A 6~)e'Aor Release 2000108108 : CIA-RDP96-00788ROO1500140007-4:]E~ Pi RX1Y REGULATION IIEUDQUARTERS, DK'PAWt'jMEN1'.r OFTHEARMY No. 70-25 AVAS11INGTON, DC1, 31 July 1074 RESEARCH AND DEVELOPMENT USE OF VOLUNTEERS AS SUBJECTS OF RESEARCH Effective 15 September 1974 This revision transfers the final approval authority from the Chief of Research and Develop- ment to The Surgeon General for all research using volunteers, except research illrolvilig nuclear and chemical warfare agents and identifies the requirement for use of active ditty military personnel as volunteers and instructs major commanders to provide assistance in their recruitment. Local limited supplententation of this regulation is permitted, but is not required. If supplements are issued, Army Staff agencies and niaJor Army commands will furnish one copy of each to HQDA (DASG-RDZ), Washington, DC 20310. Other commands will furnish one copy each to the next higher headquarters. 11~iragrapb Purpose -------------------------------I Definition ------------------- -----------2 --------- --- -- -- Exemptions ------------------ -----------------------3 - Basic principles --------------------------4 ----- -------- Additional safeguards ------------------------------------5 Approval to conduct experiment ------------G ----------- - - Civilian employees ----------------------7 Recruitment of active dut,y miIitaryvoluuWers__.____ Appendix. Legal implications ,X 1. Purpose. These regulations )rescll 0 policies and procedures q,~rnin the use of voluntaur.; as su7j_o-cts En~ I, ~ ~__e I I ~to f I wlicrein are doliuera tol L(*(l to exp unusual _IuL 1)otentially ItiTza.rdous condi, S. Th-cso regulations are applicable Worldwide, wher- ever volunteers are used as subjects in Dopm-Lineii I, of tile Ariny rescarch. 2. Definition. For tlio purpose, of these regu- lations, unusual and potentiolly liazardous I'- tions arg tilose W11171 reasonably ax-pec U,j~ 7o-involve the risk, bey norn-ift ca , - #-. ~), rivaLio-n-,-discomion, (1171,77"s, paill, dalrl~~Io OT 1) t fi-e-Ftl or d al- i7s ci n t1i, bodily 0 ,8,i, -EXe_M__p_tio&. 11~tio ~11()"'(O~Nvin",, i1crate-uorics of activities and investigative programs are exempt from the provisions of these regulations: a. Research and nonrescarch programs, Casks, k, and tests which may involve inficreat occupa- tional hazards to licalth or exposure of personnel to potontiftlly hazardous situaLions encountered as part of training or other normal duties, e.g., fliglit training, junip training,, inarksmansbip training, ranger training, fire (trills, (,.is (trills, and handling of explosives. *b _jA'WjTLp9rG1on of human factors reseAtrell whicill invo ves normal tri-lining or ottlor military duties as part of an experiment, whorcin diSCIOSLIrC of experimental conditions to participating per- *This regulation supersedes AR 70-25,26 March 1962. TAGO 58A-July 580-465-74 SMAW1. wolilf] rovo~ll III(, artificial natilro of sm.11 coll(iitiolls alld (iodeat Clio purpose of t1le i~rn Cioll. invest , Etliiviil nw(lical and clinical invesCigntioli-; I - _ invotVill" (lie bosic (Iieaso proces., or now troal_ 111CIlt pr0C0dL1r(,S con(lucted 1) ,v tile Army Nludical Sorvicc for Ule 1will,fit of 4. Basic principles. ( 'ertaill basic lir illl-,t be observed to satisfv woral, e(filcal, and--lezil concepts. _l_l1e-;v uro- a. Vottintary consew, is absolutelv essent.j.,il Li (1) 'I'lle, ~'ollllteer_ =uiavo legal capacity I,() ~HVC C011',011t, all(l 11111-4 (~i%'e CODSeLlt freCl itl \N1 lout being subjected to anv force or duress. lie ]]]list Ilave sullicient, 1111(lie-n~,taiiding, of (lie iniplication,; ot Ili,, pni'twipition to onablo, lilim to inake zin informed decision, so far as sucli knowledge (Ioe, not, colliproilli-;e f1w experillielit'. Ho will be to]d I, inucli of III(,, Julturc, (Itirlitioll, 111(1 purpose of t1w expol-inwilt, t1le nietilo(I alid Illealls bY wIlicli It, i, to be cotiducted, :111(l tile, illCM I Ventelices 2111ti liazards to be expoel(-ti, as will not inValWa[c, 010 results. Ile, w.111 1w fiffly illforillod of t11(' efl'ccl-~ upoll Ilis Ilvaltil ol. pol-on wllicll ilwy possibly collio from Ilis I)8l'IiCIj),L(i0l1 in Clio experillivilt. (2) 'LLLconsoid, of die vojjljlt.(~c~r ~\-ill be ill writing. A TTi7-ab1)ve requirettwnt8 will bo simied bv tile volunteer Ili Cite presence of aL _17777" -on-etiTov,, ApPF8yed FeF R_Q_ 10-2-2- -0 -9000108108 G.1A.RQPQ6-0Q788R001 500140007-5 J , 4", ~R 70--25 Approved for Release 2000108108: C not, involved in (,It(, research study who will attest to such si(nrliaturo in writing. (3) The LCSWX1"',_1itLV_for ascertlaini-m, t 10 11,01, eacT, _ner, quality of a-w-collsellL rests upon eac i )erson w to ini lit 0s, directs, or conc ticts T to experim t. It is, E- porsoli-ft-F respollsi i i W lie I illay not )e delegated. b. The number of volunteers used will be kept at a minimum consistent with c below. c. The experiment muqt be sucti its to contribute significantly to approved researeli and have rea- sonablo prospects of yielding militarily important results essential to an Ariny research prograin. r, which are not obtainable by other methods or means of study. d. The experiment wilt be conducted so as to avoid .ill unnecessary pitysical and litental SLIffering and injury. e. No experiniciiC will be Conducted if fliere is tiny reason inherent to the nature of the expori- ment to believe tliat deatli or disabling injury will occur. W i._:LjLQ_Y_O time dur IA-RDP96-00788 ROO 1500140007-5 5. Additional safeguards. As lidded proLection. for A OlLinteers, the follm~,ing sfl,f0('L1llTd-; will be b el provided: a. A physician approved by TbeSiirgeon. General i6ll be responsible for t1to inedical. care of volun- leers. The physician niDy or may not be the project leader but will have autliority to terminate the experiment at tiny tinie dint lie believes death, injury, or bodily harm is likely to result. b. All 11 I)f)ll I'll WS Mid il)StVt11l.101lt9 1WCOSSary to deal with likely einergency situations will be available. c. Required nic(lical trentnicilt and hospitaliza- tion will be provided foi- lilt eftsualties. d. The physician in clitti-ge will have consultants available to biln oil short, notice thrOLL1111OLIt t110 experiment who tire competent to advise or assist with complications which can be anticipated. 6. Approval to conduct experiment. It is the re sponsibility of the lictid of each in.aJor command and other iweacy to submit to The Surgeon General a written proposal for studies which come within the purview of (Iiis directive. The proposid will include for va,ch study tbe name of the person to be in clitirge, naine of the propose([ attom Iling physician, lind the detitiled plan of tlie experiment. The Surgeon General has final. approval authority for all research using volun n teors except research with nuclear or chemical warfare, agents. Propostils for research with nuclear 11 or cliemical wiirraro agents will be forwarded by The Surgeon Getterld with recommendations on. medical aspects to the 8ocrotary of the Army for approval. 7. Civilian employees. When civilian employ- ces of the Departm(~,nt of the Army volunteer uncler this program, die following instructions will be observed: w a. Any duty as ti, volunteer performed during the employee's regularly seliedulod tour of duty will be considered as constructive duty for whiell So f-4t straight time ratos aro payable. Tinic spent in n connection wifli all experiment outside the cl-n- ployco's rogularly scheduled tour will be consid- ored as voltintzill Lfor whiCIL 110 1 ymeli.t mav be imul( iior conmensatorv time all ted . Voiunt d i s c a so--, - 1 1110110 no _DIlV-,iCft1 Or mental ous ior Lnein Ily Mic project Teador with, if necessary, conipetelit medical [vice. 7-k. Ttle scient7list in, chlirge will be prepared to 0 terminate the experiment ab any stage if lie has probable cause to believe, in the exercise of the, good faith, superior skill, and caroful judgment required of him, that continuation. is likely to result in injury, disability, or deatli to the volunteer. 1. Prisoners of war will not be used under any circumstances. 2 course f. Tfic degree of risk to be taken will never ex- ceed that determined to bo required by the urgency or importance of the At-my program for which the experiment is necessary. g. Proper preparations will be made and ade- quate facitities provided to protect (It(,, volunteer against all foreseeable possibilities of injury, dis- ability, or death. It. '11c experinient will be conducted oal by y scientifically qualified persons. TI)c higlwisb de- gree of skill and. care will be required during, all stages of the experittient of persons who conduct or engage in the experiment. r luntecr will be inforined that at aTiv 71-cemployee will be so infornied--Before ac6'ep- tlince of his volunteor sel-Vices. b. Claims submitted to tbo Bureau of Em- PlOYCOS' COMI)C11sation, U.S. Department of Labor, beeatise of disability or death resulthig from all employee's voluntary participa Lion lit experiments, will include a citation to title 10, TAGO 58A Approved For Release 2000/08/08 CIA-RDP96-00788RO01 500140007-5 Approved for Release 2000/08/08 : CIA-RDP96-00788RO01 500140007Ak 70-25 United States Code, section 4503 as the Dopart- mont of the Army authority for the use of such voltnitoor services. c. All questions concerning hours of ditt pay, leave, compensation elflinis, or applielitioll or other civilian personnel replations to volLinteer oni- ployces will be presented throtigh channels to the Deputy Chief of Stiifr for Personnel, ATTN: Office of Civilian Personnel. TAGO 58A ir S. Recruitment of active duty military volunteers. Some research will require active duty militar '%, persomiel as voliniteers bocawse of flic nahire of t1le, investimitions. Rocniiiiii- is best acconi plished by research por.,ontiel re~poiisiblo for c0tidtict of the researeli. Major commanders will provide assistance to reeriiit.ing teun,;. At all 7 times recrUitill,(" will 1)(1, C01)(Illeted ill. a morally, othically, and legally ac,(,Tpt~iblO DlnllllCr. 3 AP, Anniroved EOC RPIPa-'qP- 9000108108 CIA-RUP26-00788ROO1500140007-5 AR Ap roved'For Release 2000/08/08 : CIA-RDP96-00788ROO1500140007-5 APPENDIX LEGAL IMPLICATIONS The following opinions of Tfio Judge Advoeato General furnish specific guidance for ii1t pariici- I)MAS in rOSCIArCh Using Volunteers: 1. Authority. The Secretary of the Ann.v I's authorized to conduct research and development programs inCILL(ling the procurement of services that are needed for those progranis (10 U.S.C. 4503). Tho Secretary has the authority to "a,,sicyn detail find proscribe fl)o duties" of both l1lerillwl's of the Army and civilian personnel (10 IT.S.C. 3012(o)). 2. Military personnel and Department of the Army civilian employees. Compensal-don for the disability of death of a civilian cuiployce, re- sulting from personal injury or discaso proxi- Mftto]Y caused by his employment is payable wider the Federal Employees Coin ponsa tion Act, (39 Stat. 742 et seq.), as amended (5 U.S.C. 751 ot, seq.), regardless of whether his employment was of a hazardous nature. The amount and typo of disability compensation or otbor boliefits payable by reason of the death or disability of it member of the Army resulting from injury or disease in- ciderit to service depend,-, -upon flic individual status of each member, and is covered by various provisions of law. It may be stated gonerally that under prosent laws no additional rights against the GOWrDment, will result from flie death or dis- ability of military and civilian personnel par- ticipating in experiments by reason of the hazard- ous n%turo of the operations. 3. Private citizens. It is the policy of the, United States to prohibit the acceptance or voluntary services piixticularly when they may provide a basis for a, future claim against the Government. (R.S. 3679, as amended; 31 U.S.C. 665(b)). 4. Use of appropriated funds for the purchase of insurance. As the payment of insurance, pro- iniunis on the life of an officer or employee of the United States is a form of conipensatioii w1iieb is not currently authorized, payinout of those, premiums is prohibited (R.S. 1765; Cotninissioner of Internal Rcvenve v. Bonivit, 87 F 2d 764 (2d. Cir. 1937); Canaday v. Guitteau, 86 F 2d 303 (6th Cir. 1936); 24 Conip Gen. 648 (1945)). 5. Contractor's employees. Thero appears to be Do legal objection to the use or employees of contractors in research and devolopniont, (.'xl)(,i,i- monts. It is the responsibility of the cout,racting officer to deterniine whether the t0r1l)S Of the COLI_ 4 Iract are sufficiently broad to perniit tho 1)ftrtici pation of these employees. Generally, benefits to whicji private employees may become entitled by reason Of death or disability resulting froul their oniployment, are payable under Stato law except-, penons covered by the survivors insurance pro visions of the Social Socuri~y Act (49 Stat. 623, is amended (42 U.S.C. 402)). Roinibitrsernent of the employer for ad(litional costs by reason of I his liability of his ciaployces will depond upon the ternis of each contract. These employees are not disqualified from prosecuting Claims against, the e, e, Governmont, under the Federal Torts Clainis Act (28 U.S.C. 2671 et soq~, sep AR 25-70). In cost reimbursement type research contracts with coin- niercial organizations the cost of maintaining group accident and life inquranco may be roiin- bursed to the, contractor (subject to certain ex- ceptious) under ASPR 15--205.16 provided that the approval of the head of the Procuring, Activity is obt,ailled (APP 1.0-551). 6. Irregular or fee-basis employees. Intermittent services of such oraployees tire authorized. (For exports and consultants see Sec. 15, Act of 2 Aug 1.946 (60 Stat. 810; 5 U.S.C. 55a); Sec. 501, DOD Appropriation Act, 1961 (74 Stat. 349); note APP 30-204A, CPR A7; Sec- 710 Dofenso Production Act of 1960 (64 Shtt. 819; 50 U.S.C. App 21.60); and for architects, engineers, and other technical an(I professional personnel oil a fee basis, see 10 U.S.C. 4540.). wheaier these employees can be detailed or assigned to the proposed experiments will depend ujr)'011 the statutory authority for employment and the provisions of their employ- ment agrecnicnL in each case. The Federal Em- ployocs ICompensation Act, supra, in all probability applies with respect to these irrogular and fee- basis employees for any injury or disease resulting from their employment,, idt,hough ft final doter- mination ill Such cases will. have to be niade by the Bureau of Eniployces Conip(,i)sation, Department of Labor. Subject to such restrictions and limita- tions. as may appear in the. stattitory authority under which lie is employed, it would appear that the Government may legally bear the expense of premiums upon the life of an irregular or fee- basis oniployco whose rate of compensation is not fixed by law or regulations. In this regard, it may be advisable for the Government to provide an TAIGO 58A Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140007-5 A Approved*For Release 2000/08/08 : CIA-RDP96-00788ROO1500140007-5 AR 70-25 additional allowance to the employee for financing such private hisurance ftlTallgements as, he lylay wish to inake rather than to underhtko direct, negotiations with insurance carriers for the desired coverage. 7. Conclusion. Subjoet to the above conditions, Arined Forces lwrsonnol and/or civilians on duty at installations ongaged in research in subject fields will be portaitted to actively participate in all liftses, of the program. P Z, The proponent agency of this regulation is the Office of The Surgeon General. Users are invited to send comments and suggested improve- ments on DA Form 2028 (Recommended Changes to Publications and Blank Forms) to HODA (DASG-RDZ), WASH DC 20310. By Order of the Secretary of the Ariny: official: VERNE L. BOWERS Major General,, United States Arn?,y I'lto Adjutant General CREIGHTON W. ABRAMS General, United States Ai-niy Chief of Staff DISTRIBUTTON: Active Arn?,Y, ARNG, USAG: To be dist,ribitted in accordmice with DA Forni 12-9A require- ments for AR, Research and Developirient-D (QLy lx'qr Elock No. 112) TAGID 58A 5 U.S. GOVERNMENT PAINTING OFFICEi 1974 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140007-5 9 LOOOKOOMONSOLOO-96dON"Vio 80/80/000Z OSBOIGN Jo=j PGAoiddV Tf ANNN 61- 49 N '*dOU-DSVU ON d 9310 ASVr.LO 4V(JdS:J(JO A OdSOU 10 4SdOSOOO 6 10A )'$Sv 0 dtog)vso :AS (J:31VNlUdOO:) *9 OS3II111OVi SN IiS31 NVOM -nW al -UwNlw3SSl(J -bLz9uiui3f)a z0 gov'd 16H = 07 . 6 ego_= . rr s -e2 -4.L rv n i VIA j 0, Rs ~, v 03iTA3H 1-40 - Nonvoi itind E)fi!O,'qJd 01'IVA NIVW38 EMUS31 NViAll-I 13 3r Ell S 0 11 N Ar .9 t IU d I I V 0 C; H 10 S 3 13 1 -10 d 0 SO Nh U4 N V 3 H 1 .6 3w TIN 4 Jw 3HI N I Ot ZU A J h:] IN VfW IS N Lj .3 H 1 0 N I 8n 0 :1 -1 9V -11 VA V 3 ~a U*lfl U HS ON V I A 113'481 a 000 9NIW43d 341 lJJl138 01 Nlli-l8r13,i! ~JNLAU Alivi~jSl4d Sl t ~pe-Gk ldJ *A-IIHOHS 03HSlUlld 3il ulflOHS UNt ti kWV89VNvd s NI 033h3 d3'338 bil VO FJH HIM IN3iSlSNOJ Sl 3AI.03alO 000 M3N 3t4l ~i~3zllv~41i antr Oj:i-ilills AiiN--iddna si i,DIHM SJUIA113V N01INWISAA-41 -IVDINI-13 OWV J!~IGS I LJOO N1 S.13301411S tvVwflH JO NOII:).~10dd 2AIIJ.~dIG LJOO L-ivha !fv 3H.L Ul OTNIVINOO A0110d IN-lda(13 AHI L331AJ?i l0ii S~oU GZ-()L JV -0t :io3iHns ZdGlAw 9w C39 s I ON 11 :111 1,5L8 V 0 AN I L LA I 9WIL 91V A)j . 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