PROCEDURES GOVERNING THE ACTIVITIES OF DOD INTELL.COMPONENTS THAT AFFECT US PERSONS
Document Type:
Collection:
Document Number (FOIA) /ESDN (CREST):
CIA-RDP96-00788R001500140004-8
Release Decision:
RIFPUB
Original Classification:
K
Document Page Count:
37
Document Creation Date:
November 4, 2016
Document Release Date:
May 15, 2000
Sequence Number:
4
Case Number:
Publication Date:
December 1, 1982
Content Type:
RS
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CIA-RDP96-00788R001500140004-8.pdf | 2.17 MB |
Body:
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CIA-RDP96-00788R001500140004-8
Da 0 6240.1
DEPARTMENT'OF DEFENSE
GOVEi. AIING THE
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Approved For J ,I,r1299F.198498f:e:'51Ar133F9Lf:PPEW.P.al#99.W.,99.11/49V
03D 5240.1-R
-,PRDCFDURE -13.?EXPERIMENTATICI (4 HUMAN S1JBJEC1S FOR INTELLIGENCE PURIOSES
A.ZAPPLICABILTY
This procedtTe applies to t;:perimentation OD human subjects if such experi-
mentation is col:ducted lo:, or or behalf of a DoD intelligence component. This
procedure does not apply to explilrnt2.tion on animal subjects.
P. EXPLANATION OF WEF:NED TF.!Lf73
1. Experimenta_qon in this context means any research or testing activ-
ity involving h.guan su-Sjects that may expose ruch subjects to the possibility
of)permanent or terrporary injury (including physical or psychological damage
ac damage to the teputation of sudl person0 beyond the risks of injury to
?ihichisuch sub..jertJ ar ordinarily txcsed in their daily lives.
2. Experimeatation is c.:)nl,w,e(' OD behalf.of a DoD intelligenco. com-
ponent if it 15 conc4,Ac-d unler .oniract to aat component or to another DoD
component for tbe 1),.7,ett of the intellience comporent or at the request of
such a componevA tegaic.less of 11)L. c,:stence of a contractual relationship.
3. HIT.an hjects in thin ,o.itext includes any person whether or not
such person is 3 Unil.ed State!, pe...!,ou.
C. PROCEDURES
It Experimont.,tiou on loan :;111:Jcts conducted by or on hehalf of a DoD
int e:lligence compozAent mJ-..y be uAt,rtahen only with tile .iuformfd.c,uracut.,,aL..the
ip_4:.;Lor4.1ice 1?,:i4.11) suido...111(.N?issued by the Dq.artment_of.:11callk.a.aci
linta,a11_,SarYiSfsltLir cou1il,lQ11; that. s;:iteguard lhe weliare?af-skuch-sub-
-ccs ?
2. DoD componcht not engage in or contract for experi-
aieutation on huinn ubjects VithOAT ippi-OVa] Of the Secretary or Deputy Secre-
tary of Defense, or t!ie S.-:retary or Under Secretary of a Military Depart-cent,
is appropriate.
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140004-8
13 3
03D 5240.1-R
-,PRDCFDURE -13.?EXPERIMENTATICI (4 HUMAN S1JBJEC1S FOR INTELLIGENCE PURIOSES
A.ZAPPLICABILTY
This procedtTe applies to t;:perimentation OD human subjects if such experi-
mentation is col:ducted lo:, or or behalf of a DoD intelligence component. This
procedure does not apply to explilrnt2.tion on animal subjects.
P. EXPLANATION OF WEF:NED TF.!Lf73
1. Experimenta_qon in this context means any research or testing activ-
ity involving h.guan su-Sjects that may expose ruch subjects to the possibility
of)permanent or terrporary injury (including physical or psychological damage
ac damage to the teputation of sudl person0 beyond the risks of injury to
?ihichisuch sub..jertJ ar ordinarily txcsed in their daily lives.
2. Experimeatation is c.:)nl,w,e(' OD behalf.of a DoD intelligenco. com-
ponent if it 15 conc4,Ac-d unler .oniract to aat component or to another DoD
component for tbe 1),.7,ett of the intellience comporent or at the request of
such a componevA tegaic.less of 11)L. c,:stence of a contractual relationship.
3. HIT.an hjects in thin ,o.itext includes any person whether or not
such person is 3 Unil.ed State!, pe...!,ou.
C. PROCEDURES
It Experimont.,tiou on loan :;111:Jcts conducted by or on hehalf of a DoD
int e:lligence compozAent mJ-..y be uAt,rtahen only with tile .iuformfd.c,uracut.,,aL..the
ip_4:.;Lor4.1ice 1?,:i4.11) suido...111(.N?issued by the Dq.artment_of.:11callk.a.aci
linta,a11_,SarYiSfsltLir cou1il,lQ11; that. s;:iteguard lhe weliare?af-skuch-sub-
-ccs ?
2. DoD componcht not engage in or contract for experi-
aieutation on huinn ubjects VithOAT ippi-OVa] Of the Secretary or Deputy Secre-
tary of Defense, or t!ie S.-:retary or Under Secretary of a Military Depart-cent,
is appropriate.
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13 3
AR 38140
15 February 1982
Approectf-ptiReilease 2Q00/081.08 :.CIA-RDP96-007881R001500141:40468ction ol
a research, development., or rolsted tictivio Clod
may expose an individual to the pnss. ibd y of
inlury (including
paysoca., psycho,ogical, or
social injury) that increases, the ordinary risks
of daily life for the -object (including h.! coo.
ognized risks inherent in a chosen oeoupation
or field of servlce,), or that femporariL ?id--
versely affects a person's mental or physical
condition,
(5) Exporimentstion is condacte,d "oo be.
half of" an Army intelligence component if it is
conducted under contract to that. ,,osinponciit. or
to another Army component for the benelit of
the intelligence somponent, or at the Is quest of
such a component regardless of Cie existence
of a contractual relatiomhip.
(4) Human subjects in this contest in-
cludes any person regardless of wheSher the
Person qualifies as a US person.
t.). Policy. Army intelligence components may
conduct experimentation on human subjects
only when an important fooeign intelligenve or
Cl purpose i to be served, only nft,-r the in-
.formed consent of the subject has boen ebtiucri
in writing, and only in aceordanee wits ii 11e-
lines issued by the Peparrnent of 11,s itk and
Truman Services setting 'nit conditions that
safeguard the welfare of the subjvcrs, ,!t her
applicable regula tim is.
c. Procedure. Army intelligence co:moo:lents
may not engage in or con'. tact for osTeritaen-
tation on human subjects without prior op.
proval of the Secret_ary or 'leder isocr.O.ory of
the Army.
2-19. Procedure 19, Special activities. a. Ap-
plicability atul scope.
(1) This prosedure applies to the conduct
and support of svecial activities by Ao: toy Odel-
ligence components. This procedure obit applies
to other Army compo 'tents that. Immo, de slit Tort
for special activities conducted by li,o1) intel-
ligence components and other agencios within
the Intelligence Coruniunity. These osoff doses
do trot apply to--
(a) Diplomatic or caditory attochsi oc-
tivities conducted by DOD,
2-22
tHlirence;
(c) Any functions in support of the
collection and production intelligence; or
(d) The conduct of special activities by
the military services in armed conflict or to
military deception operations targeted, for
miii-
tory purposes, against a hostile foreign pov;er.
(2) Conspiracy in this context ham the
same meaning a.s io the criminal law context
mid requires an overt act Neither the t.,!rrn
"assassination" nor the term "conspire" in-
clude military or civilian measures against on-
going international terrorist activities (which
is a defined term (see glossary) and should be
construed strictly), aircraft hijackings, or in
response to danger of substantial physical harm
to any person. These terms do not apply to
actions of the military services in the execu-
tion of lawfully ordered military operations.
(3) Diplomatic and military attache activ-
ities means the representational, information
gathering, and reporting activities performed
1.:,y diplomatic and military attache personnel
abroad.
(4) Production of inta igence means S;o3
process of developing "int,Atigence products"
which is a defined term. (seo glossary).
(5) Special activitiEs 11,11 activities corn-
duct od abroad inn support of national for6gn
policy objectives that are dr. ilgned to further
official 1.13 program t and pon.cies abroad; that
are planned and executed so tiat the role of the
United States Government, 4 ,ns4: apparent, or
acknowledged publicly and functions in srApp,rt,
of such activities, but not including diplomatic
and military attache activities or the collection
and production of intelligeu,:e r related Iltp.
port functions.
(6) Support, when used in this context,
means the provision of sssistance in the form
of transportation, training, supplies, egoipmeat
or expert personnel.
b. Po/icy. No Army intelligence cowmen
will participate in the conduct or support
special activities. No other Army compore
will provide support for special activities ext
upon the specific direction of the Secretary
Under Secretary of the Army and the Secretat
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DEPARTMENT OF THE ARMY
UNITED STATES ARMY 11ILLLIGENCE AND SECURITY COMAND
Arlinton Hall Station
Arlingtn, Virginia 22212
11oUSCOM Regulation 15-3 24 Fcbruary 1984
Boards, Commissions and Committees
HIGH PERFOWIANCE REVIEW PROCEDURES
r tIng 1982 and 1983, in keepine with the US Army Intelligence ard Security
Cand (INSCOM) goal of "extraord1,1ary performance," and seeking to move the
ccmand to a level which exceeds commonly defined parameters of performance,
INSCOM conducted a otudy of Leigh performing organizations and programs in
the public and private sectors. Several technologies, management techniques,
te:Aning experiences and programs were identified for further evaluation with
ect to their potentird to ccmtribute to the development of extraordinary
Ividual and unt performance wl':htfl the Command. This regulatien contains
.Policies and guidance for LIat evaluation, establishes proedures for
the use of INSCOM personnel as vointt:eers in evaluating and impleTcating high
pert7orming human systems and pro?tles guidance for commanders and aupervisors
!:11 further implementing and evaluating those high performing -lunan systems.
upplementation of tis regulatioc Ls permitted only after prior aproval has
leca obtained from this Headquartem ATTN: IASJA.
Fareeraph Pape
C,.PTER 1
GENERAL INFORMATION
Purpose
Applicability -----------------------
References
Scope
Exemptions
-
-
-
1-1
1-2
1-3
1-4
1-5
1-6
1-1
1-1
1-1
1-1
1-2
1-3
Explanation of terms nAd abbreviations
'TER 2
RESPONSIBILITIES
Approving officials
2-1
2-1
Commanders and Staff ":::lement Heads --
2-2
2-1
INSCOM Human Technol:wy Review Board
(HTTIL)
2-3
2-1
Chairperson et the HTRF
?Al?
2-4
2-2
Executive Secretary of the HTRB -
2-5
2-2
Regular irn Monbershi:, ------
2-6
2-2
Fx Offi to fl7Pli Momh,r, lip
2-7
-)
Al hoc [TR 3 !tembersht],
2-8
2-3
Princlp ittvestgat-,
2-9
2-3
Membun; o';:' volunteer 7-rui1:ing teams
---
2-1.0
2-4
Medical rz,onitor
2-11
2-4
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USAINSCOM Reolation 15-3 24 February' '19?
CHAPTER 3 POLICIES
47,HAPTER 4
CHAPTER 5
APPENDICES
Parranh
General 3-1
Approval 3-2 3-
Risk determinations 3-3 3-1
Risk versus benefit 3-4 1 1
Moral, ethical and legal concept3 3-5 31
Fully informed subjects 3-6
Use of non-US citizens 3-7 :7-1
Use of prisoners of war an...1 ..deainees 3-8 3-1
Medical care 3-9 3-1
Stated objectives 3-10 3-1
Physical and mental suffering 3-11 3-1
Qualifications of Invest! .tor; _ 3-12 '1-2
Minors 3-13 3-2
Recruiting of volunteers ------------------------- 3-14
Protocol guidance 3-15
PROCEDURAL GUIDANCE
Technical reports 4-1
Advising the Medical Research
and Development Command 4-2
Irformed consent 4-3
Minimum standards 4-4
More than minimal risk ------- 4-5
Contractors or vendors 4-6
Requests for exceptions 4-7
Expedited review categories 4-8
Expedited review procedures ---- 4-9
INECOM HUMAN TECHNOLOGY REVIEW ::ARD (HTR8) ACTIVITIES
Composition of the HTRB ------------------ ---- 5-1 5-1
General criteria for membership 5-2
5-1
General committee activities --------------------- 5-3 5-1
voiding possible conflicts of Leterest ---------- 5-4 5-1
Criteria for INSCOM HTR8 approval ---------------- 5-5
pedal considerations of senivity ------------ 5-6
uspensien or termination :,1' a project 5-7
ecords 5-8 e -
1
A - erms and Abbreviations
B ormat for Prparation of
C lolunteer Agr,3ement, Part
D - olunteer Agr2ement, Part
Appr
?
RQ't irch
p-
C-1
D-i
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2:4Approved F986 Release 2000/08/08 : CIA-RDP96-00788R12014001404044tion 15-3
Chapter 1
GEN AL INFORMATION
Purpose. This regulation contains INSCOM policies and guidance for the
evA.uation and implementation of E::.g'n performing human systems within the com-
mand. It --
a. Promulgates procedures and guidance for the use of INSOW personnel
as volunteers in the evaluation of high performing human systems;
b. Establishes and implemets a review process which is conlstent with
AR 70-25;
c. Insures the continued evaluation of INSCOM activities to assure that
t*le provisions of AR 70-25 are being followed;
Establishes procedures to c,btain a health hazard assessment prior to
ac-roving an INSCOM protocol issuel as required herein; and
e. Promulgates INSCOM policies and procedures to assure that 7NSCOM com-
pLnents do not engage In or contract for experimentation on human Aubjects in
v1olatton of Procedure 13, AR 381-10.
-2,. Applicability. This regulation applies to all elements of the INSCOM.
References.
a. AR 70-25, Use ot Volurv:cer cv; Subjects of Research
b. AR 381-10, US Army IntePLgenee Activities.
c. AR 70-31, Standards for Technical Reporting.
Scope.
a. Nothing in this regulation is intended to supersede requirements for
henith hazard or other safety rev required by any other regulations or di-
rec.:Ives.
b. The procedures, policies and guidance contained iA this regulation
errain to the following:
(1) Behavioral studies, re:,Jearch and/or testing involving human, sub-
jcts, regardless of whether cenducred INSCOM, a contractor, or other agency
tilizing INSCOM funds.
(2) Inclusto of human !nbjec.ts, whether as the direct or indirect
t of research, regardlos of !--,e level or risk inviAved, in the develop-
7 testing or stu('y of mJtcers ;Ictated with the missions :Ind f,:nctf.ons of
1-1
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USAINSCOM Regulation 15-3 24 February (c-
the INSCOM, )r the application of non-troditional ideas and technologies
achieving hloh performance of human resoureee,
(1) The investigation of progeams red toconologies to enhance orga-
izational aq individual excellence wheee aeth investigation involves the etoo
elusion of htinan subjects as their object.
1-5. pemptjansa
a. Ree arch, beating and studies in atieh human subjects are involved to
one or more o the following categories are exempt from thta regulation,
(1) 3onafide activities under the o)onsorship of another Departmeo.
of the Army componeat and involving surveys cr interviews where all of the ft H
lowing conditions exist:
be identified
(a) Responses are recore to such a way that subjects cant- .
directly or indirectly.
(b) The subject's respoosel, If they become known, would
place the subject at risk of criminal or teall liability or damage the s
ject's finanzeial or social standing or emplevalAlity.
subject's ow%
use of alcoht
(c) The activity does not coot with sensitive aspects of
behavior, such as illegal oonjuet, drug use, sexual behavior,
(2; Research which involves the tv,c of educational tests, provi,'
the data is recorded in such a way that thi.: bject':- cannot be identified
rectly or ineirectly.
(3; Research in non-INSCOM cducatir731 settings which involve nor:
educational otactices, such as --
(a) Regular and special educir:ional ..rate3tes.
(b) The effectiveness or the comparison among: techniques of ti
struotion, curricula, or classroom methods.
(4) Follow-up debriefings, interviews, tests, or evaluations to de-
termine how wcll participants have learned tbe information or skills transmit.
ted by training or Instructional activitiea p-nvicusiy attended by the subjee.
thereof.
b. Exemptions of other activities frem this regulation, even where suctO
activities m(,y1 be exempred from other smil i togelJtions or directives, shal
not be consacred valid for INSCOM purposes etless and on: AA confirmed by tb
iNSCOM Humae Technology Review Board oo :tibcd elsewhere in this regula-
tion.
1-2
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2441,0600edPWRelease2000/08/08:CIA-RDP96-00788R31115011440094kation 15-3
Chapter 2
REIONSIBILITIES
2-1. Alnyoving officials. The Commanding General, the Deputy Commander, In?
ligence, and the Deputy Commandcr, Support, are the designated INSCOM ap?
peoving officials. Only these offieials may approve the use of human subjects
research.
Commanders and Staff Element Head:,f. Commanders at all levels within the
re'eCOM, heads of Headquarters staff elenents, office chiefs and program direc?
!7.)rs (hereinafter referred to only as commanders and staff element heads) are
reeponsible within their respective functional areas for --
a. Insuring that the provisLons of this regulation are institutionalized
into their organizational procedures and practices.
b. Insuring that no persore; engage in or contract for experimentation
involving human subjects without he express approval of an INSCOM approving
INSCOM Human Technology Review Board (HTRB). The INSCOM HTRB is respon?
sthie for
a. Observing written procedures for the following:
(1) Initial and continuing review of research, including the reports
41 findings and actions to the investigator and the approving official.
(2) Determination of those projects which must b
(a) Reviewed more often than annually.
(b) Verified from sources other than the investigators that no
al changes have occurred siace the previous HTRB review.
(3) Prompt reporting :o the HTRB of proposed changes in the re?
(_?.h, and to the ETRB and approving official of unexpected prohlees involving
e'.