INSCOM CENTER LANE PROJECT

• Document Type: CREST
• Collection: STARGATE
• Document Number (FOIA) /ESDN (CREST): CIA-RDP96-00788R001500090010-7
• Release Decision: RIPPUB
• Original Classification: S
• Document Page Count: 95
• Document Creation Date: November 4, 2016
• Document Release Date: May 13, 2004
• Sequence Number: 10
• Publication Date: July 17, 1984
• Content Type: MF

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ARMY review(s) completed.
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UEPARTMENT OF THE ARMY
UNITED SI ATES ARMY INTELLICENCE AND SECURITY COMMAND
RC PLY TO
ii.NTION Or
ARLINGTON liALL STATION
ARLINGTON, VIRGINIA 22212
ACC
MEMORANDUM
MLMORANDUM FOR ASSISTANT CHIEF OF STAFF FOR INTELLIGENCE
SUBJECT: INSCOM CENTER LANE Project (U)
17 July 1984
1. (U) We have completed a. review of project CENTER LANE with a focus on
resources involved, results obtained and the role of INSCOM in this area.
2. (S) INSCOM has invested considerable effort over a long period of time
to develop the remote viewing technology. 'As a result the Army enjoys a
mcnopely on his revolutionary concept for intelligence collection. We must
insure that ve do not lose this knowledge and experience in any action taken
to efanee INSCOM's sole in the use and development of the technology.
(S) F em concerned about these three aspects of the program.
a- ontinued research and development. We cannot abandon the work
already done if for no other reason than to keep pace with the effort being
expended by our adversaries.
b. Current uerations. Intelliggnee users in the Army, DIA, NSA
and CTA have all tasked this methodology to augment established disciplines
and for missions that would be extremely difficult or impractical for any other
collection resource. The intelligence Community cannot afford the loss of this
capability while it waits for a total refinement and understanding of the
observed phenomenon.
C. People _involved. Chinetine iNSuOM's role affects the dedicated
personnel involved. We must insure the timely and fair reassignment of our
excellent cadre who, may or may not wish or be able to participate in some
further continuation of the proerem.
4. S) In spite of these concerns it is my opinion that INSCOM, who has
supported this project with S and IA funds and personnel assigned without
spaces, should discontinue our involvement with psychoenergetic research and
operations. To mitigate adverse Impact in the areas of concern expressed
above 1 intend to cease INSCOM CENTER LANE Project operations on 30 Sept 1984,
but allow completion of outstanding contracts and training by 31 December 1984.
This would:
WARNING NOTICE: CENTER LANE SPECIAL ACCESS
l'ROGRAM REST-RICT DITITNATION TO THOSE WITHP'SXilE"Y'
VERIFIED ACCESS TO CATEGORY THREE(3) ?
.1Er171-61P
?
SENSTTIVE INTELLIGENCE SOURCES AND METHODS
INVOLVED NOT RELEASABLE TO FOREIGN NATIONALS
44.04
ARMY reviemsfTerTplitPr Rele 200e0fkit? IIP96-00788R001500090010-7
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IACG
SUBJECT: INSCOM CENTER LANE Project (U)
17 duly 1984
a. (U) Allow the reassignment of 1CLP personnel on an equitable basis:
b. (SICL-3/N0FORN) Permit trainees to complete training and become
60% operational.
C. (S/CL-3/NOFORN) Permit timely and un:]isrupted transfer of (1)
ICLP operations to a national agency such as DIA or NSA and (2) ICU phenomena
validation and technology extension to the US Army Medical Research and
Development Command.
d- (U) Permit preparation of comprehensive after action reports,
thereby preserving vital institutional knowledge and technical details that
would otherwise be permanently lost
5. (U) Accordingly, I request that:
a- OACSI coordinate this action to insure that there is no objection
at Department of Army.
b. INSCOM be authorized to coordinate directly with DIA, NSA. and
Medical R&D Command with regard to para. 4c.
Bridier General, USA
Commanding
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Approved For Release 2004/07441i,
DAMI-ISH
ii6-00788R001500090010-7
DEPAI:TMENT OF THE ARMY
OFFICE OF 'I HE etZti 157,4 NT ;.-'3,i1EF OF grArr roR INTELLIGENCE
1:"X: 10510
MEMORANDUM THRU VICE CHIEF OF STAFF, AR
A P41 FEM.. - 41;04114 (3 :;) 7
?'1??? /
?
FOR SECRETARY Of THE ARMY
( 4,)111'4(4f4
5
-41/41,4X' I AUG 7984
SUBJECT: CENTER LANE (U)--ACTION MMORAND
1. (S/CL-1/NOFORN) Purpose: TQ obtain your appro for the
discontinuation of Intelligence and Security Commanc (INSCOM)
involvement with psychoenergetic research and operat ons.
2. (U) Discussion.
a. (S/CL-1/NOFORN) CENTER LANE is an INSCOM Special Access
Program which utilizes an aspect of parapsychology known as
Remote Viewing (RV) as the collection method for obtaining in of intelligence interest. Your approval for the Army
to engage in CENTER LANE activities .4'; most recently obtained on
1 Sep 83.
+11
b. (S/CL-//NOFORN) CDR INSCOM ha: reviewed the project Pnd
ceoched the decision to disc.oetinue cnalmTod's involvement
vith psychoenergetic research and oporotions, , Recognizing that
INSCOM has inlycsted considerable effo,- c'%/1- a long period of
time to develop the RV technology and hoick ,-, Donopoly on this
Ievolutionaly concept for 14ttellipenoe ool:octioo, he desirce
that we not lose this knowledee and experience.
c. (U) ?IN6COM ilttelld s to c:0 the following:
(1) (S/CL-1/NUiORN) Cease CoNTEr LANE operations on 30
Sep 84, but aMow contracts dnd traioiny; to continu2 to 31 Dec
84.
(2) .(5/CL-3/NOFORN) Trensico project operational aspects
to DIA and technology extemion to the US Army Medical Research
and Development Command. In thc event DIA is not interrsted in
the transfer, NSA will he con8iderd.
CENTER LANE
CLOSE HOLD/HAW)
k. ? ? .^:?'
.troO*-
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loASFI:LE1) BY CC INSCOM
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DRAM I-1SK
SUBJECT: CENTER LANE (U) - ('U TON MEMORANDUM
d. (S/ CL-1 /NOFORN) It is anticipated that discussion between
INS COM and rile abo?Fc organizaions will 3:esult a Metaorandum
of Al,rcement transtering all NT ,C:!;Z LAVE a.ctivity outside of
iNSC011, while tflsl1L irni 0 at tsrch and operetial capabilities
are pt otec ted nnd tht-, ueople nre ift-IssiFned CT) an
cq-oi rab le basis
3. (3/ CL-1 /N3FORN) t tTh c trio Secretary of the
Any approve the iNSCOM conce.,::1: for Ointinuing,involveent
psychoi,mertic reselt ioperLio6 and transferring
CENTER LANE tions
4.
0112. (
Genera:1,
ACorS .for elligance
LTC Fox/50114
Typed by C. Huggins
21 AUG 13e4 ,?
APPROVED BY
EZCPtETARY OF THE ARMY :
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Or FICA: OF THE. CHIEF OF %rm., EDE4 INTELLIGENCE
raT,FAVri MENT OF THE ARMY R ANE,
9-C
1,51-IINC;TON. DC 2..,310
gtEK.Y TO
IIENTION Of'
DAMI-ISH
SUBJECT: INSCOM CENTER LANE Project (U)
Commander
USA Intelligence and Security Command
Arlington Hall Station
Arlington, VA 22211
.1.0 SEP J34:
1. (U) Reference memorandum, INS COM, 1ACG, 17 Jul 84, subject:
INSCOM CENTER LANE Proiect (U), (S/CL-3/NOFORN).
2. (S/CL-1/NOFURN) The Secietary of the Army has approved
ending the ir%.telligenec and Security Command's (IN COM) involve-
ment with psyehoenergetic research and operations. A copy of
the OACSI, DA memorandum to the Sccietaty on the subject, with
his noted app?dval, is enclosed.
3, (S/CL-3/NOFORN) You are authorized to coordinate directly
with CIA, DIA, NSA, and the Army Medecli R&D Command regarding
transfer of uurER LANE opcnitiows and research. Any trnnsfer
of project personnel, files, equipment, ,..:ontracts, etc, should
be covered lpya Memorandum of Agreement (MOA). Any such MOA
should be proiiided fot levicw by the ACSI prior Co implemen-
tation.
4. (S/CL-i/NOFORN) The CENTER LANE Special Access Program
(SAP) should bc terminated -1?,,r transferred, as appropriate, once
INS COM involvewmt is discontinued.
a. (3/CL-3/NOI;ORN it t.h. Md i c J mi) c(mmi=lod becomes
Involved and dires tho project namc sou]d be
changed and th,: Seeretazy of Coe Army duly rouffied.
b. (3/ CL- 2 !NuFORN ) 11 a non- ri,ny its,,ency 8P,7,umes the pro-
j cc t functions, the sould bc temiared. If that agency
desires SAP 01-:)i cc Lion cold suppo rt F an in terim period this
should he provided undI a new nqme.
1 End.
as
Cene)....ai, USA
I ACcfS for Int 1.11.gono.et
CLOSE HOLD/HAND_ CARRY
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DEPARTMENT OF THE ARMY
MIMI-114N e3P
)AMI- IS
.171F-F!CF. OF Tp.ir. PIrNT c.-..14pEr or IS rAFF FOR INTELL.4.1,4Ct
20310
SUBJECT: Memc.riu of .Ag eem en t (U)
Cavil and e r
USA Intel 11 igcnc rid Soc:nri ty Command
An. HaL 1 Station
&cling ton , VA 22212
4 OPT TS:
1 ?, (5/ C-1,-2 /NO "e ) R Refe.nce m cm? rand um ? I NS COM UGC,
25 Sep 84, suj c c; Memoiindum of Ag re. em on t , Trausfer of INS COM
ER LANE r?: r, t:o DIA (S/CL-2/NOFORN).
( U ) re r.:,oe prt:Iposed Memo ran 3 f erri en ( MOA) is
,Tproved.
, / CL-2 /N:j:FORN) Request you comniler the inclusion of some
L- a 11 on the procedure to be fo flowed in transferring personnel
J) DIA, INS COM may detail the md irrdua Ls involved for Lp to one
year to allow time for DIA to id4mtify spaces. Once such spaces
:vre available, the detailed personnel may be given a Pe rmanent
Change of Station. It DIA destres a ch;mge in authorized
strench to allow for immedi ate PCS rca s ignment they may apply
for it through JCS. OACS 1, DA will tit ppo rt such a change in
t to tus if the ziib ec i becomes an issue ?
ODOM
nt Cartent.( LISA
ACO$ far inteingeice
Classifi i;:d by Cdr, IS COM
Dcias.sifI on :OAR
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US ARMY
INTELLIGENCE AND SECURITY COMMAND
CENTER LANE TRAINING AND APPLICATIONS PROCEDURES
WARNING NOTICE: CENTPR LANE SPECIAL ACCESS PROGRAM
RESTRICT DISSEMINATION TO THOSE WITH VERIFIED ACCESS
TO CATEGORY THREE (3)
_
SENSITIVE INTELLIGENCE SOURCES AND METHODS INVOLVED
NOT RELEASABLE TO FOREIGN NATIONALS
CLASSIFIED BY: CDR, INSCOM
DECLASSIFY ON: OADR
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US ARMY
INTELLIGENCE AND SECURITY COMMAND
CENTER LANE TRAINING AND APPLICATIONS PROCEDURES
INDEX
_ .
1. GENERAL
PAGE
2. DEFINITIONS
1
3. MILITARY OBJECTIVE
2
4. MILITARY APPLICATIONS
2
5. APPROVAL HISTORY
2
6, SELECTION OF PERSONNEL
3
7. TRAINING PROCEDURES
5
8. PSYCHOENERGETIC APPLICATIONS
9
9. ADDITIONAL COMMENTS
9
10. CONFIDENTIALITY
10
11. PHYSICAL ENVIRONMENT
10
APPENDIX A
A-1
APPENDIX B
B-1
11$
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6 June 1984
US ARMY
INTELLIGENCE AND SECURITY COMMAND
CENTER LANE TRAINING AND APPLICATIONS PROCEDURES
1. (S/CL-1/NOFORN) GENERAL: The procedures set forth herein
detail the activities of the US Army Intelligence and Security
Command (INSCOM) Special Access Program (SAP) CENTER LANE in
psychoenergetics. These procedures are in effect for the period
required to train and apply psychoenerge tics. ? They are
effective and do not involve any practices which expose
participants to harmful circumstances or substances such as
drugs.
2. (S/CL-2/NOFORN) DEFINITIONS:
a. (U) Psychoenergetics: A mental process by which an
individual perceives, communicates with, and/or perturbs
characteristics of a designated target, person, or event remote
in space and/or time from that individual. It does not involve
any electronic devices located or focused at the target, nor
does it involve classical photo interpretation of photographs
obtained from overhead or oblique means.
b. (U) Psychoenergetic Source: A person who perceives,
communicates with, andror perturbs characteristics of a
designated target, person, or event.
c. (U) Psychoenergetic Trainee: A'person being trained to.
be a psychoenergetic source.
d. (U) Puchoenergetic Session: A single attempt by a
psychoenergetic source and azi interviewer/monitor to perceive,
communicate with, and/or perturb characteristics of a designated
target, person, or event.
e. (U) Interviewer/Monitor: The individual who interacts
directly with the psychoenergetic source before, during, and
after the session.
WARNING NOTICE: CENTER LANE SPECIAL ACCESS PROGRAM
RESTRICT DISSEMINATION TO THOSE WITH VERIFIED ACCESS
TO CATEGORY TUREE (3)
SENSITIVE INTELLIGENCE SOURCES AND METHODS INVOLVED
NOT RELEASABLE TO FOREIGN NATIONALS
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f. (U) Remote Viewing: The name of a method of
psychoenergetic perception. A term coined by SRI-International
(SRI-I) and defined as "the acquisition and description, by
mental means, of information blocked from ordinary perception by
distance, shielding, or time."
g, (U) Coordinate Remote Viewing (CRV): A Remote Viewing
technique that requires the use of coordinates as targeting
information.
h. (U) Targeting Information:
represents the target of interest.
An abstract referent which
1. (U) Target/Site: A specific area, person or event at a
specific time.
?
j. (U) Discrete State: A typp of psychoenergetic activity
in which the source perceives his consciousness to be located at
the target.
3. (S/CL-2/NOF0RN) MILITARY OBJECTIVE: it is the objective of
these procedures to maintain the quality of psychoenergetic
training and applications so that CENTER LANE will continue to
support the broad spectrum of intelligence and
counterintelligence requirements in collection, target
acquisition, and deception.
4. (S/CL-3/NOFORN) MILITARY APPLICATIONS: CENTER LANE
_
applications of psychoenergetics include but are not limited
to: (1) targeting of key enemy military personnel from covert
agents to key battle commanders, (2) monitoring hostile military
movements, lines of communication, and specific technologies,
(3) detecting changes in the state of military units, (4)
detecting and assessing hostile intelligence efforts targeted
against friendly units/misal,gns, and (5) detecting and assessing
hostile technological capabilities in specific locations. Since
US Army personnel, units, materiel, and operations are subject
to a similar hostile intelligence service threat, CENTER LANE
can assist in devising countermeasures to eliminate or reduce
vulnerabilities.
5. (S/CL-2/NOFORN) APPROVAL HISTORY:
a. (S/CL-2/NOFORN) Concept Approval: The Commander, US
Army Materiel Development and Readiness Command (DARCOM)
approved in principle the US Army Material Systems Analysis
Activity (AMSAA) involvement in the project GRILL FLAME; which
began in April 1978 (GILL FLAME was the predecessor to the
CENTER LANE Project). in May 1978, the Assistant Chief of Staff
for Intelligence (ACSI) accepted lead responsibility for GRILL
FLAME applications. Effective 14 January 1981, by approval of
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the Under Secretary of the Army, INSCOM became the only active
operational GRILL FLAME element in the Army. Program management
for GRILL FLAME was transferred to Commander, INSCOM effective
11 February 1981. OACSI, DAMI-ISH remained the Army focal point
for policy matters and interface at the national level, Overall
DoD responsibility resided with the Defense Intelligence Agency
(DTA). Also in 1981, a joint services GRILL FLAME Committee
consisting of DIA, the US Air Force and US Army was formed.
Later the Air Force Chief of Staff directed that the Air Force
withdraw from the committee and all psychoenergetic programs. A
comprehensive program was designed to determine the operational
parameters and usefulness of psychoenergetics and, assess the
threat these phenomena posed to national security. At that time
DIA was R&D oriented and INSCOM's GRILL FLAME Project was
applications oriented. In the.FY83 DOD budget review the Budget
Subcommittee of the Senate Select Committee on ?Intelligence
curtailed all psychoenergetic activities funded by the Army in
the National Foreign Intelligence Program (NFIP), but directed
that DIA could complete the third year of their effort and that
all future Army funding be budgeted outside the NFIP. INSCOM
terminated formal involvement with GRILL FLAME at the end of FY
82; in the fall of 1982, in keeping with congressional desires,
the Commanding General INSCOM provided funding from Security and
Investigative Activities (S&IA) monies, and continued its
efforts under a provisional compartmented SAP nicknamed CENTER
LANE. On 1 September 1983, the Secretary of the Army approved
continued Army participation in CENTER LANE activities within
INSCOM and with appropriate contractors in a cooperative effort
with DIA.
b. (S/CL-2/NOFORN) Human Use Approval: GRILL FLAME was
designated a "Human Use" program as the result of an Army
General Counsel decision in February 1979, which determined that
the Project involved "Experimentation on Human Subjects," and
that relevant Human Use prot9cols did indeed apply to Project
procedures and technologies. Conduct of the Project under Human
Use regulations was first approved in April 1980 by the Under
Secretary of the Army. Appendix A contains an historical
summary of the Human Use issue, as well as a list of the
pertinent regulations, which govern CENTER LANE activities
6. (S/CL-3/NOFORN) SELECTION OF PERSONNEL:
a. (S/CL-3/NOFORN) Current Selection Criteria: After over
a year of participation within the psychoenergetic project,
source personnel were tested by the INSCOM Staff Psychologist in
an attempt to determine a suitable profile by which fu-rther
participants could be identified, The specific tests
administered were (see Appendix B for test descriptions):
(L) The Minnesota Multiphasic Personality Inventory
(MMPI).
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(2) Gordon Personal Profile - Inventory (CPI).
(3) Fundamental Interpersonal
Orientation-Behavior (FIRO-B).
Relations
(4) California Psychological Inventory (CPI).
(5)
Edwards Personal Preference Schedule (EPPS).
(6) Personal Orientation Inventory (POI).
For the most part, the group presented itself as, emotionally
stable with no marked trends. There did appear to be an
interesting similarity in defensive style, a tending toward
artistic, aesthetic, and cultural interests, and an introversive
style of emotional expression. From these test results- the
INSCOM Staff Psychologist construcced a test that may be used as
an initial screening tool in the selection of new
psychoenergetic participants. This new test is called the
INSCOM Factor Questionnaire. This instrument is used to compare
Individuals with CENTER LANE sources. A high score suggests
that individuals have similar characteristics to operational
personnel and may be potential candidates for the project. A
score of 20 or higher is considered to be similar to CENTER LANE
personnel. Individuals who score within the parameters
specified by the INSCOM psychologist would then receive personal
interviews with CENTER LANE Project personnel. From these
interviews new project participants would be selected and
trained.
b. (S/CL-3/NOFORN) Projected Selection Criteria: SRI-I
has been contracted to investigate and report on a particular
aspect of psychoenergetics relating to operational management of
personnel; that is, to determine if a personality testing
technique can be created wkich, when applied to a general
population, will delineate specific individuals who exhibit
higher degree of talent for psychoenergetic abilities.
c. (S/CL-2/NOFORN) Voluntary Consent: As required under
the regulations governing "Human Use (see para 2., Appendix A),
all personnel operate on a strictly voluntary basis, and may
withdraw at any time without any form of prejudicial action or
consideration directed against them. Further, participants are
informed of any known or potential risks that might be inherent
in program participation. This is accomplished through the use
of a verbal briefing from a knowledgeable CENTER LANE official,
and the execution of a personalized Statement of Consent form
outlining all pertinent information and considerations. The
voluntary consent requirement pertains to individuals assigned
to the CENTER LANE Project and contractors/consultants. A
sample of the voluntary consent form is attached as inclosure 5,
Appendix A.
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7. (S/CL-i/NOFORN) TRAINING PROCEDURES: To provide a
framework for the standardizing of the task of psychoenergetic
learning, a number of methodologies are being utilized and
conducted within the CENTER LANE Project. These are as follows:
a. (S/CL-3/NOFORN) Orientation Testing/Training:
(1)
Purpose: To provide new personnel with an
introduction to training and applications procedures.
(2) Administered by: CENTER LANE Project personnel and
selected contractor and subcontractors.
(3) Location: Fort George G. Meade, Maryland and other
designated locations.
(4) Duration: One to six Iponths.
(5) Description of Procedures: Orientation
testing/training is developed from the practical application of
state-of-the-art psychoenergetic technology drawn from academic
institutions, scientific laboratories, and research
establishments around the world. It is an eclectic approach,
using those methods which have applications potential.
Orientation testing is designed to determine if new personnel
have aptitudes which would be of operational value and could be
developed through training. This orientation testing consists
of a series of controlled exercises in psychoenergetic
functioning. New personnel may be asked to attempt to perceive,
communicate with, and/or perturb characteristics of a designated
target, person, or event remote in space and/or time from that
individual. Orientation training is composed of practical
exercises in Remote Viewing, lectures, literature review, and
observation of others. It includes the use of locally
significant sites, as well aii,pore remote geographical locations
as targets. A. target pool consists of a controlled group of
sites or targets and their associated targeting information.
Prior to the beginning of a training session, a target is
randomly selected from this target pool. Information available
concerning the target is kept from the trainee until after the
S ession.
(6) Training Session Preliminaries: Before a first
training session is scheduled, the person being trained is
oriented fully to the procedure to be followed by the monitor.
The trainee is instructed that he or she should state only raw
perceptions, since experience has shown that specific
definitions are quite often wrong while initial raw perception
tends to be correct. Personnel being trained are always
encouraged to express their feelings and ideas for enhancing all
aspects of the psychoenergetics collection process.
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(7) Training Session Dynamics: During the 30-60
minutes prior to the agreed-upon time of a training session, the
monitor offers some encouragement to the trainee in the same
manner that a coach might give a pep talk to his team- During
the 15 minutes immediately before the session the trainee and
monitor are generally silent. Experience has shown (unpublished
data) that this quiet time enhances the training process. The
training room is homogeneously-colored, acoustic-tiled, and
featureless, with light controlled by a dimmer, so that
environmental distractions can be minimized. During the entire
process the trainee and monitor function as a team. The monitor
provides encouragement with words of reassurance that the task
is, in fact, possible. At no time is the session conducted by
the trainee in the absence of all other persons. If the trainee
does not have any immediate sensory impression, the monitor
applies no pressure. Rather, the monitor reassures the trainee
that there is no time limit for tbe training session. If it
appears to the monitor that the impressions are in some way
contradictory or inconsistent, the monitor may then attempt
clarification by asking questions in order to verify what the
trainee first describes. All sessions are tape-recorded, and
pen and paper are available for the trainee to sketch his or her
perceptions. Experience has shown that some trainees prefer to
combine written and oral descriptions, while some prefer to work
sequentially. The average training session for orientation is
approximately 15 minutes of actual per Trainees
generally are not permitted to go bey.Ond 30 minutes as this
leads to perceptual confusion-andprventual loss of the training
affect.
(8) Post Sessio
is over, the trainee an
about the target, either
geographic sites, or--as
visiting the target site
the session results. Th
is to provide the traine
well he or she did while
are still fresh in mind.
n Dynamics: After the training session
d monitor obtain specific information
in picture descriptive form for remote
in the case of local sites--by actually
. 'The trainee and monitor then discuss
e purpose of this post-session activity
e with the satisfaction of knowing how
mental perceptions of the targeted site
b. (S/CL-3/NOFORN) CRV Training:
(I) Purpose: To provide trainees with the requisite
skills necessary to perform certain psychoenergetic applications.
(2) Administered by: Contractor and subcontractor
personnel.
(3) Location: SRI-I Menlo Park, CA; SRT-I New York,
NY; SRI-I Washington D.C.; and other mutually agreed locations
as required.
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(4) Duration: 12 to 18 months.
(5) Description of Procedure: CRV training is a
contracted service provided by SRI-I. The training involves
lectures on theory coupled with practical exercises and drills.
Particularly effective instructional procedures include active
participation wherein the trainee interacts with the curriculum
materials by responding, practicing, and testing each step of
the material to be mastered; information feedback, wherein the
trainee finds out with minimal delay whether the response is
correct; and individualized instruction, wherein the trainee
moves ahead at his or her own rate. The training procedures
have been broken down into several stages representing various
elements of CRV phenomena. These stages both facilitate
training and actually follow the predictable course of
increasing perception which builds itself in specific increments
and impact. Stages 1 through 3 appertain to general site
features, which become increasingly refined as individual
competency with Stage 3 techniques develops. Stage 4 involves
perception of specific site elements, a good portion of which
may not be available to any other intelligence techniques, save
for actual penetration of the site. Stage 5 allows the trainee
in a sense to reverse the procedure and "interrogate" his
perceptions, allowing clarification of various specific or
subtle features of the site. Stage 6 permits .the construction
of 3-dimensional models of major site characteristics, with
increasing refinements in detail. Mcperience and theory
extension indicates that additional increments exist beyond
Stage 6. Research is underway to develop and define the
parameters and potentials of these additional fields.
(6) Session Dynamics: In conducting a CRV session, a
remote viewer or trainee and a monitor begin by seating
themselves at the opposite ends of a table in a special remote
viewing room equipped with'pqper and pens, a tape recorder, and
an overhead TV camera which allows either recording for
documentation, or monitoring by individuals outside the room.
The room is homogeneously-colored, acoustic-tiled, and
featureless, with light controlled by a dimmer, so that
environmental distractions can be minimized. The session begins
when the monitor provides targeting information, in the form of
specific site coordinates, to the trainee. For training
purposes the monitor is allowed to know enough about the site to
enable him to determine when accurate versus inaccurate
information is being provided. The session then proceeds with
the monitor repeating the targeting information at appropriate
intervals and providing necessary feedback. The feed-back
procedure was designed to reinforce the trainee's contact with
the site but not to assist him by random cuing. The remote
viewer generates verbal responses and sketches, until a coherent
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response to the overall task requirement emerges. The use of
the quick reaction-response procedure has been found useful in
minimizing imaginative embellishment.
(7) Post Session Dynamics: After the training session
is over, the trainee and monitor obtain specific information
about the target. As in the case of orientation training, this
is presented in picture descriptive form for remote geographic
sites, or in the case of local sites, may involve actually
visiting the target site. The trainee and monitor then discuss
the session results, again with the purpose of providing the
trainee with the satisfaction of knowing how well he or she did
while mental perceptions of the targeted site are still fresh.
c. (S/CL-3/NOF0RN) Applications Training:
(1) Purpose: To enable acjvanced trainees to integrate
and expand acquired skills for psychoenergetic applications.
(2) Administered by: CENTER LANE Project personnel.
(3) Location: Fort George G. Meade, Maryland.
(4) Duration: Continuous.
(5) Description of Procedure: Procedures for
applications training are essentially identical as those
previously presented except in the style of target presented.
Applications targets are actual tgrgets of military interest,
such as US facilities or USSR sites Lrom which data are
avaiLable or can eventually be obtained. Targets of this type
provide a basis for judgements regarding utility, accuracy,
calibration, and depth of detail for any given trainee in a real
world environment.
d. (S/CL-3/NOFORN) Advanced Individual Training:
(1) Purpose: To provide experienced sources with
advanced individual training to meet applications requirements.
(2) Administered by: CENTER LANE Project personnel,
and selected contractors and subcontractors.
(3) Location:
contractor locations.
)
Fort Meade, Maryland and various
Duration: Continuous.
(5) Description of Procedure: Individualized advanced
training programs are developed to meet specific applications
needs. Such programs may involve training in biofeedback,
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communications skills, perturbation techniques, discrete state,
hemi-sync, search, Neuro-linguistic Programming, and alternate
target acquisition methods. One program of particular interest
is hemi-sync training conducted by the Monroe Institute of
Applied Sciences (MIAS), Faber, VA:
The MIAS hemi-sync techniques are used to teach sources to
control highly specialized mental states conducive to
psychoenergetic performance. This form of advanced
individual training is only used with sources of proven
performance and a recognized degree of maturity. Training
is accomplished in four essential phases; (1) application of
the Monroe "Discovery" series done at Fort Meade to screen
personnel and prepare for phase two; (2) Attendance at the
MIAS Gateway program for qualified personnel', conducted in a
seminar atmosphere; (3) One-on-one training sessions with
Robert A. Monroe at MIAS, whic4 are designed to "customize"
individual techniques for specific individual needs; (4) use
of specially designed hemi-sync environments during
applications training done at Fort Meade.
8. (S/CL-2/NOFORN) PSYCHOENERGETIC APPLICATIONS: CENTER LANE
sources can be used to perform psychoenergetic applications in
support of intelligence and counterintelligence requirements
(see paragraph 3, above). The dynamics of applications sessions
parallel those of training sessions. The sequence of events
consists of the following: (1) taskirvg; (2) development of a
collection plan; (3) conduct of psychoenergetic session(s); (4)
reporting; (5) evaluation. Applications sessions are always
conducted under the control and management of CENTER LANE
personnel. Sessions may be conducted at Fort Meade or other
locations as deemed necessary. Psychoenergetic
consultants/contractors may be employed when required to meet
applications requirements.
9. (S/CL-3/NOFORN) ADDITIONAL COMMENTS:
a. Selected personnel may use the hemi-sync environment in
conjunction with psychoenergetic applications/training.
h. Sources and trainees may be monitored using appropriate
non-intrusive biological monitoring equipment.
c. The maximum number of applications sessions for each
source will not exceed ten per week.
d. The maximum number of training sessions for each source
will not exceed 20 per week.
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e. CENTER LANE procedures do not involve the use of drugs,
substances, or circumstances harmful to participants. The
TNSCOM Staff Psychologist provides continuous support to the
project. Facilities at Kimbrough Army Hospital, Fort Meade, MD,
are available if required.
JO. (S/CL-3/NOFORN) CONFIDENTIALITY: Individuals performing
as psychoenergetic trainees, sources, and monitors under the
CENTER LANE Project will not have their roles identified outside
of their parent organization without their specific prior
consent, and they will be referred to in project reports only by
an alpha-numeric designator. Products of CENTER LANE such as
tapes, drawings, transcripts, rosters, or other materials which
might reveal the identity of the source will be coded to assure
the protection of their identity.
11. (S/CL-2/NOFORN) PHYSICAL ENVIRONMENT: Psychoenergetic
sessions will be conducted in an 7Tdinary room at ambient
temperature and humidity during the normal waking hours of the
participants. The only limitations on these parameters will be
for security from electronic eavesdropping and elimination of
ordinary distractions, such as radio, office machinery, and
outside noises.
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APPENDIX A
US ARMY
INTELLIGENCE AND SECURITY COMMAND
CENTER LANE TRAINING AND APPLICATIONS PROCEDURES
Historical Summary of "Human Use" Issue
WARNING NOTICE: CENTER LANE. SPECIAL ACCESS PROGRAM
RESTRICT DISSEMINATION TO-7-I.46SE WITH VERIFIED ACCESS
TO CATEGORY TWO (2)
SENSITIVE INTELLIGENCE SOURCES AND METHODS INVOLVED
NOT RELEASABLE TO FOREIGN NATIONALS
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DECLASSIFY ON: OADR
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APPENDIX A
Historical Summary of "Human Use" Issue
(S/CL-2/NOFORN) FOIAB5 February 1979, the Army General Counsel.
determined that GRILL FLAME activities involve.d testing on humanARMY
sub lects
In March 1979, The
Surgeon General's Human Subjects Research Review Board reviewed
the GRILL FLAME protocol and concluded that it -represented
technology transfer and validation of the technology transfer,
rather than research or clinical investigation, and as such,
GRILL FLAME activities did not require approval for human use.
However, the Board expressed concerns that future Army follow-on
work might be classified as research, and as such, plans should
be considered to establish credible human use review procedures
to oversee GRILL FLAME activities. In April 1979, Army General
Counsel determined that the Army could continue/proceed with
GRILL FLAME activities as long as HEW guidelines and other
appropriate precautionary measures were taken. In April 1980,
the Under Secretary of the Army approved the continuation of
GRILL FLAME activities. In October 1980, the DoD, DIA, and Army
General Counsel jointly agreed that it would be prudent to
obtain written approval from the Deputy Secretary of Defense to
conduct GRILL FLAME activities. ACSI,4-DA concurrently initiated
action to obtain Secretary of the Army approval to conduct GRILL
FLAME activities. In September '1982, INSCOM GRILL FLAME
activities ceased because of NFIP restrictions; INSCOM
psychoenergetic activities were reinitiated in December 1982,
under the INSCOM CENTER LANE Project (ICLP), an S&IA activity.
Secretary or Under Secretary approval for GRILL FLAME/ICLP
activities has been granted on 14 January 1981, 1 February 1982
and 1 September 1983. ApprQyals are generally valid for one
year.
2. (U) Regulations governing "Experimentation on Human
Subjects" are as follows:
a. (U) 45 Code of Federal Regulations, Part 46, "Protection
of Human Subjects" (Incl 1).
b. (U) Procedure 13, DOD Directive 5240.1-R (Incl 2).
c. (U) AR 381-10, paragraph 2-18 (Inc' 3).
d. (U) USAINSCOM Regulation 15-3, "Boards, Commissions and
Committees: HIGH PERFORMANCE REVIEW PROCEDURES" (Inci 4).
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A-1
..yoV
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4
r?, ;
71
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1. I ,r! ;404 ;11 Veit
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4, 1
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"410.1
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, ,44 .4? 44?14:11 et swot
proved? For Release 2004707/09 : CIA-RDP96-00788R001500090010-7
RESEARCH ACT
Liz.: LAW 9:44E
1s... 1974
t1"4').:11.r.ii:,!' Air "
C. 2I:,H It t V or th rub.:k He3Iti% seevict Act, a%
an,entL-d 10)?it articuiledby.81.1dItiga er4 the
L Et 01(-:, Gt.;triANI k. Pgefig.f4F4
L ;,at ',hall by regulation ic.-41.nrc h?et
NAM, tc: .1 paw ..?i AO for any proji:et or
tin . ? .,.i?tidut..t ol btI c.dL .I;
?;' than! in or with iis applicigticn fi3r such
tiiI t1
, to +he Secretary itvit it hat establiilicd (in
: 1,ACI1'.'i hi tcSCCrtiarybffl rrir..scritie.) .kbi (10
J.. LI', Revicio; Board') to rcv bitra anJ
i 14 hk.11'.1.1n
?.:?1 to of tho.:- littrwrt '7.0)jec5 I ?A.1,J.
"I t) k:Ntaolisll irft.)gr.JR1 ?vithin inc Dcpartinera
tinder whin c iot ,:!aritii:attol and vidance with respect t.n-u.:1 rthical
co?i:ieclioi. bititiclical or bellavintai rescurit
tw?113.1 'to pionitly and approptiatcly."
EdacAton, tind sJ wVr."?:?40.
da lit. ':hC" 11%C CP' :!rnent i :iis Act promulpat:'. such regniz,tions
:I 474(a) eit thr: Iblt 1uJth Serviec
sh.:II 31 ply WI teSpeCt :pplIs.-.44!:1:10i ,for rj.intsml
couri-,?tris -11? Act ,,-11rmed aftcr
THI-t.-"..-?E RECIILATkr,6,
.15 Cl Ali, 1\111i VIE.iE AW:TS
1. 0 I SERVICE ACt.
1
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Approved For Release 2004/07/09 : CIA-RDP96-00788R001500090010-7
CODE OF FEDERAL REGULATIONS
TITLE 45
PUBLIC WELFARE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
OFFICE FOR PROTECTION FROM RESEARCH RISKS
PART 46?PROTECTION OF HUMAN SUBJECTS
REVISED AS OF MARCH 8, 1983
,
Artrtrnwari Pew Da Inman 9nnA1n71ria ? riA_DnDan_nn7RRDnn1gnnnannin_7
Paige,4
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, PART 46-PROTECTION OF
HUMAN
SUBJECTS
Subpart Ae-Bask NHS Polley or
Protection of Human Research
Subjects
Sec.
46 101
40.107
46.103
46 104
46.105
46.106
46,107
46.108
46.109
46.110
To what do these regulations apply?
Definitions.
Assurances.
Section reserved.
Section reserved,
Section reserved.
IRB membership.
IRE) functions and operetions.
1R11 review of research,
Expedited review priseedures for
certain kind% of research involving nu
ware than minimal risk, and for minor
changes in approved research.
46 111 Criteria for IRE) approval of
seseiirch.
46.112 Review by institution.
4(s.113 Suspension or termination of IRB
approval of research.
46.114 Cooperative research.
46. 113 11111 records.
46 ISO General requirements los intorrned
conseilt.
46 117 Documentation of informed
consent.
46. !ill Applications and proposals lacking
dennue plans for involvernera of human
subjects.
46.119 Research undertaken without :he
imention of involving human subjects.
46.120 Evaluation and disposition of
applieanons and proposals.
46 121 Investigational new drug or device
30-day delay requirement,
46.122 Use of federal funds.
46.123 Early termination of research
banding; evaluation of subsequent
applications and proposals.
46 124 Conditions.
subpart B-Additional Protections
Pertaining to Research,
Development, and Related
Activities Involving Fetuses,
Pregnant Women, and Human
in Vitro Fertilization
Sec.
46.701 Applicability.
46.202 Purvase
46.203 Definitions.
46.204 Ethical Advisory Boards,
46.205 Additional dunes of the instaulional
Review Boards in connection with
activities involving fetuses, pregnant
women., or human in vitro fertilization.
46.206 General limitations.
46.207 Activities directed toward pregnant
women as subjects.
46.208 Activities directed toward fetuses in
utero as subjects.
46.209 Activities directed toward fetuses ex
uteri), including nonviable fetuses, as
subjects.
46.210 Activities involving the dead fetus,
fetal material, or the placenta.
46.211 Modification or waiver of specific
requirements,
Subpart C-Additional Protections
Pertaining to Biomedical and
Behavioral Research Involving
Prisoners as Subjects
Sec.
46.301 Applicability.
46.302 Purpose.
46.303 Definitions. ?
46,304 Composicion of Institutional Review
Boards where prisoners are involved.
46.305 Additional duties of the Institutional
Review Boards where prisoners are
in
46.306 Permitted activities involving
prisoners.
Subpart D-Additional Protections
for Children Involved es Subjects in
Research
Sec.
46.401 To what do these regulations apply?
46.402 Definitions,
46.403 IRIS duties.
46.404 Research not involving greater than
minimal risk.
46.405 Re-search involving greater than
minimal risk but presenting the prospect
of direct benefit to the individual subjects.
46.406 Research involving greater than
minimal risk rind no prospect of direct
benefit to individual subjects, hut likely to
yield generalizable knowledge about the
subject's disorder or condition.
46.407 Research not otherwise approval*
which presents an opportunity to
understand, prevent, or alleviate a serious
problem affecting the health or 'welfare of
ehildren,
46.408 Requirements for permission by
parents or guardians and for assent by
children.
46.409 Wards,
Authority: 5 U.S.C. 301; ace. 474(a), 88
Stat. 352 (42 U.S.C. 289/-3(a/),
45 CFR 46
youya....*1.14910?11411.14.1.04,44.1.0.....m,
Subpart A-Basic HHS Policy for
Protection of Human Research
Subjects
Source: 46 FA 8386, January 26, 1981, 48 81t.
9269, March 4, 1983.
46.101 To what do these
regulations apply?
(a) Except as provided in
paragraph (b) of this section, this
subpart applies to all research
involving human subjects conducted
by the Department of Health and
Human Services or funded in whole
or in part by a Department grant.
contract, cooperative agreement or
fellowship.
( I) This includes research
conducted by Department employees,
except each Principal Operating
Component head may adopt such
nonsubstantive procedural
modifications as may be appropriate
from an administrative standpoint.
(2) It also includes research
conducted or funded by the
Department of Health and Human
Services outside the United States,
but in appropriate circumstances, the
Secretary may, under paragraph (e) of
this section waive the applicability of
some or all of the requirements of
these regulations for research of this
type.
(b) Research activities in which the
only involvement of human subjects
will be in one or more of the
followinedategories are exempt from
these regulations unless the research
is covered by other subparts of this
part;
ill Research conducted in
established or commonly accepted
educational settings, involving
normal educational practices, such as
(i) research on regular and special
education instructional strategies, or
(ii) research on the effectiveness of or
the comparison among instructional
techniques, curricula, or classroom
management methods.
(2) Research involving the use of
educational tests (cognitive,
diagnostic, aptitude, achievement). if
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information taken from these sources
is recorded in such a manner that
subjects cannot be identified, directly
or through identifiers linked to the
subjects.
(3) Research involving survey or
interview procedures, except where
al/ of the following conditions exist:
(i) responses are recorded in such a
manner that the human subjects can
be identified, directly or through
identifiers linked to the subjects, tii)
the subject's responses, if they
beeame known outside the research,
could reasonably place the subject at
risk of criminal or civil liability or be
(tainaging to the subject's financial
standing or employability, and (iii)
the research deals with sensitive
aspects of the subject's own behavior.
such as illegal conduct, drug use,
sexual behavior, or use of alcohol,
All research involving survey or
interview procedures is exempt,
without exception, when the
respondents are elected or appointed
public officials or candidates for
public office.
(4) Research involving the
orniervation (including observation by
par:R:4)3ms) Of publie behavior,
eiacept where all of the following,
eonditions exist: tit observations are
recorded in such a manner that the
human suhjects can be identified,
directly or through identifiers linked
to the subjects, the observations
recorded about the individual, if they
became known Outside the research,
cowd reasonably place the subject at
risk of criminal or civil liability or he
demaeing to the subject's financial
standing or employability, and (bit
the research deals with sensitise
&Teets of the subject's own behavior
such as illegal conduct, drug use,
se a tie{ behavior, or USC lit ale01101.
15) Research involving the
collection or study of existing data,
documents, records, pathological
specimens, or diagnostic specimens,
if these sources are publicly available
or if :he information is recorded by
the in in such ,3 manner that
Page 5
subjects cannot be identified, directly
or through identifiers linked to the
subjects.
(6) Unless specifically required by
statute (and except to the extent
specified in paragraph (i)), research
and demonstration projects which
are conducted by or subject to the
approval of the Department of
flealth and Human Services, and
which are designed to study.
evaluate, or otherwise examine: (i)
programs under the Social Security
Act, or other public benefit or
service programs; (ii) procedures for
obtaining benefits or services under
those programs; (iii) possible changes
in or alternatives to those programs
or procedures; or (iv) possible
changes in methods or levels of
payment for benefits or services
under those programs,
te) The Secretary has final
authority to determine whether a
particular activity is covered by these
regulations.
Id) The Simetary may require that
specific research activities or classes
of research activities conducted or
funded by the Department, hut not
otherwise covered by these
regulations, eomply"PwOh some or all
of these regulations.
(r) The Secretary may also waive
iipplicialvility of these regulations to
specific reseatch activities or classes
of research activities, otherwise
covered...by these regulations. Notices
of these acilons will be published in
the Federal Newister as they occur.
(f) No individual may receive
Department funding for research
covered by these regulations unless
the individual is affiliated with or
sponsored by an institution which
assumes responsibility for the
research under an assurance satisfying
the requirements of this part, or the
individual makes other arrangements
with the Department.
(g) Compliance with these
regulations will in (10 way render
inapplicable pertinent federal, state,
or local laws or regulations,
(h) Each subpart of these
regulations contains a separate
section describing to what the subpart
applies. Research which is covered
by more than one subpart shall
comply with all applicable subparts.
(i) If. following review of
proposed research activities that are
exempt from these regulations under
paragraph (b)(6), the Secretary
determines that a research or
demonstration project presents a
danger to the physical, mental, or
emotional well-being of a participant
or subject of the research or
demonstration project, then federal
funds may not be expended for such
a project without the written,
informed consent of each participant
or subject,
? 46.102 Definitions.
(a) "Secretary" means the
Secretary of Health and Human
Services and any other officer or
employee of the Department of
Health and Human Services to whom
authority has been delegated.
(b) "Department or "HHS''
means the Department of Health and
Hunian Serviiies,
(c)iiinstitutiOn''AULLiatlipS ,lic
or_pilyaie entilo'r ageacy (including
federal, '41-4j riciesai
(d) "Legally authorized
representative" means an individual
or judicial or other body authorized
under applicable law to consent on
behalf of a prospective subject to the
subject's participation in the
procedure(s) involved in the research
(e) "Research" 'Means a
systematic investigation designed to
develop or contribute to generalizable
knowledge. Activities which meet
this definition constitute "research"
for purposes of these regulations,
whether or not they are supported or
funded under a program which is
considered research for other
purposes, For example, some
"demonstration" and ''service"
programs may include research
activities.
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kniige 6
----T---Appftwed-For-Release,
(I) "Human subject!! means 3
living individual about whom an
investigator (whether professional or
oudent) conducting research obtains
(I) data through intervention or
interaction with the individual, or (2)
identifiable private information.
"InterventionY includes both
physical procedures by which data are
gathered (for example, venipuncture)
and manipulations of the subject or
the subject's environment i.hat are
performed for research purposes.
`'Interaction;* includes
conmmnicarion or interpersonal
contact between investigator and
subject. !Private information''
ineludes information about behavior
Mat occurs in a context in which an
individual can reasonably expect that
no observation or recording is raking
place, and information which has
been provided for specific purposes
h:y an individual and which the
individual can reasonably expect will
not he made public (for example, a
medical record). Private information
must be individually identihabh.-
0.e.. the identity of the subject is or
may readily be ascertained by the
investigator or associated with the
information) in order for obtaining
the inform.ition to constitute research
involving human subjects.
(g) Iiiintaeisk14?hica cis that'Itie
riski of harm anticipated in the
proposed researeh are not greater,
considering- probability and
inagnitudeethan those ordinarily
encountered in daily life or Outing the
performance of routine physical or
psychological examinations or tests.
(h) "Certification' means the
official notification by the institution
to the Department in accoroance with
the requirements of this part that a
research project or activity involving
human subjects has been reviewed
and approved by thejaseitotional
Review .Board (:4B) in accordance
with the aPprovedassurans:t on file at
fiHS. (Certification is required when
the research is funded by the
Department and not otherwise exempt
in accordance with ? 46.101(b)).
45 CFR 44
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Assurances.
(a) Each inAitution engaged in
researA covered by these regulations
shall provide written assurance
satisfactory to the Secretary that it
will compl,,,- with the requirements set
forth in these regulations.
(b) The Department will conduct or
iund research covered by these
regulations only if the institution has
an assurance approved as provided in
this section, and only if the institution
his certified to the Secretary that the
research has been reviewed and
approved by an IRB provided for in
the assurance, and will be subject to
?continuing review by the IRB. This
assurance shall at a minimum include:
( I A statement of principles
governing the institution in the
discharge of its responsibilities for
protecting the rielits and welfare of
human subjects of research conducted
at or sponsored by the institution,
regardless of source of funding. This
may include an appropriate existing
code, declaration, or statement of
ethical principles, or a statement
formulated by the institution itnell.
This requirement does not preempt
provisions if these regul4itions
applicable to Department?funried
research and is intsi applicable to any
research in an exempt category listed
in ? 46.101.
(2) Designation of one or more
IRBs established in accordance with
the requirements of this subpart, and
for which provisions are made for
-..?
meeting space and sufficient staff to
support the IRB's review and
recordkeepnig duties.
(3) A list of the MB members
identified by name; earned degrees;
representative capacity; indications of
experience such as board
certi:ications, licenses, etc.,
sufficient to describe each member's
chief anticipated contributions to IRB
deliberations; and any employment or
other relationship between each
member and the institution; for
example: full-time employee, part-
time employee, member of governing
panel or board, stockholder, paid or
unpaid consultant Changes in IRB
membership shall be reported to the
Secretary.'
(4) Written procedures which the
IRB will follow (i) for conducting its
initial and continuing review of
research and for reporting its findings
and actions to the investigator and the
institution; (ii) for determining which
projects require review more often
than annually and which projects
need verification from sources other
than the investigators that no material
changes have occurred since previous
IRB review; (iii) for insuring prompt
reporting to the IRB of proposed
changes in a research activity, and for
insering that changes in approved
.research, during the period for which
IRB approval has already been given,
may not be initiated without IRB
review arid approval except where
necessary to eliminate apparent
immediate hazards to the subject: and
(iv) for insuring prompt reporting to
the IRB and to the Secretary ' of
unanticipated problems involving
risks to subjects or others.
(c) The assurance shall be executed
by an individual authorized to act for
the institution and to assume on
behalf of the insiitution the
obligations imposed by these
regulations, and shall be filed in such
form and manner as the Secretary
may prescribe.
(d) The Secretary will evaluate all
assurances submitted in accordance
with these regulations through such
officers and employees of the
Department and such experts or
consultants engaged for this purpose
as the Secretary determines to be
appropriate. The Secretary's
evaluation, will take into
consideration the adequacy of the
proposed BIB in light of the
anticipated scope of the institution's
research activities arid the types of
subject populations likely to be
' Repors should be filed with Inc Office
for Protectiort from Research Risks, Natiuual
Institutes of Health, Department of Health
anti Human Services. Bethesda, Marylaiki
20205.
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45. CFR 46 Approved For Release 2004/07/09 : CIA-RDP96-00788R001500090010-7
involved, the appropriateness of the
, proposed initial and continuing
review procedures in light of the
probable risks, and the size and
complexity of the institution.
(e) On the basis of this evaluation,
the Secretary may approve or
disapprove the assurance, or enter
into negotiations to develop an
approvable one. The Secretary may,
linth the period during which any
particular approved assurance or class
oi approved assurances shall remain
effective or otherwise condition or
restrict approval.
(f) Within 60 days after the daie of
submission to IBIS of an application
or proposal, an institution with an
approved assurance covering the
proposed research shall certify that
the application or proposal has been
reviewed and approved by the IRB.
Other institutions shall ceriity that the
application or proposal has been
approved by the 1RB within 30 days
atter receipt of a request for such a
certification from the Department. If
the certification is not submitted
within these time limits, the
implication or proposal may be
returned to the institution.
* 46.104 [Reserved'
a 46.105 [Reserved'
* .46.106 [Reserved)
* 46.107 IRB membership.
tat Each MB shall have at least
five members., with varying
backgrounds to promote complete and
3ciefitiate review of research activities
commonly conducted by the
institution. The IRS shall be
sufficiently qualified through the
experience and expertise of its
members, and the diversity of the
members' backgrounds including
consideration of the racial and
ealtural backgrounds of members and
sensitivity to such issues as
community attiooles, to promote
respect for its advice and counsel in
safeguarding the rights and welfare of
human subjects. In addition to
possessing the professional
competence necessary to review
specific research activities, the IRS
shall be able to ascertain the
acceptability of proposed research in
terms of institutional commitments
and regulations, applicable law, and
standards of professional conduct and
practice. The IRB shall therefore
include persons knowledgeable in
these areas. If an IRS regularly
reviews research that involves a
vulnerable category of subjects,
including but not limited to subjects
covered by other subparts of this part.
the IRS shall include one or more
individoals who are primarily
concerned with the welfare of these
subjects.
(b) No IRB may consist entirely of
men or entirely of .women, or entirely
of members of one profession.
(e) Each 11(1.1 shall include at least
one member whose primary concerns
are in nonscientific areas; for
example: lawyers, ethicists, members
of the'clergy.
(d) Each IRS shall include at least
one member who is not otherwise
affiliated with the institution and who
is not part of the immediate family of
a person who is affiliated with the
institution.
(c) No IRS may have a member
participaiing in the 1RB's initial or
continuing review of any project in
which the member has a conflicting
interest, except to provide
informailOn requested by the IRB.
(0 An IRS may, in its discretion,
invite individuals with competence in
special areas to assist in the review of
complex issues which require
expertise beyond or in addition to that
available on the IRS. These
individuals may not vote with the
? 46.10N IRB functions and
operations.
In order to fulfill the requirements
of these retulationS each BIB shall:
(al Follow written procedures as
provided in ? 46.103000).
Page 7
(b) Except when an expedited
review procedure is used (see
? 46.110), review proposed research
at convened meetings at which a
majority of the members of the IRB
are present, including at least one
member whose primary concerns are
in nonscientific areas. In order for the
research to be approved, it shall
receive the approval of a majority of
those members present at the
meeting.
(c) Be responsible for reporting to
the appropriate institutional officials
and the Secretary ' any serious or
continuing noncompliance by
investigators with the requirements
and determinations of the IRB.
f 46.109 IRB review of research.
(a) An IRB shall review and have
authority to approve, require
modifications in (to secure approval),
or disapprove, all research activities
covered by these regulations.
0:0 An BIB shall require that
information given to subjects as part;
of informed consent is in accordance
with ? 46.116. The IRB may require
that information, in addition to that
specifically mentioned in ? 46.116,
be given to the subjects when in the
nail's judgment the information
would meaningfully add to the
protection of the rights and welfare of
subjects,
(c) An IRB shall require
documentation of informed consent or
may waive documentation in
accordance with * 46.117.
(d) An IRB shall notify -
investigators and the institution in 0
writing of its decisioreto approve or
disapprove, the proposed research
activity, or of modifications required
to secure MB approval of the
research activity. lithe IRS decides
to disapprove a research activity, it
shall include in its written notification
' itcpcms shoidd be tiled with thc Office
for l'i7olcciion from Research Risks, National
institutes of Health, Department of Health
anti /Inman Services, Bethesda. hicarylaosi
202,11
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45 CFR 46
rage 8 _Approved For Rolease 2004/07/.09 : CIA-RDPB6-00788R001.59.0S/9.010.7.7__
a statement of the reasona for its ,
'decision and give the investigator an
opportunity to respond in person or in
writing.
(e) An IRB shall conduct
continuing review of research covered
by these regulations at intervals
appropriate to the degree of risk, but
not less than once per year, and shall
have authority to observe or have a
third party observe the consent
process and the research,
?46.110 Expedited review
procedures for certain kinds of
research involving no more than
minimal risk, and for minor
changes in approved research.
(a) The Secretary has established,
and published in the Federal
Register, a list of categories of
research that may be reviewed by the
BIB through an expedited review
procedure. The list will be amended,
as appropriate, through periodic
republication in the Federal
Register.
lb) An IRB may review some or all
of the research appearing on tha list
through an expedited review
procedure, if the research involves no
more than minimal risk. The IRB may
also use the expedited review
procedure to review minor changes in
previously approved research during
the period for which approval is
authorized. Under an expedited
review procedure, the review may be
carried out by the IRB chairperson or
by one or more experienced reviewers
designated by the chairperson from
among members of the IRB. In
reviewing the research, the re-viewers
may exercise all of the authorities of
the IRB except that the reviewers may
not disapprove the research. A
research activity may be disapproved
only after review in accordance with
the non-expedited procedure set forth
in g 46,108(h).
(c) Each 11th which uses an
expedited review procedure shall
adopt a method for keeping all
members advised of research
proposals which have been approved
under the procedure..
(d) The Secretary may restrict,
suspend, or terminate an institution's
or IRB's use of the expedited review
procedure when necessary to protect
the rights or welfare or subjects.
?46,111 Criteria for IRB
approval of research.
(a) in order to approve research
covered by these regulations the IRB
shall determine that all of the
following requirements are satisfied:
(I) Risks to subjects are
minimized: (i) By using procedures
which are consistent with sound
research design and which do not
unnecessarily expose subjects to risk,
and (ii) whenever appropriate, by
using procedures already being
performed on the subjects for
diagnostic or treatment purposes. ,
(2) Risks to subjects are reasonable
in relation to anticipated benefits. if
any, to subjects, and the importance
of the knowledge that may reasonably
he expected to result. In evaluating
risks and benefits, the IRB should
consider only those risks And benefits
that may result from the research (as
distinguished front' risks and benefits
of therapies subjects would receive
even if not participating in the
research). The IRO should not
consider possible long-range effects
of applyin3 knowledge gained in the
reseal-eh (for example, the possible
effects Ohhe research on public
policy) as among those research risks
that fall within the purview of its
responsibility. ,
(3) Selection of subjects is
equitable. In making this assessment
the TRH should take into account the
parposcs of the research and the
setting in which the research will be
conducted.
(4) Informed consent will be
sought from each prospective subject
or the subject's legally authorized
representative, in accordance with,
and to the extent required by
? 46.116.
(5) Informed co.r.iseRA,will be
appropriately documented, in
accordance with, and to the extent
required by g 46.117.
(6) Where appropriate, the research
plan makes adequate provision for
monitoring the data collected to
insure the safety of subjects.
(7) Where appropriate, there ate
adequate provisions to protect the
privacy of subjecia.and to maintain
the confidentiality of data.
(b) Where some or all of the
subjects are likely to be vuliserahle to
coercion or undue influence, such as
persons with acute or severe physical
or mental illness, or persons who are
economically or educationally
disadvantaged, appropOtte.a4dition4
safeguards have been included in the
study to protect the rights and welfare
of these subjects,
?-?14.
46.112 Review by institution.
Research covered by these
regulations that has been approved by
an IB may be subject to further
appropriate review and approval or
disapproval by officials of the
institution. However, those officials
may not approve the research if it has
not been approved by an !RB.
? 46.113 Suspension or
termination of IRB approval of
research.
-
An IRB shall have katitOrity, to'
A
suspend or terminate approval of
research that is not being conducted
in accordance with the IRB 's
requirements or that has been
associated with unexpected serious
harm to subjects. Any suspension or
termination of approval shall include
a statement of the reasons for the
IRS's action and shall be relxirtecl-
prompily to the investigator,
appropriate institutional officials, and
the Secretary.?
,
e Reports should be filed with the Office
for Protection from Research Risks, National
institutes of Health, ilepartmert of Health
and Human Services, Bethesda, Maryland
20205.
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? 45 CFR 46
?:A-pproved-For-Release--2-004/07409---C4A-RDP-96-00788R00i5OO9OO I O-
46,i4 Cooperative research.
Cooperative research projects are
those projects, normally supported
through grants, contracts, or similar
arrangements, which involve
institutions in addition to the grantee
or prime contractor (such as a
contractor with the grantee, or a
subcontractor with the prime
contractor). In such instances, the
grantee or prime contractor remains
responsible to the Department for
safeguarding the rights and welfare of
human subjects. Also, when
cooperating institutions conduct some
or all ot the research involving some
Or all of these subjects, each
cooperating institution shall comply
with these regulations as though it
received funds for its participation in
the project directly from the
Department, except that in complying
with Mese regulations institutions
mitts use joint review, reliance upon
me review of another qualified !RH,
or similar arrangements aimed at
lvoidance of duplication of et fort.
46.115 IRE records.
rat An institution, or where
appropriate an MB, shall prepare and
maintain adequate documentation of
1i;t11 activities, including the
following:
(1) Copies of all research proposals
reviewed, scientific evaluations, if
any, that accompany the proposals,
approved sample consent documents,
progress reports submitted by
in and reports of injuries
to subjects.
(2) Minutes of IRB meetings which
shall be in sufficient detail to show
aitentiance at the meetings; actions
taken by the MB; the vote on these
actions including the number of
members voting for, against, and
abstaining; the basis for requiring
changes in or disapproving research:
and a written summary of the
discussion of controverted issues and
their resolution.
(3) Records of continuing review
activities.
(4) Copies of all correspondence
between the IRB and the
investigators,
(5) A list of IRB members as
required by ? 46,103(b)(3).
(6) Written procedures for the IRB
as reqnired by 46.103(b)(4).
(7) Statements of significant new ;
findings provided to subjects, as
required by ? 46.116(b)(5).
(b) The records required by this
regulation shall be retained for at
least 3 years after completion of the
research, and the records shall be
a
Department at reasonable times and
ccessiblc for inspection and copying
y authorized representatives of the :
in a reasonable manner.
46.116 General requirements
for informed consent.
,
Except as provided elsewhere in
this or other subparts, no investigator
may involve a human being as a
subject in research covered by these
regulations unless the investigator has
obtained the legally effective
informed consent or the subject or the
subject's legally authorized
representative. An investigator shall
seek such consent only untkr
circumstances that provide the
prospective subjeetnor the
representative sufficient opportunity
to consider whether or not to
participate and that minimize the
possibility of coercion or undue
influence. The information that is
given to the subject or the
representative $hali be in language
understandable to..the_subject or the
representative,infortned consent,
whether oral or written, may include
any exculpatory language through
which the subject or the
representative is made to waive or
appear to waive any of the subject's
legal rights, or releases or appears to
release the investigator, the sponsor,
the institution or its agents from
liability for negligence.
(a) Basic elements of informed
consent. Except as provided in
paragraph ft) or (d) of this section, in
seeking informed consent the
following information s.hait be
provided to each sitbjeci:
El) A statement that the study
involves research, an explanation of
the purposes of the research and the
, expected duration of the subject's
participation, a description of the
procedures to be followed, and
identification of any procedures
which are experimental;
i (2) A description of any reasonably
foreseeable risks or discomforts to the
subject;
(1) A description of any benefits to
the subject or to others which may
reasonably be expected from the
research;
; 7(4) A disclosure of appropriate
? alternative procedures or courses of
treatment, if any, that might be
. advantageous to the subject;
(5) A statement describing the
? extent, if any, to which
confidentiality, of records identifying
the subject will be maintained;
- (6) For research involving more
than minimal risk, an explanation as
, to whether any compensation and an
, explanation as to whether any
medical treatments are available if
injury occurs and, if so, what they
consist of, or where further
inforoation may be obtained;
; An explanation of whom to .e;)
contact for answers to pertinent
questions about the research and
,research subjects' rights, and whom
to contact in the event of a research-
related injury to the subject; and
, IA A statement that participation is
voluntary, refusal to participate will
involve no penalty or loss of benefits
.to which the subject is otherwise
entitled, and the subject may
? discontinue participation at any time
without penalty or loss of benefits to
/which the subject is otherwise
eptitled.
(h) Additional elements of
informed consent, When appropriate,
one or more of the following elements
of information shall also be provided
to each subject:
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Page 10 45 CFR 46
UrtirRag-E9CKSIERse 3aRthf(laTaltakallii9kaq788R?MaNR9Minattinity to read it before
- (I) A state ,
"treatment or procedure may involve
t'yisks to the subject (or to the embryo
or fetus, if the subject is or may
;hecome pregnant) which are currently
?.unforeseeable:
(2) Anticipated circumstances
a under which the subject's
r participation may be terminated by
the investigator witpout regard to the
subject's consent;
(3) Any additional costs to the
tibject that may result front
participation in the research;
(4) The consequences of a
subject's decision to withdraw from
oboe research and procedures for
orderly termination of participation
4by the subject;
5) A statement that significant
new findings developed during the
course of the research which may
relate to the subject's willingness to
lcontinue participation will be
a provided to the subjeet; and
The approximate number of
--liubjects involved in the sooty.
(c) An Ilnliemay aperove
proseettureesIn0 ociesesourictudee or
itte44-;.$04.114 or et
-
ecuota,c1f, informed consent set
forth above, or waive the requirement
to obtain informed consent provided
the IRB finds and documents that:
(I) The research or demonstration
project is to be conducted by or
subject to the approval of state or
local government officials and is
designed to study, evaluate, or
otherwise examine: (i) programs
under the Social Security Act, or
other public benefit or service
programs; (ii) procedures for
obtaining benefits or services under
those programs: (iii) possible changes
in or alternatives to those programs
or procedures; or (iv) possible
changes in methods or levels of
payment for benefits or services under
those programs; and
(2) The research could not
practicably he carried out without the
waiver or alteration. .
(dl An LRB may approve a consent
-procedure which does not include, or
??
alemenie of informed consent set
forth above, or waive the
requirements to obtain informed
consent provided the IRB finds and
documents that:
(I) The research involves no more
than minimal risk to the subjects;
(2) The waiver or alteration will
not adversely affect the rights and
welfare or the subjects;
(3) The research could not
practicably be carried out without the
waiver or alteration; and
(4) Whenever appropriate, the
subjects will be provided with
additional pertinent information after
participation
(e) The informed consent
requirements in these regulations are
not intended to preempt any
applicable federal, state, or local laws
which require additional information
to be disclosed in order for informed
consent to be legally effective.
(f) Nothing in these regulations is
intended to limit the authority of a
physician 10 provide emergency
medical care. to the extent the
physician is permitted to do so under
applicable federal, state, or local law,
I? 46.117 Documentation of
informed consent.
(a) Except as provided in.
paragraph (c) of this section,
informed consent shall be
documented by the use of a written
consent form approved by the IRB
and signed by the subject or the
subject's legally authorized
representative. A copy shall be given
to the person signing the form.
(b) Except as provided in
paragraph (c) of this section, the
consent form may be either of the
following:
(1) A written consent document
that embodies the elements of
informed consent required by
? 46.116. This form may be read to
the subject or the subject's legally
authorized representative, but in any
event, the investigator shall give
either the subject or the representative
it is signed; or
(2) A :` 4,*k Ann" sirktoin
consent document stating that the
elements of informed consent
required by 46.116 have been
presented orally to the subject or the
subject's legally authorized
representative. When this method is
used, there shall be a witness to the
oral presentation. Also, the IRB shall
approve a written summary of what is
to he said to the subject or the
representative. Only the short form
itself is to be signed by the subject or
the representative. However, the
witness shall sign both the short form
and a copy of the 4,Immary, and the
person actually (mooning consent
shall sign a copy of the summary. A
copy of the summary shall be given to
the subject or the representative, in
addition to a copy of the "short
form,
(c) An IRS may waive, the
requirement 145r the invistigaiOrri
obtain e signed consent to-rrn for --sane
(If all subjects if it fit. Is
(I) That the only record linking the
subject and the research would be the
consrnt document and the principal
risk would be potentiai harm resulting
from a breach of confidentiality. Each
subjec will be asked whether the
subject wants documentation linking
the subject with the research, and the
subject's wisees will govern; or
(2) That the re:earch prescntt
more tilgtr. Mir:41141 ifiskof ha
sOftels and alvoivcii 119 partx4 ors
for whiett written at4.
required outside ol* r
context,
In. cases where Ole documentation
requirement is waived, Me IRB may
require the investigator to provide
subjects with a written statement
regarding the research.
? 46.118 Applications and
proposals lacking definite plans for
Involvement of human subjects.
Certain types of applications for
grants, cooperative agreements. or
contracts are submitted to the
Department with the knowledge that
subjects may be involved within the
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01
? 45 crR 4,6 Approved For Release 2004/07/09 : CIA-RDP96-00788R001500090010-7
period of funding, but definite plans
would riot normally be set forth in the
application or proposal. These
include activities such as institutional
type grants (including bloc grants)
where selection of specific projects is
the institution's responsibility;
research training grants where the
activities involving subjects remain to
be selected; and projects in which
human subjects' involvement will
depend upon completion of
instruments, prior animal studies, or
purification of compounds. These
applications need not be reviewed by
an BIB before an award may be
made. However, except for research
described in ? 46.101(b), no human
subjects may be involved in any
project supported by these awards
until the project has been reviewed
and approved by the 1RB, as provided
in these regulations, and certhfication
N,ibraittcd to the Department.,
46.1,19 Research undertaken
without the intention of involving
human saibjects.
In the event research (conducted or
funded by the Department) is
undertaken without the intention of
involving human subjects. but it is
later proposed to use human subjects
in the research, the research shall first
be reviewed and approved by an IRB,
a:, provided in Mese regulations, a
?.-enification submitted to the
Department, and final approval g vett
to die proposed change by the
Department.
? 46.120 Evaluation and
disposition of applications and
proposals.
(u) The Secretary will evaluate all
applications and proposals involving
human subjects submitted to the
Department through such officers and
employees of the Department and
the subjects and others, and the
importance of the knowledge to be
gained.
(b) On the basis of this evaluation,
the Secretary may approve or
disapprove the application or
proposal, or enter into negotiations to
develop an approvable one.
ji 46.121 Investigational new drug
or device 31)-day delay requirement.
When an institution is required to
prepare or to submit a certification
with an application or proposal under
these regulations, and the application
or proposal involves an
investigational new drug (within the
meaning of 21 U.S.C. 355(i) or
357(d)) or a significant risk device (as
defined in 21 CFR 812.3(m)), the
institution shall identify the drug or
device in the certification. The
institution shall also state whether the
30-day interval required for
investigational new drugs by 21 CFR
312.1(a) and for significant risk
devices by 21 CFR 812.30 has
elapsed, or whether the Food and
Drug Administration has waived that
requirement. It' the 30-day interval
has expired, the institution shall state
whether the Food ad Drug
Administration has requested that the
soonAnr continue to withhold or
restrict the use of the drug or device
in human subjects. If the 30-day
interval has not expired, and a waiver
has not been received, the institution
shall send a-"ktatement to the
Department upon expiration of the
interval. The Department will not
consider a certification acceptable
until the institution has submitted a
statement that the 30-day interval has
elapsed, and the Food and Drug
Administration has not requested it to
limit the use of the drug or device, or
that the Food and Drug
Administration has waived the 30-day
sueli experts and consultants as the
interval.
Secretary determines to be
appropriate. 'Ibis evaluation will take ? 46.122 Use of Federal funds.
into consideration the risks to the Federal funds administered by the
subieets, the adequacy of protection Department may not be expended for
against these risks, the potential research involving human subjecis
benefits of the proposed research to unless the requirement of these
Page H
regulations, including all subparts of
these regulations, have been satisfied.
? 46.123 Early termination of
research funding; evaluation of
subsequent applications and
proposals.
(a) The Secretary may require that
Department funding for any project
be terminated or suspended in the
manner prescribed in applicable
program requirements, when the
Secretary finds an institution has
materially failed to comply with the
terms of these regulations.
(b) In making decisions about
funding applications or proposals
covered by these regulations the
Secretary may take into account, in
addition to all other eligibility
requirements and program criteria,
factors such as whether the applicant
has been subject to a termination or
suspension under paragraph (a) of this
section and whether the applicant or
the person who would direct the
scientific and technical aspects of an
activity has in the judgment of the
Secretary materially failed to
discharge responsibility for the
protection of the rights and welfare of
human subjects (whether or not
Department funds were involved).
46.124 Conditions.
With respect to any research
project or any class of research
projects the Secretary may itnpose
additional conditions prior to or at the
time of funding when in the
Secretary's judgment additional
conditions are necessary for the
protection of human subjects.
Subpart II?Additional Protections
Pertaining to Research
Development, and Related
'Attivities faidiving Fetuses/
Pregnant Women, and Human In
Vitro Fertilization'
SOURCE:: 40 FR 33528, Aug_ X. 1975. 43 FR
1758. January it, 1978, 4.1 Fft
51559. November 3, I 978
? 46.201 Applicability.
(a) !Ile regulations in this subpart
arc applicable to all Department of
Health, Education, and Welfare
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Page 12 ,
t grants and contract .supporting
research, development, and related
activities involving: (1) The fetus, (2)
pregnant women, and (3) human in
vitro fertilization.
(b) Nothing in this subpart shall be
construed as indicating that
compliance with the procedures set
forth herein will in any way render
inapplicable pertinent State or local
laws bearing upon activities covered
by this subpart.
(c) The requirements of this
subpart are in addition to those
imposed under the other subparts of
this part.
46.202 Purpose.
It is the purpose of this subpart to
provide additional safeguards in
reviewing activities to which this
subpart is applicable to assure that
they conform to appropriate ethical
standards and relate to important
societal needs
46.203 Definitions.
As used in this subpart:
(a) ''Secretary means the
Secretary of Health, Education, and
Welfare and any other officer or
employee of the Department of
Health, Education, and Welfare to
whom authority has been delegated,
(b) 'Pregnancy" encompasses the
period of time. from confirmation of
implantation (through any of the
presumptive signs of pregnancy, such
as missed menses, or by a medically
acceptable pregnancy test), until
expulsion or extraction of the fetus.
(c) "Fetus" means the product of
conception from the time of
implantation as evidenced by any of
the presumptive signs of pregnancy,
such as missed menses, or a
medically acceptable pregnancy test),
until a determination is made,
tollowing explusion or extraction of
the fetus, that it is viable.
(d) "Viable" as it pertains to the
fetus means being able, after either
spontaneous or induced delivery, to
survive (given the benefit of available
medical therapy) to the point of
independently maintaining heart
beat and respiration. The Secretary
may from time to time, taking into
account medical advances, publish in
the FEDERAL fe. EGIS tER guidelines
to assist in determining whether a
fetus is viable for purposes of this
subpart. If a fetus is viable after
delivery, it is a premature infant.
(e) "Nonviable fetus" means a
fetus ex wero which, although living,
is not viable.
(f) "Dead fetus" means a fetus ex
utero which exhibits neither
heartbeat, spontaneous respiratory
activity, spontaneous movement of
voluntary muscles, nor pulsatiou of
the umbilical cord (if still attached).
tg) "In vitro fertilization? means
any fertilization of human ova which
occurs outside thebody of a female,
either through admixture of donor
human sperm and ova or by any other
means.
? 46.204 ?Etfilettl Advisory'
Boards.
(a) One or more Ethical Advisory
Boards shall be established by the
Secretary.. Members of these board(s)
shall be so selected that tOte board(s)
will be competent to deal with
medical, legal, social, ethical, and
related issues and may include, for
example, research scientists,
physicians, psychologists,
sociologists, educators, lawyers, and
ethicists, as well as representatives of
the gene,-al public. No board member
e,
may be a regular, full-time employee
of the Department of Health,
Education, and Welfare.
(b) At the request of the Secretary,
the Ethical Advisory Board shall
render advice consistent with the
policies and requirements of this Part
as to ethical issues, involving
activities covered by this subpart,
raised by individual applications or
proposals. In addition, upon request
by the Secretary, the Board shall
render advice as to classes of
applications or proposals and general
policies, guidelines, and procedures.
(c) A Board may establish, with
the approval of the Secretary, classes
of applications or proposals which:
45 CFR 46
(I) Must be submitted to the Board,
or (2) need not be submitted to the
Board. Where the Board so
establishes a class of applications or
proposals which must be submitted,
no application or proposal within the
class may be funded by the
Department or any component thereof
until the application or proposal has
been reviewed by the Board and the
Board hats rendered advice as to its
acceptability from aro ethical
standpoint.
(4) No application or proposal
involving human in vitro fertilization
may be funded by the Department or
any component thereof until the
application or proposal has been
reviewed by the Ethical Advisory
Board and the Board has rendered
advice as to its acceptability front an
ethical standpoint.
I 46.205 Additional duties ot
inatitutiontil'kkidt; -Boor& In
connection with activities
involving fetuses, pregnant
women, or human in vitro
I
ertiii
zatIon.
(a) In addition to the
responsibilities prescribed for
Institutional Review Boards under
Subpart A of this part, the applicant's
or offeror's Board shall, with respect
to activities covered by this subpart,
carry out the following additional
duties:.
(1) Determine that all aspects of
the activity meet the requirements of
this subpart;
(2) Determine that adequate
consideration has been given to the
manner in which potential subjects
will be selected, and adequate
provision has been made by the
applicant or offeror for monitoring
the actual informed consent process
(el., through such mechanisms,
when appropriate, as participation by
the Institutional -Review Board or
subject advocates in: (i) Overseeing
the actual process by which
individual consents required by this
subpart are secured either by
approving induction of each
individual into the activity or
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verifying, perhaps through sampling,
that approved procedures for
induction of individuals into the
activity are being followed, and (ii)
monitoring the progress of the
activity and intervening as necessary
through such steps as visits to the
activity site and continuing evaluation
to determine if any unanticipated
risks have arisen):
(3) Carry out such other
responsibilities as may be assigned by
the Secretary.
(b) No award may be issued until
the applicant or offeror has certified
to the Secretary that the institutional
Review Board has made the
determinations required under
paragraph (a) of this section and the
Secretary has approved these
detertninations, as provided in
46.120 of Subpart A of this part.
(c) Applicants or offerors seeking
support for activities covered by this
subpart must provide for the
designation of an Institutional Review
Board, subject to approval by the
Secretary, where no such Board has
been established under Subpart A of
this part,
? 46.206 General limitations.
(a) No activity to which this
suhpart is applicable may be
undertaken unless:
t I) Appropriate studies on animals
and nonpregnant individuals have
been completed;
(2) Except where the purpose of
the activity is to meet the health
needs of the mother or the particular
fetus, the risk to the fetus is minimal
and in all cases, is the least possible
risk for achieving the objectives of
the activity.
(3) Individuals engaged in the
activity will have no part in: (i) Any
decisions as to the timing, method,
and procedures used to terminate the
pregnancy, and (ii) determining the
vitihlity of the fetus at the
tesmination of the pregnancy; and
(sti No procedural changes which
may cause greater than minimal risk
to the fetus or the pregnant woman
will be introduced into the procedure
for terminating the pregnancy solely
in the interest of the activity.
lb) No inducements, monetary or
otherwise, may be offered to
terminate pregnancy for purposes of
the activity.
(40 FR 33528, Aug. 8, 1975, as amended 31
40 FR 51638. Nov. 6, 1975)
I 46.207 Activities directed
toward pregnant women us
subjects.
(a) No pregnant woman may he
involved as a subject in an activity
covered by this subpart unless: (I)
The purpose of the activity is to meet
the health needs of the mother and the
fetus will be placed at risk only to the
minimum extent necessary to meet
such needs, or (2) the risk to the fetus
is minimal.
al) An activity permitted under
paragraph (a/ of this section may be
conducted only if the mother and
father are legally competent and have
given their informed consent alter
having been fully informed regarding
possible impact on the fetus, except
that the father's informed consent
need not be secured if: (I) The
purpose of the activity is toameet the
health needs of the mother; (2) his
identity or whereablIuts cannot
reasonably be ascertained; (3)he is
not reasonably available: or i4) the
pregnancy resulted from rape.
46.208 Activities directed
toward fetuses in utero as
subjeCtS", .
(a) No fetus in wen') may he
involved as a subject in any activity
covered by this subpart unless: (I)
The purpose of the activity is to meet
the health needs of the particular fetus
and the fetus will he placed at risk'
only to the minimum extent necessary
to meet such needs, or (2) the risk to
the fetus imposed by the research is
minimal and the purpose of the
activity is the development of
important biomedical knowledge
which cannot be obtained by other
means.
(b) An activity permitted under
paragraph (a) of this section may be
conducted only if the mother and
Page 13
fathcr are legally competent and have
given their informed consent, except
that the father's consent need riot be
secured if: (1) His identity or
whereabouts cannot reasonably be
ascertained, (2) he is not reasonably
available, or (3) the pregnancy
resulted from rape.
I) 46,209 Activities directed
toward fetuses ex utero,
including nonviable fetuses, as
subjects.
(a) Until it has been ascertained
whether or not a fetus ex utero is
viable; a fetus ex utero may not be
involved as a subject in an activity
covered by this subpart unless:
(1) There will be no added risk to
the fetus resulting from the activity,
and the purpose of the activity is the
development of important biomedical
knowledge which cannot be obtained
by other means, or
(2) The purpose of the activity is to
enhance the possibility of survival of
the particular fetus to the point of
(b) No nonviable fetus may be
involved as a subject in an activity
covered by this subpart unless:
(I) Vital functions of the fetus will
not be artificially maintained,
(2) Experimental activities which
of themselves would terminate the
heartbeat or respiration of the fetus
will not be employed, and
(3) The purpose of the activity is
the development of important
biomedical knowledge which cannot
he obtained by other means.
(c) In the event the fetus er ufero
is found to be viable, it may be
included as a subject in the activity
only to the extent permitted by and in
accordance with the requirements of
other subparts of this part.
(d) An activity permitted under
paragraph (a) or (b) of this section
may be conducted only if the mother
and father are legAlly competent and
have given their informed consent,
except that the father's informed
consent need not be secured if: (I) his
identity or whereabouts cannot
reasonably be ascertained, (2) he is
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not reasonably available, or (3) the
? ,pregnancy resulted from rape.
? 46.210 Activities involving the
dead fetus, fetal MateriAl, or the
placenta.
Activities involving the dead fetus,
mascerated fetal material. or cells,
tissue, or organs excised from a dead
feius shall be conducted only in
accordance with any applicable State
or local laws regarding such
activities.
? 46.211 Modification or waiver
of specific requirements.
Upon the request of an applicant or
offeror (with the approval of its
Institutional Review Board), the
Secretary may modify or waive
specific requirements of this subpa
with the approval of the Ethical
Advisory Board after such
opportunity for public comment as
the Ethical Advisory Hoard considers
appropriate in the particular .nsiance.
In making such decisions, the
Secretary will consider whether the
risks to the subject are so outweighed
by the sum of the benefit to the
subieci and the importance of the
linowlciee to hi: gained as CO V. rraiit
ii h 'noddle:loon or waiver and that
such benefits cannot he gained exarept
through a modification or waiver.?
Any hue!) modifications thr waivers
ill be published as notices in Me
1717 or itAt. R ereis
Subpart C? Additional Protections
Pertaining to Biomedical and
Behavioral Research Involving
Prisoners as Subjects
Sovice: 43 FR 53655, Nov 16.
ti 46,301 Applicability.
ia) The regulations in this subpart
are applicable to all biomedical and
behavioral research conducted or
supported by the Department of
Health, Education, and Welfare
involving prisoners as subjects.
(hi Nothing in this subpart shall he
Lninscrued as indicating chat
eompliance with the procedures set
forth herein will authorize research
tds inc prisoners as subjects, to the
ester( such research is limited or
barred by applicable Slate or local
(e) The requirements of this
subpart are in addition to those
imposed under the other subparts of
Mis part.
5 46.302 Purpose.
Inasmuch as prisoners may be
under constraints because of their
incarceration which could affect their
ability to make a truly voluntary and
uncoerced decision whether or not to
participate as subjects in research, it
is the purpose of this subpart to
provide additional safeguards for the
protection of prisoners involved in
activities to which this subpart is
applicable.
? 46.303 Definitihns.
As used in this subpart:
(a) "Secretary- means the
Secretary of Health, Education, and
Welfare and any other officer or
employee of the Department of
Health, Education, and Welfare to
whom authority has been delegated.
tb) -MEW.' means the
Department of Health, Eduiration,
?
and 1Velfare,
(e) "Prisoner- means any '
individual involuntarily confined or
detained n penat,Mstitution.:The
teem is intended to enconipass '
individuals semenCeerto such an
institution under a criminal or civil
statute, individual e detained in other
facilities by virtue of statutes or
'commininea.f.procedures:which
'provide aiternativei to crunniul
prosecution or incarceration in a
penal institution, and, individuals
detained pcnding anaignment.
_
or sentencing.
(d) "'Minimal risk" is the
prohabilitv and magnitude of physical
or psyehologir al harm that is
normally encountered in the daily
lives, or in the routine medical,
dental, or psychological examination
)t healthy persons.
? 46.301 Composition of
Institutional Review Boards
where prisoners ape involved,
in addition hi satisfying the
45 CFR 46
requirements in ? 46.107 of this part,
an Institutional Review Board,
carrying out responsibilities under
this part with respect to research
covered by this subpart, shall also
meet the following specific
requirements:
(a) A majoilti,.4 tl? Board'
(excInsiii'of istisoiser- members) Aid
lia.v-e no association with Lh, prison(s)
4
involved? Apart from
membership on the Board!. +7,
(b) Al least one membet of the
Board $hall *.'r 'r a
Piignm,i01;sentatii.I.r.with.-
appiiiii?iiit6.4ckground arid _itit
perience to serve in that capacity,
except that where a particular
research project is reviewed by more
than one Board only one Board need
satisfy this requirement.
? 46.305 Additional duties .of the
Institutional Review Boards
where prisoners are Involved.
(a) in addition to all other
responsibilities prescribed for
institiaional Review Boards under
this part, the Board shall review
research covered by this subpart and
approve such research only if it finds
that:
(I) The research under review
represents one of the categories of
research permissible under
? 46.306taR2);
(2) Any possible advantages
accruing to the prisoner through his
or her participation in the research,
when compared to the general living
conditions, medical care, quality of
food, amenities and opportunity for
earnings in the prison, ax not of such
a magnitude, that his or her ability tQ. ,
weigh thelisk5, of the research agaillSt
the value of such advantagesin the
limited choice environment of the
prison is impaired:
(3) The risks inVolved in the
research are commensurate with risks
that would be accepted by
nonprisoner volunteers;
(4) Procedures for the selectton.of
subjects within the prison are fair to
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all prisoners and immune from
arbitrary intervention by prison
authorities or prisoners. Unless the
principal investigator provides to the
Board justification in writing for
following some other procedures,
control. subjects mug be selected'
randomly from the group of available
prisoners who meet the characteristics
needed for that particular research
project;
(5) The information is presented in
language which is understandable to
the subject population:
(6) Adequate assurance exists that
PaM01,04a10- 4.4 iiks.,,iAt?;
account a prisoner's participation in
the research in making decisions
regarding parole, and each prisoner is
clearly informed in advance that
participation in the research will have
no effect on his or her parole; and
(7) Where the Board finds there
may be a need for follow-up
CX anti nation or care of participants
at the end of their participation,
adequate provision has been made for
such examination or care, taking into
account the varying lengths of
individual prisoners' sentences, and
for informing participants of this tact.
lad The Board shall carry out such
other duties as may be assigned by
the Secretary.
tc.) The institution shall certify to
the Secretary, in such form and
C11:11111cff as the Secretary may require,
that the duties of the Board under this
section have been
46.306 Permitted research
involving prisoners.'
(a) Biomedical or behavioral
research conducted or supported by
DIEW may involve prisoners as
subjects only if:
(I) The institution responsible for
the-conduct of the research has
certified to the Secretary that the
Institutional Review Board has
approved the research under ? 46.305
of this subpart; and
t2.) In the judgment of thc
Secretary the proposed research
involves solely the following:
(A) Study of the possible causes,
effects, and processes of
incarceration, and of criminal
behavior, provided that the study
presents no more than minimal risk
and no more than inconvenience to
the subjects;
(B) Study of prisons as institutional
structures or of prisoners as
incarcerated persons, provided that
the study presents no more than
minimal risk and no more than
inconvenience to the subjects:
(C) Research on conditions
particularly affecting prisoners as a
class (for example, vaccine trials and
other research on hepatitis which is
much more prevalent in prisons than
elsewhere; and research on social and
psychological problems such as
alcoholism, drug addiction and sexual
assaults) provided that the study may
proceed only after the Secretary has
consulted with appropriate experts
including experts in penology
medicine and ethics, and published
notice, in the F I-.OF RAt. R EGISj ER,
of his intent to approve such research;
or
(D) Research on practices, both
innovative and accepted, which have
the intent and reasonable probability
of improving the health or well-
being of the subiect. In cases in
which thoseotudies require the
assignment of Prisoners in a manner
consistent with protocols approved by
the IR B to control groups which may
not benefit from the research, the
study may proceed only after the
Secretary has consulted with
appropriate experts. including experts
in penology medicine and ethics, and
published notice, in the F EDERAL
eG1S I R, of hs intent to approve such
research .
(hi Except as provided in
paragraph a) of this section,
biomedical or behavioral research
conducted or supported by DHEW
shall not involve prisoners as
subjects.
Page 15
Stibpsre 11?Additlestai Protections
for Children brayedis Sehiccfn
Itenearch.
Source: 48 FR 98111, March 8, 1933
1146.401 To what do these
regulations apply?
(a) This subpart applies to all
research involving children as
subjects, conducted or supported by
the Department of Health and
Human Services.
(I) This includes research
conducted by Department
employees, except that each head of
an Operating Division of the
Department may adopt such
nonsubstantive, procedural
modifications as may be appropriate
from an administrative standpoint.
(2) It also includes research
conducted or supported by the
Department of Health and Human
Services outside the United States,
but in appropriate circumstances, the
Secretary may, under paragraph (e)
of ?46.101 of Subpart A, waive the
applicability of some or all of the
requirements of these regulations for
research of this type.
(b) Exemptions (I), (2), (5) and (6)
as listed in Subpart A at ?46.101(b)
are applicable to this subpart.
Exemption (4), research involving
the observation of public behavior,
listed at ?46.101(b), is applicable to
this subpart where the investigator(s)
does not participate in the activities
being observed. Exemption (3),
research involving survey or
interview procedures, listed at
?46.101(b) does not apply to research
covered by this subpart.
(c) The exceptions, additions, and
provisions for waiver as they appear
in paragraphs (c) through (i) of
?46.101 of Subpart A are applicable
to this subpart.
?46.402 Definitions.
The definitions in ?4.6.102 of
Subpart A shall be applicable to this
subpart as well. In addition, as used
in this subpart:
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(a) "Childrete.!.'are persons who
Jhave not attained the legal age for
consent to treatments or procedures
involved in the research, under the
applicable law of the jurisdiction in
which the research will he
conducted.e.
(b) "Assent" means a child's
affirmative agreement to participate
in research. Mere failure to object
should not, absent affirmative
agreement, be construed as assent.
(c) "Permission" means the
agreement of parent(s) or guardian to
the participation of their child or
ward in research.
(d) "Patent", means a child's
biological or adoptive parent.
(c.) "Guardian""means an
indh.idual who is authorized under
applicable state or local law to
consent on behalf of a child to
general medical care.
i444.403 HUI Males.,
In addition to other responsibilities
assigned to IFZi3s under this part,
each I14.13 shall review research
covered by this subpart and approve
only research which satisfies the
conditions of all applicable sections
of this subpart.
? 46,404 Rtaieard. not. i_ovolv Lag
greater than minimal risk.
MIS will conduct or fund
research in which the 11413 finds that
no greater than minimal risk to
children is presented, only if the IRB
finds that adequate provisions are
made for soliciting the assent of the
children and the permission of their
parents or guardians, as set forth in
*46.406.
146.405 Reserarch involving weaker
duos minhami risk hut preventing the
penned of direct benefit to the
individtaid subject',
111-1S will conduct or fund
research in which the 1Rli finds that
more than minimal risk to children is
presented by an intervention or
procedure that holds out the
prospect of direct benefit for the
individual subject, or by a
monitoring procedure that is likely to
contribute to the subject's well-being
only if die IRD finds that:
(a) The risk is justified by the
anticipated benefit to the subjects;
(b) The relation of the anticipated
benefit to the risk is at least as
favorable to the subjects as that
presented by available alternative
approaches; and
(c) Adequate provisions are made
for soliciting the assent of the
children and permission of their
parents or guardians, as set forth in
?46.408.
?46.406 Research involving greater
than minimal risk and no prospect of
direct benefit to individual subjects,
but likely to yield generalizable
knowledge about the subject's disorder
or condition.
HHS will conduct or fund
research in which the IRB finds that
more than minimal risk to children is
presented by an intervention or
procedure that does not hold out the
prospect of direct benefit for the
individual subject, or by ar.
monitoring procedure which is not
likely to contributZ to the well-being
of the subject, only if the I14/3 finds
that:
(a) The risk represents a minor
increase over minimal risk;
(b) The intervention or procedure
presents experiences to subjects that
are reasonably commensurate with
those inherent in their actual or
expected medical, dental,
psychological, social, or educational
situations;
(c) The intervention or procedure
is likely to yield generalizable
knowledge about the subjecta'
disorder or condition which is of
vital importance for the
understanding or amelioration of the
subjects' disorder or condition; and
(d) Adequate provisions are made
for soliciting assent of the children
and permission of their parents or
guardians, as set forth in ? 46.408,
45 CFR 46
? 46.401 Research sot otherwise
unprovable which presents an
opportunity to understand, prevent,' or.
alleviate a serious problem affecting
the health or welfare of children.
HHS will conduct or fund
research that the 1148 does not
believe meets the requirements of
?? 46.404, 46.405, or 46.406 only if:
(a) The IRR finds that the research
presents a reasonable opportunity to
further the understanding,
prevention, or alleviation of a serious
problem affecting the health or
welfare of children; and
(b) The Secretary, after
consultation with a panel of experts
in pertinent disciplines (for example;
science, medicine, education, ethics,
law) and following opportunity for
public review and comment, has
determined either: (1) 'That the
research in fact satisfies the
conditions of ?? 46.404, 46.405, or
46.406, as applicable, or (2) the
following:
(i) The research presents a
reasonable opportunity to further the
understanding, prevention, or
alleviation of a serious problem
affecting the health or welfare of'
children;
(ii) The research will be conducted
in accordance with sound ethical
principles;
(iii) Adequate provisions are made
for soliciting the assent of children
and the permission of their parents or
guardians, as set forth in 46.408.
?46.408 Requirements for
permission by parents or guardians
and for await by children.
(a) In addition to the
determinations required under other
applicable sections of this subpart,
the 11413 shall determine that
adequate provisions are made for
soliciting the assent of the children,
when in the judganent of the I1413,the
children are capable of providing
assent. In determining whether
children are capable of assenting. the.
114EI shall take into account the ages,:
maturity, and psychological state of
the children involved. This judgment
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may be made for all children to be
inv,olved in research under a
gelparticular protocol, or for each child.
Was the IRB deems appropriate. If the
IRB determines that the capability of
some or all of the children is so
limited that they cannot reasonably
he consulted or that the intervention
or procedure involved in the
research holds out a prospect of
direct benefit that is important to the
health or well-being of the children
and is available only in the context of
the research, the assent of the
children is not a necessary condition
for proceeding with the research.
Even where the IRB determines that
the subjects are capable of assenting,
the IKI3 May still waive the assent
requirement under circumstances in
which consent may be waived in
accord with ? 46.116 of Subpart A.
1-h) In addition to the
determinations required under other
applicable sections of this subpart,
the Wit shall determine, in
accordance with and Co the extent
that consent is required by 46.116 of
KN, Subpart A, that adequate provisions
are made for soliciting the permission
of each child's parents or guardian.
Where parental permission is to be
obtained, the 1R1J may find that the
permission of one parent is sufficient
for research to be conducted wider
? 46.404 or 46.405. Where research
is covered by ?1 46.406 and 46.407
and permission is to be obtained from
parents, both parents must give their
permission unless one parent is
deceased, unknown, incompetent, or
not reasonably available, or when
only one parent has !cgsl
responsibility for the care and
custody of the child.
(c) In addition to the provisions for
waiver containelt in 46.116 of
Subpart A, if the IRB determines that
a research protocol is designed for
conditions or for a subiect population
for which parcelsl or guardian
permission is not a reasonable
requirement to protect the subjects
(for example, neglected or abused
children), it may waive the consent
requirements in Subpart A of this
part and paragraph (b) of this section,
provided an appropriate mechanism
for protecting the children who will
participate as subjects in the research
is substituted, and provided further
that the waiver is not inconsistent
with federal state ot local law. The
choice of an appropriate mechanism
would depend upon the nature and
purpose of the activities described in
the protocol, the risk and anticipated
benefit to the research subjects, and
their age, maturity, status. aid
condition. a
(d) Permission by parents or
guardians shall be documented 'in
accordance with and to the extent
required by ? 46.117 of Subpart A.
(e) When the 1RB determines that
assent is required, it shall also
sss.
Page 17
determine whether and how assent
must be documented.
? 46.439 Wartha
(a) Children who are wards of the
state or any other agency, institution,
or entity can be included in research
approved under I* 46.406 or 46.407
only if such research is:
(1) Related to their seatus as wards;
or
(2) Conducted in schools, camps,
hospitals, institutions, or similar
settingsin which the majority of
children involved as subjects are not
wards.
(b) If the research is approved
under paragraph (a) of this section,
the IR.kJ shall require appointment of
an advocate for each child who is a
ward, in addition to any other
individual acting on behalf of the
child as guardian or in loco parentis.
One individual may serve as
advocate For more than one child.
The advocate shall be an individual
who has the background and
experience to act in, and agrees to act
in, the best interests of the child for
the duration or the child's
participation in the research and who
is not associated in any way (except
in the role as advocate or member of
the IRB) with the research, the
investigator(s), or the guardian
organization.
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'Pa" 18 .....,...74.13.9179Xeci,f9r.Relean.21,04/0.7109 CIA-RDR.96:0978?RQQ.15,000.9.0.0ifig__
HUMAN SUBJECTS
Minimum Criteria Identifying the
Viable Fetus
On March 13, 1975, regulations
were published in the FEDERAL
R EG1STER (40 FR 11854) relating to the
protection of human subjects in
reearch, development, and rcLicd
activities supported by Department of
Health, Education, and Welfare
grants and contracts. These
regulations are codified at 45 CFR
Part 46.
NOTICES
Elsewhere in this issue of the
FEDERAL R EGISTER, the Secretary
is amending 45 CFR Part 46 by,
among other things, adding a new
Subpart B to provide additional
protections pertaining to research,
development, and related activities
involving fetuses, pregnant women,
and in vitro fertilization.
Section 46.203(d) of Subpart fl
provides inter alia as follows:
The Secretary may from time to time,
taking onto account medical advances,
publish in the FeDEIAL R EG3SIE,
MI 46
guidelines to assist in determining whether a
fouls is viable for purposes of this subpar*.
This notice is published in
accordance with ti 46.203(d). For
purposes of Subpart B, the guidelines
indicating that a fetus other than a
dead fetus within the meaning of
fi 46.203(f) is viable include the
following:
an estimated gestational age of 20 weeks or
more and a body weight of 300 grams or
it ore
FEDERAL REGISTER, VOL. 40,
AUGUST II, 1415
U.S. GOVERNMENT PRINTING r 1903 0 ? 406-756
a
a:*
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r .
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PROCEDURE 13. EXPERIMENTATION ON HUMAN SUBJECTS FOR
INTELLIGENCE PURPOSES
A. APPLICABILITY
This procedure applies to experimentation on human sub-
jects if such experimentati-on is conducted by or .on behalf of
a DoD intelligence component. This procedure does not apply
to experimentation on animal subjects.
B. EXPLANATION OF UNDEFINED TERMS
1. Exnerimentation in this context means any research or
testing activity involving human subjects that may expose such
subjects to the possibility of permanent or temporary injury
(including physical or psychological damage and damage to the
reputation of such persons) beyond the risks of injury to
which such subjects are ordinarily exposed in their daily
lives.
2. Experimentation is conducted on_behalf_of a DoD
intelligence component if it is conducted under contract to
that component or to another DoD component for the benefit of
the intelligence component or at the request of such a com-
ponent regardless of the existence of a contractual rela-
tionship.
L
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3. Human subjects in this context includes any person
whether or not such person is a United States person.
C. PROCEDURES
1. Experimentation en human subjects conducted by or on
behalf of a DOD intelligence component may be undertaken only
with the informed consent of the subject, and in accordance
with guidelines issued by the Department of Health and Human
Services, setting out conditions that safeguard the welfare of
such subjects.
2. DoD intelligence components may not engage in or
contract for experimentation on human sdhjects without appro-
val of the Secretary or Deputy Secretary of Defense, or the
Secretary or Under Secretary of a Military Department, as
appropriate. [Requests for such approval submitted by Army
intelligence components will b.c addressed through command
channels to HQDA (DAMI-CIC), WASH DC 20310.]
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, `afetavkia.7. :'"4 ;kW'', ' vitog
7.A 4,
1:6WAVE
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DoD 6240.1-
DEPARTMENT OF DEFENSE
PnOcU1iE GOVERNING THE
P
ri? it T 1 F
pOrit EiTralIGE.NCE COMPONENTc'
T AT AFFECT UrtliT91 TATES PERSONS
-00
EcEri B Eft 1982
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Ur'":)Eri SECRETARV OF DEFENSE. FO q POL4CY
DoD 5240.I-R
-1PROCEDURE-11.--EXPERIMENTATION ON HUMAN SUDIECTS FOR INTELLIGENCE 'PURPOSES-
A.i/APpLICWLITY
This procedure applies to experimentation on human subjects if such experi-
mentation is conducted by or on behalf of a DoD intelligence component. This
procedure does not apply to experiment?tion on animal subjects.
R. EMANATIONOF UNDEFINED TERMS
_ . _ _
I. Experimentation in this context means any research or testing activ-
ity involving human subjects that may expose such subjects to the possibility
oflpermanent or temporary injury (including physical or psychological damage
and damage to the reputation of suet) yersons) beyond the risks of injury to
whichlsuch subjects are ordinarily exc.osed in their daily lives.
2. Experimentation is conducted on behalf _of a DoD intelligence com-
ponent if it is conductcd under contrAct to tat component or to another DoD
component for the benefit of the intelligence component or at the request of
such a component regardless of the existence of a contractual relationship.
3. Human subjects in this context includes any person whether or not
such person is a United States per5on.
C. PROCEDURES
I o Experimentation on human subj4ts conducted by or on behalf of a DoD
intelligence component may be undertaken only with the -informed.neasent-ai.4.h.
lj&ieek,s, iAnancorslancianujAbnguidelLnes-issued by the_Department_af-Hcalth?.aai
11,14.AA,SepLisela kattiag-ont--conditionnthat safeguard.the-waliaraZremcb-sub-
jac.1.5.
2. DoD intelligence compenatui,tt may not engage in or contract for experi-
mentation on human subjects without approval of the Secretary or Deputy Secre-
tary of Defense, or the Seeretary or Under Secretary of a Military Department,
as appropriate.
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13-1
.00"'
i'Hruary 1:98:4
AR Pt
iltersonnel mayitsippf9y044gprbe.p2A?9 q49,449.7m9yAggs-qpipAgencp78813pqARTINgAvout the
ge,nce Components to state and local law en-
eercemvit authorities only when lives are en-
. ? ,
dltegtered and only pursuant to a request by the
heed of 'Such authority. Such requests must be
epproved by the Seeretary or Under Secretary
of the Army. Under these circumstances explon;
personnel may be provided to such agency pro-
\deed participation in law enforcement activi-
ties is limited as follows:
(a) Only personnel with technical skills
not readily available to such law enforcement
authorities, which can be utilized to prevent
death or serious injury, may be provided;
(h) Provision of such personnel will be
limited to that necessary to prevent the death
or serious injury that is threatened, but in no
ease shall such assistance he provided for more
than 'i2 hours;
(a) Such vrsoniiel ore not used to ap-
prehend persons who are suspected of corn-
milling, or who are about to commit, a crime,
(d) Use of such personnel does not 'vice.
late the Posee Comi tatus: Act.
(3) Einergericy ?asieilace. In emergency
nar:ions, where life is endmgercd, the request:
required in (1) ami (2) above may be ?oral,
provided that. it is reduced to writing and sub-
mit led to HQDA(DAMI-C1(.1) within 72 hours.
Where hfe is endangered, do.tbl as to the legal-
ity and propriety of the requested ossistanee
inner this procedure should 1:e resolved in favor
;if providing the assistance.
'2-17. Procedure 17. Assignment of intelligence
eersonnel to other agencies. a. Apidicabifity
dnd :u?ope. This procedure applies to the as.
sigienent of DA intelligence personnel to other
egencies within the federal government. This
prim:educe does not apply to--
I) Assignment to state or local govern-
ments, corporations or other private organiza-
ions.
(2) Assignment to another agency within
the intelligence community when part of the
purpose of the assignment. is to gain expenienco
end knowledge about the activities of the ()thee
agency. (Reporting or report in this contest
operation or personnel of an agency that is not
available publicly.)
b. Policy. Employees of Army intelligence
components who are assigned to work for and
under the direction of another agency of the
federal government will conduct themselves
for the duration of their assignment as if they
were employees of that agency. Any responsi-
bilities to provide information to or services
for DA will be stated expressly and made a part
Of the terms of the assignment.
C. Procedures.
(1) Assignment of employees of Army in-
telligence components to other agencies within
the federal government is governed by DOD
Directive 1000,17. The memorandum of agree-
ment concerning such assignment and required
by subsection D((;) (c) (1) of the Directive shah
inel ode- -e
(?) An identification of the Arn-y intel-
ligence component from which the employee
hen been assigned by DA.
(6) A !statement delineating the em-
ployee's responsibilities, if any, for reporting
to the DA about matters thot come to the em-
phtree's attention while on assignment outside
the )epartnient.
(2) Other than is permitted by the terms
or the memorandum of agreement pursuant to
Der) Directive 1000.17, an employee of an Army
olielligenf,.!0 component on assignment to an-
other agency of the federal government may not
report to any Army component the operations
or personnel of the agency to which the em-
ployee is assigned.
Aftsr completion of an assignment to
another agency of the federal government and
retuen to DA, an employee remains under the
same restrictions, as to reporting., that applied
when the employee was on such assignment.
2-18. Procedure 18. Experimentation on human
subjects. a, A pplicability a ad !copc.
) This procedure applies to ,experiinen-
ltion on human subjects it such experimenta-
tion is C011tha ted bY or on behalf of any Army
intelligence component. This procedure does not
apedy to experimentation on animal subjects.
2-21
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Aporimentinnon in this context ineans (6) The collection and
a research, development, or related aOtiVitY that teiiiirence;
may expose an individual to the poiisibility of
injury (including physical, psychological, or
social injury) that increases the ordinary risks
daily life for the inibject 0:minding the rec-
ognized risks inherent in a chosen occunal ion
or field of service), or that temporindin :A-
versely affects a person mental or physical
condition,
(3) Experiment:- conducted 'a be
La if of" an Army intid ponent if it is
tonducted under cont ;i to tiint component ot
to another Army component for the benefit at
tJu : intelligence component, or at the Ye.41-0,:t of
such a component regiirdlesn of the existence
n contractual relationship.
(4) Human sobjects in this centoit
in-
:hdes any person regartiless of wfn:ither the
peroa qualities as a US person.
Policy. Army intelligence ertpeimi ts may
conduct experimentation on human Inubjects
only when an important foreign intellii.nnice or
I purpose is, to ne served, only after the in
-
ed consent of the subject 1:41$ been ebtitiord
in writing, and only in accordance with guide-
'les issued by the Department of Henan and
Ilernan Services setting out conditions that.
safeguard the welfare of the subjects, and :lither
arpplicable vntnilationn.
n. Procedure, Army in-fir:Ili.. ince components
rimy not engage in or contract for experimen-
tation on harnan bjccts ivithout prior an-
nroval of the Secret or Under Secretnry of
the Army.
-19. Procedure 19. Special activi(ies, a. Ap-
plicability aiui scope,
(1) This procedure applies to the conduct
and support of special activities by Army intel-
ligence components. This proceditte also applies
to other Army components that provide support
for special activities conducted by Dol) ntel
ace components and other wencins within
ntelligenee Community. These pnoccdures
eft apply to--
(a) Diplomatic or military atri
conducted by DOD,
?;Pri' 1982
dr
in support of the
colection anti roducton intelligence; or
(d) The co!;aillet of spec nil activities by
the military services in armed nordlict or to
irdlitary deception operations targeted, for mild.
tar) purposes, against a hostile foreign power.
Conspirnny in this context has the
meaning :Is el the criminal law con
requires, an overt act., Neither the term
"assassination" r'or the term "conspire" in-
clude military or in '? inn 771eU'$A agairist on-
going internationnI terrorist activities (which
is :4- defined term (see glossar)) and aionuid be
constried strictly), ,aircraft hijackings, or in
response to da tiger of inabsteintial physical harm
to any person, These terms do not apply to
actions of the military services in the execu-
tion if lawfully oriqered military operations.
Diplomatic!. iind, .militain, attache activ-
',ties means the representational, information
gathering, and repotting activities performed
by diplomatic and Inilitary attache personnel
abroa d.
S a a
and
(4)
auction of intelligence rnear ti
process, of developing "intelligence products"
which is a defined term. (see glossary).
(5) Special activities mean activities con.
duct d abroad in n-Tort, of national foreign
no ley objectives that are ansinned to further
0111dal US programa and policies abroad; that
are planned and executed so that the role of the
United States Government is not apparent, or
acknowdedged publicly and functions in support
of such acti.vities. but not including diploma*
and military at inche activities or the collection
and production of intelligence or related sup.
port finctions.
(6) Support, when used in this conte
Meall8 the provision of assistonce in the
of transportation, tyaining, supplies. equipirm
or expert personnel.
b. Policy. No Army int.cUigence compone
will participate in the conduct or support
special activities. No ether Army compot
will provide support for special rictivities e
upon the speciiie direction of the Secreta
under Secretary of the A rmy and the Seere
2-
2-
(S
thi
D(
an;
pr4
me,
fui
reg
get,
2-22
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USAINSCOM Regulation 15-3 24 February 1984
CHAPTER 3 POLICIES
General
Approval
Risk determinations
Risk versus benefit
Moral, ethical and legal concepts
Fully informed subjects
Use of non-US citizens ----------- --- ________
Use of prisoners of war and detainees -----
Medical care
Stated objectives
Physical and mental suffering
Qualifications of investigators
Minors
Recruiting of volunteers
Protocol guidance
guidance
11.
CHAPTER 4 PROCEDURAL GUIDANCE
CHAPTER 5
APPENDICES
Paragraph Page
3-1 3-1
3-2 3-1
3-3 3-1
3-4 3-1
3-5 3-1
3-6 3-1
3-7 3-1
3-8 3-1
3-9 3-1
3-10 3-1
3-11 3-1
3-12 3-2
3-13 3-2
3-14 3-2
3-15 3-2
Technical reports
4-1 4-1
Advising the Medical Research
and Development Command
4-2 4-1
Informed consent
4-3 4-1
Minimum standards
4-4 4-1
More than minimal risk
4-5 4-1
Contractors or vendors -0-
4-6 4-1
Bequests for exceptions
4-7. 4-2
Expedited review categories
4-8 4-2
Expedited review procedures 4-9 4-2
????00.
INSCOM HUMAN TECHNOLOGY REVIEW BOARD (HTRB) ACTIVITIES
Composition of the HTRB
5-1 5-1
General criteria for membership 5-2 5-1
General committee activities 5-3 5-1
Avoiding possible conflicts of interest 5-4 5-1
Criteria for INSCOM HTRB approval 5-5 5-1
Special considerations of sensitivity
Suspension or termination of a project --
Records
A - Terms and Abbreviations
B - Format for Preparation of a Research Protocol-----
C - Volunteer Agreement, Part A
0 - Volunteer Agreement, Part 3 ------------
5-6 5-2
5-7 5-2
5-8 5-3
it
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A-1
B-1
C-1
D-1
".`
41,
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DEPARTMENT OF THE ARMY
UNITED STATES ARMY INTELLIGENCE AND SECI.
Arling.ton Hall Station ,
Arlington, Virginia 22212
O.S.USCOM Regulation 15-3
OMAN))
24 February 1984
Boards, Commissions and Committees
HIGH PERFORMANCE REVIEW PROCEDURES
DAJ.riug. 1982 and 1983, lia keeping wil:h the US Army Intelligence and Security
Comm(ind (INSCOM) on of "extrnordlary performance," and seeking to move the
command to a level which exceeds commonly defined parameters of performance,
Ct:c INSCOM conducted a. 3tudy of hlgh performing organizations and programs In
the public and privnte sectors. Several technologies, mnnagement techniques,
triaing experiences and programs were identified for further evaluatton with
t.o their potential to contribute to the development of extn:aor.itnary
Individoal and anIt performance u7Shin zhe Command, This regulation contains
'T-EOM folictes and gAlidance for that evaluation, establIshes procedures for
;11e use of INSCON personnel as volunteers in evaluating ac4 implem.euting high
Aperforming human. systems And provids guidance for commarders and supervisors
;n further implementing and evaluating those high performing human systems.
l''-' 'S,.Tplementation of this reguIntion ts permitted only after prior approval has
obtatned from this Headquarter, ATTN: USJA.
t,*
C;4APTFR 1 GENERAL INFORMATION
CHAPTER, 2 RESPONSIBILITIES
Applicability ---
References ---
cope
Exemptions -----------------------------
Explanation of terms And abbreviations-------------
Paragraph Page
Approving officials --------------
2-1
Commanders and Staff Element Heads ----------------
2-2
INSCOM Human Technology Review Board (HTR) -------
Chairperson of the HTRB ---------------------------
2-4
Executive Secretary of the HTRB
2-5
Regular HTRB Membership --------------------------
f-
Ex Officio HTRB Membe.rs'ilp ------------------------
2-7
Ad hoc NTR3 Membership --------- ------- 2-9
Princip,711 it!vest17,acor ----------------------------
2-3
Members of volunteer rr?cruiting teams-------------
2-10
2-11
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2-1
2-1
2-I
2-,
2-2
1-2
2-3
2-3
2-4
2-4
. .
' 24 Februab
tv 1984
..
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, ,..
..
,
c
,
,
Chapter 1
,
..
,
,
GENERAL INFORMATION
,
,
. 1-1. purpose. This regulation contains INSCOM policies and guidance for the
evaluation and implementation of high performing human systems within the com-
mand. It --
a. Promulgates procedures and guidance for the use of INSCOM personnel
as volunteers in the evaluation of high performing human systems;
,
,
,
,
' b. Establishes and implements a review process which is consistent with
,
AR 70-25;
. .
4,
4
c. Insures the continued evaluation of INSCOM activities to assure that
the provisions of AR 70-25 are being followed;
d. 'Establishes procedures to obtain a health hazard assessment prior to
approving an INSCOM protocol issued as required herein; and
e. Promulgates INSCOM policies and procedures to assure that INSCOM com-
ponents do not engage in or contract for experimentation on human subjects in
violatiOn of Procedure 13, AR 381-10.
?
1-2. Applicability. This regulation applies to all elements of the INSCOM.
1-3. References.
a. AR 70-25, Use of Volunteers as Subjects of Research.
b. AR 331-10, US Army Intelligence Activities.
c. AR 70-31, Standards for Technical Reporting.
1-4. Scope.
a. Nothing in this regulation is intended to supersede requirements for
health hazard or other safety reviews required by any other regulations or di- ,
rectives.
b. The procedures, policies and guidance contained in this regulation
pertain to the following:
(1) Behavioral studies, research and/or testing involving human sub-
jects, regardless of whether conducted by INSCOM, a contractor, or other agency
utilizing INSCOM funds.
(2) inclusion of human subje:.ts, whether as the direct or indirect
object of research, regardless of the level or risk involved, in the develop?
ment, testing or stuCy of matters associated with the missions and functions of
1-1
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Approved For Release 2004/07/09 : CIA-RDP96-00788R001500090010-7
USAIN COM"
Regulation 15-3
24 February 1984
the INSCOM, or the application of non-traditional ideas and technologies In
achieving high performance of human resources.
(3) The investigation of programs and technologies to enhance organ-
izational and individual excellence where such investigation involves the in-
clusion of human subjects as their object.
1-5. Exemptions.
a. Research, testing and studies in which human subjects are involved in
one or more of the following categories are exempt from this regulation.
(1) Bonafide activities under the sponsorship of another Department
of the Army component and involving surveys or interviews where all of the fol-
lowing conditions exist:
(a) Responses are recorded in such a way that subjects cannot
be identified directly or indirectly.
(b) The subject's responses, if they become known, would rt
place the subject at risk of criminal or civil liability or damage the sub-
ject's financial or social standing orwemployability.
(c) The activity/does not deal with sensitive aspects of the
subject's own behavior, such as illegal conduct, drug use, sexual behavior, or
use of alcohol.
(2) Research which involves the une of educational tests, provided
the data. is recorded in such a way that the subjects cannot be identified di-
rectly or indirectly.
(3) Research in non-INSCOM educational settings which involve normal
educational practices, such as --
(a) Regular and special educational strategies.
(b) The effectiveness or the comparison among techniques of in-
struction, curricula, or classroom methods.
(4) Follow-up debriefings, interviews, tests, or evaluations to de-
termine how well participants have learned the information or skills transmit-
ted by training or instructional activities previously attended by the subject
thereof.
b. Exemptions of other activities from this regulation, even where such
activities may be exempted from other similar reeelations or directives, shall
not be considered valid for INSCOM purposes unless and until confirmed by the
INSCOM Human Technology Review Board as prescribed elsewhere in this regula-
tion.
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24 February
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Chapter 2
RESPONSIBILITIES
2-1. Approving officials. The Commanding General, the Deputy Commander, In-
telligence, and the Deputy Commander, Support, are the designated INSCOM ap-
proving officials. Only these officials may approve the use of human subjects
in research.
2-2. Commanders and Staff Element Head-a_. Commanders at all levels within the
INSCOM, heads of Headquarters staff elements, office chiefs and program direc-
tors (hereinafter referred to only as commanders and staff element heads) are
-responsible within their respective functional areas for --
a. Insuring that the provisions of this regulation are institutionalized
into their organizational procedures and practices.
b. Insuring that no persons engage...J:1 or contract for experimentation
involving human subjects without the express approval of an INSCOM approving
official.
2-3. INSCOM Human Technology Review Board (HTRB). The INSCOM HTRB is respon-
r
sible for --
a. Observing written procedu.rcN for the following:
(1) Initial and continuing review of research, including the reports
of findings and actions to the investigator and the approving official.
(2) Determination of those projects which must be --
(a)
Reviewed more often than annually.
(b) Verified from sources other than the investigators that no
material changes have occurred since the previous HTRB review.
(3) Prompt reporting to the HTRB of proposed changes in the re-
search, and to the Ern and approving official of unexpected problems involving
risks to the subjects or others.
b. Insuring that changes in approved projects (during the period for
which approval has already been given) are not initiated without HTRB review,
except to eliminate immediate hazards to a subject.
c. Reviewing proposed protocols at meetings attended by a majority of
members except when an expedited review is used. For the protocol to be ap-
proved, it will receive the approval of a majority of those members present.
d. Reporting to the CC any serious or continuing noncompliance with HTRB
requirements and determinations found by investigators.
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e. Conducting a continuous review of research studies at intervals pro-
per to the degree of risk, but not less than once per year.
f. Insuring the observation by a third party of the consent process an]
each investigation, as appropriate.
g. Recommending safeguards or special conditions to a protocol. When
such recommendations are made, the approving official may take the following
action:
(1) Not reduce the safeguards or conditions, and approve the proto-
(2) Require additional safeguards.
(3) Disapprove the protocol.
(4) Refer the protocol to a higher echelon approving authority for
action and review.
2-4. Chairperson of the HTRB. The DCSPPM is designated Chairperson and a reg-
ular member of the HTRII and is responsible for chairing HTRB meetings, keeping
the CG informed of HTRB activities, aie, recommending approval/disapproval of
HTRB regular membera to the CG.
2-5. Executive Secretary of the HTRB. The DCSPPM will designate a member of
his staff to be the Executive Secretary of the HTRB. The Executive Secretary
of the HTRB ts responsible for --
a. Insuring that the responsibilities
graph 2-3 are carried out.
b. Preparing and distributing the agenda for each meeting to all HTRB
members.
of the HTRB prescribed in-para-
c. Insuring that all HTRB members are afforded the opportunity to com-
ment on HTRB actions conducted under expedited review procedures.
2-6. Regular HTRB mephership. The INSCOM DCSOPS, DCSPER, DCSSYS, SJA, Command
Chaplain and DARCOM LNO, are each responsible for nomination of an individual
to serve as a regular member of the HTRB. Nominees may be from their respec-
tive staffs, subordinate command functional counterpart staffs, or may be the
nominating element head. Nominations will be submitted to the HTRB Chairperson
(DCSPPM) for approval/disapproval by the CG. Nominations may be by letter, DF
or message, and will contain the information required by paragraph a, below.
a. Nominees will he identified by name, earned degree, current position
and duties, and experience, such as board certifications and licenses. The in-
formation in the nomination will he complete enough to describe each member's
chief expected contributions to HTIUB reviews.
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b: Nominees will normally be military officers in the grade of 0-5, or
above, or civilian employees, GS-I3 or above. Nominees will have diverse back-
grounds to insure thorough review of research studies involving human volun-
teers as research subjects. Nominees should be of varied racial and cultural
backgrounds. Nominees should have displayed sensitivity to such issues as com-
munity attitudes, and respect for advice and counsel and for the rights and
welfare of human subjects.
c. Confirmed nominees will serve as HTRB members for an indefinite term,
and will be expected to have final authority to speak on behalf of their activ-
ity.
2-7. Ex officio HTRB membership. The incumbents of the following positions
will serve as ex officio, non-voting members of the HTRB:
a. Chief, CENTEX.
b. 'Command Psychologist.
c. Chief, Human Technology Office.
d. Chief, Public Affairs Office.
2-8. AA hoc HTRB membership. The rollowing will serve as ad hoc members of
the INSCOK HTRB:
a. The Staff Advisor for Scientific and Cryptologic Affairs.
b. A physician, as approved by an INSCO1'!. approving official (pare. 2-1).
Physician nominees for ad hoc membership will be provided as requested by the
Chairperson.
2-e9. Principal investigator. The principal investigator for each project
covered by this regulation is responsible for --
a. Maintaining adequate records on the following:
(1) Receipt, storage, use and disposition of all investigational ma-
terials and devices.
(2) Case histories that record all observations and other data im-
portant to the study.
(3)
Volunceer agreement documents.
b. Preparing progress reports, including anneal reports, as determined
by the approving authority and the INSCOM. HTRB.
c. Promptly notifying the approving auth3rity, through the INSCOM UTRB,
of any adverse effects caused by the research.
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d. Insuring that the research has been approved by the proper authority
and the INSCOM HIlla before starting, changing or extending a study.
e. Insuring that all subjects, including those used as controls or their
representati4es, are fully informed of the nature of the research to include
potential risks to the subject.
f. Insuring that investigational materials and devices are administered
only to subjects under his or her personal supervision and that of a previously
approved associate investigator.
g. -Insuring that volunteer recruiting teams are briefed as to the nature
of the research and the ethical principles in this and related regulations.
2-10. Members of volunteer recruiting teams. Members of volunteer recruiting
, , . ? _
teams are responsible for?
a. Establishing volunteer requirements prior to recruitment.
b. Undertaking recruiting in a morally, ethically and legally acceptable
manner.
2-11. Medical monitor. The medical morlitor-of each project is responsible for
and is hereby delegated the authority to terminate the effort if --
a. Subjects are at risk of life or limb.
b. It appears the risk is significantly greater than anticipated at the
time of review and approval of the project.
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Chapter 3.
POLICIES
3-1. General. Experimentation involving human technology or human subjects
)nducted by or on behalf of any INSCOM component may be undertaken only with
tele informed consent of the subject, and in accordance with guidelines issued
by the Department of Health and human Services (OHHS), setting out conditions
Hest safeguard the welfare of such subjects. The provisions of this regulation
censtitute INSCOM implementation cf those guidelines.
Approval. INSCOM components may not engage in or contract any research
cr testing involving human subjects without advance approval through the INSCOM
HUB by an INSCOM approving official, or higher level official, where appropri-
nte. This approval is required regardless of the degree of risk involved.
3-3. Risk determinations. The INSCOM 4TRB will render all risk determinations
leearding INSCOM research or resting involving human subjects.
3-4. Risk versus benefit. The degree of potential risk involved in any pro-
ject will never exceed the expected benefits of that effort.
3-5. Moral, ethical and legal concepts. The moral, ethical and legal concepts
on the use of human subjects will be followed as outlined in this regulation.
Voluntary consent of each human subject is essential. Military personnel are
not subject to the Uniform Code of Military Justice (UCMJ) for choosing not to
tike part as human subjects.
3-6. Fully informed subjects. Only perlons who are fully informed and volun-
teer to take part may be used as human subjects in INSCOM research and testing
activities.
Use of non-US citizens. Research may be conducted outside the US that
involves non-US citizens; however, all requirements of this regulation applic-
aaie to human subjects shall be equ,ally applicable to non-US. citizen human sub-
jects.
3-a. Use of prisoners of war and detainees. The use of prisoners of war and
deainees as human research subjects is prohibited.
3-9. Medical care. Volunteers will be authorized all necessary medical care
for injury or disease that is the proximate result of caking part in approved
INSCOM research or testing activities.
3-10. Stated objectives. Each project will be designed to achieve its stated
objectives. The proposed number of subjects will be the minimum needed to In-
sure that statistically significant results are obtained.
3-11. Physical and mental suffering. Each pcoject will be conducted in such a
manner as to avoid unnecessary physical and mental suffering. Preparations
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will be made and adequate facilities provided to protect the subject and in-
vestigators against all foreseeable injuries, disabilities, or death. A pro-
ject will not be conducted if any reason exists to believe that death or injury
will result. The degree of potential risk will never exceed the expected bene-
fits of the iroject.
3-12. Qualifications of investigators. Only persons judged qualified by the
appropriate approving authority will conduct human subject studies. The physt-
clan responsible for the health and welfare of the subject may or may not be
the principal investigator. The physician is authorized to stop the project at
any time he or she believes that injury, disability or death may result.
3-13. Minors. Minors may not be involved as human research subjects without
advance approval in each case by the INSCOM HTRB.
3-14. Recruiting of volunteers. Volunteer.erecuiting will be accomplished by
personnel responsible for the conduct of the Particular project, or as other-
wise specifically approved by the INSCOM HTRB.
3-15. Protocol guidance.
a. Each approved protocol will bereviewed at least annually and on a
continuing basis as determined by the INSCOM HTRB. Annually means once each
12-month period. 7
b. The decision as to whether a research protocol involves more than
minimal risk shall be made by the INSCOM HIM
c- The research protocol will be prepared in accordance with the in-
structions contained at appendix B.
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Chapter 4
PROCEDURAL GUIDANCE
4-1. Technical reports. Technical reports will be prepared as prescribed in
AR 70-31 and follow the format of MIL-STD-847A. When applicable, these reports
will contain the following statement:
For the protection of human subjects, the
investigators have adhered to the policies
of AR 70-25 concerning the use of volunteers
as research subjects.
4-2. Advising the Medical Research and Development Command. Two copies of
technical reports of study will be forwarded to the Commander, US Army Medical
Research and Development Command, ATTN: SGRD-HR, Fort- Detrick, Frederick,
Maryland 21701. When HQD4 approval, .or higher, is required, information
copies of material forwarded for approval will also be furnished to the office
above. These will include as a minimum, two copies of the protocol, a copy of
the volunteer agreement and all minutes of INSCOM HTRB meetings reviewing the
proposed project.
4-3. Informed consent. Subjects will be given adequate time to review and un-
derstand all information before agreeing to take part in a project. The volun-
teer agreement documents will be written in language that is easily understood.
by the subject. The documents listed below will be discussed with each subject
before his or her acceptance.
?
a. The Volunteer Agreement (appendix C). ,
b. The Explanation Portion of the Volunteer Agreement (appendix D).
4-. Minimum standards. The laws, customs and practices of the country in
which the research is conducted will take precedence over procedures required
by this regulation, where applicable. The project must meet the sane standards
of ethics and safety, however, that apply within the US involving US citizens.
When standards vary, the more stringent will apply. A minimum age of 18 is re-
quired for US citizens taking part in research conducted outside the US, re-
gardless of the laws of the country in which the effort is being undertaken.
4-5. More than minimal risk. When it has been determined that the risk in a
human subjects study is more than minimal, then advance approval is required
through HQDA (DAM1-CI) by the Secretary or Under Secretary of the Army. In ad-
dition, a medical monitor shall be recommended by the INSCOM HTRB and approved
by the CC.
4-6. Contractors or vendors. Contractors or vendors holding approved MIMS
assurance of compliance shall be corr3idered in compliance with this regulation.
Tn the absence of such an assurance, a special assurance will be negotiated
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j
with the contractor or vendor. In all cases, however, the INSCOM HTRB must ap-
prove the INSCOM participation in or utilization of such contractors or ven-
dors.
4-7. Rtamsts_for exceptions. Requests for exceptions to this regulation will
be submitted-A? the INSCOM HTRB Chairperson (DCSPPM) with full justification.
1
4-8. Expedited review. categories. Categories which may be processed in the
expedited review procedures are as follows:
a. Recording of data from subjects who are 18 years of age or older,
using non-invasive procedures routinely employed in clinical practice. This
category does not include exposure to electromagnetic radiation outside the
visible range (e.g., X-rays, microwaves). It does include --
.
(1) The use of physical sensors that are applied either to the sur-
face of the body or at a distance and do not--involve input of matter or signif-
icant amounts of energy into the subject or an invasion of the subject's pri-
vacy.
(2) Such procedures as
(a) Weighing.
(b) Electrocardiography.
(c) Electroencephalography.
(d) Thermography.
(e) Detection of naturally occurring radioactivity.
(f) Diagnostic echography.
(g) Electroretinography.
b. Voice recordings made for research purposes such as investigations of
speech defects, improvement in language utilization, etc.
c. Moderate exercise of healthy volunteers.
d. Study of existing data, documents, records, pathological specimens,
or diagnostic specimens.
e. Minor changes in previously approved research during the period for
which approval has been authorized.
4-9. Expedited review procedures. Under an expedited review procedure, tha
IITRB Chairperson, or one or more HTRB review?rs designated by the chairperson,
may carry out the review. These reviewers may exercise all of the authorities
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of the HTRB except that of disapproval, which may only be exercised as pre-
scribed elsewhere in this regulation.
a. When the expedited review procedure is used, the reviewers will fur-
nish complete copies of all their actions and related materials (e.g., research
plan, protocol, etc.) to all other members of the HTRB. The HTRB Chairperson
will submit a written report of expedited review actions to the CC within ten
working days of approval action.
b. An expedited review procedure may be restricted or suspended to pro-
tect the rights or welfare Of subjects at any time based upon either direction
of an approving official or request by any member of the HTRB.
to
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Chapter 5
INSCOM HUMAN TECHNOLOGY REVIEW BOARD ACTIVITIES
5-1, Composition_ofiithe HTRB. Membership in the INSCOM UTRB will consist of
the chairperson; at least six other regular members, appointed by the CC from
eelong the nominations submitted in accordance with paragraph 2-6 and 2-8,
abcve, or from other sources; an executive secretary; and such other ex officio
and ad hoc members as prescribed in chapter 2, above. One regular member will
be not affiliated with the INSCOM and not part of the immediate family of a
person affiliated with the INSCOM.
5-2. Cenerak.criteriafor. membership.. At least one member of the HTRB will be
from a praessiOn6o'SY1L;i0activii-Y primarily concerned with the welfare of hue
man persons. At least one member will be non-scientific, such as a lawyer,
ethicist or member of the clergy. THE INSCOM HTRB may invite persons with spe-
cial competence to assist in the review of complex ?Issues that require exper-
tise beyond that available on the HTRB. These persons normally will not vote,
unless he or she is serving as the non-iNgCOM member of the HTRB.
5-3. General committee activities. Each regular and ad hoc committee member
shall have one equal vote, and the entire committee will be vested with the re-
sponsibility to determine if a proposed activity is acceptable. Acceptability
will be in terms of Army Medical Department (AMEDD) commitments and regula-
tions, applicable law, standards of conduct and practice, and with full consid-
eration for the particularly sensitive nature of the INSCOM's role is an intel-
lieence component.
a. At least five voting members 4.11 be required to constitute a quorum
at each committee meeting.
b. All actions of the committee will be by majority vote of members
present.
5-4. Avoiding possible conflects of interest.
a- Except to provide information requested by the HTRB, no INSCOM ETRB
member may take part in a review of any project which is sponsored by that mem-
ber's organization or office of employment or assignment, or in which there may
otherwise be a conflict or appearance of a conflict of interest.
b. The intended approving official may not be a member of the HTRB. The
approving official may not approve research for which he or she is also a prin-
cipal or associate investigator. A higher echelon of command must review and
approve such projects.
5-5. Criteria for INSCOM HTRB approval.
_
a. In evaluating the risks and benefits for projects under considera-
tion, the INSCOM HTRB should consider only those that may result from that
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USAINS6OM Regulation 15-3
particular project, unless a clear linkage has been established to other pro-
jects.
b. To approve an effort covered by this regulation, the INSCOM HTRI1 must
determine that all of the requirements below are met.
(1)
Risks to subjects are minimized by using procedures that are --
(a) Consistent with sound investigation design and do not unnee-
essarily expose subjects to risk.
(b) Already being used on subjects for diagnosis or treatment,
when appropriate.
(2) Risks to subjects are reasonable in relation to --
(a) Anticipated benefits, if any, to the subjects.
(b) The importance of the knowledge that may be expected to
result.
(3) In making an assessment for the selection of subjects, the spon-
sor has adequately considered --
ducted.
(4)
(a) The purpose of the investigation.
(b) The setting in which the.?-research investigation will be con-
informed consent will be secured from each subject.
(5) Informed consent will be properly documented.
(6) The protocol takes adequate provisions for monitoring the data
collected to insure the safety of the subjects.
(7) Adequate provisions exist to protect the privacy of subjects and
to maintain the confidentiality of data when appropriate.
5-6. Special considerations of sensitivity. Some or all of the subjects may be
vulnerable to special considerations of sensitivity because of past assignments,
affiliations, etc. In such cases, additional safeguards will be included to
protect the rights and welfare of these subjects. In no instance will the
INSCOM be a party to any research which involves the use of persons with acute
or severe physical or mental illness, or those who are economically or educa-
tionally disadvantaged.
5-7. Suspension or termination of a project.
a. The INSCOM will suspend or terminate a project that -
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(1) Is not being conducted according to the HTRB's requirements.
(2) Has been associated with unexpected harm to the subjects.
b. Suspensions or terminations of a project will include a statement of
the reasons for the HTRB's action, and will be reported within 24 hours to the
principal investigator and the approving official.
5-8. Records.
a. The HTRB executive secretary will prepare and maintain adequate docu-
ments on HTRB activities, including --
(1) Copies of all proposals reviewed, scientific evaluations that
accompany the proposals, approved sample consent documents, progress reports
submitted, by investigators, and reports of injuries and adverse reactions.
(2) Minutes of HTRB meetings showing attendance; actions taken by
the INSCOM HTRB; the vote of these actions, including the number of members
voting for, against, and abstaining a decision; the basis for requiring changes
or disapproving a project; and a wsitten summary of the discussion of contro-
verted issues and their resolution.
tigators.
(3) Records of continuing review activities.
(4) Copies of all correspondence bepween the HTRB and project inves-
*
(5) A current list of HTRB members.. Members will be identified by
name, earned degree, representative capacity and experience, such as board
certifications and licenses. The information will be complete enough to des-
cribe each member's chief expected contributions to HTRB reviews. Any employ-
ment or other relationship between members and the INSCOM will be noted.
(6) Written procedures, including agendas, expedited review proce-
dures, etc., for the HTRB.
(7) Statements of significant new findings.
b. The records required by this regulation-will be retained permanently
under AR 340-18-13. Such records will be reasonably accessible for inspection
and copying by authorized DA personnel and representatives of the Federal Food
and Drug Administration.
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USAINSCOM Regulation 15-3
APPENDIX A
TERMS AND ABBREVIATIONS
Section I - Terms
A-1. Approving official. The INSCOM Commanding General, Deputy Commander, In-
telligence, Deputy Commanders Supoort, or higher level official, who has been
delegated authority to approve the use of human subjects in research.
A-2. Associate investigator. A person who may be deeply involved in the
exe-
cution of research but does not have overall primary responsibility.
A-3. Consent. The legally effective agreement to take part as a human sub-
ject. The agreement may pertain to one's own participation or be in behalf of
another person. Three terms associated w4h this meaning that distinguish be-
tween the' legal validity of such agreements' are subject consent, permission,
and assent. These terms are defined below.
a. Subject consent. Agreement by an adult person who has autonomous
legal capacity to consent to taking part as a human subject. This form of con-
sent pertains only to adults who have not lost their legal caoacity to consent.
0
b. Permission. Agreement by a "legally authorized representative" for
taking part as a human subject of another person who does not possess autonc-
mous legal capacity to consent in his or her own behalf. A legally authorized
representative is a person or judicial body authorized under applicable law to
grant permission (also known as third-party consent).
c. Assent. The affirmative agreement to take part as a human sub ect by
a person not possessing autonomous legal capacity to consent in his or her own
behalf, but who is capable of understanding what is proposed ani able to ex-
press an opinion as to willingness to participate. Assent is concurrence in
what is proposed, but is not a substitute for subject consent because, unlike
consent, assent has no legal effect.
A-4. Experimentation. Any research or testing activity involving human sub-
jects that may expose such subjects to the possibility of permanent or tempor-
ary injury (including physical or psychological damage and damage to the repu-
tation of such persons) beyond the risks of injury to which such subjects are
ordinarily exposed in their daily lives.
A-5. AmEdited review procedures. Thoss procedures used In research involving
no more than minimal risk and those used for minor changes in approved investi-
gations. These procedures minimize time required for review.
A-6. Health care practitioner. An individual trained to interact with pa-
ttents to provide diagnostic or treatment procedures within established profes-
sional standards.
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A-7. Human sublect. Any person, whether or not such person is a US citizen,,
about whom an investigator conducting research, testing or studies obtains data
through interaction with that person. Both physical procedures and manipula-
tions of the subject or the subject's environment are included. Human subjects
may be thought of as direct objects when the research is to determine the ef-
fects of a neW system on man (for example, the psychological effects of a par-
ticular interrogation technique on an individual) or as indirect objects when a
test is conducted to determine how man affects the ultimate performance of a
system (doctrine, concepts, training programs).
A-8. Human Technology Review Board (HTRB). A body set up to provide Initial
and continuing review of research involving tae use of human subjects. HTR3
fulfills all the functions of a human use committee as described in AR 70-25.
It is fundamentally similar to an Institutional Review Board (IRB) discussed in
guidelines issued by the DHHS for human research, but has somewhat different
authority as compared to an IRB. Within DOD, authority to approve the use of
human subjects in research Is vested in commanders. In the INSCOM it is vested
In the CG, and has been delegated to the .DCG-I and DCG-S for matters under
their respective functional control. App7ovIng officials act on recommenda-
tions of validly constituted HTRBs. Outside DOD, IRBs tend to be vested with
this authority.
A-9. Legally authorized representative. A person or judicial or other body
authorized under applicable law to consent on behalf of a prospective subject
to the subjeet taking part in the procedures involved. In the research.
A-10. Medical monitor. This person is a military or Department of the Army
civilian physician who is responsible for observinghuman subjects during the
conduct of research.
A-11. Minimalijisk: When used in the context of this regulation, this means
that the risks of harm anticipated in the proposed research are not greater,
considering probability and magnitude, than those ordinarily encountered in
daily life or during the performance of routine physical or psychological exam-
inations or tests.
A-12. Principal investigator. A person, regardless of title, who is primarily
responsible for the actual execution of the research.
A-13. Protocol. The written, detailed plan by which research is to be con-
ducted. The plan contains, as a minimum, discussion of
a. The objectives of the project.
b. The information to be collected.
c. The means by which it will be collected and evaluated.
d. An assessment of potential risks and benefits to subjects.
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e. Safety measures.
f. Other means to be used to reduce the risks to subjects.
A-14. Research. A systematic investigation designed to develop or contribute
to general knowledge concerning military or intelligence problems. The term
does not include individual or group training of personnel such as combat read-
inees, effectiveness, proficiency or fitness exercises. This definition is
unique to this regulation and is not intended to identify an effort for funding
under appropriations intended for Research, Development, Telt and Evaluation
(ROTE). "Research" in the sense applied in this regulation will be funded
according to the project, effort, etc., to which it applies;
A-13. Research and development. Any scientific inquiry, investigation, or
validation performed or directed to test hypotheses or develop concepts con-
cerning physical or biological principals or laws. Research is a major explor-
ation of the unknown and contains unpredietable elements. Development ,usually
is confined to the qualification Of elaboration of known principals.
A-I6. Systematic investigation. A formal inquiry generally described in a
protocol that sets forth explicit objectives and formal procedures designed to
reach those objectives. The term includes clinical investigations, but does
not include post-tra:tning or post-therapeutic inquiries intended only to evalu-
ate individual progress or responsiveness to training or therapy.
A-17. Test and evaluation. An effort or asaessment to- validate proposed or
existing standards or concepts of performance, either of humans or of material.
A-18. Test participants. Humans directly involved in test and evaluations,
but who are not themselves the direct object of such activities. Generally,
test participants are not regarded as receiving any direct benefits as a result
of their participation in the test (for example, a new doctrine or training
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Section II - Abbreviations
ACSI-
------------ ----- ---------- Department of the Army Assistara
Chief of Staff, Intelligence
AMED--------------------------------- Army Medical Department
A,I---------------------------------- US Army Research Institute for the
Behavioral and Social Sciences
The INSCOM Center for Excellence
CFR-
DA-------
DARCOM--
DCS
DCSOPS------------
HPT:F
HTRB--
Code of Federal Regulations
Department of the Armi,
US Army Materiel Development and
Research Command
------- The INSCOM Deputy Chief of Staff for
Personnel
The INSCOM Deputy Chief of Staff
for Plans, Programs and Modernization
The INSCOM Deputy Chief of Staff
for tperatioas
Department .of Health and Human Services
The INSCOM High Performance Task
Force (no longer constituted)
The INSCOM Human Technology Review Board
US Army Intelligence and Security
Command
MACOM----------- ------------------- Major Army command
SJA The INSCOM Staff Judge Advocate
TSG-----------------
The Surgeon General ol the Army
United State3
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APPENDIX B
FORMAT FOR PREPARATION OF A RESEARCH PROTOCOL
Section I
GENERAL INFORMATION
1. Project title. (Enter complete project title - if this is an amendment to
an existing project, identify by indicating "Amendment Noe to" immediately
preceding the title).
2. Investigators.
a. Principal investigator. (Enter .full name, rank, title, organization
and telephone number).
b. Associate investigators. (Identify all associate investigators and
area of. the project for which each is responsible. Include full name, rank,
title, organization and telephone number for each).
3. Location of the project. (Identify all locations at which the project will
be carried out and specify which portions will be done at each location and who
is the point of contact at each location. Include telephone number for POC).
4. Period covered by the project. (Gime month and year of expected start and
completion dates).
Section II
INTRODUCTION
5. Synopsis.
a. (Enter a. short, one-page or one-paragraph, summary of the proposed pro-
ject, similar to the abstract of a scientific paper).
b. (Enter a lilt and brief description of safety measures for human sub-
jects involved in the project).
6. Medical application. (Explain briefly the medical importance, including
psychological considerations, and possible usefulness of the project).
7. Objectives. (State briefly but specifically the objectives-bf the pro-
ject. Include items below, where applicable).
a. Study design. (Double-blind, crossover, etc.).
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. ,
24 February 1984
b. Technologies to be employed. (List tte generic technologies to be em-
ployed in the project).
c. Type of population involved. (List the subject population to be ob-
served).
8. Status. (State what has been accomplished or published in the proposed
area of study and describe how this project will relate to, differ from and/or
advance that which has already. been accomplished).
9. Bibliography. (List all references used in preparing the protocol).
10. Authority. (Cite the specific authority for the INSCOM to engage in thi3
project. Indicate date of approval, and if not yet approved, indicate specific.!
approval authority needed for this project. ---Identify any POC in approval au-
thority%s organization with whom coordination has been effected.
Section III
'PROTOCOL PLAN
11. General approach.
a. (Outline expected accomplishments in sufficient detail to show a clear
course of action).
b. (Include discussion of the technological validity of the proposed re-
search procedures).
c. (List the chronological steps to be taken).
12. Project subjects. (Give as a minimum the information below).
a. Number of subjects. (Indicate the total number of subjects expected to
complete the study).
b. Age range,.
c. Sex.
d. Inclusion criteria. (State specific and detailed reasons for inclusiol
of subjects by class, or individually, as appropriate).
e. Diagnostic criteria for entry.
f. Evaluations before entry. (Include any physical or psychological exam-
inations, medical history, etc., which is to be done on each subject befor
entry into the project).
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USAINSCOM Regulation 15-3
g. Exclusion criteria. (Include a complete list detailing the subjects,
diseases, medications, etc., which constitute the criteria for exclusion from
the project).
h. Source of subjects. (Describe briefly where subjects will be ob-
tained).
1. Subject identification. (Describe code system, if any, which will be
_
wed in the project),
1. Subject assessment. (Describe the methods used to assign or allocate
the object of this research to particular subjects).
k. Risks and benefits. (Discuss the analysis of risks and benefits to
subjects and to those conducting the research).
1. Minimization of risks. (Discuss the precautions to be taken to mini-
_ . _ _ _ _ . . .
mize or eliminate risks to subjects and those conducting the research).
mo Corrective actions. (Describe hypothesized adverse reactions and
cor-
rective actions expected to be taken if such adverse reactions occur).
n. Special equipment. (Describe any special medical or nursing care or
equipment needed for subjects admitted to the project).
13. Project technologies.
a. (State the complete name and6.40cription of all technologies to be
used, including procedures for their application).
b. (Identify the source of all technologies and related items, devices,
etc. List all components and manufacturing and quality control plans/
procedures, where applicable).
c. (Identify the methodology (6.t application, if different from procedures
described above).
d. (State the schedule, administration and duration of each aspect of the
project).
e. (Describe in detail accompanying devices amd their intended use. Iden-
tify whether these are classified as medical devices and whether the medical
devices amendment to the Federal Food, Drug and Cosmetic Act applies).
f. (Discuss labeling to medical devices, where applicable).
1!,. Evaluations made during and following the project. (A proiect schematic
may be included, or the items may `)e listed as indicated below. In either
case, it is important to identify the person who will perform each evaluation).
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a. Specimens to be collected.
(I) Schedule of collections.
(2) Evaluations to be made on specimens.
P I
24 February 1984
(3) Stora. (If applicable, state where and if special conditions
are required.)
(4) Labeling and disposition.
(5)
Laboratories performing evaluations.
(6) Special 'precautions.
b. Clinical/behavioral. assessments. (Include how adverse effects are to
. . _
be recorded).
c. Vital signs. (State when desired and the frequency).
d. Follow-up procedures.
e. Disposition of data. (St.ate location and duration of storage. Include
pertinent information regarding Privacy Act and AR 381-10 considerations, if
applicable).
f. Methods used for data collection. (State critical measurements used as
end points to characterize safety, efficacy or equivalency).
15. Dmayture from protocol for individual subjects.
a. When allowed. (Use flexible,, but definite criteria. If none is to he
allowed, so state).
b. Who will be notified. (Include both those regarding the individall
subject, if appropriate, and those elsewhere within the INSCOM. Must notify at
least the HTRB).
16. Adverse reactions. (Must correlate with paragraph 12m, above).
a. Definition of subject reactions.
b. Immediate reporting procedures.
c. Routine reporting procedures.
d. Potential post-project adverse reactions.
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Section IV
ADMINISTRATION
17. Modification of protocol. (Describe the procedure to be followed to
_ . _
modify, terminate or extend the protocol).
18. Disposition of unused project material? (Give a statement pertaining to
disposition of unused project material and devices, if applicable).
19. Publications and reports? (Describe use, including potential restric-
tions, of information and publications and reports arising from the project).
20.- Funding. (Identify- source of funds and any special or unusual funding
im-
plications).
21. Medfcal_monitor.? (State the name aria telephone number of medical monitor
when applicable).
22. Protocol review. (Identify the human use committee or institutional re-
view board which will provide inieial, continued and annual review of this pro-
Lccol).'
(Signature)
(Name, rank and organization of person submitting protocol)
(Signature)
(Name, rank and organization of principal investigator)
(Signature)
(Name, rank and organization of approving official)
Attachments
A - Proposed Volunteer Agreement
B - Proposed Explanation Portion of the Volunteer Agreement
C - Review of Scientific and Human Research Issues (if applicable)
D - Biographic Sketch of principal and associate investigators
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I
APPENDIX C
, VOLUNTEER AGREEMENT
Part A
USAINSCOM Regulation 15-3
I,
, having attained my eighteenth
(18th) birthday, and otherwise having full capacity to consent, do hereby vol-
unteer to participate in an investigation study entitled:
under the direction of
.041.kore+.....e.....topsbak,,vrayd**N-1.191?11182.1..awin?ReNdie.
, arra-
01.111013.1 +A.M.
*
The implications of my voluntary participation; the nature, duration and
purpose, and the methods and neans by which it is to he conducted; and the in-
conveniences and hazards to be expected have been thoroughly explained to me by
, and are sec forth in Part B of this
? _
Agreement, which I have signed. I have been given the opportunity to ask ques-
tions concerning this inventigative study, and any such questions have been
answered to my full and complete satisfaction.
I understand that I may at any time during the course of this investigative
study revoke my consent, and withdraw from the study without prejudice; how-
ever, I may be required to undergo certain further examinations, if, in the
opinion of competent authority, such examinatpns are necessary for my health
or well being.
?
Signature
Witness's 'aignature
Date
Date
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I S
APPENDIX D
VOLUNTEER AGREEMENT
Fart B
Explanation Portion of the Volunteer Agreement
1. Project title. (The title of the project and the place where it is to be
conducted).
2. Principal investigator. (Must agree with the protocol).
3. Discussion. (A statement that the study involves research. An explanation
of the purpose of the study and the expected duration of the subject's partici-
pation. A description of the procedures to be followed, An identification of
any experimental procedures. A statement giving information about prior, simi-
lar, or related studies that provide the rationale for this project).
4. Risks or discomforts. (A description of any reasonably foreseeable risks
or discomforts to the subject).
5. Benefits. (A description of any benefits to the subject or to others that
may reasonably be expected from the study).
6. Alternative procedures. (A disclosure of proper alternative procedures or
courses of treatment, if applicable, that might be advantageous to the sub-
ject)
7. Confidentiality of records. (A statement describing the extent, if any, to
which confidentiality of records identifying the subject will be maintained.
Also, if more than a minimal risk is involved, a statement that authorities
outside the US may inspect the records).
8. Subject's rights. (An explanation of whom to contact for answers to perti-
nent questions about the study and'the subject's rights and whom to contact In
the event of study-related injury to the subject).
9. Voluntary participation. (A statement that
a- Participation is voluntary.
b. Refusal to participate will involve no penalty or loss of benefits to
which the subject is otherwise entitled.
c. The subject may discontinue participation at any time without penalty
or loss of benefits to which the subject is otherwise entitled).
10. Compensation and medical treatment. (For a study involving more than min-
imal risk, an explanation as to whether any compensation and medical treatment
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USAINSCOM Regulation 15-3 24 February 1984,
are available if injury occurs and, if so, what they consist of, or where fur-
ther information may be obtained).
11. Additional comments. (When appropriate, one or more of the elements of
information below will also be., given to each subject.
a. A statement that a certain treatment or procedure may involve risks to
the subject - or to the embryo or fetus if the subject is or may become preg-
nant - that are currently unforeseeable.
b. The anticipated circumstances under which the subject's participation
may be terminated by the investigator without regard to the subject's consent.
c. Any additional costs to the subject that may result from participation
in the study.
d. The consequences of a subject's decision to withdraw from the study and
procedures for the orderly end of the subject's participation.
e. A statement that new findings developed during the course of the study
which could affect the subject's willingness to continue will be given to the
subject.
f. The approximate number of subjects involved in the study.
g. The precautions to be observed by the .subjectbefore and after the
study.)
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SqATEMENT OF CONSENT
INSCOM CEMER LANE PKJECT PART.ICIPANT
IAGPA-F-SD Date:
1. (S/CL-4/NOFORN) I, _ _ _ voluntarily accept assignment
to the INSCOM CENTER LANE PROJECT (ICLO-and rally understand that:
a. (U) Army General Counsel - n ;.:3 determined tint ICLP constitiJes
experimentation on human subjects. As leguLl-ed by Procedurc 13 of DoD Directive
5240.1-R, approval for project activities has hcen granted by lecretary of the Army.
b. (S/CL-3/NOFORN) The aim of ICLP is to develop highly skilled personnel who
are capable of conducting professional lc:vel :ntellige'nce/counterintelligence
operations through use of psychoenergetic methodology. 'Development of ICLP
personnel will be accomplished with special training based on mission requirements.
c. (U) Assignments in. IcLP are governed by the sensitivity and degree of
expertise required for the position- I will be assigned in accordance with my
capabilities and experience, regardless of my rank or previous position. The to
the nature of training involved, the duration of my participation is indefinit.
Records of my involvement will be available to project personnel, but otherwise
protected under project security measures.
d. (U) The primary consideration in any cancer development or assignment
action will be ICLP mission and operational i-equirements. I understand that
exemption, interruption, or delay in normati career development patterns--such ts
branch schooling and assignment opportunitie:::--may prejudice future promotion ard.
assignment potential. I have been assured, however, that every effort will be made
to preclude the adverse effects listed above on my career.
2. (S/CL-3/NOFORN) PSYCHOENERGETICS (PE) include various processes by which
individuals psychically interact with objects, locations, and organisms.
a. (U) There is no demonstrated risk of permanent or temporary injury
(including physical, psychological and/or damage to participants' reputation) to
project personnel beyond risks to which they w)uld ordinaril,Ni be exposed in their
daily lives.
b. (U) I may temporarily choose nct to perform PE at specific times, or
permanently discontinue participation without prejudicial effect.
WARNING NOTIE:
CENTER LANE SPECIAL ACCESS PROGRAM
RESTRICT DISSEMINATION TO THOSE WITH VERIFIED ACCESS
CATEGORY CL-4
NOT RELEASEABLE TO FOREIGN NATIONALS
CLASS IFIED BY: CDR, INSCOM
DECL: OADR
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APPENDIX B
P96-00788R001500090010-7
US ARMY
INTELLIGENCE AND SECURITY COMMAND
CENTER LANE TRAINING AND APPLICATIONS PROCEDURES
Psychological Test Descriptions
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APPENDIX B
Psychological Test Descriptions
1. The Minnesota Multiphasic Personality Inventory (MMPI):
Developed by S. R. Hathaway, Ph.D., and J. C. McKinley, M.D.
The Psychological Corporation. The MMPI is designed to provide
an objective assessment of some of the major personality
characteristics that affect personal and social adjustment. The
point of view determining the importance of a trait in this case
is that of the clinical or personnel worker who wishes to assay
those traits that are commonly characteristic of disabling
psychological abnormality. The carefully constructed and
cross-validated scales provide a means for measuring the
personality status of literate adolescents and adults together
with a basis for evaluating the acceptability and dependability
of each test record. Nine scales were originally developed for
clinical use of the inventory and were named for the abnormal
conditions on which their construction was based. The scales
were not expected to measure pure traits nor to represent
discrete etiological or prognostic entities. Since they have
been shown to have meaning within the normal range of behavior,
these scales are now commonly referred to by their
abbreviations--Hs (hypochondriasis), D (depression), Hy
(Hysteria), Pd (psychopathic deviate), ME (masculinity
-
femininity), Pa (paranoia), Pt (wsychasthenia), Sc
(schizophrenia), and Ma (hypomania)--or by their code numbers to
avoid possibly misleading connotatfions. Many other scales have
subsequently been developed from the same items; Si (social
introversion) is one that is commonly scored. There are also
three validating scales: L (lie), F (validity), and K
(correction).
2. Gordon Personal Profile,..-: Inventory (GPI): Developed by
Leonard V. Gordon, Ph.D., The Psychological Corporation. The
GPI is companion instrument to the Gordon Personal Profile
(GPP). It measures four additional traits, namely Cautiousness
(C), Original Thinking (0), Personal Relations (P), and Vigor
(V). The two instruments used together provide an economical
coverage of eight important factors in the personality domain.
Both have been found to be appropriate for use with high school,
college, industrial, and general adult groups.
3. Fundamental Interpersonal Relations Orientation - Behavior
(FIRO - B): Developed by Will Schutz, Ph.D., Consulting
Psychologists Press, Inc. The fundamental interpersonal
dimensions of the FIRO Theory are; Inclusion (I), Control (C),
and Affection (A) and are defined behaviorally as follows: I -
The Interpersonal need for inclusion is the need to establish
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and maintain a satisfactory relationship with people with
respect to interaction and association (both positive or
negative). C - The interpersonal need for control is the need
to establish and maintain a satisfactory relationship with
People with respect to control and power. A - The interpersonal
need for affection is the need to establish and maintain a
satisfactory relationship with others with respect to love and
affection.
4. California Psychological Inventory (CPI): Developed by
Harrison C. Gough, Ph.D., Consulting Psychologists Press, Inc.
The CPI is intended primarily for use with "normal"
(non-psychiatrically disturbed) subjects. Its scales are
addressed to personality characteristics important for social
living and social interaction, i.e., to variables that are woven
into the fabric of everyday life. "Folk concepts" such as these
are hypothesized to be relevant .to the prediction and
understanding of interpersonal behavior in any setting, culture,
or circumstance. Thus, although the inventory has been found to
have special utility in work with particular kinds of problems,
e.g., delinquent and asocial behavior, it can also provide
information of value in regard to educational, vocational,
familial, and many other issues.
5. Edwards Personal Preference Schedule (EPPS): Developed by
Allen L. Edwards, Ph.D., University of Washington. The EPPS was
designed primarily .as an instrument for research and counseling
purposes, to provide quick and convenient measures of a number
of relatively independent normal *personality variables. The
statements in the EPPS and the variables that these statements
purport to measure have their origin in .a list of manifest needs
presented by H. A. Murray and other noted psychologists. The
names that have been assigned to the variables are those used by
Murray. These 15 measurable personality variables are;
achievement (ach), deferencv (def), order (ord), exhibition
(exh), autonomy (aut), affiliation (aff), intraception (int),
succorance (sue), dominance (dom), abasement (aba), nurturance
(nur), change (chg), endurance (end), heterosexuality (het), and
aggression (agg). In addition to the above 15 personality
variables, the EPPS provides a measure of test consistency and a
measure of profile stability.
6. Personal Orientation Inventory (POI): Developed by Everett
L. Shostrom, Ph.D., Educational and Industrial Testing Service,
San Diego, California. The profile on the POI shows the degree
to which the subject's attitudes and values compare with those
of self-actualizing people. A self-actualizing person 4.s one
who is more fully functioning and who lives a more enriched life
than does the average person. Such a person is developing and
utilizing his unique talents to the fullest extent:.
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TAB
I
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IACG
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DEPARTMENT OF THE ARMY
UNITED STATES ARMY INTELLIGENCE AND SECURITY COMMAND
ARLINGTON HALL STATION
ARLINGTON, VIRGINIA 22212
REPLY TO
ATTENTION OF
MEMORANDUM OF AGREEMENT
BE
USA INTELLIGENCE AND SECURITY COMMAND AND THE DEFENSE INTELLIGENCE AGENCY
SUBJECT: Transfer of the INSCOM CENTER LANE Project to DIA
(S/CL-2/NOFORN)
1. (S/CL-2/NOFORN) PURPOSE. This Memorandum of Agreement is intended
to clarify the elements necessary for an effective transfer of the US
Army Intelligence and Security Command (USAINSCOM) psychoenergetic
intelligence collection capability to the Defense Intelligence Agency
(DIA). This course of action is based on an agreement by DIA to accept
the INSCOM CENTER LANE Project (ICLP) as a "package-deal" without a loss
of any INSCOM personnel spaces. It is intended that the transfer will
take place with minimum disruption to operations and training.
2. (U) REFERENCES.
a. (U) Memorandum, IACG, INSCOM, dtd 17 July 1984; subject:
INSCOM CENTER LANE Project (U) (TAB A).
b. (U) Memorandum, DAMI-ISH, OACSI, dtd 1 August 1984; subject:
CENTER LANE (U)--ACTION MEMORANDUM (U) (TAB B).
c. (U) Ltr, DAMI-ISH, OACSI, dtd 10 September 1984, subject:
INSCOM CENTER LANE Project (TAB C).
d. (S/NOFORN) Memorandum of Agreement, DIA, dtd 17 August 1984,
subject: "Operating rationale and terms of agreement for the
participants in DoD psychoenergetics activities" (TAB D).
WARNING NOTICE: CENTER LANE SPECIAL ACCESS PROGRAM
RESTRICT DISSEMINATIO1-70?TITOSE WITH VERIFIED ACCESS
TO CATEGORY THREE ( 3)
SENSITIVE INTELLIGENCE SOURCES AND METHODS INVOLVED
NOT RELEASABLE TO FOREIGN NATIONALS
CLASSIFIED BY: CDR, INSCOM
DECLASSIFY ON: OADR
COPY OF COPIES
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SE
IACG
SUBJECT: Transfer of the INSCOM CENTER LANE Project to DIA
(S/CL-2/NOFORN)
3. (S/CL-2/NOFORN) BACKGROUND. USAINSCOM has invested
considerable effort since 1977 in developing psychoenergetic
operational methods. Intelligence consumers in the US Army, US Air
Force, DIA, NSA, CIA, and NSC have all tasked this methodology to
augment other intelligence systems. These agencies have recognized
the value and potential of the intelligence application of
psychoenergetics; it is likely they will continue to task the
system. The transfer of ICLP capability to DIA must be done in such
a way as to maintain continuity and momentum of effort, as well as
the state-of-the-art expertise exclusive to this time-proven, highly
respected activity.
4. (S/CL-2/NOFORN) SCOPE. The effective transfer of ICLP to DIA
requires the cooperation of INSCOM, DA (ACSI), and DIA.
5. (S/CL-3/N0FORN)) AGREEMENTS, SUPPORT, AND RESOURCES
REQUIREMENTS. The "package deal" concept has been agreed to in
principle by all parties involved. This concept has as its intent
the transfer of all personnel, documents, equipment, and office
space from INSCOM to DIA. The transfer of ICLP personnel to DIA
will not involve the transfer of any INSCOM spaces. ICLP has been
an active intelligence collection unit since 1978. It is intended
that the unit will remain an operational element under the direct
OPCON of the Assistant Vice Director for Scientific and Technical
Intelligence (DT), DIA.
a. (S/CL-2/NOF0RN) Personnel. All personnel assigned to
INSCOM and working on ICLP will be encouraged to PCS to DIA for
assignment to the DIA element that will perform the psychoenergetic
training and collection mission. (Operational participation with
CENTER LANE is strictly voluntary and falls under the guidelines of
DoT) directive 5240.1-R, AR 381-10, and Code of Federal Regulation,
Title 45, part 46.)
b. (S/CL-2/NOFORN) Documents. All documents maintained by
ICLP will be transferred to, and become the property and
responsibility of, DIA. INSCOM will be permitted to retain access
to command and control and historical ICLP documents.
c. (S/CL-2/NOFORN) Equipment. All ICLP equipment, rental
agreements, and on hand supplies will be transferred to DIA. ICLP
automatic data processing equipment and automobiles will remain with
INSCOM.
d. (S/CL-2/NOFORN) Office Space. The affected agencies have
agreed that the best course of action would be to continue to use
the ICLP facilities at Ft. Meade, MD, which consists of two
buildings, T-2560 and T-2561. Use of the Ft. Meade facility will
provide the least amount of turmoil for the personnel involved,
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IACG
SUBJECT: Transfer of the INSCOM CENTER LANE Project to DIA
(S/CL-2/NOFORN)
permit continued operations and training with the least amount of
disruption, and permit the best use of these buildings, which over
the years have been modified to support this unique activity.
Coordination with post authorities must be initiated to assign
buildings T-2560 and T-2561 to DIA.
6. (U) RESPONSIBILITIES. USAINSCOM ICLP Project Manager will:
a. (S/CL-2/NOFORN) Function as INSCOM POC for transfer of ICLP
to DIA.
b. (S/NOFORN) Coordinate for use or transfer of present ICLP
physidal facilities (bldgs. T-2560 and T-2561).
c. (S/CL-2/NOFORN) Coordinate transfer of ICLP equipment,
contracts and rental agreements from INSCOM to DIA.
d. (S/CL-2/NOFORN) Coordinate the transfer of all ICLP
personnel to DIA. Counsel all ICLP personnel concerning the
transfer and insure ICLP personnel are aware that they will be
performing operational remote viewing at DIA.
e. (S/CL-2/NOFORN) Coordinate for transfer of all relevant
documents maintained by ICLP to DIA.
7. (S/CL-2/NOFORN) EFFECTIVE DATE. ICLP is scheduled to cease
operations on or about 30 September 1984, at which time it will be
available for transfer to DIA. It is expected that the transfer
will be completed by 31 December 1984. Until completion of the
transfer process ICLP will remain in its entirety within USAINSCOM.
HAPIT?E =ER
Major General, USA
Commanding
JAMES A. WITETA%
Lieutenant General, USA
Director
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DEPARTMENT OF THE ARMY
UNITED STATES ARMY INTELLIGENCE AND SECURITY COMMAND
ARLINGTON HALL STATION
ARLINGTON, VIRGINIA 22212
REPLY TO
ATTENTION OF
12 FEB 1985
IACG
SUBJECT: Memorandum of Agreement, Transfer of INSCOM CENTER LANE
Project (ICLP) to DIA (S/NOFORN)
HQDA
ATTN: DAMI-ZA
Washington, D.C. 20310-1001
1. (S/NOFORN) Reference: Letter, INSCOM, IAGPA-F-SD, 21
December 1984, subject: Transfer of CENTER LANE to DIA
(S/CL-2/NOFORN) (Incl 1)
2. (S/NOFORN) Attached is the proposed INSCOM/DIA Memorandum of
Agreement for the pending assumption of operational control of
ICLP by the Defense Intelligence Agency.
3. (U) Request your review of attached MOA.
4. (U) Upon your approval, the MOA will be transmitted to DIA
for their review and approval. Anticipated effective date for
attachment of ICLP to DIA is 15 February 1985.
2 Incl SO ST
as Maj r General, USA
Commanding
CLASSIFIED BY: CO, INSCOM
DECLAS: OADR
EC,-"i 1,..,;ILA3ABLE TO FOREIGN NATIONALS
f.
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SECRE.
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Approved For Release SEC. REI-00788R0015000900107
DEPARTMENT OF THE ARMY
UNITED STATES ARMY INTELLIGENCE AND SECURITY COMMAND
ARLINGTON HALL STATION
ARLINGTON, VIRGINIA 22212
REPLY TO
ATTENTION OF
IAGPA-F-SD
21 December 1984
SUBJECT: Transfer of CENTER LANE to DIA (S/CL-2/NOFORN)
HODA
ATTN: DAMI-ZA
Washington, D. C. 20310-1001
1. (U) DAMI-ISH Letter, 4 October 1984, subject: Memorandum of
Agreement. (Incl 1)
2. (S/CL-3/NOFORN) Discussions with Defense Intelligence Agency
(DTA) management now indicate that DIA will not be able to accept
the transfer of INSCOM CENTER LANEProject (ICLP) assets until FY
1986. This is a result both of present Congressional restrictions
on use of NFIP funding for psychoenergetic intelligence collection
activities and a- severe shortage of non-NFIP resources at DIA.
DIA has requested operational control (OPCON) of ICLP as an
interim measure, and has agreed to accept all command and control
responsibility and liability for ICLP until such a time as
Congress approves use of NFIP fonds for psychoenergetic-related
activities (expected no later than the first quarter of FY 86).
3. (S/CL-2/NOFORN) Based on the above, CG, USAINSCOM, has
determined that the best course of action to permit the continued
use of ICLP technology is to place the Project under DIA's OPCON.
The target date for the action is 31 January 1985, which allows
necessary time to aecompliSb preparation and staffing of a new
,1\p?ripv -(yric;:': CENTER LANE
THREE (-3)
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IAGPA-F-SD 21 December 1984
SUBJECT: Transfer of CENTER LANE to DIA (S/CL-2/NOFORN)
Memorandum of Agreement delineating the responsibilities of both parties. Th
period of the OPCON will not exceed one calendar year.
4. (S/CL-3/NOFORN) DIA has agreed to officially notify Congress of their
assumption of responsibility for CENTER LANE.
4
5. (S/CL-2/NOFORN) The MOA will be forwarded to your office prior to submissi
to DIA. Additionally, in a separate action, CENTER LANE will be disestablished-,
as a Department of the Army Special Access Program (SAP). ACSI will be notified'
when this is fully accomplished.
_
,.-) --""-
e? 2:in
I Incl HARR jE. SO TER.
as Majot General, USA
*Commanding_
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r?
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DEPARTMENT OF' THE ARMY
OFFICE OF THE ASSISTANT CHIEF OF STAFF FOR INTELLIGENCE
WASHINGTON, DC 20310
REPLY TO
ATIENTION
DAMI-ISH
SUBJECT: Memorandum of Agreement (U)
Commander
USA Intelligence and Security Command
Arlington Hall Station
Arlington, VA 22212
4 OCT 191
L. (S/CL-2/NOFORN) Reference menorandum, INSCOM, IAGC,
26 Sep 84, subject: Memorandum of Agreement, Transfer of INSCOM
CENTER LANE Project- (TCLP) to DIA (S/CL-2/NOFORN).
2. (U) Reference proposed Memorandum of Agreement (MOA) is
approved.
3. (S/CL-2/NOFORN) Request you consider the inclusion of some
detail on the procedure to be followed in transferring personnel
to DIA. INSCOM may detail the individuals involved for up to one
year to allow time for DIA to identify spaces. Once such spaces
are available, the detailed persopnel may be given a Permanent
Change of Station. If DIA desires a change in authorized
strength to allow for immediate PCS reassignment, they may apply
for it through JCS. OACSI, DA will support such 3 change in
status if the subject becomes an issue.
Classified by Cdr, INSCOM
Declassify on: OADR
CENTE
4P r
or Release 2004/07Alitl
_CO
/LLIAM E. ODOM
I utenant Ganeral, USA
AColS for Intelligence
ON NATIONALS
NOT RELEASABLE TO
-00788R001500090F0V02-Y
CLOSE HOLD/HAND CARRY
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DP96-00788R001500090010-7
DEPARTMENT OF THE ARMY
UNITED STATES ARMY INTELLIGENCE AND SECURITY COMMAND
ARLINGTON HALL STATION
ARLINGTON, VIRGINIA 22212
REPLY TO
ATTENTION OF
TACG
SUBJECT: Deactivation of INSCOM CENTER LANE Project (ICLP)
as a Special Access Program (SAP) (U)
BODA
AT TN: DAMI-ZA
Washington, D.C. 20310-1001
1. (S/NOFORN) This letter seryes to notify you of the
deactivation of the INSCOM CENTER LANE Project, the attachment
OPCON of CENTER LANE assets and resources to the Defense
Intelligence Agency, and the retirement of CENTER LANE as an
active project nickname, effective as of the date of this letter.
2, (U) Request that the necessary actions be taken to officially
discontinue CENTER LANE as a Secretary of the Army designated
Special Access Program.
?HARRY E. SOYSTER
Major.General, USA
Commanding
CLASSIFIED BY: CG INSCOM
DECLAS: OADR
BLE TO FOREIGII NATIO:,71.5.T;;$
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