A PtT9/f: -00788RO01 100440601
pproved For ReW -6
_fs@e 20 _96	
	
(1976 AIN)	
	
6@:*f-_r-.-_'L4__C-!iF Pre	
	
--15 1@ r-"C-anE 7; a t LU z:; n s e c C r. a L c I	
I C I c 21 S @,c c a
P	
or 0',,;er @I a:"@ a@:@[ C r I:w z 71 a L.2 e 5 r@	
ap,,)24_C6L_40r, Of eSLaIZ, I-ic;d an2 acCE-,-ec-, or
roc e	
whic', are ir. his intercs,s, cr tha! increises cr@inarv riSks of	
daily lile, incluc!_4@q -,-he recc,Enized Tisks in his Cccu-	
parloF, or field Of bervice,	
	
(2) SuInie-c-, -means at_v w,'10, know`r,;@ly or un-	
Lo@-,Tingly, is subjected-to an act or oinisslon, WneLher at riSk' or not,	
Lhe Object of which is ;o contribuce to 'Knowledge to be Fa4ned as a	
part@of work to be perfprTied under t1he sccpe oz this contract.	
(b) The Contract@r, before undertplking tO De7forr, any sL*..,d*,,7 -'n-
r	
4
kVolving human subjects, whether at, risk, or not, S""lal-11 @nsur& LhaL the	
subje. following Ininimum conciitions are compl,jed with:	
authc	
(1) The P!_C)T'()Sr_-d sLudv has bcen revilewed and av!-)roved bV a coi-=,_L@ee	

1
eetinE the re(IU2rements set f orth in Chapter 46 ol Ti tic- 45 of the Code
L	
1) f Federal ions,
:	
(2) T,- i e num.Der of human subie cts used will be 'Kt,?rL to rhe mirimuai	
number that will reasowably achieve tbe requilred results.	
(3) The ,4tudy mus!@ be such a5 to con,ribure si@-nifjcantly to	
scientific a@!d have reasonabIc prcspecrs of vic-ld-ing impor-	
tant resultb essential to an Ar-my @es4@arch prOgraM.	
(4) The study will be conducted only by persons possessing the	
recuisite scientific oualifications. The hizhest de@7rae of skill and
'	
ca@e will lie required
during all 4
@tages of study of persons w"ho con-	
I
duct or assist in the study.	
(5) The humman, subject will Ib@ infoi-mec' tha' at ,,-iv t-imc	

t"he course of his participation iie has thr- revoke his consen-_
r gnt co	
and withdraw from -further -participa@Aor. wit'-ou@ prEjudice zo Lfmse2f.
J	
(6) ParLicination b,,- subjects will- ',,)e imi-edia@-_`v t@-=.A-,2ted- 4:7
it SU'115eq'; I en N@ al -@,T,@! a r@s aj I t"I I' S
a"" tv
gieater Li-,an anticipated at t-he time rev-_Iew and appioval was -rante@2_
(7) There shiall be nc greater inLrusion into the -@rivacy of
humnan sub t@ct Lhar. -_`E absol-6@ely -T@ecessa-y for the co,)6uct of ,ht, s-,ut--
involved, Zxcept for t"If SI-11 DU"Isslon of repurts and cL,ier daLa
lncios,_@rt 2
Approved For Release 2003/09/16 : GIA-RDP96-00788RO01 100440007-6
-Approved For Release 2003/09/16 CIA-RDP96-00788RO01 100440007-6
L
b% n r o 71 o a 1 C L' C t. S a L
t C "E@ Dn L T I ZI D'- 1! i@ L C T 1 2
C,
(F@) Tri e 's t. 6 V7 1 i-@ C 1 1. e 6 s C z-c E!
C E. 1C' :_ IT! @_ Z'L 7 1' CZ' 1 r, 11-1 :71:
(9) No sr-ud-, . viI2 tj F
re if a n n r c r, t r ca o n L c
beiir=ve that 6eat-1., c: dlisablini@ i niur", i s 1, ik I to o c c u r S u f f i C -L' e r" t
a F. i ui a "or 1 a'bo r a to ry ex ')@- --i-me n :-z' ,C, r c e r i or. s , m 1.1; t nPve .:,,E en
C C, r-. e t e d t o e a s s u r a ri c e c f a L c c p z c F F r) r i o r L c t h e I_; s e o f
hu-man subjects.
(10) 7-he degree of risk to be taken will never e:xceed that which
is justifieb by the benefit t'o the subject and/or the 'PummandtLrian
I -
Qf the knowledge to be gained.
(11) A physician will be iesponsible -1ror Z-he medical care of
subjeczs. Even if not the lDrc.-ect leader, Llhe physicia,-, vill have
authority to ter-min2tE the study at any time -nat he belfcves death,
injury or I;aru, is 1-11kely to r@@sult.
(12) preTaratiopts w-il-I be Ta6e, an@ adeq-Ljat.e facillzies
prov@decl.. to protc-,:,t zhe subjecz arLins-L all _1u1'(_,SLEL
of injury, d-isalbility, or Geatri. This.includes
' '**'trcatment As;rr,ay be
hospitalization an6 medical,
all a parat.us and instr-Linients nec:-,-_,ssL:-y to deal
situations will be available.
.:@a' ')C'Sqibi Lie-S
but is riot limired to
required. in addition,
with li'Ke3y emergency
( 131 ) Hunian subjects will hive no PhyFiCal OT mentEl COT)ditions
which will make participation more hazardoiiss for them t1han it would
be for normal healthy persons, unless such condition Is a necessary
prerequisite for the particular study kinvolved. In any such case,
the use of human subjects with tuch pr@'&-ex_isttin& conditions must have
been sr)ecific2lly drFcribed and juSE-i-Fied it; ',-he scope of_ the worl" to
be perll:ori-iied under this contrac4
(14) The ScienLi-ficL11, aualified persoi, conduczing -LhE@ srud3, and
each member of hi& resc@z_rch '_C-.Lm' v-* 12 be LC
subject 's participation aL any sz.agc- if 'ric has leasor, tc 6@_'-_'Cve' in
the exercise of LI)c tione. faift. Suverior
P-T I C, C & Y1 U i u C, T-11 E2 1-1
reou'red c' him) tha. cont@nuation is 1 i 'K Ey t C' T e S U -1t
L L - 2-r! urN
ability, or death r-o thE 'human sulbiect.
(c) The C(.)nt7acLo---, bi-f@c-'re perri-,-@`['tinL. aijy persori tu
as & lku-ian sul)ject. whct_@ilcl at 7isk ur rio.-@, shall insure t-he
follc,'.7inE. mirl-murr, con(fitior;s Ere Lui-iipaied ,,@iLh:
Approved For Release .2003/09/16 :2C,IA-RDP96-00788 ROO 1100440007-6
'Approved For Release 2003/09/16 CIA-RDP96-00788ROO110044000,7-6
C 'ncc
ve c un-,, c n, t w b,_ c) b r a n c a e. a t E
4T', acCC7@1n'.:o 'Wjt@l tiie c@ 'n@s c'-ausE
(2)
of '-hv individual or lega2lv a,,1t1;1C17_i7-d T-o,,.rcf@e-,,_a,_ive@!, sc lruat_(-6
a s t c, b c -a'--, I e f1c, E.-ee powtfr o,.' choict: without
any .;sc of fc')rr-e, doccit, @uress, cons@Ta_,-.L, coercioiL, or
:L"..-.1-c-Per inEucemenl The clemer.@s c@@ infL =12@ .@01@ neces5.nrv tc, svch
cc nse-, n T 'I u u-, e
(i) A fair ex-pi aria t ion of the proce6ures to be foilowed, 7, d t r) e i r
PU7DCSCS, 4r1C1U(!iL"g idLMTif4_CBt1*0n Of aFIV e u exre I-
PVOC-d Tes which are r-
riental.
(ii) ' A description of any azteidant discoi-.,cr@s or ris Y, s re as a n a b I Y
to be anticil%ated.
( iii) A description of any' benefits reaso--aDIy to r-,e antic' Dated.
( iv) A disclosure of any- appropriate procel`@_,res t1riat
might be advan7ageous to "he jubject.
(V) An offer to answer an), questions concerning the Drocedure.
(vi) An instruction that the sub ect is free to revoke @)J-S LCnSenL
and to discontinue pariicipattiori at any time without prejudice to
hirTiself.
(d) Exculpatory !anguage through which tne subject iE. iij@aje t_- waive,
or appc:ar to waive, any cf his* le-al includ-in't- any ----1ease lfrono
liabi.1iry for is proh "bitted.
(e) Prior consent by a subiect or 'his
tative shall be obtained in all ca5es. Such consenL shall be in vrit-ing
whenever it is r-2asoriably possible to do so. The consent forr, may be
read to the subject or his legally author@zed rc_,pT-cse1r1LativL-, but in any
event he or his legally author4Zed' represi@ntative misz be given adequate
opportunity to read it and to ask any queitions they might have. This
consent form should then be signed by Lhe@ .'sulbjec:-, or his ie@!aily a-utnor-f-zed
represeiiLativc and by a Witness not direc@lv 4nvo`ived In thc study. Oral
consent may be used on!y when it lips lo,@en spec' ficailv desc@.ii)pd arid
justified in the scope c, f the work to be PeT`FC11_Me6 Under thIs ccn:-a1-t
or apprc,ved In wrnltin- by -_he conf_racL-@'nc offiL_or. 'Nher) so
aria Sul
use@, oral consent is _)ject Lo all Lhe _Z@ami_ 5-'ancards @@S tc
LOi!SC1-,'., t@VCEIr)ll .,hat Lh@_ s4_gr;L,_ure of ti;e sub-ecr or his lei:allv
al@horil-_-cd represenLative is iiot reqo-Ired.
P-zicr LC cor.6uct cl- 111-2, Qhe COT-[ractor ShP11- 51.@IDMJ_z for
Lo the con:T-Pc@-@nv ol-ficer 2 detei 1-d cc.,scription of L11L Means
3
Approved For Release 2003/09/16 : CIA-RDP96-00788RO01 100440007-6
4
Approved For Release 2003/09/16 -.,CIA-RDP96-00788 ROO 1100440007-6
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in,4 Cal Pn ir- n- c c,
CIT. a
V e ona
PriSDDerS L)k War Will T10t anV C-'@E:j,,!T_S-a,,C S.
Approved For Release 2003/09/16 CIA-RIDP9@-00788ROO1 100440007-6