714 vl~ I U AZZ" th, 4 A.' For Release 2000/08/08 CIA-RDP96-00788ROO1500140004-8 DoO 6240.1, "ENSE L~EFAATM ENT" OF DEI ANi' %-S GOVERNING THII: P C', i f rH N THAT Al""I"c""Y 1r, F) ATE I B E ft 1982 Apo roved For 40 1 9P %t ,PO~ _. p"V -e 4, a -P ".. ,- DoD 5240.1-it HILIttkN SIM.TECTS FOR IMLLIGENCE' KWO.SES A. .,-"'APFI. I CAR 11, ITY This P170Cedl.Te. applies to t,,,I,eri.merjTat.i0rI On human subjects if Slich experi- mentation is c,~,:djcted by or ou INt-half (if a DoD intelligerce comp()IIent. Thils procedure does Uot 3pply to CxV,- ",erA,?t ion on anim,11 subjects. P. EXPI.XSATI0'A' OF V~MF,,NED 7c" Egeriineli,t,a-c.Jon in thit, contlext means any research ')I- testing Activ- i ty involvi-n'g-iiiman 'S'Y~jecLs tt-jt iwv eApose ruch subjects to the po,~sibility of permanent or ten-porary injury (incli'ding PhYsical. of Psythologicall damage an~ damage to Ow -,ejInt,,tJOfI of SIA1~11 b"YQa(I the risks of i,3jury to which such sub -tj are urdioari~y in their daily lives. e t. 2, Expe r imeat a t i arl i S C DI) +.1 e(, ("ri IA. h a 1, f oa Do'D 1 :1 t 4-IgE,,IICC, com- ponent if it i~ d un'ler to t 'IL ('0111ponert. or to another DoD componenL for ti.,e bcc~t-kl-t of the iule'.Vli~,vnce compocent or at the request of such a comporwi.-L of ihn e.~::stence uf a coritractual relaticsship. 3. lh~.Fan ,-;uhjt'c's in L)-iieM, includes ally j)ej-!~on w1jeth,!r ()y not peri;on is a Uni',ed State!, C. PROCTIOURE", It on haaa~i rcts ConducLvd bY or on of a DoD ilite-1.1igence COMF)0,~e;!L lkl~-Y I~e u~t1jert,4ell only WiLh 1~'Ie vu i de- A,sc,,, , i &sued by LlIe s~ifvjuaLd U DO) intellivellf.' ~,.~AY not engage in or contract for experi- ,%-,utatioli 0u Sill) ~ j e c L s v -i L! ioI~,pfjroval Of the Secretary or Deputy Secre- tAry of Defense, or tlio Scrr(~tsry or Uneer Secretary of- a Military Departt:ent, as A~propviate. -8 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004 .0101~ Q V III Itil I-1 t~ 0 W) f IE i I I OU11 J ~d x,-) oSddi- jou Roc allip"),loAd ~ilTjj, wrv ;'kn! p) J11,4G,j 110 to .~q p:)~,vij)1100 S, 11(d", (I'ms j! 81jartill", lil'uJI14 uo 11oflu, -Tkowu klx;) 'Y~ L w) .81 a.111paoij 1-4-, pol[ddl" -jr,,44 ',',IuTpud~u oil f~t, atp .1ok-11111 SUITITirm I'll? 01 U.!PW.I j1?JJjaj wJ-1 j0 Otj~dl" J;1kjj(yjt1- Waut 11.11 Ts"3 9 fit" it) florloldlaw .1,nlj~V -11111a tl),T~ q;)(qm o1 aqj jo 111,1110~4.00 i0 suovlvm~)do aqj Juatiodulo-') 9mtv Amu 0~ J~md,u ~Jwa smu jljaluu.TOAW~ j)1;iDj-10j Xj~ JO -.111 04 aw) un ul w, juilut)(Tillo.) if cut I v ki v p ')~).~ci 1 u: o 13 r I , , wol IjOfl Ju ill nplamolixotil ojl~ It! $11"`4 '14L1 i;t IIINI 1,)[D0 (3-0 ;U,411111, t1i) alpim tiol -UT) OM TI UU101) ~UYi I V(j ol, i i ,,1U1 11CW. 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X'-mj~ulv m, 11~~ -N,Vt I'LM ~IjVJF 01 iquoulodluo.) p jDuun!--.I,)d 10 11o1pxW.o ox;-- aq In .1 Ali 381-10 15 February JAW, Apprc(vod,,,FpriRelease,2000/UiOa.., CIA-RDP96-007a&RGOrt&00ilA(IQQ48ctjori ot, in. )er,lon's merital or Oi-L-sical versely affects a 1 condition, that rany exj)ose tin individu;il to the of 0, injury (Wcliidij-Lg physical, jjiycho,ogival, or social injury) that increases the ordinary risks of daily life for tile ~ojbject rk-l- ognized risks infiefent in a chosen ix,,nlT1Af' or field of ser%-'X0., (.,r t1hat tonwor,,H).., v1- (3) Experimenu.tion iS COMILICiA "(111 be- balf of" all Army in[elligence componctit if it i,4 conducted under contoict to that or .to another Arin~- compontnt for the bonvilt of the intelligence vomt)onent, or at tht-,~ ~! qw:!st of such a component rc~grardless of Cie existence of a contractual n~httiunship. (4) Human sub icctq in this oonteNtl in- cludes. any person regardless of "Ov,'Iter the person qualines its a LIS person. '6. Polity. Army intellilmien, eo!,nI)uv-nt,,: mlv 41' cosiduct experin'tentation on hunian subjeO.-S only when an important fkweign Cl purpose i-, to be !iervcd, onlv :ift, r t1;(, ' m- fornied consent of the subject has bovii olk6nH ill Writing, and only ill accor'linve "vit) lines issued 1"Y Ole Pepar lit of :And Human Services seltimr out con:!Hloms 1hat. vafegimrd the welfare of ld,,c subji,ci-s, !tod -1 her aj..,oplicable r,-:gulatiowi. C. Procedure. A rai y inh,Jigwnce conipa:wi:fs may not eng;lge in or coWr"ct for tation oii human withui,t urior q). 1, p,roval of the Secreuiry or Under ~-wk,r-htrv of the Array. 2-49. Procedure 19, Special avliNide,4. a. Ap- plicabilitV aad scolm. (1) This pm~.eMtre applipi to t1'.,-- conduct arld support of sl,ocinl activitic,,i by At i,iy oAol- ligence components. 'I"his provedure al~~(- applies to Wier Army compouents that. prov--,do stiIijiurt for special activities eonducte(l by 1;-o1) intel- ligence Cori) pon er, ts alld other agencios Ivithill 0) ,e Intelligenen Cojanamity. 1'hose !).~-occdares do rot apply to-- (a) Diplomat.ic or rfilit~xy tivities conducted by DOD. t ~. I I i~'vllvo A the (c) ikity functions in support ~ collection and production intelifirence; or W) The conduct of speci!ll activifiev by the. military servieps in armpd conflict or to military deception or~erations targeted, f~.-jr mili- t~~iu 1.)Urpoges, again3t it bosiile foreign pimer. (2) Con,,.piracy in thip context ham -~he me meamnj,- a8 i1 tl~CL Cj-irjljj-jal law cont,~xt nmd requires an uvert, act. Nlcither the tcrin 9~W I SWIS."'ination" nor the term "congpire" in- clude military or civilian me;usures agidnst on- going fid 'emational terrorist activities (wHch i~; a do.6rod term (~ce Oonsvry) and should be con.,Arued strirtly), ai;rcraft hijackings, or in respoitse to danger of subitrx, Hal physical ha rm to mly r,er-son. These terms do not apply to nct;ons ef the military services in thci fmoCu- -4 tion of' lawfully ordered 1-rji1i!Dr,Y OpOrUtiOnl. ('9 Diplomatic and mi,131tary attachc aciv- it.te~i means the reprementational, inforniat 1011 prathering, and reporting acITAties perlorined - I Itache pentonilel 1~y divloinat;r nrld Tnflit.lry -'U abro;.W. (4) ProductAin of' int(1;:T,(!nco nl~-Wls process of developing "int-,~higence proflurt.,i" which is a olefined lerun. (vo glossary). (5) spexiat activit4s ill ~.m activities CIM. ~ucl(~d abroad in support of' national for6ril polioy o1jectives that are dc ."p-ned to furt;iLr oflicial U3 prograini aml pollck~s i,,hroad; th-,,tt are plaitrod and executed so Vial. the m'e of tlhe T-,T.rli1,e(l Stafi~s Goverment i., nt)t appflrent, (Ir Ucknowledged publitly and functions in imppolt of such activities, but not including diploinatic and military attjjcjt(~ t(jLiVitiCS or the collwji)a ar.,d production of intellig-Ti,-e )r related sur,. port functions, (6) SuMmrt, when us,ld in this colitc'm (' meami the provision of ii,smistm)ee in the foljL~ of tn-misportation, trairting vipplies, efl.Ap 0 me!t or expert personnel. b~ Policy. No Ariny intelligence comporler, -ticipate in the, conduct or rt will pai SUPPO, tit special aetivities. No other Army conlpomv~ will provide support for special vxtivffic,~., excv -, upon the sjv(:,ffic direction (A the Seeretarjf,,." Uzi&r '-.,eerctary of the Aamly and the 3,ecrr-tjr,A,. t tit ' M11 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 DEPAR'7 ENT OF TFE ARMY UNITED STATES APXY iirELLIGENCE A0 SECURITY COMMD Arlia-.,,ton Hall Station Arling--in, Vtrginia 22212 U~,,ol''SCOM Regulation 15-3 24 Fcbruary 1984 Boar,.Is, Corwii.,i s ions and Committees HIGH PE'RFOP'1-!0;(E REVIEW PROCEI)IJRES 1982 and 1983, in keeptn,,, wtt-h the US Army Tntellij,,-2nc,~ ar,i Security C.I,--~and (TNSCOM) goaL of "extraordl-,ary performance," and se,3kiig w move the (-(-,-~rnand to a level which exceeds corMonly defined paraM~!ter3 Of p4-!rformanc,2, INSCOM conducted! a ,;tu(iy of 1~,L",,h performing org-inizations and I-,rograms in if,.e public and private sectors. Sc~veral technologies, nanaqcment i:ech '~iqUC 3, :.-;;ining experiences, and programs w,-re identified for further ewaluation with ,.C, ""ect to their potent t,.~l to Corit, rtbu,~(-- to the development of ext'.raorlinary 1~1.vidua'!- and uw.t perforni,ince w~ '.Iiin 'rhe Coutnand. 11its regulatlca contaIns COM -policies and guiLlarce for -hat e,~,aluation, establishes prr),.e!du!-is For thr. use of INSCOM personnel aq w,itirl,-eers in evaluating -ind imple~Tviting high pcr-~ormfng human syi~tems and pro% !.,Jes guidance for commar~ders and 7wpervisors ~ii further implementing and t2v,1bj;i,,-tng those bigh performing 'wrian avstems plementation of t:'-iis regula Lior t,i permitteci only aftor prior a~ proval has t,et-n obtained froin this [Teadquart:c,:-;, ATTN: IASJA. Pa r o,~,Pag, r a p e h CJ,~11TE,R 1 GENERAL INFORMATION Purpose Applicability 1-2 1-1 Referunces 1-3 1-1 Scope 1 -.4 1-1 Exemptions ------------------------------- 1-5 1-2 Explanat.1-on of terais ;i.id a~brcviations -------------- 1 -.6 1-3 I'E R 2 RESPONS 1B1 LI.TIE'S Approvinq, officials C, Commanders and Staff ';.::1ement leads 2-2 2-1 INSCOM Hurnan Revtcw Board (HTRL,) 2113 2-1 Chairperson ot the 11TRr, --4 2-2 Execi~rive Secre!-ary of the HTRB )-5 2-2 R e g u la r I I " R,'~ 6 2-2 c Fx Offi, to H""PT" 11).er' ~!p 2-1 j A.1 hoc M'M 2--3 Prinelp 1 2 - 9 2 - 3 Me!-.ibor~, 0!- Vf-'Urlteer- .- -uJI-Ing te:ms 2- 10 2-4 Approved For Release 2000/08/08 CIA-RDP96-00788ROO1500140004-8 C L Appr ved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 USAINISCOM ulation. 15-3 24 Febr-uary19-" R~~ Par.,i ~irnP,'i T)h (JULPTER POLICIES 3 General 3-1 Approval 3-2 3.1 Risk determinations ------- 3-3 Risk ersus benef it 3-4 Moral, ethical and legal conce-,,tci ------ -- 3-5 Fully informed subjects 3-6 Use of non-US citizens 3-7 USe of prisoners of war an.1 du!:ainees ------------- 3-8 Medical care 3-9 3-1 Stat('d objectives 3-10 3,. 1 Physical and mental suffering -- -----------3-11 3 ... I Qualifications of investig.-~tors --------- 3-12 11 Minors 3-13 3 Recrutting of volunteers 3 - v, Protocol guidance --------_------ -- 3-15 3- i.'HAPTER PROCE DURAL GUIDANCE 4 TechnIcal reports ------- ------- 4-1 Aevising the Medical. Research and Development Commantl 4-2 Informed consent 4-3 Minimum ~itan.,Iards 4-4 More than minimal risk 4-5 Contractors or vendDrs 4-6 Requcsts for exceptions 4-7 Expedi'Ited review (.,_n~egories 4-8 Expedited review procedures 4-9 ("11APTER INSCOM HUMAN TECTIIiOLOGY REVIr'.4 lr#'-ARD -a (,t',RB) ACTIVITIES ~Composition of the HTRB 5-1 General c-iteria 'or membership 5-2 General committee activities -----------------.------ 5-3 voiding possible conflicts of 1~nterest 5-4 ~ C Criteria for INSCOM HTRB approval 5-5 Special considerattons of 5-6 uspen.sic-n or- termination c., a Project 5-7 5 - - 2 ecords 5-8 5- ~ - A?PEITDICES, A - erms and Abbrevt~it:lons A-; B - ormat for Pr~2para(Aon of i R,:, irch Pr C - Folunteer Agr3e:nent, Par: D -- olunteer Agr 2erient , Part Appr~ ved For Release 2000108/08: CIA-RDP96-00788ROO1500140004-8 24 A'pommd M6 Release 2000108108: CIA-RDP96-00788RD M,0094W.46%i-nn. 1.5-3 Cliapter I GEN*~'--~T 71"ORMATION Purpose. ThIs regulation cow-aills TNSCOM policie!3 and guidzirce for the 11lua7DTn--and implementatioa of performing human systems Orith.~n tl-.e com lr,~111d. It - a* Promulgates procedures .-vid guidance for the use of' INSCOV personnel ,~i17 Volunteers in r-he evaluation of' hip,li performing buman systems; b. Establishes and impleme%iu-; a raview procogs which I.s con,~ Istent w1th AR 70-25; C. Insures Cie contintied evalLiation of INSCOM activities to assure that t.lie provisions of Aft 70-25 are being followed; d. ''Establishe,-.3 procedures to ~,,bt.31n a health hazard assessment prior to ,i,,-)roving an INSCO,14 protocol issucl n!; required Inerein; arid e. Promulgates INSCOM polici,os and procedures to assure that "N'SCOM co-a ,.,.iiints do not enga,,..;e In or con';,z,i.,(-*t, for exper-Lmenta t ion on human -~;ubjects in of Procedw~e 13, AR 381-10. -2. Applicability. This reguliiv Loa applies t-,:) all clewnts of t~,E, INSCOM. References. a, . AR 70-25, ot Voluw-c-,-:~ w, Suhject-~~ of Rese~lrzh,, b. AR 381-10, US Army Intel ' I'l-,etwe Activities. c. AR 70-31, Standar"is for 7,?chn1ca1 Reporting. Scope. a. Nothing in this regulzitl.,~n is kntended to supersed2- requJ7-emeyits for 1,E.,,i-Lth hazard or otl,er szifecy re~v,e?w-1. r,~qtuired by any oth#~~r regulat"ons or di- b. The procedures, policiu-, and guidance contained J.!i this regulation 1,,~r~.-ain to the followririg,: (1) Behavioral studies, rv~;earch and/or testing involving hu-naa sub regardless of whether -,cndL,(--C-ed t- INSCOM, a contractor, or ofher agency t, Y 'It"Lizing INSCOM fune"s. (2) IIICIUS~CW. C)f I-,timan !:o`)jt,1-*t.,;, whether as rhe direct (.~r indirert ;-cL of re.iearch, rogardlo!,s of -,e '.,-vel or risk, inw,-.1ved, in th,:~ dev c I o p - testing or stu(~ of ra,jtrers wLt:h tht~ misslon,3 nnu' f~,iictfons Approved For Release 2000/08/08 CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 USAINSCOM Ri.-gulation 15-3 24 February P` the INS COM, Or t b ~2 a~,Pl I cation of nontr.-,, :ion a L ideas and tech no lo,,Ytes rc achieving h1l.,;'i performance of human resoor",,o:.. The investigation of progi-ams -11 toc:-noloc'-itis to enhance or,';~. izational aiL' individual excellence whei-e -,,,( i inveStigati~tn involves the. J-~- CAUSiOll Of h1.1 Inan subjects as their object:. T~~m ~_f.ons- a# Rr-.,,-.. arch, Le-3ting and studies In hum..zn !.-,ubjects are involv,--(., Lit one or more 4) the following categories ire OX'!Mpt from thiq regulation. (1) 3on;ifide activities under the ;i)onsorship of another Depart7IE-11 of the Army c?mp-oneat and involving surveys cr interviews w11-2re all of t1he fc-L- lowing conditions exist: ~ (a) Responses are recor_-'e~. in such a w.-.,y Chat subjects canr- tte identificd directly or indirectly. (b) The subject's respo,iso~~;,Lf CleyI)QCOTle known, would place subject sk of criminal -,)ritl ility or damage the the at ~:- liab S~,- ri Ject's finar,~~.Ial oi- so(.-.ial standing or l (c) The activity doeo al".)"'i1. sensil:Lve aspects C' wii-h of Ci iubJect'sow% such as illegal d.rulg use, sexual belia,vior, behavior, use of alcoh.: 2,' which irviolv,_~s Research the ti!:r of educitional tests, prov-1 i:he is such, a wiy that: cannot be identified data recorded tti,'- in rectly incirectly. or -I~ISCOM educ-sAL)!7al s4?.i:?.-.in,-.3 ;,.,1-iich Involve (3, Research in non educational ,'iactices, such as (a) Regular and ipeciil educirilo-ial (b) The effectivi2ness or the zo-ciparison amori~.- nchniques of 4,1 struction, curricula, or classroom methodks. (4) Follow-up debriefi-,igs, bests, ar evaluations to termine how vc~ll participants haive learnel t", 1 he information or skills trans-m~'-_ ted by trainlr~g or Ins!.ructional 1--vious-Ly attended by the subjei_. thereof. b. Exomptions of ot'her activitte!-l fr,n 1:1!is rf-gulation, even where st,,,,'-! activities tric,y be exempred from other s--mil t -ogl_l,itfons or directives, sha", n(-.)t be cons:~,.'cred v,-3lid for INSCOA rless and untiL confirmc~d by C-2 Tt!chnology Review Bo,.- rd i:, -ih(-1 re in this reg, 1'i'- TNSCOM 11%imail I t 1. 0 n Approved For Release 2000108108: CIA-RDP96-0078BRO01500'140004-8 I 21'AffOY610d PWRelease 2000/08/08 : CIA-RDP96-00788RMISC044(kgp4l-Bt ion 15-3 Chapter 2 RE31ONSIBILITIES roving officials. I'lie comma-lding General, the Deputy Commander, Tn- A pp I 1. 'MgCTIce, and !~he Deputy, Commandcr, ~(.*)tipport, are the designated INSCOM ap- 1,i (:,ving officials. ci'tily tliose ofil,--ial,; may approve the use of human subjects research. Commanders nnd Stil[f ElOnelit 1[e.3d_,7 . Commanders at all levels within the '''S"0M, heads of Headquartt!!:s stiff elarients, office chiefs and program direc )rS (hereinafter referred to onLy as commanders and staFf Pelement heads) arc-,: r ~-ponsible within their respectivo functional areas for a. Insuring th,it Lhe j)rovis6.-,ns of this regulation are ins titutionalized lmo their organizat~~nn;il procedur,s and practices. b. Insuring that no person- engage in or contract for exp,:!rimentatiori. 1--volving human subjecLs wit'.hout -lie t~xpress approval of art INSCOM approving Icia 1. INSCOM Human Technology Revif-w Board (HT'RB). The INSCOM HTIM is respon- ,i!.-)Ie for a. Observing written procedures for the following: (1) Initial and continufng review of research, including rhe reports 1 1 o' ftridings and actions to the in-,esi_-igator and the approving official. (2) Determination of projects ;,.,hich must be --- (a) Reviewed more oft'en than annuall, (b) Verified front sources other than the Investigators that no .,rial changes have occurred si~ice previous TITRB review. (3) Prompt report-Ang -.o the HTRB of proposed changes in the ro- ~-ch, and to the 11"RB and approvinp: official of unexpected involving ~~.s to the subjects or others. b. Insuring that changes L,, approved projects (during the period for ..i..,-h approval has alr~2.idy been g,1--en) are not initiated without 14,TRB review, C J."pt to eliminate Immedia te to a subject. C. Reviewing F)To[)OS~ld pro:'-oc,ols at meetings atterided by a rmajority of except when an expedLted r,.,v'ev is used. For t~e protocol to be ap- -c,,~ed, it will rece:.v,_, the approk-it of a majority of those members*present. d. Reporting ro the CG any. .-,, r~,otis or cooLinuing nonconplianc,! wif-h ITTRR r~(.ttirements and dett.,rintrtattons fo~ind by, investigators. 2-1 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 CIA-RDP96-00788ROO1500140004-8 tSAPN'SCO4 1-Ull:i(Ill ', 5-3 2.4 February 10'. e. Co"""t"" ~' CO'ItLfIuOuc~ revtei of 'j 1 r,.. t Interval,; prt- Per to 6 e r ve 111. risk, but ilot leL;3 PO, y e,i r f* ln:~i~ring the observation by a ii:irty of the ,',olisent proccn;s :i:,, each investl~ ';ation, as appropriate. 9- RE!~~Ommending safeguard,3 or spt-cia condit ix.)ns to a protocol. Wr,.! i such recomme; IJations are made, the approvi Officl,al iray take the followin, action: Col. (1) Not reduce tae safeguards or -,:,ilittons, and approve the pro-:r- (2) Require additional safeguard!-. ( 3 'J Disapprcive the protocol. (4) Refer the protocol to a h~lgijcrr a,)prnving authority fo- action and r(!v iew. 2-4. ~hairpvrpon, of the TITRB. The DCF)PFA L, 3 ~~!t;igrinz:ed ClwiLrperson an~ a ular member -)f the '4TRB and is responsible -~,L' chairtngy HUM meetings, keepli. I the CG info,:aied of HTEB activities, and r,!C: O;T,,,,ie rid U~g approval/disapproval oF- HTIRB regular n raiber,,; to the CC. 2-5. Execut:,,;~ Sect. etary of the ii'rRB. "'he 7.J':~PPM wt1l ieslgriate a member hA staf f to 1~ e t h e Executive Secretary of IITRB~ T',.o F,-ecuttve Secretif- of the HTRB J.~ responsizAe for -- 80 In,iuFlng that the responsiblliti,-~; :,f the IRTRB prescribed In 'par~i- graph 2-3 aro Iarried out. b. Pr2paring and distributing the fDr ea,-_)i meeting to all roambe r s . c. lns'i~irig that all HTRB zembers art.- ~i'.forde:l rhe erportunity to co-)--- ment on 11TRB ; 4' t,".ons conducted under expe('At:!,~! review procedures. -1 2-6. E.(Lgula-L 1IT11,3 riembership. T"'he INSCCIM OCSPER, MSSYS, SJA, Comma4-' Ciaplain and )'~RCOIM LNG, are each responsible !-or no~nlnatlo:i of in in~ilvidu~'. to serve as a regular member of the 1179.11. NoAlnees nay be from their respoc- ti,ie staffs, .3tibordinate command functional c~L~nterp.irt sta::Fs, or may be LI,o nominating elcment head. Nominations will he stbrnitted t,) tlie 11TRB Chairperscii ('DCSPPM) for Z.P Prova I /di sappr oval by the CC. 14ominations may 'he by letter, D1 or message, a,,,d will. contain the information rEquire-.1 by par~!graph a, below. a. Nominfes wIll he identified by na"ic, oiarne(' Aoqrce'., current positio- and duties, ar.d experience, such is boattl ckt-_!'1tCa'_1o1S atid 11censes. Vie I i~- formation in :Iie noininat ion will 'ne orrufTi to describo each nember' i; Chief expectcd ontributions to HTRB revif-,-.. 2-2. Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 4 17ebruary 1984 USAINSCOM Px-~.ulati,-)n '15-:3 b.' Nominees win norrnall~, mLlitary officers I..n the grade of 0-5, or -Il or 3bove. Nominees will have diverst, bacir ve, or civilian empioye~s, GS rounds to inSUre 'khorough revt2t4 of researcn studies involving, h,.(r.,ian volun- teers as researc'~~i 3u1)Ject.,.:, Noml iee!, sfiould be of varied racial and cultuxal i. iclgrounds. Nominees should hivc .!is;)3ayed sensitivity to such issues as c',T1 !7i-.1nity attitudes, aid respect fnr and counsel and for the rig~iLs an,.! w,~'Ifare of human sul-1-je,-ts. C. Confirmed, noniine,~s wil-i- ~4erve as HTRB members for an indefinite term, will be expected to have final authority to 9peak on behalf of their 'he Ex officlo ~un m,-~mbersiiip. incumbents of the f0.11OWL P031LIOT S serve as ex officio, rnOlTibers of the ITTRB: a. Chief, CENTEX. b., ' Command Fsycholo~:,ist. c. Chief, Human Technology Office. d. Chief , Publ Ic Af fai~rs Of f,'-ce . Ad hoc lirm membershilp- Tk~! following will serve as ad hoc-. members of IN COM 11TRB: a. The Staff Advisor for Scientil:ic and Cryptologic Affairs. b. A phystcii-,n, as npprovf,A h~i an INSCOM approving officiaL (para 2-1). Drsician nominees ior ad Fioc will be provided as requc-5.;ted by the Y L' C'na i rpe rson. 2, Principal irxesLigall'or. 'rhp principal investigator foc cach project covered by thii regulatton i'r, responsible for a. Maintaining , adequate recoi-Is on the following: (1) Recetot, '.~toraige, 117,0 '~JVJJ:l disposition of all ma- ',-erials and devices. (2) Case histortes Thai racord all cbservations and ot1.!!r data im- po:tant to the study. (3) Volunteer agrPement documents. b. Preparing progress rep0r-i~-,, ~'-ncluding annual reports, as det--rinined )y ti'le approving aut.-'ir)rf~,y and t1he 'INSCOM HTRB. C. Promptly notityii,g the appi"oving, authority, througl.- tFie T'~'SCOM HTRB, )I Liny adverse off .-,~c .s .-,iusod hy t'i,~ rest-,arch. 2 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 Appr ved For Release 2000/08/08 : CIA-RDP96-00788RO01 500140004-8 L'~AINSCCM Re:;~'Iaticn 15-3 24 Februciry V) d Ins~trtng that the rescarch has becii approv d by the proper author-' and the INSC"11,11 HTLR3 before starting, chano-ing, or extending a study. e. ln..~ -T.ring that all subjects, inciudln;,, those used as controls or th,' rePre9eat-ati-.,4,,s, are fully informed of ;:he m..Iture of the research to inCL,1 potential r-L.-A3 to the subject. fo Inguring that investigational materials and devices are administer,~-] only to subji-.-,ts uncler his or her personal sup.'rvisioa and that of a previously approvea ass~;-~iate inve.,3tlgator. I g. InT~ring that volunteer recruftin;'-!, t',,,ims ar~-- briefed as to the nature of the reseac,-h and the ethical pi-inciplwt '.n iLhis and related regulations. 2-10. Members of volunteer racruitin;,. tea-ms,, 'Llfembers of volunteer recruitim,-, t~~2ams are renp onsible for --- a. Est Iblishing volunteer requirement,; prior to recruitment. b. Undertaking recruiting in a worally, ethiciily and legally acceptlb' manner. 2-11. Medical monitor. I'he medical mor.It-.OL' each project L3 responsible f~ and is hereby delegated the authority ~,) L~ite C~ui ofrlor'- if --- a. Sul--)jects are at risk of lifo--. or lii~ b. It appear3 the risk i~i significaw: ,reiter th in anticipated at -,I time of review and approval of the project. 2-4 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 2:, FebruaTV 1.984 USAINSCOM Repuntion 15-' I f:haPter 3 110111CIES i-1. General. .-perinentation E 1-i,rolving - human technology - or hurlan -` qubject~~- with; -,Auc~e belialf oE -S'i- compo, ent may be undertakerionly J any , or on by :~-. informed nt. of the in itecordance with gi-lidel-flies issuer, conse tv the Departmentu~: an~' Fervlce!! 01)"14"), Setting cor~ditiorv: oir: r-3fegua -ir:- -~f `,:lie provistors. of this rep~~ul rd the welf, tior .,~titute ILNISCO,~-lc, Lhce guidolinCS. A-p j) r o v a 1.-. IN 0'-! ccmponen~i i,ia~ noc engage in or cont,*act any ru-se r zesttng, involv ing iluman 3u.)4e(-t,. wi~tuur- advance approval throu,,h the. INSC"Ot" j ~ 11 1 - 13 by an IN I - 1 17 'SCOM approvinsT offtci (-r iiigher level off"clal, wh~!rE! rlp: opri.- I Thl,,-, approv:il U, ro,~ufred ril.-~,~~dt.-,sq oF t1he dei;ree of risk involved. -3- Risk determinations. 'flie HTRB will render all risk dererminations t~.-.arding INSCOM or t:estAi-.,,.; 'L!~4ulving Ic-li,.Tan sub1,,ct,,;. Risk versu7,-, The pOtCT)tial risl'. involved In anY T)r(j-- w ill ne-.rvr rhe e c t,,~ i ctnoflts oE that offort. Moral, ethical and con-.'~uits. The moral, othical ind le,,al concrlpt~., C~ the use of hurnan subje s will followed aj ou4.1ined ir this regulation. consent of' each human subjac:: is ess~-ntial. Nilitary porsonnel are suh.ject to the Uniform 'oJe of' Military Ju~;tlce (t1CMj) for choo~3.Lng not- to -.e part as human :z,jl)je(--tq. Fully inforz-.red subjo-,.-t-s. On!y pt-rFons wf,o are fully Informed and liolun 'C':'r to take part ri.iv ~-,e 1.-, hi:.Tian subjects, in INSCOM re~-earch ind to9cing ivittes Use of non-US citizens. may br, conductPd out,.3!,ie the [IS thot c%Lves non-US cittzen~3; however, all, i '-equirements of 011.3 regulation applic- ~e to burnan sabiects shall he eqt..-,j1ly applicable to non--,JS cittzr.-i humaa sub- Use of prison~~r~.~ of war and i,ralnees. The 11se ~Of prisoners i)f w.ir and -iillues unan r-,~se,--~rch SUbjec.,-~ is prohibi ted Medical care. VoLunteers be authorized all necegsary care .njury or disease that is the pr1.-)x1;nat:e result of takin& parr .--n approved "';,iCOM research or tclsring 4,113. -ictivtti.. Stated objectivt~s. Each prc ject will be designed to achieve its s-~ated c t I The propos,od nomber ot will be the nini'llur n,-~Aed lo in that qt3tfsticallv 1;~S,AlLs are ol)ti1nef' PhN-i(.-al and u~feri-~- 1:1ch P,:Cje-A wl F, c-)nduet,-~d ia !much a !.,rier as to avold unaeces,;ary and mental. suf F,?rillg. flrepal.-3tjors Approved For Release 2000/08/08 CIA-RDP96-00788ROO1500140004-8 Appr ved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 USAINSCOM 1~,.-tjlaticn 15-3 2-4- Febri,-Axy, I() will, be madl.- and adequate facillities PL'OV:I.JL'IJ LO Ole subject and ,,iestigators )gainst, all foresecal)ie injii-ic~;, disabilities, or death. A pi, Iect will not be conducted if any reasoa exL:i~s to b(!Iie,,,e Ciat death or ,,;Ill result. T~ie degree of potential rlEk wtI] never exteed t1le expected ben fits of the p"roject.. ficati 3-12. Quali (ns of invest I 1,,ators 0,,i]), i)ersoiis jud~,~--d qualified by t-1 w appropriate approving authority til con.,:u-t 'riuman subjert --,-udies. The phys cian responsl~blf- "or the health and wel t bare A the subject may or may no the principa ~ irvestigator. The physlci-n -L--, authorized to !-.top the project- I any time he or she believes thac injury, df.t;:ibility o,. death may result. ,3-13. Minora. Minors may not be invulve,., ~-,, humar roseat,"n subjects with~:-:,. advance approval in each cat:;e by the INS'ON IVIRB. - 3-14. Recru.-ktilig (2~ volunteer:i. Volunteer recuiti,lg WL1.1 ~h(? accomplishe!, personnel re Sponsible for the conduct (,,! (:Ii- particular pr~:,Ject, or as otlik, Ase specifically approved by the INSC0,11 HTIU1. 3-15. Proto(-*()l guidance. at Ea h approved protocol. will b(! re~ bowed i,k le,ist annuilly and on continuing ba3fs as determined 'by the I'iSC(,',l ',P.'RB. AnnuaLly means once 12-month period. b. The decision as to whether a protocol involves mort- Ci Taini-,,,ial risk hall be made by the INSC('/,If IITR~'). C. Th research protocol will h,.! pr~~pared in accordance with the structions coitained at appendix B. Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 3 - 24 Approved For Release, 2000/08/08 : CIA-RDP96-00788RO01 500140004-8 24,Februarj 1984 USA~NSCOM Regulation 15-7. Chapte:~ 4 PROCEDOVA, C.UIDANCE 4-1,- TechAical reports. Technical reports will. iv, prepared as prescribed ~-n AR 70-31 and follow the format of MIL-S'Err-847A. "When appl'cable, these reports will conta.-hi the following statement: For rhe protection. c-f human subjects, the investigatot-s havo a,!her~fd to the policies of AR 70-25 concernin;a the use of volunteers as research subject.s. 4-2. Advising the Medical Researcli arid Development Command. Two copies of t,ichnical reports of study will be forlwardod to the Commander, US Army Medical Rvsearch 'and Development Command, A'I'TN: SGRD-ffR, Fort Detrick, Prederic'k, Maryland 21701. When HQD4 appro,.al, or higber, is required, infornaticri copies of niaterial forwarded for approval will also he furnished to the off".ce above. These will inclu,.ie as a mLn1P,1U!T;, two copte,3 of the protocol, a copy of the volunteer agreement arid all ininutei of INSCO"M HTRB meetings reviewing the proposed project. 4-3- Informed consent:- Subjects wilL be given adequate tAme to revtew and o!.- der9tand all informa',ton before agrcoing; to take part in a project. The volar- teer agreenient documents will be ,~Itteri in Langua..;e that is easily underst,.,.cd by the subject. The documents listed below will be discus:;ed with (-,;ich subJ~!ct bofore his or tier acceptance, a. The Volunteer Agreement (appondl-x C). b. The Explanation Portion of whir Vilunteer Agreecient (appendix D). Minimum standards. The laws, custroins and practice3 of the countr'. ~.fi w1itch the research is conductecL will t-.ike precedence over procectures' roquir-~-J by thi.-. regulation, where applicable. The project r-nU:3t fnf,:~,2.16- the :3ariv stardarJ-, of ethics and safety, however, that ripp[y %-Athin tlie US involving) US citlze-;s- WhE'l standards vary, t"IP. mor(.~ 4il', apply. A mintmuri age oF 18 Is re- qui,,7ed for US citizens taking par"- In -esearch con,lucted the U'3' gardless of the laws oE the countrY irt 14iich the effort is being undertaken. 4-5. 'More than minimal risk. Wb-:!Il L"- 11W-3 been determine-c!' that- the risk In "I ht,.man Jects study is more than ninlmal, then advance ~ipproval 1:3 through TiQr.,A %'DAMT-C]') by the Secretary or t"rider Se,.-.-.t!tary f:)f the Arr,,iy. In ad- dition, a medical monitor shall be lecorixifnded by tlie INSCOM HTRB' arl appro,ied b,7 the CC. 4-6. Cont-actors or vendors. or vendors lh~'-)Illng approved D~-f, assurance of compliaitce shall be con-i~'ored in compi-iarice writh thfs reaulati(,v-t., Tri the abs(nice of such an. assura-icca, i -,pecial a,i'surance will h,,! nego~Laf-.,!d 4-1 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 USAIN,'3C.CM Re) u atiwa -3 24 February 1?8'4 with the con ractor or vendor. in all however, the INSC,0M I-IMB must ar-- prove thle IN COM participation in or ut U1 z it ion of such contractc r's or ven-- dors. 4-7. Reques-,3 for .2xceptions. Reque3L9 for e~cceptlons to this regulation will be submitte to Dh-e_IN!3C.CM IFIRB Ualrperson (D('SPPM) with full justification. L-8. Fxpedited review categories. Catogorie,; which may be processed in the ux~)edited re~ i i!~ dures are as follows: a. Recordio-, of data fron subjocts who arre 18 years of are or olderl usin?, non-invasive procedures routirely employed in clinical practice. Thl s; c.atu.gory does not Inclutle cKposure tc elecLromagnetfc radiation outst&, the vistble rang-* (o g. , x--rays, m1crawavo-j) Lt does include -- r (I,' face of the icant amouht: (2' The ise of physi.cal sensors that are applied either to the stir-, or at a ~Istar,ce ane do noL Lnvolve input of matter or signif- of energy into C-ie SUbj(`Ct. 01- an invasion of thie Subject's prl_ Such procedureS as (a) Weighing. (b) Electrocardiography. (c) Electroencephalography. (d) Therm-ography. (e) Detecl--ion of natur.-.illy occurring radioac.-ivity. (f) Diagnostic echogra,.0-ty. (g) Electroretinograp1hy. b. Vo ce recorcings made for re!-;earch purposes such a:3 invest Igat ions of ~~D(Iech defects, improvement in langua;'C W'iLIZitt0n, etc. C. mo(Iarate 42xercise of heall-1hy vc,Lur,teers. d. St?dy of uxi.:ating data, records, pathological specimens, ;:r diagnostic sp:!cimens- e. Mijor chang,-!, in F.xeviousl~ reL:e.-Arch durin,'- the Pariod fo-1. .hizh approval has I)een authorized. !.-9 . Expedited review procedures. II'n(!,-r in expedited review procedure, tli~ HTRB C~airper3on, or _!'~e or more HTIZFI~ re-,I~,w-rs (Ie!;I-,nat(,d I,y the chairperson, may carry out the review. Tl!ese review-:s !rliy exerc-Ise all of the autllorltitr,; Appr ved For Release 2000/08/08 CIA-RDP96-00788RO01 500140004-8 Approved For Release 2000108108: C IA-RDP96-00788 ROO 1500140004-8 February 1984 USAINSCOM Reg--ilatlon 15-? the TITRB except that of disa~~.rova', which. may only be exerci ,-~d as pre- SCII-Ibed Clsewhere in this a. When the expedited revieij procedtire is used, tlio reviewc-i-i will. fur- complete copieg of all !-.heIr ~.~--Ions and related ma.Le-riaLs researcl, protocol, etc.) to all ot',T- of the HTRB- The HTRIt cliairper,130rl ,;111 submit a written rer,-ift, of reviev actions to tine Cc, within ten w.)rking days of approval Ic. b. &i expedited revllew prcct!(IuLr,? may be restricted or :3uspEttded to pro Gie rights or welfara of at any time based upon e1Lthitt- direction All approving offizzial or tE!que,;. by any member of the iTRB. ",,- I Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 U-',~~AINSCCX Rc~~jla,,,-ion. 15-3 24 February E' THIS PAGE 171-E',,,'TITONALI,~ 1' FT "K 4-4 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 f I FApproyetWbr Release 2000/08/08 : CIA-RDP96-007MAMM0440 n I - 5 -3 OW4 Cha~iter 5 INSCOML rEMTOI~rGY RL"TEW BOARD ACTIVITIES --~-hip in the PISCWI~ 11-11B ,71' Composi-1-:401-1 or the -1. con~,ist of' .-1-2 i-~e I I J- .1 o airp4arson; at least i.r regular members, appointed by f ch six otl the CG rou %c,ncthe nominatious sul)-fj'gtt:c1~,ccordance with p'ac-agraph 2-6 2-8, aid 1~,- or from other sourci-,, -,.,,t.-,cut1ve secretary; and surh ve -a~i other ex nfficio , ad hoc ifferabers as Trosc~~Ibedabove. Ole regular member will ~n - hapt~--r 2 not affiliated with the - of , o -incl not part of tie [mm?diat-.- famil%y son affiliatc-,d with the . 1NSC0k! General criteria for meinber.Oitp. At lea,,It one member of the 'ITRB will be !r-"m a prof ess ionTpos It Ion/ ac tivity priliarily concerned wtth the wcl.f'are of hu- min. persons. At least c~r~ memb;E-z- will- be non-scLentific, such ~.s a lawyer, -~hiciit or member of the cl,~rgy. ',"HE PTSCOM HTRB may invite perso-~s wil~'i spe- cial competence to assist in tho -t-vlew of coaplex issije~,, that r,!-J~aire exper- rise beyoild that available on the TJ'FB, nese persons normally w-A'.11 not vote, 1-iless lie or she Is servtag as the non-INSCOM member of the 11TRB. 5 -3 General -comml.~,:ree activ-1tir?-. Fach regkil3r and ad hoc commit.tee tneinbcr E;h:ill have one e(joal v()Le, and the er!t1lce comnittee will vested %ijl.th the ie- ~.,-,),,nsibility to determine if a pro,~oz;ed activity is accepLable. k, c: e p t-b i I i t Y Will be in terms of Army 'Hodical C,.~-pra,ument (AMEDO) commitments and reg~ila- t(ons, applicable 1.3W, standards cl' conduct and practice, and with if'Llll consid- e,:.i~:Lon for the particukarly sensi:!.-vt, iiature of the INSC'Wii role a~; an intel- ~~,ence component, a. At least five voiring m,,m.:,,cY-s will be required ta constitute a quorum ach committee m~~etfrig. b. All actions r-if i.-Jie com-AtteEi will be by majorit,1 vote of nember.-% se fit . Avoiding possible con'l-V.cts of tn.er2st. a. Except to proviee lnfo.-;-~, to i rPqUO--!:ed by the ITR-R, -,ao LNSCOM Hl);Ua ...,31)er iray take pari, iii a r~~v.-',ew of .iny project which i-, 5P,-M:3ort!d tbe~t rie-m- organizatioa Or uCfire of k!mpi.,)yTn,2nt or aqsignment, or In ijh.1,-.-t thcre iray o,,.:ierwise be a conflict or 0;' a conflAct of intere~:;t. b. The intf~ndee apprxiing of,`Lii,il may not 11~ a member of the HTRF~- n.. e -I goff-frial m3y not approvp~ research for which he o: she Is -Aso a pria- AYLI or associate investig--.%tDr. ik hij;her echelon of comma-nd anust review and prove such projecl-S. Criteria for TNI~('01-1 HTRB a. In evaluaring Lhe r1sks and for projects: UTII(~17 con,,3Her;i.- ...1.-)n, the INISCO'M H'.RB ~110L!ld considl--~r only tliosc that clay re~---ul- from that 5-1 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 US#j*"eAf aleaff ?000/08/08 : CIA-RDP96-00788ROO1500140604-8 24 Februar-7- particull" pro Je ct unless a Ki , hoo- o!-, tali Its he d to otl".er- jects. b * To approvq an effort: coverod 1-, this roi,lul i~ 1~:n, tile INSCOM W'. determine.% that all of the requirement 3 are met. Rls~ 9 to subjec ts are min i-i" zed 'L).,,, us ing ,-.)rocedures thit (a) ConsisteTIt With ~'OU-Ai investi.gatton (lesign and Jo no'- essarily expose sutijecta to risk. (b) Already being used o~i subjects for diagnosis or trc when appropriate. (2) Risks to subjects are in relation to (a) Anticipated berieflt,', If any, to the subjects. result. (b) Tha importance of knowicdge that may be expe,---l (3) In making an assessriient for the s,A.ection of subjects, th-.! sor has adequately conqtdered -- (a) The purpo3e of the ton. ducted. (b) The settiig in w],,LcIt ln~e research ini.restigation will le c (4) Informed con~;c~it will be wcore~. frcvn e~tch subject. (5) Triformad corise-,-it will he p-1-:perly docomented. (5) Tht---! protocol. takes alequ.,te provisiotis ~'or monitoring tl- d' collecterl to Insure the safety of the SU+i-~CtS. (7) Adequate provLsions i,) protect the privacy of subJ,2,. to maintain the confidentiali:y of dota wh,-,ri ap:-)topriate. 5-6. Sp?cial cons llerationc, of So'.To?, or all. of the subject-, vulrier3lEe to ot si..!isitivity because of past assi-.1- affiliations, ctc. In such case,;, add~,.Lonal ~safeguarls will be inclt, prot.ect Oie right-,, and welfare of thvs,, subj~,,~r..s. 1-i no instance w1 i 1 INSCOM be a party ~o any research whIch hivolve..; the use of persons wit':i ."'I or severe physical or mental, illnt-s,;, Oose wlo are economically or --,~!-,Ic tionally aisadvantaged. 5-7. Suspelsion or ternination of a. The INSCOM will siis end or rerim i;ia te a projec-t tlh~:it -- Approved For Release 2000108108: CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 CIA-RDP96-00788ROO1500140004-8 1984 USAINSCOM PeF,,IC-lation 15-.3 Felruar (1) Is not 't,ein,-, con&:cteri a,-cording to t1he TITRB's relutriMeTILS. (2) Has been assoziate(A unexpected harm to t"ne subjects. f a project will Inc' Jde a statement of' b. Suspeasicrs or ternJn,.JL.'; ') ti~~~ reasons for the HTRBs -.ictlor,., ~,nd will be reporl~ed wLth.'Ji 24 to the principal investigator and the apf--N,,ing official. Records. a. The IMM exe-` utij.:! secrct:.ary will prepare and naintain ad.?~quato docu- on ITTRB acttvitiOS, incluains, (1) Copfo-s of all pro-,3,;a1!- revIeved, scientific evaluatiorls, that .,,,.company t1he proposals, -,a:role consent documents. progri?ss reports ,~at-fnitted by investigators, and reports of inj!Lries and 2,1verse reactions. (2) Mi~nutes of 11-ITRB no tirq!~3 showing attendance; actIc-ris taken by INSC01M 11TRB; U-C vote of Hic ,,, a(:cions, lnclud~-tig the nutrber of members v,)',:!ng for, a.,,afnst, anJ ;i iectsion; the basis for requiring changes or disapproving I project; ni4i a of the discusaton of' contro- v~.,rced issues and (3) "L1.e,-orJs of (-1)nt-inu[-1), cc-A-2w activities. (4) Copl;-s o," ill'l corr,~s[]OrZ~nce between the H-RB and project Inves- Itur". (5) A cu i-cei~ 1.1-stU117:,B nembe L'-entifled 6f rs Members w.M by be earned degree ,,, ".epr,.~senta,lve c,--ipacity experience,suc!h as, and board or~Afications licenses. lnfocr,~ation be completeen,),-Igh and The wfll to des- each merr,~.bei:'schlef i~xpect&]to HTRB reviews. Any ~--~riploy- ~L or OCILr r~~Jat,.~.)P,3htp rl,~:U'L,ors IINSCOM noted. hetwee.:l and thtf I will be (6) Writiefi pro-,dkire! , tniclmilng a,,-,,endas, e-,rpoditetl rc,7iew proce- etc., for (7) Statecnent,,; oi' sij,n-;*i.-,:u,.;-- new fl.ridini',s. ulatton will. be. retained permanently b. The recor,ls required by *..~Is reg n, er AR 340-18-13. Such racord3 All be reas,-nably acccssible for insfl(!cti(-.!n copying by auth-:)rizcd DA and representatives of the F-adera-1. Food Drug Administration, 5--3 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 : CIA-RDP96-00788RO01 500140604-8 USAIIIISCOIJ Regulation 15-3 24 Februarv THIS PACE INTENTION~L 'Y LEFC BLANIK if C-4 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000108/08 : CIA-RDP96-00788ROO1500140004-8 USAINSCOM Regulation 15-2 I:i Feb,ru.ary 1984 FE APPI,NDIX A UB?EVIATIONS ,Sec. t Teirns 1 Approving off c I ~il. Tbe irsrcl~t c',ommanding General, De-)uty Conmander, In- tctligence, Deputy Corimander, sun,:)ort, or higher level official, vho has been (',-Legated authority tu apdrove t1te k,.,3~i i-,f human subjects in rescarc-1. A -- " - Associate Investf.gator. A )(,i-.-,;cn who may be deeply involied in tfie exe-, CIA ton of research bur- does riot hat,e o,7(! rall primary respons thility. A-3. Consent. Thia lc-gaiky effecl,_j~ve agreement to take part as a human sub j c~ c: t . The agreemet,t iu,-ay pertain Lo ones own participation or be ia behalf of another person. Three terms as3crtated with this meaning that dis,:1.nguish be tween the' legal valUdity of su& ii?reements .are subject consent, permission, j WId assent. These terri-3 are defincd below. a& Subj2ct consent. Agreewer,.t by an adult person who fies autonomous ~ ~skT~_to taki,i- ?art as a human subject. This Corm of can-, capacity to co seiit pertains only t3 adults whi: have riot lost their legal cz.,,,acity to consent. b. Pertrissior. Agret~ment ~y 3 "legally authorized reprc!seritative" for L~iking part as a human sulblect cf anoLher person who does riot possess autono- 1'o;~'3 legal capacity to _-,onsont In ~A.s or her own behalf. A legally aut~tortzed ,t~l:resentattve is a per,3on or Jvtdiclal body authorized under applicable law to ,,,::int permission (also knou~n, as thlrd-party consent). c. Assent. ji,~cfjmel-lt to take part as a bullinil sub"ect by iPerson not possessing autonomok,~: legr-:.l capacfty to consent in hi!i or ter own Jeiialf , but who is capable of' understanding wl~at is proposed and able to ex j)l-~'S!3 an opinion as to wMinp,ic-~.:; to participate. Assent is cor.,currence in ,,4!1 it is proposed, bi,.t 1,; n,:-.;t a for subject consent bec;~.use, unlike ~~lsont, assent has -io le('8,1 E'ffe_',v:. 6 A- Experimentation. AT-01 Y'ese.-I-0 "I o~! testing activity tnvolvinf~ human sub- J~,-t~,ts that may expo:;~a such !;ubject~ to the possibility of permanent or tempor- phyqic~Ll or damage and dariage (,.,,j the renu- ,~I*y injury (including be-ond LN rislks of injury to which such E~,tbject a r e ~~-ion of such purs:)ns) or(linaril exposed tn their Jally 111ves. A -.5. Expedited revi,~w procedijre~;. procedures used in researcli involving minima]___~_isk and for winor changes In approv~!d investi n:) -.i-,ore than th()S~.! LiSed g.?,: tons . These PT-oct!durer, minimiz.~ t.?m~~ required for review. A-t). Health care priccirloner. A,. ii-lividual trained to interac!: with pa !i i, , ~:i i: sto provtde ,r proce-AureS within establtslhed profes )n a I standards. A-- L Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 8 Approved For Release 2000108108: CIA-RDP96-00788ROO1500140d04- I - USAINSCOM ~e;~' ia~ 'ion 15--3 24 February A-7 tbiman su~,Ject Any ,)erson, whetlh~:,r about lot 1;u(,,,h per-scTI is a U,~ citiz,-, investigator conducting roscarcl,, testing or s-udles obtains dJ*_.1 through interaction with that person. '30t'l proced- ures and manipul..-i .1 1 tions of the subject or the subject's envir,)Txk4:nt are includ,!d. Human subje,-A azy be thou,j;ht of as direct, objects when tho! research is t(:) determine the fects of a 9,!*w System on mati (for example, tli- psyc-hological effects of a par- ticular inteccogation technique on an indtv- * or as indi)-ect objects when i test is con",acted to determine how man aff-2!;-_t:.3 the ultimato performance of zi system (doc~.-,Ine, concepts, training progra.i~). A-8. Human Technology RevJew Board (TITRB). A body set iip to provide Initt.-i'l and cor iag review of research invotvin.~!, r ie use of human subjects. 11'r fulfill:? all. the functtons of a human u!~ie c -)nittie as described in AR 70-" It is funda7~!ntally sitailar to an Instituti:)na~ Rovie,,~, Board (IRB) discussed I-) guidelines i3sued by the DIMS for human ro~:eArcb, emit has somewhat differ4~- authority as, co.-,pared to an IRB. Within Dur, authorilly Lo approve the use human subjec,.A In research is vested in In the ':NSCOLI-1 it is ia the CC, iind has been delegated to tlie V(,*,';-1 an(i DC(3-S for matters un~!.- their respective functional control. App,~c,~Ing oCficials act on recommeno- tions of val~ldl~r constituted HTRIIs. Out,,iid;_.~ DOD, 11~1'1s tend to be vested wl, 'I this authori A-9. Legal I authorized representative. A V~!rson or judicial or other bo,li authorized u,,ider applicable law to con-,ont on behaIC of a prospective subjs.-. to the subje.,-'.t taking part in the procedureF, 1~,Avolved in the research. A-10. Medic,31 monttor-. This per-son Is a rrf ~ ttary ~)r Department of the Ar,~i-., civilian physician who is respon5lble for A,,-;,:,rving human subjects during t'~,%! conduct of r- I-search. 7 A-1 I Minimz~l risk. When used In the rontcxl: of tnis regulation, thIs mea:,~--. t'hat thf~ ris~.s of harin anticipated in the ;)r.-.~posed rese;irch are not r e t r considering probability and magnitude, thin those ordinarfly encountered In daily life or during the performance of' rouLino physical or psychological eXam- iaations or t,,sts. A--- 12 Principal investigator. A person, -A less of title, who is primari",, responsible for the actual executton of the research. A-13- Protcqol, The written, detailed p1an by which r(-_-,-ar(,-,,h is to be cc ck.i ct e d The plan contains, as a minimum, d',~---ssion of a. Tht! objectives ot the project. b. Tho inforoation to be collected. c. ThQ,means by which It w~.11 bt~ c_)1*.t:-.~:od, anA eviliiate,i. d. An assessment of potential r1sks .tvoi to s,,bjects. A-2 : CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000108/08 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 Februetry 1984 e - Safety meJGk1-e!3 . USAINSOOM Resilation 1_5-" f . Other mea-i:3 t:o be uE,ed t,~, r-.!dace the risks to subjects. A '4. Rosearch. A system--itic in-?:2 r ij-;i~t ion to general' knowled~,,e conc~.rnlng mllttary or not include imiLvidual. or 'n-itning fne-3,4, effectiveness, proficienc-.r (~r ~-Fitness to this regulation a~%,~ is ;)c tn',~?nded appropriations inrended for Tlos~?I:rch, "),r f: "Research" ia the sens,~, applied ir~ ~-Irding to the project, ef[ort, to whlc,b desi,gned to develop ~)C. contribute intelli,,,ence problem3. The term. of' personnel such as ..-.(:jmbat- read- exercises. 1"his definition is to Identify an eff,,')rt. for funding Development, T~:!st ane Evaluation J thin regulatic'n wiLl. be funded it applies. 'e C Research and d -velopmenl Any scientific Inquiry, investl 2ation, or 1[datiori performel or directed t(,,. ti~sit hyporhes~2,,t or dev2lo.o cc~:.cepcg con C, r"'ing pliysical or b1ollogical priticipals or Liws. 'Iesearch -Is a n;.1jor explor ~~)n of'the unknowa aiid concains unpredictable elements. Developrimt usually confined to the qualification or ~,,Iaboratioii of knolm prfncipalE~, Systemztic .1 nvest ig.;1: Ion. A fc:~.rmal Inquiry generally desotibed, in a eypl ~cit ()~',ectives and formal procedutes designed to those ob4ectives- Tli,2 teri. includes clInical Inv-!stt~,,atton~., bul: (iov, include or postk-- ~)c rap,!utic inqtilrios intencled orl 7 to evallu- individual progross or rk!Sp0r1'1-'_V1-.1C'!_,:_3 to triining or ~herripy. Test and -.valua~:Jori. An :!fort or assessirent to validate pc-oposed or 1~,~.sting standards or concepts oL' p.-Iforriance, elther of liumans or cf* ma'--2r,ial. Test part Ict r,an_~~ Him,. n.~ ~IrC-Crly itIV01V~-2d, In --es:: and f,%raluati.cm,3, Ott who are not th,.~;sei,es the object of such acf7ivj-_ie,;- t,~ ~ r part Lcipant s ar e not rel',,ardec As rcce Iving any d ir ect be nef I ts as a reru It of Lheir part fei p:i t Lon In the te:-,~t (for example, a new doctrine or tr;.iini,ig ur) r.(- e p t Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 t Approved For Release 2000108108: CIA-RDP96-00788ROO1500140004-8 USAINSCOM R 15-3 24 Februanv .1 SectIor, II A I --- -.)a 1 r, nt of the Arr..,,, Assistan,t Ch'_c( Sta.Ef , TnVeI..!.i..-,P_nce ----------------------------- ---------------------------------------- CENTEX ---------------------------------- ------------------------------- DA ------------------------------- DARCOM ------ Army m,.2.ical T.,.:-Partment UIS Arm '7 Research In3ti.tut:e for the Behavi_)t-al and Social Sciences T.V-o-'04 Center for Excellence Code a', Federal Regul,,~t ions Dcpart;,,~(.~nt of the Arm,, VS At--,., 'Materiol rleve.'.opr~ient and Rc!3(,:;r_+ Com,.nc~~id D-~,S Tht.- IN..C.OM Deniitv Chief of Staff for r e r a o iv i, ~, 1, D,," S 11 PI - - - - - Th o* D,21)uty Chief of Staff f o C Pro,~rai,,1,n a-d 'Mo(iernization "Al! , I ,~,M D:!puty Chit f of Staff f o pt~ -1 t 10--is HIRB ----------------------------------- Eepart~ioit- 0j: .,i(! Human Servtco- Th~7~ HLF~'~ Perfo,.iizincp Task Forcc .1-1r) Constituted) The IN",001 Hur,.m Te~-hl,o').ogy Review Boa::.' I --------------------------- I'S Arr..- md: Security SJA ------------------------------------- Ma jor crm.,iiand The I.N13,C-Tri S,.d ~'f Judgo Advocate -------------------------- Tha Su~-t,,eon of' the Arrmy at C:,. A-4 Approved For Release 2000108/08: CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 CIA-RDP96-00788ROO1500140004-8 .4 February 1.984 USAINSCOM Regulation FORMAT FOR PR1':PXRA'[1O'z4 071 A RESEARCH PRO'1,`)COL Secz ton 1 C11"NEIIJU, ~ct titli.--. (Enter complete project title -- if thls is an anien&ierll.- 2roL an existing project,, identify by indicattrg "Amendment No.--to" immedia','-_-u~'y preceding the title). 2.- Investl?ators. a. principal investipator. (Enter fu1l name, rank, title, organizai.ion an~ telepl,,,.)ne number) b .' kisociata ~'nveqttg.-Ators. (LientLfy all associate invest-l-ators and area of f-hT`Tr--o'-jecL for which caOt Is rc,3ponsible~ Inci-.ide full name, rank, title, organization and telephone number For eacti). 3. Locatin-i of the pro1ect. (Identify all locations at which the project will Lo car7li-e-]-'out an,i sp-ecT.~)-,--wh.Lch will be done at: -acl~i locatiori and w,,o is the poiat of contact at eac-h locatloTn. Include teleph(.,,,ie number -for POC'!. 4. Period- covered ~~.y tl!e Tp rc J e1c.t I.Civu month and year of exi)-ected start aA conipletion dates). Sect Lo:1 11 I L, 17. R C ! "I U (11 T I C IN 5. Sy. no ps:'-!; a* (E'1t:(!T' S11OT't, or oae-p.trnraph, y of tlc pr,5posed 3 sumrialr ;'rf- ject, simi'.ar ~Iie ab,-.rraill-ta L;cientl,ftc paper). to of b. (T-.,-ater li-t and ~rtef64'escriptfon, of a safety measures for human jects invollredth.! project). ir. 6. Medical applicattor. (Ex-,Ia--'.n importance, includfng briefly the medical psychologic,,al.siderations, pos-jible usefulness tl-.c )roject). con and of 7. Objectives. (,tate brllc.flybut spe-:if-.cally bjectiveg bf the the o ~rc- i er- t Inc-Ludleorrs 'holow, It wli,~re 11. Stuc'Ly design. Ind , C~-O.;Sover, etc.). B--1 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 CIA-RDP96-00788ROO15001406o4' -'8 L5-3 24 February 198 b. T~chiologles to Ie empi,oyed. (L~ st t~e generic tt,chnologi,a:3 to be emr- plu,,; ed in , thin project Type of pol--jul~,tion Involvei. 'Uht! si-ibject populatLoa to be ob- rved) S t 8 C US - (Sta,le whac, "~.a!3 be(.-..n accoiq)1!:ihc!d or published in the proposo~ oro r e .1- ami d,ascrl~,! how 0, Ls ict wtil rel.~ te to, dlfftr f~-OM and/or, teat whIch already been accompll.~ihed). 9. BibIiogr:iI)h),. all rE-ferei,.(-e:j u-~(I in preparing the protocol). t0. Auth2ri,-y. (cite the- 9-~,~ctrtc autbority for the INSCOM to enga.-c- in thi5 -ect. In.11cate da!--u of ~tpp-roval, aad If not yet approved, indicate specific pro., I approval aut'iDrity nee-lo,! If"o, this proj(!.-t. Identify any POC in approval a'.t- anization wil~h whem cot)rdfn~.ctun has been ffec'~erl. r ho L I ty'.s o rj;~ k e s2ctloll TTI P ROI 0 t' 01, PI.,A.N 11. General anproach., a. (01, tItne expec':ed accomplishrient,,; ia sufficteitt detail to show a clear Of faction). b. (Include disci.v;slon of the validity of the proposed re- search -oro edures). C (List thc chronologic,al sl,-ops i:.o ~,c- taken). I Project subjects. 'Give as a minint:n I-Ior-ration below). ~i NuImber of sub.jectt~ (Indfcate t~o? 1:()tz:I1 number of subjects expected o J f! t e -717- -S i 1) . Age rMIPQ C, . Sex d . In L~I usion critteria i,ltat.e s-pt7ci,:ic ard detailed reasons 'or inclusio-I subjects by cla~,-I, oc inAividualLy, as appropriate). e. Di4gaostic critertzi fur f. EV itions bt ~,,-)re ertry. lu It- any physi cal or psychologl cal L~ 1-11 i I Ir.;:itions, to be done on oach subject T)~~fcr,, entry [:-Ito the project 001500140004-8 Approved For Release 2000/08/08 CIA-RDP96-00788R Approved For Release 2000/08/08 CIA-RDP96-00788ROO1500140004-8 February 1984 USATINSCOM Regul-ition 15-3 t1-c subjects, Exclusion criteria. (Im- a -omplete list: detailinp ,-!t~~,iases, merlicat[oi:m, eLC., WhiC1, .)n,AAtUte Lhe. crtterl.j for exclusion from rl,t- project). h . Source of subjects. briefly where sobjects Trill Ix! ob- 1. Subject idei:i,.~iflcat.Aan- 04,scribe code sy5tem, will LE~ any, w1hich 'be in the project' I subject aF-ses;3,nent the methods u.;cd to assign -,,r allocate ob J:. cr of thig re.,;oavcii to part. ar subjects) k Risks and (T)[!~,uss the analysis of risks and beneff-ts to Jects and to tl,,o~;c conducting 0~., re~~earch)- 1. Minimization of rl.~A:3. 1,31~~cu!.,s the prec-nutlons to mint- to lie takza ze or eliminaLe to subjects .,.ind those conducting the research). MO Corrective actions. (Descriho hypothesized adverse reactioniand cor- rec ac,:ions eypected to be ta,,i~,,-i If 311ch adverse t: reactions occur). ive ne S ecial equlpmt?nt. Oes---ilbe any special medical or cz.,tre nurst.,,~,g or cqul,.pment needed for subjects adnit-,--d to tile project). i 2. Lroject a. (State Cfle complete name ~.escriptlon of all. tcichnolo,,~-Jes to be including proccdu:es lor their application). (Identl fy the source of technologies ind re! ated iterv, , devices Llst all coaponent -i and manufic turing and.. quality control plans/ P"..;"Aures, where ~pl.lica-blv). (Identify the met ho,! A,ogy for ap p1 icat ion, if dif ferenr- from procedures zibo,je). (State the srhedule, adildrL-tratLnn and luration c1 each asPect of the 'n d,~~atl devices amd their Intended itse. IJ e n-- (Describe I whether these dire clar,:;Med ;-;,3 racdical devices; and whather Che mr-dical -,e Fed,.~r-.-il F~-A, Drug and Cosme~i- Ao" applie!;` 1. -es ameridint nt to t1 f. (Discuss to n~2dic~;l wl-lere ai,, plic.11ble) L Evaluations (lm- 1, ind I i,,, th(~ P"OJC (A pro ject s -chomar. tr: m-tv be included, (-,r ~Iio lt,!:n:~ m,~L%, )t! I i:-,tod as ind Icatt-:1 holow. In otther C.'';o, it ts lmpi,rtini. to ble.,~Clfy i-If!" P(If~;Ofl w1hc will perfori,,i ~ac`i e-aluatlon). B Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 CIA-RDP96-00788RO0150014004-8 USAINSCOM Ro;;ul.ation 15-3 24 Febru~ry* a. sp,,cimns -:o he collected. (1) 5(2iedile of crllections. (2) E,,,aluatioas te be made on _iper L;1.4,ns. (3)~ stora.&5e. (If applicable, si where and if special conditic,: are require ~ ~ ~ ) (4) LabeliLng 2nd disposition. (5) Laboratol-les jerforming (6) 2rec ial - p recau t ions b. Cli Acal/behavioral assessments. (Ii-clu&! how idverqe effects are be recorded i, C. Vi ti -signs. (State when desii:ed anal the Erequency.). d. Fol:cw--up procedures. e. Disj~csition of data. (State loc.it-lon and ditration of storage. Inc I I pertinea-ti tmation regarding Privacy A,,t ind AR 381-10 considerations, applicable) f. Metliods used for data collectlor. critical measurements used end points t.-o characterize safecy, efilciicy C.- equivalency). 165. peparture from proto-col for individ.ua". :;i:,b jects. a. When allowed. (Use flex-lble, bLiL deffnite criteria, If none is to allowed, so tate). b. C will -be notified. (Inclur'le b,.-,th thost, regiritng the indivtd~-.-O subject, if ro iate, and tho~-,e elsewhere withtn C e INSCOM. Must notify pp Pr east the H1, ;B). (Must c~)rrelare wi.th rara'gr..aph aove) j.6. Ad,.ierSE! reacittons. a. Definition ol[ subIect reactimis. b. IMME:.~iate reporting procedures. c. Routirl, reporring procedures. d. Potenti,al post--project advorsc, ro,jc, ',,is- B-k Approved For Release 2000/08/08 CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000108108: CIA-RDP96-00788ROO1500140004-8 rebrVary 1984 Sectton IV USATN'SCOM %~,V.ilation 15-21 Modificacion (if prco:ocoi. 'Describe the procedure to be followc!d t-, !difY, teCiuinaLe 0C cxtend Disposition of linused TIIV.-I~rial. (Give a qtatornent p(.!rtaining to t ma r A IpOSiLion of unw,;,!tj proj~ :111"d devices, if applicable). Publications reDorts. (De:icribe use, including potent!-31 restric- I-Aons, of informat" -on and piiblic-u-I-ns, and reports arising from Ow project). .Kun(Ling (IdentifN so r -iirce .-)f rind any special or unusu~I. funding Lia- ications Med-ical moni.tor. (St, ate tini riarne and telephone number of medlcal monitor, 0 cn applicable). Protocol revi!~-,,. (Identify 11,e Ituman us~:! committce or institlitional. :re- t,w board which will provide ini continued and anno,,.it revlew r.-,kf this pro-- C ('~,kme, rank and org~~nizatf,-,n of stibiAtting orotocol) ture) !71e, rank of "ITZE1, r311k and org,',uI.z.--,tJLcr, oL official) t: a c hme r, 1: s A Proposed Volunt2er Agreem,2nt Propo,,ed Explawiticii Fortion zhe VOILinteer Aveetaent RevIew of Scientific and lumar, Research Issueq (if applicable) Biographic Skatc-h o" pr!,icipal and associate investigatot- P-5 Approved For Release 2000108/08: CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 CIA-RDP96-00788ROO1500140004-8 USAINSCOM ~f~iulation 15-3 24 Februarv THIS PAGE INTENTIONALIA LET-7 "LANNX, Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 9 0 1 a Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 USAINSCOM Itepilation 15--i '!4 February 1984 APPLiNDIX c VOIJ.-TEEk AGREEK2.11T Par t A having attained my eigbteentl, T, _rtyl-cl -.iy I -1ca plc_ i ty to co nsent , do hereby vol-, i_*~ e rto particIpate. in an Study entitled: and the direction The implication!, m-,, participation; the nature, c:tjrationkind or and the meciio,,,,~ r1eacis !q ~.I-ttch it is to be conduc,'Vd;in-- kind the -ciiiveniences and to be vxr~:2d ~iave becr. thoroughly explaL,i!de Ivizard, to m by and are set f(-,rtl- in F`k?xV. this B of wh~'.ch I nave s I iv,! tx!en g!,ven the opport-anicy ues-- :o ask q I- 1~,oq concerning aveLittgat.!,,,e, si~ijdy, nnd aTI'l such quescloli-,been thlf.s :L hav--2 .,,i!-,,v(2red to COMMI.Vte. ray fUll all'"' I understand that I may at: an): tl-me fit'ring the course of thi,,; ti,,ve~jtigative _6y revoke my con,;ent, a),(, witi-c'riw j'rom the study wi~hoat pre.,"IdIce; h~)W- 1 may be rec.ufred to undeti,o cortain further exai.,inations, if , In tite o,~)`r-Aon of competent nut'nority, !i.10; E!~cl.~tminatic-ns are necessary fcl- my 1kealth; ,4ell being. sig,n~iLurv Date De, t e Approved For Release 2000/08/08 CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 CIA-RDP96-00788ROO1500140004-8 USATINSCOM FE2ulation 15-3 24 Febriuary THIS PACE INTENTIONALU.' LEFT BLANK C-Z Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 ",i F ebruary 1984 USAINSCOM ReE;ulatlon 15-3 T, P EIN D I X D Vo1A!N',--rER AGREEMEN" Part B Explanati.,)n Portioc. of the Volunteer Agreement 1. Project t1tle. (The title of 'lie project and the plaoe where it is to) hr~ crl) n d j-ct j~ ) . 2 Principal investigator. (Must agree with the protocol). .3 Discussion. (A. ostatei*a,,~rt that the &tudy, iavolves research. An explanation the purpose of the ~tudv and expected duration of the subjev:'s partici- F-3 t ion A description of the to be followed. An identLfication oJ any experimental procedures. A st-aement givfng information about prLor, sirli-- I.-Ir, or r6lated studies that provide the rationale for this project). 4. Risks or discomforts. (A des,-ription of any reasonably fore 3,:!,i!ab1E- risk.~. .,)I. discomforts to the subject). 5. Ben6f its'. (A description of -iny heriefits to the subject or to others that Tni,, reasonably be expected from tht-- studF). 6. Alternative procedures. (A dLs..-Josure of proper alternar-ive orz)cedures or courses of, treatcoien--, if 1pplic;t':)le,, that might be advantageous to t~,~e sub t Confidentiality -)f recor~ls. 3tatement describing the exl:ent, Lf any, to 1 1 ch coiif identia 1i ry of record.- L lent if ying the subject will be maint ained if* niore than a aitnirnal ris'k ts involved, a statement that tuthorities the US may inspect fte Subject's right -3 (An exl-.1lanaLlon of whom to contac.t for answerg to perti- questioi-is about th,? stu,ly ari(i Ole subject's rights and whom to contact In ",e event of study-ralated Injury to the subject). Voluntary participatlon. (A sr;!.t~:~rienr that -- a. Participation is voluntary. b. Refusal to -participate will. involve no penalty or loss of 1-enefits to ,,filch the subj~--~ct ii; OthLrwi-se entttl,2d. (7. The subject -.-My di!~-contin,:-~, pn~,ticipation alt- any tirrE! W1t1'.,.)ut renalty loss of ben,2fits to .4111C11 the :,;jbJ,--,c1-- is otberwise entitled). Compensation ani tre.-,-7.ont (For a stu(iy lnvolv-Lng than mfn- rt-,k, an ex, 011 A, pla,ii to her any compensa, lion aild med i-a~ treatmz!-nt Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-'8 USAINSCO'l Re-,,nlation 15-3 24 Februar-,T 19-F., 4 1 a'..-e available if injury occurs and, il s~), of, or where fIIT- t~ier infor=t.ior. may be obtaincd). Additional comments. (When appropriate , one or more c-~f the elements "w-ill also be given to e,.ch :~iv,bject. Iiiforma!_-ion below a. A statement that: a certain treatnert, proco(iijre moy oc involve risks he subject oi- to the embryo or fetus LF 4ubJ(,.,-v Is become pre~!- t I or may - - n~int - triat are currently urifo resceable. I .ch the subject'sparticIpatto b. The anticipated circumstances unAei wm may be termi,nated by the investigator gar-~ to the t's consent, without re~ subjec c. Any additional costs to the subject participatf- that. may result from in the study d. The ~.onscquences of a subject's doc-!SjOlto withdraw fr-~mthe study x~: procedures f r the orderly end of the subject,~part icipatiori. e. A stqtement that new findings develop, durir.g the courseof the stu,~ d which cculd affect the subject's willingTiessco,ittnue will tl~_~ be given to subject. , f. The Ipproximate number of subjects in~,(.-)'Lved ii,, the study. g. The precautions to be observed by rl:o subjoct bef~-_)re and after study.) D-2 Approved For Release 2000/08/08 : CIA-RDP96-00788ROO1500140004-8 F,AWppgcfiAr Release 2000/08/08:CIA-RDP96-wWIMEkM500440-MA-dn 15-3 The proponent of -this re ul~ition is the Staff Judm- Advocate: I ~j j'~ Users are invited to f'onrard coments and suggested improve- inges to ments on D,' Forra ^028 ("Ir.,cc-mmended Chz~ Pub"J.J.,cations and Blank Frmms) to thIs Headquarters, ATTN-. IASO'A. Folt THE COMANDER: OFFICIAL: Of t, V~e of 47iCer LOUIS D. KIPY, Colonel, GS - Chief of Staff DIS,'MIBUTION: ~A 6 C (2 cys) I'lus S~-.aff Judge Advccate (30 cy-) Approved For Release 2000/08/08 CIA-RDP96-00788ROO1500140004-8