse of these disc2Jes and in the de. .. ,,> , , velopiiicnt of tecluiirjucr Lor tlicir -. ,-. . .. - ~ '. .I control I~RS otteii .tclirr.. ! ! .I .. dclilieratr risk tu ilirm~elics Iicrxm. , . :,- I ally. It is :!IIO:I~~~Iclw :I>!.> .irlil c!.~II- A-< gerr whicli thcr .ICCC~J~C~in iiiic widi .^/ - .. . and be!ond tlie c:dl of duty th:it ice .I -- - are noic coinliaraiivelr snle irom pla,grics that 2 ;cncr3tiori or LIVO n:o claiincd ~IICI:\ ictiiiib III Iw:c niiiii- hen. \\-e holm ihrbc ii~iifor t:ieir courasc aiid >:iciirici.il c!c\ution to the b- "?riiieiit of tlic lot o[ heir fellow I "1 .acre IIB still con.piruoiis l>lxnl. spices iii uiir LII~I~ICII~:~ilisc:ist. and its treJtiiXxiit. 1:e~r.irch iii t!ict iiitidci II iiiin his of uch prticiji~iiit in accordance Letter: with military practices. %'hilt it will k soirie rii~rritlir:-rt "hltliou$i wc have Mil the active before 711 the meilir;il ~l:ita can support 01 scvecil meinlcrs of the be evaliiated. it is cviiiplrrcly clear Cciicr:il Conlerciicc. 1 would like to now that. iii tlic Q fcrcr project. in make particular inmuon of the time which !uirr :inup Ii:rr ~~:~rtici~~.iictl,xid energ dcvotcil io this proqnni most of tlie objecri\es noted above liv rlir General Sccrcvxy of the \Var hare been met. For the beiiclir of rioii- 3crvire Coiiitiiis~ioii,G. bV. Cliaiiiben. mcdinl render, I prhal)5 sllolild ex- In this, as in our iiutiicrous oilier plain, :I\ h:is been expI;iiiicil in tietail contncts with him, he 11:is slior,~n ;1 to each of tlic voluiiteeir. tliat Q broad appreciation of the ainis 01 the fever is 110t :I code ilc,i:.iiatioii 11ui llcdical Scrrice 2nd of the other par- rhc accepted iiiedicnl naiiie OIn dis- ricipatin: qencics. He has mxle Iiiin ease hxirig a world-widc di,rnbtirion, 5ell consranrlv xail:ible. iervinq as a and one which was the cause of con. spiritual leader mid as an xiniiiiis- sidcnble ditfiruliy to us in \\.orld IVar trator." 11. It also occiirs in oiir o~vncountry. It is with pride iii the courage and pzrticularly in the \Vestern jcntes. unselfi5h decotioii of the men who "It is our belief that enth volunteer participated in this project that we in this prograin has bccii hilly aimre indicnte tlim thev properly beloii: it1 of the potciitial hxalds of tlic direa5e die ranis 01 tliosc i\Iin have :one to which he u:i, ckpose~!:iiid rye kiioiv "above and be:oiid the call of dutc." that iii each iiimiice tlieir pnrticipa- 5iist;lin these nieii with \our lcticrs tion was witliuut proiiii,c oi reimrd niiil your pratei, nr they carry oii lor or mnreri;iI $.in. 1 lie coiir:ige sliorrn Cod and couiitry. A Plea for Sacrificial Advance

By L. I;. llicksoii - Vice-President, Cerrernl Confrrriice APPENDIX 17

Seventh-day Adven'tist War Service Commission 6840 Eastern he., ... Washington 12, D.C. October 1, 1955

Maj. Gen. S. B. Hays, The Surgeon General Department of the Army Washington 25, D. C.

Dear General Hays,

Your good letter to Elder Olson has been turned over to me for reply because of the fact that he is away from the office at this time.

I have been delayed in writing because I have checked very carefully with Lt. Col. W. D. Tiggert before releasing anything from our publications. I am enclosing a copy of the article which will apprear in our general church paper, THE WIEW AND KEF-4LD. ..

Elder @Isonjoins mo in sx>rsssing to 7% ou: lee? appreciation for the very kindly letter which you mote about tke participation of our men in this project. The men them- selves are more than happy to engage in a project which will result in the easing of sufferin? and the saving of lives. - We also appreciate the kind of attention which has been given to the expressed wishes of the men who have participated in this study.

May God guide you as you carry on in your important work.

Very sincerely yours,

SJG. W. Chambers G. W. Chambers Secretary, L'ar Service Ccumissicn.

GWC-ec

6 APPENDIX 18

HEALQUAXlERS U.S. Army Medical Research and Development Command Office of The Sureeon General

MINUTES OF OPER;\TI@NWITECOAT PEETING

Time : 1415 hours, 17 March 1959

Place: Washington, D.C.

Those present were:

Colonel F.W. Timerman, MC ) Executive Officer, Ea. bed X6D Comand Colonel W.D. Tigertt. MC ) CO, US Amel Unit, Tcrt Detrick LTC Erael Martin, MSC ) Enlisted Br. Pers 6 Trng Div. OTSG Maj. William Wagner, XSC ) Manpower Er. Pers & ‘irng Div. OTSG Mr. Edward Zimmer ) Comptroller, IaWC Mal. William C. Lushre, MSC ) Support Div. US he3 R63 Command

1. The meeting was opened by Col. Timmernan to explain the purpose of the meeting was to come to on agreement and place on paper :he facts, factors, aad policies of Operation Whitecoat. He asked Col. Tigert: :o give a shorr background of this operation.

Col. Tigertt stated ‘that during the past four years volanreers fron Seventh Day Adventists Church and drafted into the Armed Services had been obrakcd for vsr!: J: hLs xi:. !?e -21: pxti~d~r1;r.:or?zer.-e+ thet durino the past few weeks, seventy (70) personnel who he h9.d cont-cted at XXTC, BAMC appeared to be lost to his organization. Be emphasizzd che fact that there is an exceptionally good relationship between the UC Army Medical Unit, Fort Derrick, and ihe Seventh Cay Adventist Church. Tiis re1a:ionship was essential to contime wo:k at his laboratory. He belixes that by failing to follow through on the promises, or at least the indications, of assignment that have been given to Seventh Day Adventist F‘rsonnel by Col. Tigertt during his visit in January of this year, vocli be a definite blow and an indication of lack of good faith with the orpkxzation. HE had special concern for one particular soldier who had been assigned to Fort Relvoir and had mitten to his church indlcating tha-- Sespitc the promise of Col. Tigertt he had not been alluded to folhk’ tnrough 03 Operation Whitecoat.

Col. Timierrnan asked at this point if we hzd authori::tlon for che overstrength, emphasizing th2.t he realized that rhere is ycally no such :nhg ES an authorized oversrrcngtn, but requested clarification as to n..rL authorization existed for those personnel carried in 0pera:ion ‘nhitecoac.

2. Fir. Zinmer produced a paper signed Cy General H..ys and General Creasy indizsrin; chat 200 spa,:-.es vzre reqgired and fi;r:\.~K indicz:cc! tl&r ar. one Lime tnc spaces were Ziven for this projec; znii iar.er xichGIdt.5. - 3. Maj. k‘zryer Indiczted thzt on the kJgUSt OTSG personnel rssters from DCSJLCC in per. i, diri..cted that :hose personnel be carried overstr?ilgtir. Because TAG0 and 5ESPers hive ngt he% cocnieteiy czlcu3 ::.?i ;is :o :\:Is projec:. They constantly cwstion the venture or tile pc :runnel reports that indicate a tclativc1.y large overstrength in this are;. ;,:aj. !da;ner 1 A' I i..ll.L LU attempted to transfer spaces to the Hedical Unit, Fort Detriclc has those spaces saved as a result of manpower surveys. DCS/LOG indicated that this was not authorized and that the spaces would be lost.

4. Lt. Col. Martin stated we do not have an overstrength in the Medical Department and that until such a time as the Army Medical Service is understrengthed, it would not be poksible to carry an overstrength I as such and assigned it to US Army Medical Unit, Fort Detrick.

Col. Timerman asked if it was right and proper that Colonel Tigertt should be contacting the people down at BAMC and if he should advise OTSG of this visit. Col. Martin indicated that he had not heard of Col. Tigertt's visit until 13 Feb.

Col. Timmerman asked if BAMC followed through the proper reporting of personnel that had been interviewed for Operation Whitecoat.

Col. Martin said to the best of his knowledge, this has not been done exactly has been indicated as Brooke should report these personnel. 5. Col. Timmerman then asked if those personnel stay in Operation Whitecoat during their entire period of service.

Col. Tigertt indicated about fifty percent of the cases do. This depends of the experiment and the work that is being carried on with the individual and as soon BS the person has legitimately been released from the program, he is returned to duty.

Col. Partin indicsti; 6 new regulation io keep hiiu at his iCYG slaiiun for the entire tour of duty.

6. Col. Tigertt asked why personnel who were designated for Operation Whitecoat should be denied specialized training. He enphasiz2d the fact that these personnel are good men, educated and in a number of cases will continue their education in medicine and if it were the policy that personnel who would participate in Operation Whitecoat would be denied the additional specialized training that would be available to them at Fort Sam Houston, he felt sure that a large number of those personnel who had ordinarily applied for Operation h'hitecoat would no longer appvj. He wen: cn to say that the medical facility of his unit was operated in a largc measure by Operation !Jhitecoat personnel and that their value was not being lost to the service if they were to allow them to take specialized training.

Col. Xartin stated that the Army Hedical Service has a limited number of personnel spaces tha! can be uscd for the trainin:: in medical specialiries and that personnel that are so earmarked lose their flexibility and CUS: be assigned to a particular station to permit the best use policies of en1is:ed personnel who are traincd at Army medical training centers. At this poiar, Col. Martin indicated that he would maintain definite and inmediate attezpts to recover the enlistea man viho had been assigned to Forc Selvoir and attempt to have hi.m assigned to US Army Xrdical Unit, Fort Dstrick.

Col. Timmcrnian asked Col. Tigertt hcw many personnel vould ordinarily be needed for the opcration ci this mit. Previous correspondence indicated that 200 personnel wuld be require$.

2 APPEXJIX 18 Col. Tigertt stated that he had never had 200 men assigned.at any one time. That he believed that 160 was the maximum. At the present time, approximtely 50 men are SO assigned. The bulk of these personnel being due for discharge within the next 3 months. He indicated that this is the reason that he is actually recruiting new volunteers for his laboratory.

7. Col. Timerman asked Col. Tiggrtt what percent of the men approached do volunteer.

Col. Tigertt indicated that approximately 80% of Seventh Day Adventists vho qualify and are approached by him do volunteer for this particular assignment. He indicated also that his recruiting at the EXTC was based on future needs of his organization, but was not depende3t on a particular schedule and that he felt that it would be useless to try to establish a steady input of personnel into the unit because this would result in a great loss of personnel. He further explained that when he did make his visit he spoke to those people who were in such a state of training that they could be assigned without disturbing prior commitments or prior allocations on this particular individual.

Col. Timerman sumled up the progress reporting and stated that he would discuss these facts with Gen. XcFinch and ask that he confer uith Gen. Hays to determine what priority should be given to this program. Personnel and Training Division representatives indicated that a very high priority must be assigned if so-called overstrength should be assigned to US Army Medical Unit, Fort Detrick, at a time when other CONUS organizations were understrengthed. After such a priority is established by the Surgeon General, necessary action will be taken to see that the required personnel are furnished. Col. Timerman asked that the representatives fro? Personnel and Traiciag Divizion +-ahthe necessary action to orient DESPer first and TAG why an overstrength would show up in one unit while an understrength might appear in another unit. He asked that representative from the Manpower Branch can attempt to obtain an authorization for those personnel.

Lt. Col. Martin indicated that he would prepare a memo indicating the proper method for contacting, earmarking, and ship?ing of Wnitecoat . personnel, so that those vho had been selected vithin the priority that was established by The Surgeon General would bc designaced a h’hitecoat. Re stated that he was not in a position to.give us a decision as to whether personnel participating iri Operation h’hitecoat would 10s: their designation if they attempted a course in advanced training;. Medical Techniciaa ae Medical Unit, Fort Sam Houston, but that he would explore this with the proper people in the Personnel and Training Division and rcport upon their decision.

The meeting was adjourned a: 1530.

3 . ', y' APPENDIX 19 ./ \ I

, TO: 03, lledical Unit FfMK: Hq. U.S. ,'Lmgr DATE: 27 dun 60 001.P:EIT KO 2 Ft. Detrick, I;d. 1.iedlcal R&D Cutranand Lt 81 Lcchrs/61566/mn

For your revlew and comment, FOR THE ~VNANDE..:

FRA?IK R. SWAK Captain, ISC Adjutant

-.

.... 1 I.TDCN-D! I W/C Volunteers COMMLHl NO. I TO CG, FPJJ Commmd FROM Enlisted Branch, 27 Jun 60 Pers and Tng Div. Maj Sanders/66617/tsh

( rdination ad adjustment will be nude by this officc witn Iw) Comaand. 4. To enable the Enlisted Branch, Personnel and Traifiin;: Division, TSG, to coordinato assipnts the following is recomendedr

a. Prior to visitztion at Brooke Amy Xcdical Cente: Sy Comnding Officer, Xedical Unit, Fort Detrick, for the pu~saof selection of 3otentizl canadates a letter for signature by Cornding herd, ,9E;D Coz-And shculd be dispatched to Cornanding General, Srooke Amy &dical Ccnter reqaesting rcrmission to intedew the potential candidates and the date of the proposed risi:.

b. Arrangements and coordination should be made b-.zomnding Officer, Xedicdl Unit, Fort Detrick Fiith Comadin!: Generd, Brooke b~vi*iedical Center to Le notified on a rxurrine basis when a sufficiezt number of d5itional candidates are 2v.vailable for interview.

C. Candidates selected for the project i&llb$ rzmi-ted by Brooke Amy ::edical Center to The Adjutant CTner.11 on DA Fon 333 (R2p-L or' personnel avelablc for sssigmmt on completion of training) for assigmnent. aport will indicate ~G.I earnirked for \l/C project TSC".

.' d. special order3 zssignin~thcve personnel Hill bc to USA Hedical Unit !?!,C:.C5) Fsrt %ti%&, 1kqian6. kiem hili iixludo inr:tructions to mport to :.'alter Reed Anny >!edical Center (?!+Ol), [email protected] 12, D. 2- Orders dU. also indicate "camrked V/C project TSC". I

.U-I.-U"I-. .... US" ....1 I-*. ".*I mm I I SWJECT: W/C Volunteers : 27 June 1960

e. R&D Cornand should advise this office the dates Ccmmanding Officer, lkdical Unit, Fort Detrick will visit Brooke Am &dical Center for the purpcsc of selectine candidat5s. A repcrt should be submitted indicating the msselecte6, NOS in which being trained, and date3 of availability. I. This office upon notification by PAD Command of the date that the Comnding Cfficer, Medical Unit, Fort Detrick will visit Bmke Am %dical Center, will dispatch the following message:

"Personnel selected as ![hits Coat .rolunteers and reported on DA Fonn 333 report for assigment will be reported 6th from final week as "earmarked for W/C projcct TSG". Assignment orders will assign enlisted men to LEA Nedical Unit (3405.05), Fort Detrick, lkryland, reporting for duty at tlalter Reed Amy I%&cd Center (3401), Washington 12, D. C. Orders Kill also indicate "eamrked 11/C project". Personnel selected who are beyond 6th from final week will bt reported by electrical means to The Adjutant General, Infonation ta TSG identified as W/C project TSG".

5. The above message will bo dispatched, one time ofly, unlese eosigrment inotructions should be amended, ..

6. Request cometit u&G~. cciiczmimce.

f%.Wo1,mc Peraonncl and Training Division

. -_ ._

\

3 *. APPENDIX 21 / AR W2.5

1. Purpose. These regulaLions prescribe poL- c. Ethical uiedid and chid investigations des md procedures governing the use of voluu- invo:ving the basic disem process or new treat- teem as subjects in Department of the Army re- ment procedures ccnducted Ey the Army XedlcaI search, including research in nuclear, biological, Service for the benefit of patients. and chemical warfare, wherein biiman beings are 4. Basic principles. Certain basic piiucipks deliberately exposed to unusual or potentially must te observed to satisfy mod, ethical, and le- hamrdotw cpnditions. These regulations are ap- gal concepts. Tliwe are- plicable worldwide, rvherever volunteers are used a. Vnlimtmy consent is absolrltely ejsentia1. as subjects in Department of the Army research. (1) The volunteer nil! have legal upacit? 2 Definition. For tha purpoje of tiles rep- to give consent, and must give conwnt lations, unusual and potentially hazardous condi- freely without being subjected Lo any tions ars thexhich may be reasonnbiy espected force or duress. He must have suiticbnt to involve the risk, beyond the cormal u11 oi duty, understanding of the iniplicztions of his of privation, &%omfort, distress, pain, dnmqe to participation to enable him to oldie an, health, hdiip harm, physic11 injury, or death. informed decision, so fzr 3s such howl- - I 3. Exemptiond. The fo1lor;ing cxegories of edge does not compromise the erperi- I activities. and hrestigative progrzms are exempt ment. He will be told as much of the from the prohiom of these regukioils: nature, duration, and purpose of the ez- I o. Xesearch and nonreserrch programs, kks, periment, the method and means b,- and :em nhich my inrolve inherent occupa- which it is to be conducted, and the in- ! tionai hazardi :o health UK esposure oi personnel conveniences and hazircls to be cxpcteti, i to potentidly haznrdous situations enconntered a3 as mill not invalidate the results €iz wiil I part of tx'hing or fither nornxd dutiest e.g.. flight be fully informed of the effects upon iLis training, jump ttxining, mnrksmansXp rraining, health or person niuch may possibly ranger tmining. 5re chil!;, gas c1:iii;. aid h.;inrlling come fTom hi; participation in thz ex- of esplarires. periment. b. That portion of humin fnctors research (2) The consent of the volunteer +lI b in I I n-hich involre3 norrnd tr&irq or other military nriting. A clocurneiit settirig fort!i sub- stantially the above requiremenu xi:] I duties 35 part of nn esprrinient, wherein disclostwe h ! of experinientd conditions to pxrticipniiny per- sipd by ilir voii:r.trer in thz prwnce sonnel ~ouldrered the nrtificiai 1r;1ture of such of at Icut oiie wicnes; not boire;l in conditions and defeat the 1):crpose of the inresLi- the research study who will attest :o siich gntion. signturd in writing. i 1 i

I Ii i AR i0-2.i

epd LS rn1unLu-y overtima for which PO payment leave, compensation chiins, or applifiztion of other ,- nS.7 be nde nor compensatory time Fsrted. ci~ilianpersonnel regrlnticm to volunteer em- Tie employee ail1 be so informed before aecep- b ployees will tie premtecl :hroiigh channels to the tnxe uf iiij vniuntwr services. 3eputy Chief of Staff for Pcmnnei, ARK: t. C!nims submitcd to the Bureau of Em- OEca of Civiliin Personnel. plorees' Compmqtion, Department of Labor, U.S. 8. Implementing instructions. He& of ma- lx~aujeof disabbilitp or death resulting from an ercplorea's voluntary pnrticipatiou in experiments, jor commands and other agencies sill issue neces- dl iclude a cimrjon to tiile 10, rriited States sary implementing instructions io subordinate &+ section 4503 as the Deprrtment of the Amy units. Copies of implementing instructions will authority for the u58 of such volunteer services. be furnished to the Chief of Research and Develop- c. All quastions concerning hours of duty, pay, ment...... ~ i..-~..... _.~~~.,:-- __.__

..

3 \. AR 33-25

b

1 DLtribiition:

~ Actiuc Ann>/:" To be distribi~tedin accordance with DA Form 123 quiremen?, for DA Regula- tion+-Resenrch and Development-D. SO: Xona USSR: Kona

1

5 SUEJJECT: Immunization of Potential Volunteers for Studies of Infectious Discases at U.S. Army Medical Unit, Fort Derrick, Karyland

THRU : 'Fort Sam Houston *$?&/!-A 7 &67 Fort Sm ilouston, Teras 70234

TO: Commanding General U.S. Continental Amy Command For: Monroe, Virzinia 23351

1. References.

a. AR 49-562.

b. DA message 767602, dated June 1966.

c. DA message 748103, dated January 1966.

2. The investigation of infectious diseases conducted by the U.S. Army Medical Uni:, ForC Detrick, Maryland, includes studies in xhich volunteers (Prajec: WiiITEC02.T) are exposed to selected bacteria, viruses, and rickettsiae. It is importat thet :hese individuals have no pricr experience, i.e., imunization or natcral.. infection, with eithcr the specific or rcl;.;eii nirrosr;.misas. vol,x:eers :or ;:!is p=o:r~.. are obtained fro3 thz group of Conscientious Objector soldiers und?rgoing training at the :k.Gica? Training Center, Fort Sm Iious:on, Texas. :Within the spaces n1:oca:ed for this project indivilude desiring :o participate are cssigned to the U.S. Amp Medical Unit, Fort Detrick, Maryland, on coqlction 0' their training.

i APPENDIX 22

AKPSH-T- PX

I SUBJECT: -Immunization of Potential Vclunteers for Studies of Infcctious Diseases at U.S. Army Medical Unit, Fort Detzick, Maryland

3. Required ircnunizations for ail active duty persosnel are contained in AR 40-562 and DA message 748103 to include yellow fever, typhus, md plague. The program for Project UHITZCOAT includes studies in volunteers of microorganisms closely related to ihese disease producing agents and additionally to cholera. It is 1nper;tive that potential volunteers not be given these vsccines until a final determination as to their partici- pation in Project WHITECOAT has been aade.

4. DA message 767602 states th:: 1munizatior.s for typhus, yellow fever, cholera, and plague will not ta administered to Ch8S 1-A-0 (Conscientious Obfector) personnel pri-r to arrival at the U.S. Amy Hedicnl Training Center, Fort Sam Ha,. n-on, Texas. However, recent experience demonstrates increasingly lxge number of 1-A-0 personnel have had these innunizations adm1nis:ezed at reception stations prior to reporting to this co=-and. .. 5. Request that all concerned ZLin be directed to comply with the provisions of reference lb, abov.-. Failure to do so will prcclcde studies on soae infectious diseases chat are of vitcl concern to the United States Army and will result ia a void in Project KSTEWAT.

.-

Copy furnished: CO, USA Mad Unit

2 P.

MESSAGE ROUT1 NE MR SCHWAB, MIL PERS SPEC, X59915 UNCLASS I F I ED 1 7 FROM; HQ OPO WASH DC ..

TO : CGUSCONARC

' INFO: * CG 2ZOOKE ARMEDCENT FT SAM HOUSTON TEX, CGUSAOXE FT MEADE MD, CGUSATHREE FT K?HERSON GA, CGUSAFOUR FT SA:. HOUSTON TEX, CGUSAF I '/E CHGO I LL, CGUSAS I X SFRAN CCL I F, ' COUSARECSTA FT DIX NJ, COUSARECSTA FT CAMPBELL KY, ' COUSARECSTA F7 KNOX KY, COUSASECSTA F'i BRAGG NC, ' COUSARECSTA FT JACKSON SC, COUSARECSTA F7 BENNING GA, CDUSARECSTA FT POLK LA, COUSARECSTA FT BLISS TEX, COUSARECSTA FT LEONARD WOOD MO, COUSARECSTA FT LEWIS .* k!ASH, S/US-MICC WASH DC, COUSARECSTA FT 9RD CALI? I NR : DA 767602 01 18372 JilN 6c FROM EPPHP-P ACJCOH. All pass to lower echelons. SUBJECT: .. [mmunization for C!ass 1-A-0 Personnel Immunizations for typhus, yellow fever, cholera and plagfie will not repear not be adninistered t3 C!~SS!-P.-c7 . personnel prior to arrivtl .tt ,the US Army hcfical Training ..-Center, fort Sam Houston,Tezss. . APPENDIX 23

LC-

DEPARTXENT OF THE A8ib;:Y HZADOUARTSRS UNlTiD STATES CONTINENTAL ARMY COMMAND rOAY MONROL VIRGINIA 23561 I ! 23 February 1967

SUBJECT: Imunization of Potential Volunteers for Studies of Infectious Diseases at U.S. Amy Medical Unit, Fort Detrick, llaryland

TO: SEE DISTRIBUTIC24

1. Attached letter states that Class I-A-0 (conscientious objector) personnel are receiving typhus, yellow fever, cholera and plague immunizations at U.S. Amy Reception Stations prior to bcink assigned to U.S. Army Medical Training Center, Fort Sam Houston, Texas.

2. DA message 767602, June 1966, prohibiting such hnunizations for Class 1-A-0 personnel has been incorporated in change 3, paragraph 2-3d(4), AR 612-10, 9 Dec&qber 1966. .. .. 3. Addressees will take action to insure campliance vith above cited directives.

.-

FORTHEC-nER: -

1 Incl SIDXEY G' TZ Ltr, AICSH-T-PX, Colonel &. USAMEDTC, 31 Jan Adjutant Gannczal 67, subj as abv

DISTRIBUTION: 'CG, COSUSA TSC co USXMEDTC USA Med Unit. Ft Detrick

2 I

.-

.. 1 ~ ~~ APPENDIX 24

PROJECT VJ$!ITZCOt',T Houston, Texas, this being the largest single group of 14-0soldiers. In this 1. What Project IVHITECG.4:? is one location. men could bc found X!IO Pro)ect V'JHITECOAT is t:.? name *~,ould be likely to meet the ~~CCSFXY given to a research prcqram ccncuctcd qualifications. TtiroGgh the years The by the US. Army AIeciical Lzi:. Fort pian has proved successful. Delrick. Xaryland. Participan:- in this Not only has it been convenie-t fGr project are Seventh-day Aciver tist sol- the medical unit to recruit thrvoiun- diers who volunteer specificall:- far this teers from a single place. but the cF.ccri duty. They take part in studics .imed at have been pleased rvith the high kvel ui developing medical protective rneasures performance and a minimum of aisci- against disease producing or -anisms plinary problcns :rnciig the Seventh- whichmight bc dissemina: d by an day Adventist men. enemy in the went biologica :--ariare (germ warfare) is ever used agxst this 3. Who selects the volunteers? country. Once in the SprinS and GI:CC i: :::c Fal:, the CO of ?kc mcdiczl uxL: ar?. hi; 2. Why cre Seuenrh-day iixntists invited to volunteer for this n.;? executive oEccr travcl to iort Sam Houston where they ex:end the o?:cr- Although much of the rtsc.rcn per- tunity to volunteer to all Scveiitn-day formed in the US. Amy Xe...c31 Unit Adventist soldiers in the training criitrr involves laboratory animals. :o-;.e as- there. pect? nf the work re;*xc +:x .?. .;$!.;=- There are always more who vo!c-'z: teers. than they can accept. io they endcxor These vo1un:cers must be men in good to choose thc men wh? hzve the sk:i!s to health who are motivztert to hzxrd some fill the necessary jobs. ana who :????.r risk for a humanitarian caujr 1-21 pur- ' to psychologisally and emricx:!:; poses research, the doc:or. ?refer a be of eqtiippcd to fit smoo:hly ir...fo the wx. group with as much jimilari. ci back- . They may consult :he c:.s?lain cr tlii ground as possiblc. Tkvs!,.:r.:cers must possess a good educa:;on ax- varicty church represe2xt:ves cor.c?rr.?n:: :?.e:: 2 opinions or recomrre:idat:ons in c9::zi:i of skills in order to FLllriie . ::;us jobs cases, but the se1ect:on is 'z:: necessary in the operat:on of m?t. ?mi? ::-.: x unit commander and his assis'Gnt. In the early djys oi its c. ;zxzation. someonc struck ujan the iae: c. sueking 4. Does cite Seventh-day Adrinr!s: volunteers from arr.oi:;. the I Y xh-day Church encourage irs nen !!J uolur.:ecr Adven::s: b;sic ~:zk.~~s2.. ;.r; Szrn ;a? this kki ;f sarcice? 2 3

2 APPENDIS 24

The Amy took care before instituting time he will be assigncd to a more con- their plan to inquire of the church ?f the vention;l t=sk X cun::cr cf tlx cxn proposed type of volunteer service vould work in biologrcal. chemical. or otiicr conflict with the tenilnts of the Seventh- iypes of laboratories. Some are as:zi;c4 day Adventist faith. X:er due cons:der- as clerks, hospital specialists. zx~.al ation. our churc!~Icadcrs rrzlied. in sub- handlers. or otlter jobs in kfcpinr with stance, that for a man to volunteer to be their proiessiocal or technical Alii. made sick so tha: other people mi:h: be 7. Do the volunteers lire and tiork in made well is ful!y consistent with Chris- Washington, 5. C.? tian princip!es. Nearly half of the volunteers are as- Since that time, the director of the signed duty at the Walter Reed .Umy N a t io n a 1 Servicc Orgmization bas hfedical Center in Kashington, zed 1:ve accompanied the o5ceri of the WHITE- in the Walter Reed ;\iinex in r.cirby COAT unit on thcir 5erni-annu:l -?crcit- Forest Glcn. ?.;ary!::.d. Tk r;..;!o:.::::. ing trips to Fort Sam Houston. His pur- howe\.er, live and lvurk at Fort Detrick pose is not to recruit. btit to reassure the in Frederick. !2rylanci. which is aboxt men of our dcnornicational apprsval of 50 miles north oi W.:-sk:::::on. this type of service. Whether a man voi- 0. Are t.hcre cdran:ages jur lie ij I unteers for WHITECOAT service must voluntecr? be entirely his own decision. As mentioned beiore there ars no 5. Ate there special compensations3. special compcnsatiocj for this :ype of oflcred for those ulio colutitcer? servicc. but scme iiitfl cu~sidc: :: sii ai- There are no special romvenrationr vantagc to knou tiiiere the? wll be as- ofiered for those \iix vc~:unteerto mve signed. The Y.~WXCO.\T ~,:~?..I~.:PTI. in WHITECOXT. It is commendable for knows he will bc near W'ash.nStm. .- a man to be willing to fsce risk in order Thee is also a greats \'arii.tv ,,i jcli to render a speciai scrvice. but he skould . oppoxunitifs in YHITECOAT tnan tile look for no special iavorr in return. mcdical soldier xho has bcen drz;ic-ii uvould fiad in most assignments. 6. Do the men snentl their chole Amy The NHITECOAT vd~ctcer:s ;.!so service period being made sick? assured hc ivill cot j:!f;cr ti? ic?,

3 APPENDIX 24

of couxe, the world headcuarters of the ical examinatim of this small Srnup of Seventh-day Adventist Churcn. Plans individuals has shown no defin:tc relz- have been initiated :or the establishment tionship between their subsequent CC.?I- of a dcnominatlonally opcratcd service- plaints and their participation in :Lis men’s center in a beau:iid park-iike program. Most feel they have bme5tcd setting near Columbia Urion College in by the very thorough ?hpisic3l z:cnza- Takoma Park. This will be In operation tions they have undergone upun z::r:al in 1961. in the unit. In a few individcal; :lese 9. Are there disadvantages in voluri- examinations have discloscd 3revioci:y teering for I?HITECOAT? unknown health problems. Seed!ess ro Many of the men who have served in say, these problems nave received zpp-0- WHITECOAT were asked. “If you had priate medica! attention ana !,crsans it to do over again. would you ,till vol- with such proble-s have been cxc:uic;-... unteer?’’ The vast majority reply that from particigation in any P’LOIE~~\v:.:c:i they would. Segatlve replies include the might be harmful to them. followin:: comments: 10. Do you think it ;s a good idell fo; 1. “I’ve missed my opportunity to 60 our men !o be Sroiipcd tcgctirar :)I c overseas.” single unir? I!‘oulLn’t thy io >:::z? Some have used lcave time, however. spiritually if they were sca::errd? to take trips overseas in I7;ii:arS aircrait. I include tics lost qucstion b-cxse I: 2. “I‘ve not been happy m my job.” or is asked of mc so frequcntp in one :cr~. “1 didn’t get along me11 yith so and so.” or anothcr. Let me say first. ?hat ..\.e a3 3 A certain ;mos~.t01 this is to be cx- church haw nothing to sav about .:;here pected in any assignment. soldiers of our faith are asi?p.;:’.. ‘i5:; .- 3. “My buddy didn’t volunteer and he is determined solely and entire!? u:: ;kc made Spec. 5.” Army. As the centurior. said :o Jes~s.”I Promotions in the unit are as good or am a man under acthority, hw1r.g si- better than in most areas, but there are diers under ime: and I say to thj zxn, no slots for volunteers above Spec. 4. Go. and he goctli: and io another..Coxs 4. “I shouldn’t have risked my and he corncth.” health.“ Thc Army has dccided that :hc,-e :.:- Over 1,000 Seventh-day Adventists diers irom Serenrn-day .+dre,:ti.:: bsri- have patticlpated in Project IVHITE- grounds have a di,;ii-.ct serucc IC :C?.~L: COAT. Of this number lcss than Vi doim to their country. I! is their dctii-?~t: have fclt that sacn parriclparion had gather thcrn 12 a ccrtain unit to ?::?@rr affected their hea::h. YE:^ C3Xf811 med- 2 given task. i 6 1 t

4 APPENDIX 24

!

So the key question is not whether it is a good idea fcr the s7iritual i;-ell-be- ing of thcse mcn for thexi 111 be grouped together in one spot. Since thc Ammy has choscn to dc this, snd has brought them to the very hexquarters of our church, the question is rather what can we do to in!luence their lives for good at this sensitive and significant time in their development. This :s the reason a civil- ian chaplain h3s been appointed here, and why p!ans for a Servicemen's Cen:er are bein: developed. Many are concerncd about the public image of our church mat is pro!ec:cd by an Army unit that is so preioiniGi:cly Seventh-day Adventist. Some of thcse .. men are rrxture ChriFtiana and arc living lives that are a rcal credit to their church. Others have new? developed a meaninrtul Chtidian kith at thc:r o'sn. and projcc? a poor maze of the ctiurch whose name they hear. ! We concerned to yeserve the fair are ! name of the church. but we are even more concerned to help thcce young r.en from Advcntist iar.ilies to find a vitA ., faith in Christ inr thexselvcs. W5 will probably have a better opportunity to do it here. with proper f3criitiei. than if ! they were sent ehcrvhere. I -Thomas Gre-n. Civilian Chap!ain Washington, D. C. area

5 Project !.:XTLCZ.T Is :he official desipation of the volunteer prozran

conductci by thc US .\ray :cdical Research Institute of Infectious Diseases.

This progrm originated i7 19% folIoulng il acrics of meetings between

reprceentrtives of the Gi .zzal Conference of thc Scvcnth-day Adventist

Church end of The Surgeon Gmcral of the Amy. The individuals nost closc-

ly asiociatci with Lhis i:;axc of the progra verc Elder IJ. X. Ecach.

Sccrctcry 0: :h? C.n_::zrsl Ci?fzrxce cnr! 2rf:sdicr Gewral \I. 3. Tiprtc, ..-,,-

who, at :hac ti;:* as a cc.icne1, was Chicf of the Spccial 0pera:ions Branch,

:!alter Reed Amy Insticut? of Research (!ZXIR), !:ashia;ton, D. C.

Project .3IIYXC:T vas cstablishcd originally to Ceterzina the vulser-

ability of can tG artack fith biological weapons using 9 fever as a protot;.?-.

At thst :ir..d th Fru;rx \.?LS zn intezr-1 part of ;!:;.iX, and all voluntccr

6CUdiC.j vrc coa~:ii:er! b: :>e ;!alter Keed co-,.?or.xt .?t Fort %trick. COlo;~~:;

Ti;crtr was dcrignotcd by the Secretary of the Any as thc person responsi- blc for all vsluii:cc participation la this zultifaccted research project.

On 20 Jcne 1955 rhc ::j Any litdfcal Unit, Tort Dctiick vas xtivztcd by :.?2:C Genera? Crd2r !::. 37 under coxind of Co?oncl !?. 5. Ti:.?rtt. ,,,'itti activation of this unit, rzspoxibility for ?rojecc ;v~IIXCC~'LTwas

*1 trcnsferrcd fron I!altcr Rccd Amy Institute of Research to the US Amy I 't!edical En?:, uhcrc it has rcczdncd to dcte. The nhrc of the US Am.y

Kcdicd Lait was chsnzcd in January 1969 to the US Amy Hedlcnl Research

Institute of Iurccticus Discascs (USSrIID).

Pcrsccacl for Froject i21TLCOAT arc recruited from ~ilitaryTersonnel

vith a 1-A-0 (conscientiouo objec:or) classification undcrgoin~Basic and

Advanced Indivi2ual Trolnics at the f!-c!ical Traiaing Center, Fort Sa

Houston. Twice a year, thc Corrtanding Officer and the Detzchmnt Comsnder,

USli.ZII3, and the Director of the National Service Grganlzation of the

Sevcnth-dty 2.d\v-xitist Gcxrd Confcrcxc intervie:.i personnel tt the Ilcdic2.l

Training Center considered eligible for Project XiII'iXOAT. They are given

a coqlcte ad ccr?rrhensi$c es?lxztfon of tkc pr0gz.m including discus-

5113 of ths risk Lw.-?*:cc!. T!:c fclle.:iz; :'.cy t!!c:; zzc fztcr-.-ic:::5 ic?i-

vidually and dfered an additional opportunity to ask questions. At that

tlm they ray indicate thcir desire to participoto in Troject GiITIXCAT.

The n::>cr of iLlvfduals volnrccrin; for this ~L-CI::~ is y,encrslly r.xh

larger than the nr-rher thnr can bc accqted. Sclcctioa is based on suit-

ability of thc voluatecr for this particular assigment and the needs of

USKZIID,

Those selected Ere assignzd to the Instituze specificzlly for partici- patim in ?rojrct 51TXC.T. I-:.zdiarcly upon arrivrrl crch !.?!iTLCXT clcizber undcrgocs o thorou3i c.??ical exxinstion. This iucludcs a cciqletc

2

. APPENDIX 26

I history, e detailed ph::sical exnuinatioq, and cxtcnsivc la5oratory

rtudies. 0cca;io:ialIy SO= abnorc:ality is detcctcd' which had not becn

previously reccgnizcd. Scch an abno~~alitycay disqualify him frou

participation In a rcscarch study.

bftcr c.izinis:rttivc proicssinz they are assiw.ed to various non-

cmbatant type duties such as nedical laboratory technician, medical corps-

man, medical supply clerk, medical snintenancc technician, anlrd

caretaker, etc. I.:IIT::C:.T ?ersomcl t;caxally rcafn at USfXXIID durias

thc recaindcr of their r:i?itacy scrvics o5lip:ion. Thcse individuals

are full tim soldiers 221 rccci:.E no qccin? consideration for partici-

pating in volunfeer studics.

hhen a rcsenrch s.r;iy in voiunicur is ii, bc codiic:ed, ttc r:r+izid

nmbcr of hXSTXCA7 perscnncl are &iVen a corqmAiensivc briefing by :he

Cocmcading Officer as to the purpwe and nature the project, the risk of - fnvolvcd. 2nd cxzi;l., :.h:t is cxpctcd of each p2r:icipant. After answr:

ing any questions thc: cisht clrlsc, each subject is interviewed individually,

given an additional cpportunfty to ask qt;cstions, and then indicatcs lriG

desires as to participation in thdt particular study. If he voluiiteers

hc is required to si n tt- standard consent fom. Khcn an individuaL

lndicatcs that he m~ldprefer not to pertlciyazr in a particular stl;dy

it usually is fcr pczsoilzl rczscns such as his vife tiavins a baby, he is

to be best cxi at his 9i.ster's weddin:., or nmc slniilar retson. APPENDIX 26

I I~ediatelyupon arl:.:ission to the research vard tach volunteer under- goes a tI..orou:li r.ctIic3l evaluation to ussure that he ha3 not developed

8oa~!condition that would contrnindicate participation in the study.

Tbc present rcccarch prozra of USlilZII3 is cocpletely unclassificd and the results. if appropriate, 3re published in the mcdicel literature.

The results of studies in t.3icli IXITCCCAT volunteers participate are ia-

Eluded in these publications.

The present authorize2 strenzch of Project IZIECG.’J is 172.

4 .. . .i; AFPEhD)IX 27 DUTIES SECRETARY XDICAL DIVISIOX I PROCEDUlLES FOR IN-PziTIENT PXOJECT

1. Type protocol for the project. The cover shcct and the dlsrribution page ucually stay tii- samz for all protocols, only the project number changes (See Tab A).

2. Prepare the nas:Zr bleedins schedule for the protocol. Thk is done by correlating the ;:iformation thzt is contained in the appendixes of tSe protocol (See Tab 2:.

3. After the protocol is approved at the Procotol ?!ccting (vhich consists of the Conmnier, Scientific Advisor, and the Research Division Chizfs), &he protocol is ret.,pcd with the suggested ccrrections and the C, Medical DLvision and the Ccmndcr sign the covzr zheet.

4. The protocol ir forwarded to I!QDA (SGW-?IF.), [Lashingcon, D.C. 20314 for further approv:.l.

5. When final s?;:oval is given the protocol i.; distributed tccording to ;he distriburion I-sr contained in the protocol (See Tab C).

6. T'ne Chief, :.:e

7;- Identify volurteers from project listing and type DF (See Tct D) telling them !:iier to report for interview. For this interview you nced to have adaission sneets ready for thc volunteers to conplete (See Tab E) and the c0r.s-nr s:i.;cmnts for each man with his ntze, rank, and sDrvice, ninrhcr (Sec Tab i . 0b:ain cach nsn's 'nealch rcccrd and nt!.ic!i !-.is initial voluncrz. ;iysical to it, also puil his voiunteer researdl recurd card.

8. After the r:e.ting, Chief, ?!cdical Division vi11 arivise ycu who was selected 3s thz :lnci?lcs and slternatcs. Typ? DF hifDrxi:15 -11 selected voluiiceLr; wncr. to report for project admission (See Tab G).

3. Notify the .':jgtsr.:, L'S.!!.IPIID of the selectecs and rhte of projcct so that he can a.-range for fils for clie project, mail diseribution chanl;cs, ctc.

10. Fonard tkc hxlrh records to tlic Tqard Secrctary.

11. Preparc xsc:r Ish;szs:y slips La d-;licxtG icr thc ;srinciyis ar15 ..b"L,LL"rj' IC- ^. ?.-I- lI\ alternntcs s-lcc~csand ior.:ard co tl:c iiiniccii i,'.~."-- ,ULC *Ll 'L,.

1 . APPZNDIX 27 . ..

12. On day of admission scnd admission sllccts for principals and altcrnatcs to Ir'sltcr Rced, Rcgi!jtror Divigion. hhcn you know for sure whb is going to pirticipttc on the projcct, call tllc Jezistrar (6-576- 2180) and tdvisc ~l!cn which ndciission shects to canccl; also obtain the Registrar Nuzbcr for cach psticnt and forward this inCormation to the Ward Sccrccary.

13. Whcn admission foldcrs coinc back fron HPAYC, assemble them into Clinical Record folders. Type a label with nane, project number, and title of project and plxc in tipper left hand corner. On tight corner of thc foldcr plccc the ndaissim card. On the left side of the folder place a copy of thc protocol with the man's consent statement on top and send the rccorcls to the Ward Secretary. She will assemble all the data recorded fron the project and gct it ready for dictation of the narrative and overs11 surmary.

14. Mid-way through the projecp. Chief, Yedical Division and the Commander will discuss the aicount of convalescent leave and blood money-the c.en snould receive. Prepare DF to the Adjutant and >E: Budget and Fiscal Officer advising thcm of the amounts; the Budfiet and Fiscal Officcr will see that thc vouchers 3rc typed; the Adjutan: will ensure that the leave papers are prepared(See Tab I). ForiJard a DF co NRI Bud~ctand Fiscal Officer.. for recoupmnt of serarate rations, for the men (See Tab J).

15. Sone projects have year lcn; b?cedir.g dates. You are responsibie for maintaining a suspense file ana for keeping record of all of these blemflngs; you must prepare the DF for blood letting at least one week .. in advance of the bl.ceding date so that the men will report for the bleeding (See Tab I;).

16. When the narrative swaarics have been typed, sisned and the overall sumary co.i;?lcted, the l!ard Secretary will return the project charts to Secretary ;,:odical Division. You arc responsible for hsving a copy made of each cover shect and sending the copy to the Registrar Division, XTTX: I;edical Records Library. The charts are then filed in Building 1412, sccmd floor records room.

17. Prepare a mstcr foldcr for all the projcct inforaation. It should contain a list of the voluncecrs who participated, a cajy of the protocol, publications, a suelmry of the findings of each of the assistant invcs t ,2;:;~oi.s , a CC:~ of :lie narrative sux:nry on each rm 2nd the overall surmury, a copy of anytliinz that I:JS reported in thc US?L!ZIID Ani~unl Report rcgtrding thc !xojcct, Provide this informtion to the Chief, Medical Division v1io will summarize all the data.

'2 APPELDIX 27 1 .

18. Prcparc projcct information card (SSe Tab L).

19. Add project i2formation to running list of proj.ects performed at USAHIJID (Sce Tab Ll).

3 , APPENDIX 27 * . U.S. AUlY WDIClL P.ESEAlXII ,INSTITUTE OF IXFECTIOUS DISEASES FKEDERICK; PlAEYL'C4D 21701 ..

'I t !

..

~PROPIIYLiUIS OF SARDF'LY FEVER

..

.- SUBMITTED BY: ..

Chicf, Mcdical Division /

APPKWED BY:

Coloncl, 1,ledicsl Corps Commdinz

.. ._

4 . ~~dilicjor prcvcncs viral ~IIIICSS. -itlis typc O: stuay iln2n.c iccn done prcviously. Smdtly icvcr viriis has bccn given to voluiitccrs in ochcr projccts and tlic tcst dru; (Tiloronc). has bccn Glvcn to hcdthy voluncccrs and paticnts with viral illiicss or cancer. Those studies suggest Tiloronc uny modify viral illricss.

~ Voluntcers will be studied in four groups. Onc croup will rcccive a singlc dosc of Tiloronc by nouth follolwd by a shot of sandfly fevcr virus given by nccdic into an am vein 24 hours 1atir. A second group will rcccivc a sinclc dosc of Tiloronc by nouth follodcd by 3 shot of clcar fluid given by necdlc into an arm vcin 24 hours later. A third zroup will rcccivc a singlc dosc of plnccbo (a fake pill which l~okslike Tilorone) by couth fo1lowcd by a shot of sandfly fever virus Siven by needle into an arm vein 24 hours latc:: A fourzh group will receive a single dose of placebo by mouth fo1loi;cd by a shot of clcar fluid given by necdlc into an arx vein 24 hours later.

Volunteers will not know which group they are in. The shot of virus and clcar fluid look alike as do Tilorone and the fake pill, so no voluxrecr will kno:? whether i-,e has gotten the shot of virus or clcar fluid or Tilorcnc or the fAe pill. Tinose volunteers vno get a fake pill and a shot of clesr fluid will have no reason to fe-1 bad or get sick 2t all. So~ec'Pe~, .however, a man nay feel sick just because people around haars sick.

Volunteers Ziwn sandfly fcvcr virus are cxcpxtcd to get sic!: and fecl likc thcy have the flu. Fever, headzchc, ceskness, ani Tain in the nuscles, joints and stoxzcii nay occur. Soze %ill get sick to the sconach and chrcr: up. Sone voluntecrs vi11 fee?. so sick thcy von'~eat, vi11 lose weight and just want to be left alone. OtFxrs wi:h :he s87.e shot of vi:~swill fecl just a little sick and nap feel like ?layir,; cards. ping pong-or reading.

Tilorone is not expectcd to produce any bad effects.

ldany thousands of people hme +.ad sandfly fever and a hundrrd or so . voluntccrs hzve bccn given sandfly fever. Xobody has died or had lastin: effects from the aiscasc. .. The risks and hazards of participation in thls study are expected to be vcry srsall, though smc risk is present, as in any research project involving huians . .. Mslc is rcduccl by (a) disqualifying voluntecrs with abnonalitics on history, physical or lskoratorjj exxiinscion, (b) chooshg of 3 dose oi Tiloroiic cspczted nor to producc bad cifccrs, 2nd (c) daily checks and exaidiintion 0: VOlu!?LCCKr; ixclc?iP.; 13bc-?:or:~ tcsts to dctecr u;lexpcc~cd problcras or La'! rcsults or any. pr-olltxi.

' Each vol.c:ntccr Tiill bc (a) hospitalized about 15 days, (b) sccn as an outpatient 4, 10, s!?d 46 C!ZYS fo!.loi, zG ,,,ci:: CCfCb.> dnily uri:>.c :L~:S *.:l:ilc Iiospit:.lized, cl;r;n~ r,:x!:s oil ,;Chissioi? .:nd 2;;:; addition.11 tCs:s t!ic doc~o1-sfcc? STC ncedc;! to :nkc GOO'! 05 lib. 4pprosimotcly 371 :::1 of blosd !;ill be :::,.en. APPCUDIX 27 WTER IILLEIIIKC SCliEDULE

.1S Ear 73 -5 0730 2 ! 5 7 16 Mar 73 -4 0730 2 .. 17 Mar 73 -3 0730 2 18 Mar 73 -2 0730 2 19 Mar 73 -1 0730 2 2 . 20 liar 73 0 0 0730 2 10 15 5 6 1330 15 12 1930 1s 62

21 tfar 7: 1 18 0130 15 24 0730 2 15 30 1330 15 36 1930 15 62

2 Nar 73 2 48 0730 2 .. 15 5 1 60 1930 15 37 ~

23 Mer 7: 3 72 0730 2 15 84 1930 .. 1 .- 15 32

~ 1 24 Har 73 4 96 0730 2 . '15 - 17 ,1 25 tlar 73 5 120 0730 2 15 ~ 17 1 '. 1 26 Nar 73 6 144 0730 2 15 . 17 1 27 tlar 73 7 168 0730 2 10 15 5. 32 1 28 Mar 73 8 192 0720 2 15 17 1 1 29 tlar 73 9 226' 0730 '2 15 17

30 Mar 73 10 240.' 0730 2 17 1 3'hpr 73 14 0730 2 10 5 17

17 Apr 73 28 0730 2 10 5 17 ! 1 15 Nay 73 56 0720 10 5 15 - 36 50 27 0 35 301

.. ... f...... =i , 6. :. .. '. DISTRIIIUTION , I r .' Cownde r 1

Deputy Commndcr I '1 ! 4 Scientific Advisor '1 12iDr. Thcodorc E. Koodward, Professor and Hcad, Dcpattscnt -.-- of Ncdicfnc, Univcrsity of Xarylafid School of Pledicins 1 . Chairman, AIDSB - Washington, D. C. 1 fir. Pladison J. Cawein, Senior Group Director, Clinical Research, >Icrrcll-?;ationd Laboratories 2 . Chief, Ncdical Division 1 Chief, Physical Scicnccs Division 2 Chief, Pathology Division 4 Chief, Virology Division 4 Chief, Btctcriology Division, 1 Chicf, b.?hal Asseswent Division 1' Chief, Xcrobiology Division .1 .- .. Principal and Assistant Investigators .. 6

eicf h'ursc, Ward 200 5

1 / File - Medical Di-..ision 5

'. , -VOI.UlITI:I77 ACEtT?IT.:!T APPENDIX27 .. '. 1, , having attained by

eighiccnth (18th) birthday, and othcrwisc having full capacity to consent, I do hereby voluntccr to pirticipatc in a rescarch study cntitled:

PROPIIYLAXIS OF S"2L":DCLY FEVER

under thc direction of Dan Crozier, Colonel, Hedical Corns '. The implications of my voluntsry'participation; thc nature, duration and purpose; the methods and means by which the study is to be conducted;

and the incoavcnicnces and hazards to be expected have been thoroughly

expiaincd to ne by Color.el Crozier , and arc set forth in

full on the rcvdrse side of this Agree~cnt,which I have initialed. I have been given an opportunity to ask questions concerning this rasearcti study, and any such questions havc b;eeii answcred ta-my full and completc .. satisfaction. ..

I-nderstand that I may at any time during the course of this research study revoke my consent, and withdraw from the study without prejudice.

I understand that in thc event of ny withdrawal or ternination the 2ttendhg physicians may fitd it necessary for me to undergo certain further est".inz- tions if, in the opinion of the attending physician, such examinations zre necessary for my hcalth or well being. ..

- .. ..

. .. SigiiiLure DJtc ~ I was prcscnt during thc ex?lans:ion referred to above, RS well as the I Voluntccr's opportunity for questions, and hereby witncss his sicnziurc. .. i-2 PROCEDURES FOR III-PATTl?~!'? PROJECT

1. Proccdurc for Rcoricstjnr, In-Patient Pilhs: All requests for films will : be submitted in letter format to Commander, Ihlter Rced Army Medical Center.

A'ITN: Welfare and Recreation Branch, Washington, D.C. 20012. The Theater

Officer, I?F.ANC it'clfnrc and Recreation Branch, will forward the request through llealth Services Command to Regimal Manager, Army and Air Force

Motion Picture Service, 4th Floor, 1775 K Street fn3, I.lashington, D.C.

20315. These requests must indicate complete justification, dates of showing, and number of viewers. Requests must be submitted at least six

'(6) wceks in advance of the showing date. If. this time limit cannot be met, the request should be telephonically submitted to WJXC (6576-3182)-- followed by the written requcst. Should additional coordination be .. necessary, Plr. Green, Army and Air Force Notion Picture Service (6-254-

4056), should be contacted direct. Under circumstances where sufficient lead time 'fi given, thrce 16 mm film per week will be sent to us by rcail. Should lead time be insufficient, coordination should be made with blr. Green, . -

AAlW'S, so that films can be picked up by courier.

1 2. Convnlcsccnt Len=: Prior to conpleti.on;the project, the Ik-dzaster will get leave addresses for all individuzls. DA Forms 31 are pre;rared on the ilagna card typcwriter. inserting personal infornatioa, and ].cave rC addresses. Amount ts Convnlesccnt leave to be .given is determined by the

Chief, Ncdical Division. APPENDIX 27

3. .Transportatjon: If Forest G1.m Dctachmcnt Sergcant is unable to arrange

I transportation - our courier with a bus or othcr vchfcle as required, will be scheduled to transport FG personal to USAtIRRIID for the project. Upon completion of the projcct, they will be returned to FG.

4. Mail Distribution: Mail clerk will be fumishcd a listing of all personnel on project. Mail for these people, will be taken to the project ward daily.

5. SDA Notification: Mail clerk will notify appropriate area SDA authorities of the project in order that religious services can be provided personnel on project.

6. USAXXIID Accivicics !:otificatior,: Upon receiving notification that 2 projecthas been scheduled, double-check with the following offices to insure they have been notified also, and havc initiated appropriate action: -

8. Budget h Fiscal Office: For newspapcr, PI0 release (if appropriatc). subsistence, blood vouchers.

b. Bldg 1h30 Nail Room: To send mail to 142.5 mail room, rather than holding in pcrson's mil box.

c. Wardmastcr: To schedulc barber nppointmcnts, if ncccssary. I

d. Sccrctnry, >!cdical Division: To ini:iatc action on rations rcioupccnt, I .~alcsccnt lwvc status, and rnii

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U e4 (? U In d 1 I I I I I d N N N c* n h 8. P- 8. I. P- APPENDIX 29

WXITECOAT VOLLNTEER

RFCXUIT?XXT PXOCECLXE

R&W?f3 APPENDIX 29

1. XO coordinate with Comnder and Elder Smith to determine time frame of recruitment visit to MTC, FSHT. Deternine if Elder will travel with Cdr and XO and if Elder's wife is going. I 2. Telephonic coordination with Personnel Officer, hC to determine how many volunteers are in cycle.

3. Firm time framc of visit to MTC, FSHT and prepare letter to Cdr, MTC requesting authority to visit for recruimnt of Whitecoats. (See inclosure 1.) 4. Determine and define losses of Whitecoats for approximately 7-8 months. 5. Send list of division Whitecoat losses and request chiefs to submit requests to XO, with NLT date. (See inclosure 2 DF for format.) 6. Receipt division Whitecoat requirements and assemble in consolidated report. Route copy to Cdr for his info. 7. Approximately 20/30 days in advance of visit, coordinate with Personnel Officer, MTC for: a. Billet accomodations (Building 107 or motel). Make arrangements for Elder's wife if appropriate.

b. Itinerary of visit with MTC: (1) Depart Frederick Tuesday night.

(2) Have MPO nake arrangements to pick up at FSHT airport or if rental car advise no requirenent.

(3) Courtesy visit with Cdr, MTC at approxiaately 0930 Wednesday.

(4) Wednesday afternoon after M lunch 1330/1400. arrange for briefing of troops by Cdr, USAXUID at Service Club in ?lTC area. (See icclosure 3 for subject matter - Elder Smith generally makes a few comments concerning the church's position on SDA's serving as Volunteers. (5) Thursday - all day Service Club in HTC area. (a) Arrange for coffee, milk, and donuts with Personnel Officer.

(b) Interested Volu2teers are scheduled in for personal interviews (approxinately 1 every 1% minutes).

(c) ?rior to lining up for personal interview, they as a group are offered the opportunity to ask questions concerning the program. They also fill out questionnaire which Elder Smith provides. It is used for discussion during interview. (See inclosure 4.)

1 APPENDIX 29

(d) Personnel Officer provides XO with Form 20 from 201 File for XO's review. I (e) XO prepares resume of each person intervieved.' Name, SSAN, background information, desirability rating 1-4.

(6) Friday morning:

(a) Provide list of selected Volunteers to Military Personnel Officer.

(b) Exit interview with Cdr, MTC if available. c. Ask Military Personnel Officer to coordinate with FSW SDA Chaplain. Be may want to be present during briefings and interview stages.

8. Few days prior to departure:

a. Connie assemble:

(1) Pencils - one pack sharpened.

(2) Two yellow tablets.

(3) Few sheets of carbon paper (for making up Whitecoat selection list in duplicate). (4) Volunteer sign-up sheet for a. .. 6)Two copies of each individual's TDY orders for presentation to Military Personnel Officer for nonavailability statemen's for mess and billets as appropriate.

(6) Extra set of XO's orders for rent-a-car if appropriate.

b. Arrange for cmrier to airport and pick up upon return Friday night.

9. Effect trip and recruiting:

a. Thursday night generally spent to make up list of Volunteers selected and prepare alternate list of approximately 10% of the number selected. (This takes care of individuals who are medically boarded, do not complete AIR, or for other reasons drop out of program.) Select individuals for alternates from later cycle of AIT if Fossible.

b. Provide lis: of selected Khitecoats to Xilitary Persome1 Officer Friday A.M. Ask that he give copy of list to local SDA Chaplain for posting on cnurch bulletin board.

2 d. Pick up nonavailability statements from Military Personnel Officer prior to departure. Pay for rooms if not qone so when you arrived.

10. At some time during visit, be certain that Elder has a chance to review selected list or make an extra copy for him. He generally reixivc~zay inquiries also. 11. Upon return:

a. Prepare list of tentative assignments of Volunteers to divisions and include expected arrival date and background education.

b. Provide division chiefs copy of tentative assignments (a above).

c. Provide copy to Frederick SDA Chaplain. Assimilate his copy for married personnel. He assists in house hunting.

d. Interview each Whitecoat or have SGM do so and firm tentative assign- ments - alter as appropriate.

3