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REPLY TO
ATTENTION OF
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DEPARTMENT OF THE ARMY
UNITED STATES ARMY INTELLIGENCE AND SECURITY COMMAND
ARLINGTON HALL STATION
ARLINGTON, VIRGINIA 22212
IACC
17 July 1984
MEMORANDUM FOR ASSISTANT CHIEF OF STAFF FOR INTELLIGENCE
SUBJECT :
INSCOM CENTER LANE Project (U)
-
1. (0)
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
monopoly on this revolutionary concept for intelligence collection.
We must
insure that we do not lose this knowledge and experience in any action taken
to change INSCOM's role in the use and development of the technology.
3. (S) I am concerned about these three aspects of the program.
a. Continued 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.
Current operations.
Intelligence users in the Army, DIA, NSA
and CIA 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. Changing INSCOM'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 program.
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 I 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
CLASSIFIED BY: CDR, INSEL
..
PROGRAM RESTRICT DISSEMINATION TO THOSE WITH
DECLASSIFY
VERIFIED ACCESS TO CATEGORY THREE (3)
REVIEW OK!
CADA
SENSITIVE INTELLIGENCE SOURCES AND METHODS
INVOLVED NOT RELEASABLE TO FOREIGN NATIONAL.S
COPY 3 OF 3 COPIES
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ARMY review(s) completed.
*
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IACG
17 July 1984
SUBJECT:
INSCOM CENTER LANE Project (U)
a. (U)
Allow the reassignment of ICLP personnel on an equitable basis.
b.
(S/CL-3/NOFORN)
Permit trainees to complete training and become
60% operational.
c.
(S/CL-3/NOFORN)
Permit timely and undisrupted transfer of (1)
ICLP operations to a national agency such as DIA or NSA and (2) ICLP 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.
HARBYZE. SOYSTER
Brigadier General, USA
Commanding
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DEPARTMENT OF THE ARMY
OFFICE OF THE ASSISTANT CHIEF OF STAFF FOR INTELLIGENCE
WASHINGTON, DC 20310
REPLY TO
ATTENTION OF
DAMI-ISH
AS SCAN
1 AUG 1984
MEMORANDUM THRU VICE CHIEF OF STAFF, APMY C
ARMY GENERAL COUNSEL
Cel. 22 Aus. 1984
FOR SECRETARY OF THE ARMY
SUBJECT :
CENTER LANE (U) -- ACTION MEMORANDUM
aprimer
8/23/84
1. (S/CL-1/NOFORN) Purpose: To obtain your approval for the
discontinuation of Intelligence and Security Command ( INSCOM)
involvement with psychoenergetic research and operations.
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-
formation of intelligence interest. Your approval for the Army
to engage in CENTER LANE activities das most recently obtained on
1 Sep 83.
b. (S/CL-1/NOFORN) CDR INSCOM has reviewed the project and
reached the decision to discontinue the command's involvement
with psychoenergetic research and operations. Recognizing that
INSCOM has invested considerable effort over a long period of
time to develop the RV technology and holds a monopoly on this
revolutionary concept for intelligence collection, he desires
that we not lose this knowledge and experience.
c.
(U) As such, INSCOM intends to do the following :
(1) (S/CL-1/NOFORN) Cease CENTER LANE operations on 30
Sep 84, but allow contracts and training to continue to 31 Dec
84.
(2) (S/CL-3/NOFORN) Transfer project operational aspects
to DIA and technology extension to the US Army Medical Research
and Development Command .
In the event DIA is not interested in
the transfer, NSA will be considered.
CENTER LANE
CLASSIFIED BY CG INSCOM
DECLASSIFY ON OADR
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NOT RELEASABLE TO
FOREIGN NATIONALS

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€
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1 AUG 1984
1
₺
DAMI-ISH
SUBJECT :
CENTER LANE (U) -- ACTION MEMORANDUM
d. (S/CL-1/NOFORN) It Is anticipated that discussion between
INSCOM and the above organizations will result In a Memorandum
of Agreement transfering all CENTER LANE activity outside of
INSCOM, while insuring that tasearch and operational capabilities
are protected and the people involved are reassigned on an
equitable basis.
3. (S/CL-1/NOFORN) Recommendations Thic the Secretary of the
Army approve the INSCOM concept for discontinuing involvement
with psychoenergetic research and operations and transferring
CENTER LANE functions.
..
. . . .....
...
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4
Migadier General, USA
Acting ACofS fer Intelligence
.. . ... .
LTC Fox/50114
Typed by C. Huggins
2.3 AUG 1984
APPROVED BY
SECRETARY OF THE ARMY
......
.
:
CHARLES R. DOMINY
COL, GS
EXECUTIVE TO THE
.-
SECRETARY OF THE ARMY
. .
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CENTER LANE
DEPARTMENT OF THE ARMY
OFFICE OF THE ASSISTANT CHIEF OF STAFF FOR INTELLIGENCE
WASHINGTON, DC 20310
REPLY TO
ATTENTION ON
DAMI- ISH
10 SEP 1334
SUBJECT :
INSCOM CENTER LANE Project (U)
Commander
USA Intelligence and Security Command
Arlington Hall Station
Arlington, VA 22211
1. (U)
Reference memorandum, INSCOM, IACG, 17 Jul 84, subject:
INSCOM CENTER LANE Project (U), (S/CL-3/NOFORN).
2. (S/CL-1/NOFORN) The Secretary of the Army has approved
ending the Intelligence and Security Command's ( INSCOM) involve-
ment with psychoenergetic research and operations. A copy of
the OACSI, DA memorandum to the Secretary on the subject, with
his noted approval, is enclosed.
3. (S/CL-3/NOFORN) You are authorized to coordinate directly
with CIA, DIA, NSA, and the Army Medical R&D Command regarding
transfer of CENTER LANE operations and research. Any transfer
of project personnel, files, equipment, contracts, etc, should
be covered by" a Memorandum of Agreement (MOA). Any such MOA
should be provided for review by the ACSI prior to implemen-
cation.
4. (S/CL-1/NOFORN) The CENTER LANE Special Access Program
(SAP) should be terminated*er transferred, as appropriate, once
INSCOM involvement is discontinued.
a.
(S/CL-3/NOFORN)
If the Medical RED Command becomes
involved and desires SAP protection, the project name should be
changed and the Secretary of the Army duly notified.
b.
(S/CL-2/NOFORN)
If a non-Army agency assumes the pro-
ject functions, the SAP should be terminated. If that agency
desires SAP protection and support for an interim period this
should be provided under a new name.
1 Encl
as
TAXES W. SHUFALT
Brigadier General, USA
Soting ACofS for Intelligence
CLOSE HOLD/HAND CARRY
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PAMPIAD HATIGMAI C

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TAB
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DEPARTMENT OF THE ARMY
OFFICE OF THE ASSISTANT CHIEF OF STAFF FOR INTELLIGENCE
WASHINGTON, DC 20310
REPLY TO
DAMI - ISH
SUBJECT :
Memorandum of Agreement (U)
4 OCT 1901
Commander
USA Intelligence and Security Command
Arlington Hall Station
Arlington, VA 22212
1.
(S/ CL-2/NOFORN)
Reference memorandum, INSCOM, IAGC.
26 Sep 84, subject:
Memorandum of Agreement, Transfer of INS COM
CENTER LANE Project ( ICLP) 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
LO DIA.
INS COM 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 personnel 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 a change in
status if the subject becomes an issue.
Mm EOdom
WILLIAM E. ODOM
Lieutenant General, USA
ACofS for intelligence
Classified by Cdr, INSCOM
Declassify on :
OADR
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CENTER LAME
FOREIGN NATIONALS
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,
US ARMY
INTELLIGENCE AND SECURITY COMMAND
CENTER
LANE TRAINING AND APPLICATIONS PROCEDURES
WARNING NOTICE :
CENTER 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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SECRET
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1
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ENCLASSIBED
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US ARMY
INTELLIGENCE AND SECURITY COMMAND
CENTER LANE TRAINING AND APPLICATIONS PROCEDURES
INDEX
PAGE
1.
GENERAL
1
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
10. CONFIDENTIALITY
10
11. PHYSICAL ENVIRONMENT
10
APPENDIX A
A-1
APPENDIX B
B-1
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9.
ADDITIONAL COMMENTS

1
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IAGAP-F-SD
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 psychoenergetics. They are
effective and do not involve any practices
which expose
participants to harmful
circumstances
or substances such
as
drugs .
1
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,
and/or
perturbs
characteristics
of
a
designated target, person, or event.
c. (U) Psychoenergetic Trainee:
A person being trained to
be a psychoenergetic source.
d.
(U) Psychoenergetic Session:
A single attempt by a
psychoenergetic source and an
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 THREE
(3)
SENSITIVE INTELLIGENCE SOURCES AND METHODS INVOLVED
NOT RELEASABLE TO FOREIGN NATIONALS
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1.
.
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f.
(U)
Viewing :
Remote
The
name of
a
method
o f
psychoenergetic perception.
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:
An abstract referent which
represents the target of interest.
i. (U) Target/Site:
A specific area, person or event
at a
specific time.
j. (U) Discrete State:
A type of psychoenergetic activity
in which the source perceives his consciousness to be located at
the target.
3.
(S/CL-2/NOFORN)
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
o f
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/missions, 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 (GRILL 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
(DIA).
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 protocols 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 further
participants could
be
identified.
The
specific
tests
administered were ( see Appendix B for test descriptions ) :
(1)
The Minnesota Multiphasic Personality Inventory
(MMPI).
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(2)
Gordon Personal Profile - Inventory (GPI) .
(3)
Fundamental
Interpersonal
Relations
Orientation-Behavior (FIRO-B).
(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 constructed 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
LANE
score of 20 or higher is considered to be similar to CENTER
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 which,
when applied
to
a
general
population, will delineate specific individuals who exhibit
a
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 d
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
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-1/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 months.
(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
series of
controlled
exercises
in
psychoenergetic
of
a
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 as more 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
session.
(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
The
data) that this quiet time enhances the training process.
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 impressions, the monitor
applies no pressure.
Rather, the monitor reassures the trainee
that there is no time limit for the training session.
If
î t
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 perception.
Trainees
generally are not permitted to go beyond 30 minutes as this
leads to perceptual confusion and eventual loss of the training
affect.
&
(8)
Post Session Dynamics :
After the training session
is over,
the trainee and monitor obtain specific information
about the target, either in picture descriptive form for remote
geographic sites, or -- as in the case of local sites -- by actually
visiting the target site. The trainee and monitor then discuss
the session results.
The purpose of this post-session activity
is to provide the trainee with the satisfaction of knowing how
well he or she did while mental perceptions of the targeted site
are still fresh in mind.
b.
(S/CL-3/NOFORN)
--
CRV Training:
(1)
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; SRI-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
Stage 4 involves
competency with Stage 3 techniques develops.
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.
Experience
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 paper 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 feedback
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/NOFORN)
Applications Training :
(1)
Purpose :
To enable advanced 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 targets of military interest,
such
as US facilities or USSR
sites from 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 :
Fort
Meade,
Maryland and
various
contractor locations.
(4)
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, which 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) tasking; (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.
b.
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
INSCOM Staff Psychologist provides continuous support
to the
project.
Facilities at Kimbrough Army Hospital, Fort Meade, MD,
are available if required.
10.
(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 ordinary
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 THOSE WITH VERIFIED ACCESS
TO CATEGORY TWO
(2)
SENSITIVE INTELLIGENCE SOURCES AND METHODS INVOLVED
NOT RELEASABLE TO FOREIGN NATIONALS
CLASSIFIED BY :
CDR,
INSCOM
DECLASSIFY ON:
OADR
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APPENDIX A
Historical Summary of "Human Use" Issue
1.
(S/CL-2/NOFORN)
In February 1979, the Army General Counsel
determined that GRILL FLAME activities involved testing on human
ARMY
FOIAB5
subjects,
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, ‘DA concurrently initiated
action to obtain Secretary of the Army approval to conduct GRILL
FLAME activities.
In
September 1982,
INSCOM GRILL
of
FLAME
activities
ceased
because
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.
Approvals 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 (Incl 3).
d .
(U) USAINSCOM Regulation 15-3, "Boards, Commissions and
Committees :
HIGH PERFORMANCE REVIEW PROCEDURES" (Incl 4).
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L
PRR Reports
NIH
PHS
HHS
PROTECTION
FUSIAN SUBJECTS
CODE OF FEDERAL REGULATIONS
45 CFR 46
Revised as of March 8, 1983
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0, 0:

[Stamp]
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[Typed body]
NATIONAL RESEARCH ACT

PUBLIC LAW 93-348

JULY 12, 1974

INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM

SEC. 212. (a) Part I of title IV of the Public Health Service Act, as
amended by section 103 of this Act, is amended by adding at the end the
following new section.

"INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM

"SEC. 474. (a) The Secretary shall by regulation require that each entity
which applies for a grant or contract under this Act for any project or
program which involves the conduct of biomedical or behavioral research
involving human subjects submit in or with its application for such grant or
contract assurances satisfactory to the Secretary that it has established (in
accordance with regulations which the Secretary shall prescribe) a board (to
be known as an 'Institutional Review Board') to review biomedical and
behavioral research involving human subjects conducted at or sponsored by
such entity in order to protect the rights of the human subjects of such
research.

"(b) The Secretary shall establish a program within the Department
under which requests for clarification and guidance with respect to ethical
issues raised in connection with biomedical or behavioral research involving
human subjects are responded to promptly and appropriately."

(b) The Secretary of Health, Education, and Welfare shall within 240
days of the date of the enactment of this Act promulgate such regulations as
may be required to carry out section 474(a) of the Public Health Service
Act. Such regulations shall apply with respect to applications for grants and
contracts under such Act submitted after promulgation of such regulations.

THE CODE OF FEDERAL REGULATIONS,
45 CFR 46, IMPLEMENTS THESE AMENDMENTS
TO THE PUBLIC HEALTH SERVICE ACT.

[Handwritten annotation]
(illegible notation follows, unable to read) (?)

[Interlinear insertion]
," (small mark inserted above "human" in "behavioral research involving human subjects conducted") (?)

[Stamp]
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1
T
.
CODE OF FEDERAL REGULATIONS
TITLE 45
PUBLIC WELFARE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
OFFICE FOR PROTECTION FROM RESEARCH RISKS
1
PART 46-PROTECTION OF HUMAN SUBJECTS
REVISED AS OF MARCH 8, 1983
:
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45 CFR 46
- PART 46-PROTECTION OF
HUMAN
SUBJECTS
Subpart A --- Basic HHS Policy for
Protection of Human Research
Subjects
Sec.
46 101
To what do these regulations apply?
46.102
Definitions.
46.103
Assurances.
46 :04
Section reserved.
46.105
Section reserved.
46.106
Section reserved.
46.107
IRB membership.
46.108
IRB functions and operations.
46.109
IRB review of research.
46.110 Expedited review procedures for
certain kinds of research involving no
more than minimal risk, and for minor
changes in approved research.
46 111 Criteria for IRB approval of
research.
40.112 Review by institution.
40.113 Suspension or termination of IRB
approval of research.
46.114 Cooperative research.
40.115 IRB records.
46 116 General requirements for informed
consent.
46 117 Documentation of informed
consent.
46.118 Applications and proposals lacking
definite plans for involvement of human
subjects.
46.119 Research undertaken without the
intention of involving human subjects.
46.120 Evaluation and disposition of
applications and proposals.
46 121 Investigational new drug or device
30-day delay requirement.
46.122 Use of federal funds.
40.123 Early termination of research
funding; 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.
46.201
Applicability.
46.202
Purpose.
46.203
Definitions.
46.204
Ethical Advisory Boards.
46.205
Additional duties of the Institutional
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
utero, including nonviable fetuses, as
subjects.
46.210 Activities involving the dead fetus,
fetai 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
46.30!
Applicability
46.302
Purpose.
46.303
Definitions. .
46.304
Composition of Institutional Review
Boards where prisoners are involved.
46.305 Additional duties of the Institutional
Review Boards where prisoners are
involved.
46.306 Permitted activities involving
prisoners.
Subpart D-Additional Protections
for Children Involved as Subjects in
Research
Sec.
46.401 To what do these regulations apply?
46.402 Definitions.
46.403 IRB duties.
46.404 Research not involving greater than
minimal risk.
46.405 Research involving greater than
minimal risk but presenting the prospect
of direct benefit to the individual subjects.
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.
46.407 Research not otherwise approvable
which presents an opportunity to
understand, prevent, or alleviate a serious
problem affecting the health or welfare of
children.
46.408 Requirements for permission by
parenti or guardians and for assent by
children.
46.409
Wards.
Authority: 5 U.S.C. 301; sec. 474(a), 88
Stat. 352 (42 U.S.C. 289/-3(a)).
Subpart A -Basic HHS Policy for
Protection of Human Research
Subjects
Source: 46 FR 8386, January 26, 1991, 48 FR
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.
(1) 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
following categories are exempt from
these regulations unless the research
is covered by other subparts of this
part:
(1) 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
all 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, (ii)
the subject's responses, if they
became known outside the research.
could reasonably place the subject at
risk of criminal or civil liability or be - obtaining benefits or services under
damaging 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
observation (including observation by
participants) of public behavior.
except where all of the following
conditions exist: (i) observations are
recorded in such a manner that the
human subjects can be identified,
directly or through identifiers linked
to the subjects, (ii) the observations
recorded about the individual, if they
became known outside the research.
could reasonably place the subject at
risk of criminal or civil liability or be
damaging 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.
(5) Research involving the
collection or study of existing data.
documents, records, pathological
specimens, or diagnostic specimens.
if these sources are publicly available
or if the information is recorded by
the investigator in such a manner that
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
Health 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
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.
(c) The Secretary has final
authority to determine whether a
particular activity is covered by these
regulations.
(d) The Secretary may require that
specific research activities or classes
of research activities conducted or
funded by the Department, but not
otherwise covered by these
regulations, comply with some of all
of these regulations.
(c) The Secretary may also waive
applicability of these regulations to
specific research activities or classes
of research activities, otherwise
covered by these regulations. Notices
of these actions will be published in
the Federal Register 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 no way render
inapplicable pertinent federal, state,
or local laws of 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
Human Services.
(c) "Institution " means any public
or private entity or agency (including
federal, state. and other agencies).
(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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(!) "Human subject" means a
living individual about whom an
investigator (whether professional or
student) conducting research obtains
( 1) data through intervention or
interaction with the individual, or (2)
identifiable private information.
"Intervention includes both
physical procedures by which data are
gathered (for example, venipuncture)
and manipulations of the subject or
the subject's environment that are
performed for research purposes.
"Interaction" includes
communication or interpersonal
contact between investigator and
subject. : "Private information"
includes information about behavior
that occurs in a context in which an
individual can reasonably expect that
no observation or recording is taking
place, and information which has
been provided for specific purposes
by an individual and which the
individual can reasonably expect will
not be made public (for example, a
medical record). Private information
must be individually identifiable
(i.c., the identity of the subject is or
may readily be ascertained by the
investigator or associated with the
information) in order for obtaining
the information to constitute research
involving human subjeers.
(g) "Minimal risk " 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 examinations or tests.
..
(h) "Certification "' means the
official notification by the institution
to the Department in accordance with
the requirements of this part that a
research project or activity involving
human subjects has been reviewed
and approved by the Institutional
Review Board (IRB) in accordance
with the approved assurance on file at
HHS. (Certification is required when
the research is funded by the
Department and not otherwise exempt
in accordance with § 46.101(b)).
5 40.103 Assurances.
(a) Each institution engaged in
research covered by these regulations
shall provide written assurance
satisfactory to the Secretary that it
will comply with the requirements set
forth in these regulations.
(b) The Department will conduct or
fund research covered by these
regulations only if the institution has
an assurance approved as provided in
this section, and only if the institution
has 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:
4
(1) A statement of principles
governing the institution in the
discharge of its responsibilities for
protecting the rights 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 itself.
This requirement does not preempt
provisions of these regulations
applicable to Department-funded
research and is not 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
recordkeeping duties.
(3) A list of the IRB members
identified by name: earned degrees;
representative capacity; indications of
experience such as board
certifications, 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. 1
(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
insuring that changes in approved
.research, during the period for which
IRB approval has already been given,
may not be initiated without IRB
review and 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 institution 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 IRB in light of the
anticipated scope of the institution's
research activities and the types of
subject populations likely to be
' Repons should be filed with the Office
for Protection from Research Risks, National
Institutes of Health, Department of Health
and Human Services, Bethesda, Maryland
20205.
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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.
limit the period during which any
particular approved assurance or class
of approved assurances shall remain
effective or otherwise condition of
restrict approval.
(f) Within 60 days after the date of
submission to HHS 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 certity that the
application or proposal has been
approved by the IRB within 30 days
after receipt of a request for such a
certification from the Department. If
the certificanon is not submitted
within these time limits, the
application or proposal may be
returned to the institution.
§ 46.104 [Reserved)
$ 46.105 [Reserved]
§ 46.106 [Reserved]
§ 46.107 IRB membership.
(a) Each IRB shall have at least
five members, with varying
backgrounds to promote complete and
adequate review of research activities
commonly conducted by the
institution. The IRB 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
cultural backgrounds of members and
sensitivity to such issues as
community attitudes, 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 IRB
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 IRB regularly
reviews research that involves a
vulnerable category of subjects,
including but not limited to subjects
covered by other subparts of this part,
the IRB shall include one or more
individuals 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.
(c) Each IRB shall include at least
one member whose primary concerns
are in nonscientific areas; for
example: lawyers, ethicists, members
of the clergy.
(d) Each IRB 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.
(e) No IRB may have a member
participating in the IRB's initial or
continuing review of any project in
which the member has a conflicting
interest, except to provide
information requested by the IRB.
(1) An IRB 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 IRB, These
individuals may not vote with the
IRB.
$ 46.108 IRB functions and
operations.
In order to fulfill the requirements
of these regulations each IRB shall:
(a) Follow written procedures as
provided in § 46.103(b)(4).
(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.
$ 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.
(b) An IRB 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
IRB's judgment the information
would meaningfully add to the
protection of the rights and welfare of
subjects.
(+) 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 ;
writing of its decision to approve or
disapprove the proposed research
activity, or of modifications required
to secure IRB approval of the
research activity. If the IRB decides
to disapprove a research activity, it
shall include in its written notification
' Reports should be tiled with the Office
for Protection from Research Risks, National
Institutes of Health, Department of Health
and Human Services, Bethesda, Maryland
20205.
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45 CFR 46
a statement of the reasons 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
IRB through an expedited review
procedure. The list will be amended.
ai appropriate, through periodic
republication in the Federal
Register.
(b) An IRB may review some or all
of the research appearing on the 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 reviewers
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 § 46.108(b).
(c) Each IRB 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 of 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:
(1) 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
be 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 from risks and benefits
of therapies subjects would receive
even if not participating in the
research). The IRB should not
consider possible long-range effects
of applying knowledge gained in the
research (for example, the possible
effects of the 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 IRB should take into account the
purposes 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 consent will be
appropriately documented, in
accordance with, and to the extent
required by § 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 are
adequate provisions to protect the
privacy of subjects and to maintain
the confidentiality of data.
(b) Where some or all of the
subjects are likely to be vulnerable to
coercion or undue influence. such as
persons with acute or severe physical
or mental illness, or persons who are
economically or educationally
disadvantaged, appropriate additional:
safeguards have been included in the
study to protect the rights and welfare
of these subjects.
§ 46.112 Review by institution.
Research covered by these
regulations that has been approved by
an IRB 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 IRB.
$ 46.113 Suspension or
termination of IRB approval of
research.
An IRB shall have authority to
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
"IRB's action and shall be reported
promptly to the investigator,
appropriate institutional officials, and
the Secretary. º
' Reports should be filed with the Office
for Protection from Research Risks, National
institutes of Health, Department of Health
and Human Services, Bethesda, Maryland
20205.
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§ 46.114 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 of 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 these regulations institutions
may use joint review, reliance upon
tnt review of another qualified IRB.
or similar arrangements aimed at
avoidance of duplication of effort.
$ 46.115 IRE records.
(a) An institution, or where
appropriate an IRB, shall prepare and
maintain adequate documentation of
IRB 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
investigators, and reports of injuries
to subjects.
(2) Minutes of IRB meetings which
shall be in sufficient detail to show
attendance at the meetings; actions
taken by the IRB; 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 required 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
accessible for inspection and copying
by authorized representatives of the
Department at reasonable times and
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 of the subject or the
subject's legally authorized
representative. An investigator shall
seek such consent only under
circumstances that provide the
prospective subjectFor 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 shall be in language
understandable to the subject or the
representative. No informed 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 (c) or (d) of this section, in
seeking informed consent the
following information shall be
provided to each subject:
* (1) 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;
(2) A description of any reasonably
foreseeable risks or discomforts to the
subject:
(3) A description of any benefits to
i the subject or to others which may
;reasonably be expected from the
research;
: (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
information may be obtained;
NA
(7) An explanation of whom to
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
?
(8) A statement that participation is
7
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
entitled.
(b) 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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45 CFR 46
Page 10
treatment or procedure may involve
¿risks to the subject (or to the embryo
For fetus, if the subject is or may
Èbecome pregnant) which are currently
unforeseeable:
* (2) Anticipated circumstances
$ under which the subject's
participation may be terminated by
¿ the investigator without regard to the
¿subject's consent;
¥ (3) Any additional costs to the
"subject that may result from
participation in the research;
(4) The consequences of a
asubject's decision to withdraw from
ythe research and procedures for
orderly termination of participation
by 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
continue participation will be
provided to the subject; and
(6) The approximate number of
subjects involved in the study.
(c) An IRB may approve a consent
- procedure which does not include; or
which aftera, some or all of the
elements of informed consent set
forth above, or waive the requirement
to obtain informed consent provided
the IRB finds and documents that:
(1) 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 be carried out without the
waiver or alteration.
(d) An IRB may approve a consent
procedure which does not include, or
elements of informed consent set
forth above, or waive the
requirements to obtain informed
consent provided the IRB finds and
documents that:
(1) The research involves no more
than minimal risk to the subjects;
(2) The waiver or alteration will
not adversely affect the rights and
welfare of 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.
(1) Nothing in these regulations is
intended to limit the authority of a
physician to provide emergency
medical care. to the extent the
physician is permitted to do so under
applicable federal, state, or local law.
§ 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 "'short form" written
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 be said to the subject or the
representative. Only the short form
itself is to be signed by the subject of
the representative. However, the
witness shall sign both the short form
and a copy of the ermmary, and the
person actually obuuning 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 IRB may waive the
requirement for the investigator to
obtain a signed consent form for some
or all subjects if it finds either:
(1) That the only record linking the
subject and the research would be the
consent document and the principal
risk would be potential harm resulting
from a breach of confidentiality. Each
subject will be asked whether the
subject wants documentation linking
the subject with the research, and the
subject's wishes will govern; or
(2) That the research presents no
more than minimal risk of harm Jo
subjects and involves no procedures
for which written consertos normally
required outside of the research
context.
In cases where the documentation
requirement is waived, the 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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period of funding, but definite plans
would not 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 IRB before an award may be
made. However, except for research
described in § 46.10!(b), no human
subjects may be involved in any
project supported by these awards
until the project has been reviewed
and approved by the IRB, as provided
in these regulations, and certification
submitted to the Department.
9 46.119 Research undertaken
without the intention of involving
human subjects.
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.
as provided in these regulations, a
certification submitted to the
Department, and final approval given
to the proposed change by the
Department.
$ 46.120 Evaluation and
disposition of applications and
proposals.
(a) The Secretary will evaluate all
applications and proposals involving
human subjects submitted to the
Department through such officers and
employees of the Department and
such experts and consultants as the
Secretary determines to be
appropriate. This evaluation will take
into consideration the risks to the
subjects, the adequacy of protection
against these risks, the potential
benefits of the proposed research to
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.
$ 46.121 Investigational new drug
or device 30-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. l(a) and for significant risk
devices by 21 CFR 812.30 has
elapsed, or whether the Food and
Drug Administration has waived that
requirement. If the 30-day interval
has expired. the institution shall state
whether the Food and Drug
Administration has requested that the
sponsor 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 statement 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
interval.
§ 46.122 Use of Federal funds.
Federal funds administered by the
Department may not be expended for
research involving human subjects
unless the requirement of these
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 impose
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 B -- Additional Protections
Pertaining to Research
Development, and Related
"Activities Involving Fetuses."
Pregnant Women, and Human In
Vitro Fertilization'
SOURCE: 40 FR 13528, Aug. 8. 1975. 43 FR
1758. January 11. 1978, 43 FR
51559. November 3. 1978
§ 46.201 Applicability.
(a) The regulations in this subpart
are applicable to all Department of
Health, Education, and Welfare
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· 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.
following 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 REGISTER 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 utero which, although living,
is not viable.
(1) "Dead fetus" means a fetus ex
utero which exhibits neither
heartbeat, spontaneous respiratory
activity, spontaneous movement of
voluntary muscles, nor pulsation of
the umbilical cord (if still attached).
(g) "In vitro fertilization" means
any fertilization of human ova which
occurs outside the body of a female,
either through admixture of donor
human sperm and ova or by any other
means.
§ 46.204 Ethical Advisory
₫
Boards. 1
(a) One or more Ethical Advisory
Boards shall be established by the
Secretary. Members of these board(s)
shall be so selected that the 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 general public. No board member
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:
(1) 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 bas
been reviewed by the Board and the
Board has rendered advice as to its
acceptability from an ethical
standpoint.
(d) No application or proposal
involving human in vitro fertilization
may be funded by the Department of
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 from an
ethical standpoint.
§ 46.205 Additional duties of the
Institutional Review Boards In
connection with activities
involving fetuses, pregnant
women, or human in vitro
fertilization.
(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
(e.g., 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
determinations, 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
subpart is applicable may be
undertaken unless:
( 1) 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 (fi) determining the
viability of the fetus at the
termination of the pregnancy; and
1
(4) 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.
(b) No inducements, monetary or
otherwise, may be offered to
terminate pregnancy for purposes of
the activity
[40 FR 33528. Aug. 8. 1975, as amended at
40 FR 51638. Nov. 6, 1975)
§ 46.207
Activities directed
toward pregnant women as
subjects.
(a) No pregnant woman may be
involved as a subject in an activity
covered by this subpart unless: (1)
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.
(b) 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 after
having been fully informed regarding
possible impact on the fetus, except
that the father's informed consent
need not be secured if: (1) The
purpose of the activity is tormeet the
health needs of the mother; (2) his
identity or whereabouts cannot
reasonably be ascertained; (3) he is
not reasonably available; or (4) the
pregnancy resulted from rape.
$ 46.208 Activities directed
toward fetuses in utero as
subjects --
(a) No fetus in utero may be
involved as a subject in any activity
covered by this subpart unless: (1)
The purpose of the activity is to meet
the health needs of the particular fetus
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 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
father are legally competent and have
given their informed consent, except
that the father's consent need not 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.
§ 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
viability.
(b) No nonviable fetus may be
involved as a subject in an activity
covered by this subpart unless:
(1) 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
be obtained by other means.
(c) In the event the fetus ex utero
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: (1) 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
fetus 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 subpart,
with the approval of the Ethical
Advisory Board after such
opportunity for public comment as
the Ethical Advisory Board considers
appropriate in the particular instance.
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
subject and the importance of the
knowledge to be gained as to warrant
such modification or waiver and that
such benefits cannot be gained except
through a modification or waiver.
Any such modifications or waivers
will be published as notices in the
FEDERAL REGISTER
Subpart C-Additional Protections
Pertaining to Biomedical and
Behavioral Research Involving
Prisoners as Subjects :
Sowiee: 43 FR 53655, Nov 16. 1978
§ 46.301 Applicability.
(a) 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.
(bi Nothing in this subpart shall be
construed as indicating that
compliance with the procedures set
forth herein will authorize research
involving prisoners as subjects, to the
extent such research is limited or
barred by applicable State or local
law.
(c) The requirements of this
subpart are in addition to those
imposed under the other subparts of
this part.
§ 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 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) "DHEW" means the
Department of Health, Education,
and Welfare.
(c) "Prisoner" means any '
individual involuntarily confined or
detained in a penal institution. The
term is intended to encompass
individuals sentenced to such an
institution under a criminal or civil
statute, individuals detained in other
facilities by virtue of statutes or
commitment. procedures which
provide alternatives to criminal.
prosecution or incarceration in a
penal institution, and individuals
detained pending arraignment, trial,
or sentencing. :.
(d) "Minimal risk " is the
probability and magnitude of physical
or psychological harm that is
normally encountered in the daily
lives, or in the routine medical,
dental, or psychological examination
of healthy persons.
§ 46.304 Composition of
Institutional Review Boards
where prisoners are involved.
In addition to satisfying the
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 majority of the Board ...
(exclusive of prisoner members) shell
have no association with the prison(s)'
involved, apart from their
membership on the Board'
(b) At least one member of the!
Board shall be a prisoner, or a.
prisoner representative with
appropriate background and
experience 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
Institutional Review Boards under
this part, the Board shall review
research covered by this subpart and
approve such research only if it finds
that:
(1) The research under review
represents one of the categories of
research permissible under
§ 46.306(a)(2);
(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, are not of such
a magnitude that his or her ability to. .
weigh the risks of the research against ..
the value of such advantages in 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 selection 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 subjecta must 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
parole boarda will not take into,
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
0
(7) Where the Board finds there
may be a need for follow-up
examination or care of participants
after 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 fact.
(b) The Board shall carry out such
other duties as may be assigned by
the Secretary.
(c) The institution shall certify to
the Secretary, in such form and
manner as the Secretary may require,
that the duties of the Board under this
section have been fulfilled.
§ 46.306 Permitted research
involving prisoners ..
(a) Biomedical or behavioral
research conducted or supported by
DHEW may involve prisoners as
subjects only if:
( 1) 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
(2) In the judgment of the
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 FEDERAL REGISTER,
of his intent to approve such research;
8
(D) Research on practices, both
innovative and accepted, which have
the intent and reasonable probability
of improving the health or well-
being of the subject. In cases in
which those studies require the
assignment of prisoners in a manner
consistent with protocols approved by
the IRB 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 FEDERAL
REGISTER, of his intent to approve such
research.
(b) Except as provided in
paragraph (a) of this section.
biomedical or behavioral research
conducted or supported by DHEW
shall not involve prisoners as
subjects.
Subpart D -- Additional Protections
for Chikiren Involved as Subjectu in
Research.
Source: 48 FR 9818, March 8, 1983
§ 46.401 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.
(1) This includes research
conducted by Department
employees, except that each head of
en 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 (1), (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 § 46.102 of
Subpart A shall be applicable to this
subpart as well. In addition, as used
in this subpart:
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(a) "Children" are persons who
· · have 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 be
conducted.
(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) "Parent" means a child's
biological or adoptive parent.
(e) "Guardian" means an
individual who is authorized under
applicable state or local law to
consent on behalf of a child to
general medical care.
§46.403 IRB duties.
In addition to other responsibilities
assigned to IRBs under this part,
each IRD shall review research
covered by this subpart and approve
only research which satisfies the
conditions of all applicable sections
of this subpart.
§ 46,404 Research not involving
greater than minimal risk.
HIS will conduct or fund
research in which the IRB 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.
§ 46.405 Research involving greater
thas minimal risk but presentlog the
prospect of direct benefit to the
individual subjects.
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 holds out the
prospect of direct benefit for the
individual subject, or by #
monitoring procedure that is likely to
contribute to the subject's well-being
only if the IRB 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 a
monitoring procedure which is not
likely to contribute to the well-being
of the subject, only if the IRD 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 subject3'
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.
§ 46.407 Research mot otherwise
approvable 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 IRB does not
believe meets the requirements of +
§ § 46.404, 46.405, or 46.406 only if:
(a) The IRB 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.
5 46.408 Requirements for
pennission by parents or guardians
and for nasent by children.
(a) In addition to the
determinations required under other
applicable sections of this subpart,
the IRB shall determine that
adequate provisions are made for
soliciting the assent of the children,
when in the judgment of the IRB the
children are capable of providing
assent. In determining whether
children are capable of assenting, the
IRB 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
involved in research under a
particular protocol, or for each child,
as 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
be 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 aasenting,
the IRD may still waive the assent
requirement under circumstances in
which consent may be waived in
accord with § 46.116 of Subpart A.
(b) In addition to the
determinations required under other
applicable sections of this subpart,
the IRB shall determine, in
accordance with and to the extent
that consent is required by $ 46.116 of
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 IRB may find that the
permission of one parent is sufficient
for research to be conducted under
$ $ 46.404 or 46.405. Where research
is covered by §§ 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 legal
responsibility for the care and
custody of the child.
(c) In addition to the provisions for
waiver contained in § 46.116 of
Subpart A, if the IRB determines that
a research protocol is designed for
conditions or for a subject population
for which parental 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 or 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, and
condition.
(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 IRB determines that
assent is required, it shall also
determine whether and how assent
must be documented.
§ 46.409 Warda,
(a) Children who are wards of the
state or any other agency, institution,
or entity can be included in research
approved under $9 46.406 or 46.407
only if such research is:
(1) Related to their status as wards;
or
(2) Conducted in schools, camps,
hospitals, institutions, or similar
settings in 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.B 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 of 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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45 CFR 46
1
NOTICES
HUMAN SUBJECTS
Minimum Criteria Identifying the
Viable Fetus
On March 13. 1975. regulations
were published in the FEDERAL
REGISTER (40 FR 11854) relating to the
protection of human subjects in
research, development, and related
activities supported by Department of
Health, Education, and Wetfare
grants and contracts. These
regulations are codified at 45 CFR
Part 46.
Elsewhere in this issue of the
FEDERAL REGISTER, 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 B
provides inter alia as follows:
The Secretary may from time to time.
taking into account medical advances.
publish in the FEDERAL REGISTER
guidelines to assist in determining whether a
ferus is viable for purposes of this subpart.
This notice is published in
accordance with $ 46.203(d). For
purposes of Subpart B, the guidelines
indicating that a fetus other than a
dead fetus within the meaning of
§ 46.203(f) is viable include the
following:
an estimated gestational age of 20 weeks of
more and a body weight of 500 grams or
more
FEDERAL REGISTER, VOL 40,
AUGUST 8, 1975
U.S. GOVERNMENT PRINTING OFFICE : 1983 0 - 406-756
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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 experimentation 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.
Experimentation 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.
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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 on 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 subjects 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 be addressed through command
channels to HQDA (DAMI-CIC) , WASH DC 20310. ]
-
.
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DoD 5240.1-
.
i
DEPARTMENT OF DEFENSE
-
1
.
-
PROCEDURES GOVERNING THE
ACTIVITIES OF
DOD INTELLIGENCE COMPONENTS
THAT AFFECT UNITED STATES PERSONS
+4,
DECEMBER 1982
Qual 2
1
.
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UNDER SECRETARY OF DEFENSE FOR POLICY

GIA-RDP96-00788R001500090010-7
· DoD 5240.1-R
-PROCEDURE -13 .- EXPERIMENTATION ON HUMAN SUBJECTS FOR INTELLIGENCE PURPOSES
A
APPLICABILITY
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 experimentation on animal subjects.
B.
EXPLANATION OF UNDEFINED TERMS
1. Experimentation in this context means any research or testing activ-
ity 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 com-
ponent 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 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 person.
c.
PROCEDURES
le Experimentation on human subjects conducted by or on behalf of a DoD
intelligence component may be undertaken only with the informed consent of the
subject, in accordance with guidelines issued by the Department of Health and
Human Services, setting-out conditions .that safeguard the.welfare of-such-sub-
jects.
-
2. DoD intelligence components 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 Secretary or Under Secretary of a Military Department,
as appropriate.
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13-1
J04/07

AR JA1-t8
15 February 1982
personnel may Apppoved Fon, Release 2904/07/09 - GIA-RPR96-00788R091500099810-7out the
gence components to state and local law en-
forcement authorities only when lives are en-
d'togered and only pursuant to a request by the
head of such authority. Such requests must be
Approved by the Secretary or Under Secretary
of the Army. Under these circumstances expert,
personnel may be provided to such agency pro-
vided 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 ;
(b) Provision of such personnel will be
limited to that necessary to prevent the death
or serious injury that is threatened, but in no
case shall such assistance be provided for more
thau 72 hours;
(c) Such personnel are not used to ap-
prehend persons who are suspected of com.
mitting, or who are about to commit, a crime,
or
(d) Use of such personnel does not vio-
late the Posse Comitatus Act.
(3) Emergency assistance. In emergency
situations, where life is endangered, the request
required in (1) and (2) above may be ,oral,
provided that it is reduced to writing and sub-
mitted to HQDA (DAMI-CIC) within 72 hours.
Where life is endangered, doabt as to the legal-
ity and propriety of the requested assistance
under this procedure should be resolved in favor
of providing the assistance.
2-17. Procedure 17. Assignment of intelligence
personnel to other agencies. a. Applicability
and scope. This procedure applies to the as-
signment of DA intelligence personnel to other
agencies within the federal government. This
procedure does not apply to --
(1) Assignment to state or local govern-
ments, corporations or other private organiza-
tions.
(2) Assignment to another agency within
the intelligence community when part of the
purpose of the assignment is to gain experience
and knowledge about the activities of the other
agency. (Reporting or report in this context
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(6) (c) (1) of the Directive shal!
include -...
(a) An identification of the Army intel-
ligence component from which the employee
has been assigned by DA.
(b) A statement delineating the em-
ployee's responsibilities, if any, for reporting
# to the DA about maiters that come to the em-
ployer's attention while on assignment outside
the Department.
(2) Other than is permitted by the terms
of the memorandum of agreement pursuant to
DoD Directive 1000.17, an employee of an Army
intelligence 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.
(3) After completion of an assignment to
another agency of the federal government and
return 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. Applicability and scope.
(1) This procedure applies to experimen-
tation on human subjects if such experimenta-
tion is conducted by or on behalf of any Army
intelligence component. This procedure does not
apply to experimentation on animal subjects.
2-21
Incl 3
ase 200
₹GIA RDP96-0078
BR091500030010-

.AR 381-20
February 1982
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"Experimentation in this context means
a research, development, or related activity that
may expose an individual to the possibility of
injury (including physical, psychological, or
social injury) that increases the ordinary risks
of daily life for the subject (including the rec-
ognized risks inherent in a chosen occupation
or field of service), or that temporarily ad-
versely affects a person's mental or physical
condition.
(3) Experimentation is conducted "on be-
half of" an Army intelligence component if it is
conducted under contract to that component of
to another Army component for the benefit of
the intelligence component, or at the request of
such a component regardless of the existence
of a contractual relationship.
(4) Human subjects in this context in-
cludes any person regardless of whether the
person qualifies as a US person.
b. Policy. Army intelligence components may .
conduct experimentation on human subjects
only when an important foreign intelligence or
Cl purpose is to be served, only after the in-
formed consent of the subject has been obtained
in writing, and only in accordance with guide-
lines issued by the Department of Health and
Human Services setting out conditions that
safeguard the welfare of the subjects, and other
applicable regulations.
c. Procedure. Army intelligence components
may not engage in or contract for experimen-
tation on human subjects without prior ap-
proval of the Secretary or Under Secretary of
the Army.
2 -- 19. Procedure 19. Special activities. a. Ap-
plicability and scope.
(1) This procedure applies to the conduct
and support of special activities by Army intel-
ligence components. This procedure also applies
to other Army components that provide support
for special activities conducted by DoD intel-
ligence components and other agencies within
the Intelligence Community. These procedures
do not apply to ---
(a) Diplomatie or military attache ac-
tivities conducted by DOD.
(b) The collection and production of in-
telligence;
(c) Any functions in support of the
collection and production intelligence; or
(d) The conduet of special activities by
the military services in armed conflict or to
military deception operations targeted, for mili.
tary purposes, against a hostile foreign power.
(2) Conspiracy in this context has the
same meaning as in the criminal law context
and requires an overt act. Neither the term
"assassination" nor the term "conspire" in-
clude military or civilian measures against on-
going international terrorist activities (which
is e defined term (see glossary) and should be
construed strictly), sircraft hijackings, or in
response to danger of substantial physical harm
to any person. These terms do not apply to
actions of the military services in the execu-
tion of lawfully ordered military operations.
(3) Diplomatic and military attache activ-
ities means the representational, information
gathering, and reporting activities performed
by diplomatic and military attache personnel
abroad.
(4) Production of intelligence means the
process of developing "intelligence products"
which is a defined term. (see glossary).
(5) Special activities mean activities con-
ducted abroad in support of national foreign
policy objectives that are designed to further
official US programs and policies abroad; that
are planned and executed so that the role of the
United States Government is not apparent, or
acknowledged publicly and functions in support
of such activities, but not including diplomatic
and military aftache activities or the collection
and production of intelligence or related sup.
port functions.
(6) Support, when used in this context,
means the provision of assistance in the form
of transportation, training, supplies, equipment
or expert personnel.
b. Policy. No Army intelligence component
will participate in the conduct or support of
special activities. No other Army compores
will provide support for special activities excel
upon the specific direction of the Secretary @
Under Secretary of the Army and the Secretar
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I
!
1
1
c
8
P
2.
p
2.
(
th
D
an
pr
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reg
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USAINSCOM Regulation 15-3
24 February 1984
CHAPTER 3
POLICIES
Paragraph
Page
General
-----------------------------------------
3-1
3-1
Approval
3-2
3-1
Risk determinations
3-3
3-1
Risk versus benefit
3-4
3-1
Moral, ethical and legal concepts
3-5
3-1
Fully informed subjects
3-6
3-1
Use of non-US citizens
3-7
3-1
Use of prisoners of war and detainees
3-8
3-1
Medical care
3-9
3-1
Stated objectives
3-10
3-1
Physical and mental suffering
3-11
3-1
Qualifications of investigators
3-12
3-2
Minors --------------
3-13
3-2
Recruiting of volunteers
3-14
3~2
Protocol guidance
-----
-----------------------
3-15
3-2
CHAPTER 4
PROCEDURAL GUIDANCE
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
4-6
4-1
Requests for exceptions
4-7
4-2
Expedited review categories
4-8
4-2
Expedited review procedures
4-9
4-2
CHAPTER 5
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
-------
5-6
5-2
Suspension or termination of a project
5-7
5-2
Records
---- ---------------
---
------------
5-8
5-3
APPENDICES
A - Terms and Abbreviations
--------
---
A-1
B - Format for Preparation of a Research Protocol
B-1
C - Volunteer Agreement, Part A
C-1
D - Volunteer Agreement, Part 3
----
-------------------
D-1
-------------------------------
---- ------------
-----------------
---------------------------
------------------
---------------------
-----------
------
=====---------
------------------
------------------
--- ----
----
---------------------------
-----------------
------------
-----------
--------------
---
----
-----
-----------
11
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DEPARTMENT OF THE ARMY
UNITED STATES ARMY INTELLIGENCE AND SECURITY COMMAND
Arlington Hall Station
Arlington, Virginia
22212
USAINSCOM Regulation 15-3
24 February 1984
Boards, Commissions and Committees
HIGH PERFORMANCE REVIEW PROCEDURES
During 1982 and 1983, in keeping with the US Army Intelligence and Security
Command (INSCOM) goal of "extraordinary performance," and seeking to move the
command to a level which exceeds commonly defined parameters of performance,
the INSCOM conducted a study of high performing organizations and programs in
the public and private sectors.
Several technologies, management techniques,
training experiences and programs were identified for further evaluation with
respect to their potential to contribute to the development of extraordinary
Individual and unit performance within the Command. This regulation contains
INSCOM policies and guidance for that evaluation, establishes procedures for
the use of INSCOM personnel as volunteers in evaluating and Implementing high
performing human systems and provides guidance for commanders and supervisors
In further implementing and evaluating those high performing human systems.
Supplementation of this regulation is permitted only after prior approval has
been obtained from this Headquarters, ATTN: IASJA.
CHAPTER 1
GENERAL INFORMATION
Paragraph
Page
Purpose
1-1
1-1
Applicability
- --- --------------------- ----------------
1-2
1-1
References
1-3
1-1
Scope
1-4
1-1
Exemptions
1-5
1-2
Explanation of terms and abbreviations --**********
1-6
1-3
CHAPTER 2
RESPONSIBILITIES
Approving officials
2-1
Commanders and Staff Element Heads
2-2
2-1
INSCOM Human Technology Review Board (HTRB)
2-3
2-1
Chairperson of the RTRB
2-4
2-2
Executive Secretary of the HTRB
2-5
2-2
Regular HTRB
Membership
----------
2-6
2~2
Ex Officio HTRB Membership
2-7
2-3
Ad hoc HERB Membership
2-8
2 - 3
Principal Investigator
2-9
2-3
Members of volunteer recruiting teams
2-10
2-4
Medical monitor *****
2-11
2-4
----------------
--------
---------
---------------------
-------------
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24 February 1984
Approved For Release 2004/07/09 : CIA-RDP96-00788R00450009001Régulation 15-3
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;
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 381-10, 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 subjects, whether as the direct or indirect
object of research, regardless of the level or risk involved, in the develop-
ment, testing or study of matters associated with the missions and functions of
1-1
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USAINSCOM Regulation 15-3
11
24 February 1984
T
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 not
place the subject at risk of criminal or civil liability or damage the sub-
ject's financial or social standing or employability.
(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 use 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 regulations 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.
1-2.
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24 February Approved For Release 2004/07/09 : CIA-RDP96-00788R661566696dosylation 15-3
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 lleads. 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. in 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-
sible for
--
a.
Observing written procedures 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 HTRB 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 CG any serious or continuing noncompliance with HTRB
requirements and determinations found by investigators.
2-1
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USAINSCOM Regulation 15-3
24 February 1984
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 and
each investigation, as appropriate.
..
Recommending safeguards or special
conditions to a protocol.
When
such recommendations are made, the approving official may take the following
action:
col.
(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 HTRB and is responsible for chairing HTRB meetings, keeping
the CG informed of HTRB activities, and recommending approval/disapproval of
HIRB regular members 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 is responsible for ==
a .
Insuring that the responsibilities of the HTRB prescribed in para-
graph 2-3 are carried out.
b.
Preparing and distributing the agenda for each meeting to all HTRB
members.
,
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 membership. 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 be identified by name, earned degrees, current position
and duties, and experience, such as board certifications and licenses. The in-
formation in the nomination will be complete enough to describe each member's
chief expected contributions to HTRB reviews.
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b. Nominees will normally be military officers in the grade of 0-5, or
above, or civilian employees, GS-13 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.
will
2-7.
Ex officio HTRB membership.
The incumbents of the following positions
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.
Ad hoc HTRB membership.
The following will serve as ad hoc members of
the INSCOM HTRB:
a. The Staff Advisor for Scientific and Cryptologic Affairs.
be A physician, as approved by an INSCOM approving official (para 2-1).
Physician nominees for ad hoc membership will be provided as requested by the.
Chairperson.
2-9.
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) Volunteer agreement documents.
b. Preparing progress reports, including annual reports, as determined
by the approving authority and the INSCOM HTRB.
c. Promptly notifying the approving authority, through the INSCOM HTRB,
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 HTRB before starting, changing or extending a study.
e. Insuring that all subjects, including those used as controls or their
representatives, are fully informed of the nature of the research to include
potential risks to the subject.
*
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 monitor of each project is responsible for
and is hereby delegated the authority to terminate the effort if --
*
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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USAINSCOM Regulation 15-3
Chapter 3
POLICIES
3-1.
General. Experimentation Involving human technology or human subjects
conducted by or on behalf of any INSCOM 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 (DHHS), setting out conditions
that safeguard the welfare of such subjects. The provisions of this regulation
constitute INSCOM implementation of those guidelines.
3-2. Approval. INSCOM components may not engage in or contract any research
or testing involving human subjects without advance approval through the INSCOM
HTRB by an INSCOM approving official, or higher level official, where appropri-
ate. This approval is required regardless of the degree of risk involved.
3-3. Risk determinations. The INSCOM HTRB will render all risk determinations
regarding INSCOM research or testing 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
take part as human subjects.
3-6.
Fully informed subjects. Only persons who are fully informed and volun-
teer to take part may be used as human subjects in INSCOM research and testing
activities.
3-7.
Use of non-US citizens. Research may be conducted outside the US that
involves non-US citizens; however, all requirements of this regulation applic-
able to human subjects shall be equally applicable to non-US citizen human sub-
jects.
3-6. Use of prisoners of war and detainees. The use of prisoners of war and
detainees 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 taking 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 project 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 project.
3-12.
Qualifications of investigators.
Only persons judged qualified by the
appropriate approving authority will conduct human subject studies. The physi-
cian 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 recuiting 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 be reviewed at least annually and on a
continuing basis as determined by the INSCOM HTRB.
Annually means once each
12-month period.
b.
The decision as to whether a research
protocol involves more than
minimal risk shall be made by the INSCOM HTRB.
C.
The research protocol will be prepared in accordance with the In-
structions contained at appendix B.
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USAINSCOM Regulation 15-3
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
ag 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 HQDA 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.
₡
The Volunteer Agreement ( appendix C).
b.
The Explanation Portion of the Volunteer Agreement ( appendix D) .
4-4.
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 same 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 (DAMI-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 CG.
4-6.
Contractors or vendors.
Contractors or vendors holding approved DHHS
assurance of compliance shall be considered in compliance with this regulation.
In the absence of such an assurance, a special assurance will be negotiated
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with the contractor or vendor.
In all cases, however, the INSCOM HTRB must ap-
4
prove the INSCOM participation in or utilization of such contractors or ven-
dors.
4-7.
Requests for exceptions.
Requests for exceptions to this regulation will
be submitted to the INSCOM HTRB Chairperson (DCSPPM) with full justification.
4-8.
Expedited review categories.
Categories which may be processed in the
expedited review procedures are as follows :
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)
Electrocardiogra
(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, the
HTRB Chairperson, or one or more HTRB reviewers 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 CG 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.
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a
Chapter 5
INSCOM HUMAN TECHNOLOGY REVIEW BOARD ACTIVITIES
5-1.
Composition of the HTRB. Membership in the INSCOM HTRB will consist of
the chairperson; at least six other regular members, appointed by the CG from
among the nominations submitted in accordance with paragraph 2-6 and 2-8,
above, 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.
General criteria for membership. At least one member of the HTRB will be
from a profession/position/activity primarily concerned with the welfare of hu-
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 ia serving as the non-INSCOM 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 as an intel-
ligence component.
a. At least five voting members will be required to constitute a quorum
at cach committee meeting.
b.
All actions of the committee will be by majority vote of members
present.
5-4.
Avoiding possible conflicts. of interest.
a. Except to provide information requested by the HTRB, no INSCOM HTRB
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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24 February 1984
particular project, unless a clear linkage has been established to other pro-
jects.
b. To approve an effort covered by this regulation, the INSCOM HTRB 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 unnec-
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-
Bor has adequately considered ==
(a) The purpose of the investigation.
(b) The setting in which the research investigation will be con-
ducted.
(4)
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 written summary of the discussion of contro-
verted issues and their resolution.
(3)
Records of continuing review activities.
(4)
Copies of all correspondence between the HTRB and project inves-
tigators.
#
(5) A current list of HTRB members .. Members will be identified by
name, earned degrees, 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 Commander, Support, 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 with 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 capacity to consent.
b.
Permission. Agreement by a "legally authorized representative" for
taking part as a human subject of another person who does not possess autono-
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 subject 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 and 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.
Expedited review procedures. Those 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-
tients to provide diagnostic or treatment procedures within established profes-
-
Sional standards.
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A-7.
Human subject. 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 the use of human subjects.
HTRB
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.
Approving 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 subject 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 ,observing human subjects during the
conduct of research.
A-11.
Minimal risk. 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-
iness, effectiveness, proficiency or fitness exercises.
This definition 1s
unique to this regulation and is not intended to identify an effort for funding
under appropriations intended for Research, Development, Test and Evaluation
(RDTE) .
"Research" in the sense applied in this regulation will be funded
according to the project, effort, etc., to which it applies.
A-15.
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 unpredictable elements. Development , usually
is confined to the qualification or elaboration of known principals.
A-16.
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-training 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 assessment 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
concept).
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Section II - Abbreviations
ACSI
Department of the Army Assistant
Chief of Staff, Intelligence
AMED -----------------------------------
Army Medical Department
ARI
US Army Research Institute for the
Behavioral and Social Sciences
CENTEX-CDCON -------------------------
The INSCOM Center for Excellence
CFR
Code of Federal Regulations
06 -------------------------- ---------
Department of the Army
US Army Materiel Development and
Research Command
DOSPER ---------------- -- --- - -- - - ------- -
The INSCOM Deputy Chief of Staff for
Personnel
DCSPPM
The INSCOM Deputy Chief of Staff
for Plans, Programs and Modernization
DCSOPS
----
-------------- -
The INSCOM Deputy Chief of Staff
for Operations
-------------------
----------
Department of Health and Human Services
DHIS-
HPTF-
-----------------
------------
-
HTRB
INSCON -----------------
-------
MACOM
Major Army command
SJA ------------------------------------
Us --------------------
The INSCOM Staff Judge Advocate
The Surgeon General of the Army
United States
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The INSCOM High Performance Task
Force (no longer constituted)
The INSCOM Human Technology Review Board
US Army Intelligence and Security
Command
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24 February 1984
USAINSCOM Regulation 15-3
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 No.
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. (Give 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 list 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).
ject.
7.
Objectives.
(State briefly but specifically the objectives 'of the pro-
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 the 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 this
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 inclusion
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 before
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
used in the project) .
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).
m.
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 and description 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 for application, if different from procedures
described above).
d. (State the schedule, administration and duration of each aspect of the
project) .
@
(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).
4
14.
Evaluations made during and following the project. (A project schematic
may be included, or the items may be listed as indicated below. ]
In either
case, it is important to Identify the person who will perform each evaluation).
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ÚSAINSCOM Regulation 15-3
24 February 1984
a .
Specimens to be collected.
(1)
Schedule of collections.
(2)
Evaluations to be made on specimens .
(3)
Storage. (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 .
Disposition of data.
( State 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.
Departure from protocol for individual subjects.
a.
When allowed. (Use flexible,, but definite criteria.
If none is to be
allowed, so state) .
b.
Who will be notified.
(Include both those regarding the individual
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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USAINSCOM Regulation 15-3
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.
Medical monitor. (State the name and telephone number of medical monitor,
when applicable).
22. Protocol review. (Identify the human use committee or institutional re-
view board which will provide initial, continued and annual review of this pro-
tocol).
(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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USAINSCOM Regulation 15-3
APPENDIX C
VOLUNTEER AGREEMENT
Part A
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:
and
under the direction of
The implications of my voluntary participation; the nature, duration and
purpose, and the methods and neans by which it is to be conducted; and the in-
Conveniences and hazards to be expected have been thoroughly explained to me by
, and are set forth in Part B of this
Agreement, which I have signed.
I have been given the opportunity to ask ques-
tions concerning this investigative 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 examinations are necessary for my health
or well being.
Signature
Date
Witness's Signature
-----------
Date
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24 February 1984
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USAINSCOM Regulation 15-3
APPENDIX D
VOLUNTEER AGREEMENT
Part 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),
9
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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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 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.
The precautions to be observed by the subject before and after the
study . )
.
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STATEMENT OF CONSENT
INSCOM CENTER LANE PROJECT PARTICIPANT
IAGPA-F-SD
Date:
1.
(S/CL-4/NOFORN)
I,
voluntarily accept assignment
to the INSCOM CENTER LANE PROJECT ( ICLF) and fully understand that:
(U)
Army
General
Counsel
determined
that
ICLP
constitutes
experimentation on human subjects.
As required by Procedure 13 of DoD Directive
5240.1-R, approval for project activities has been granted by Secretary of the Army.
are
b. (S/CL-3/NOFORN) The aim of ICLP is to develop highly skilled personnel who
capable of conducting professional
level intelligence/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. Due to
the nature of training involved, the duration of my participation is indefinito.
Records of my involvement will be available to project personnel, but otherwise
protected under project security measures.
action will
d.
(U)
The primary consideration in any career development or assignment
be ICLP mission and operational requirements.
I understand
that
exemption, interruption, or delay in normal career development patterns -- such as
branch schooling and assignment opportunities-may prejudice future promotion and
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.
8.
(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 would ordinarily be exposed in their
daily lives.
b. (U) I may temporarily choose not to perform PE at
specific times, or
permanently discontinue participation without prejudicial effect.
WARNING NOTICE:
CENTER LANE SPECIAL ACCESS PROGRAM
RESTRICT DISSEMINATION TO THOSE WITH VERIFIED ACCESS
CATEGORY CL-4
NOT RELEASEABLE TO FOREIGN NATIONALS
CLASSIFIED BY: CDR, INSCOM
DECI: OADR
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APPENDIX B
US ARMY
INTELLIGENCE AND
SECURITY COMMAND
LANE TRAINING AND APPLICATIONS PROCEDURES
CENTER
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.
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
The
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),
Mf
(masculinity-
femininity),
Pa
( paranoia) ,
Pt
( psychasthenia) ,
Sc
(schizophrenia), and Ma (hypomania) -- or by their code numbers to
avoid possibly misleading connotations.
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 G. Gough, Ph. D., Consulting Psychologists Press,
Inc.
The
CPI
intended
for
is
primarily
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
These 15 measurable personality variables
are;
achievement (ach), deference (def), order
(ord), exhibition
Murray.
(exh), autonomy (aut), affiliation (aff),
intraception (int),
succorance (suc), 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 is 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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1
:

SECRET.
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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
IACG
MEMORANDUM OF AGREEMENT
BETWEEN
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 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
COPY
OF
COPIES
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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/NOFORN) ) 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/NOFORN)
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
DoD 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.
A11
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,
Approved For Release 2004/07/09 : CIA-RDP96-00788R001500090010-7
SLUNCI

Approved For Release 2SECRET
/07/09 / CIA-RBP96-00788R001500090010-7
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
physical 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.
HARRY E. SOYSTER
Major General, USA
Commanding
JAMES A. WILLIAMS
Lieutenant General, USA
Director
.
Approved For Release 2004/07/09 : CIA-RDP96-00788R001500090010-7
SECRET

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TAB
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Approved For Release 2004/07/09 : CIA-RDP96-00788R001500090010-7

SECRET
Approved For Release 2004/07/09 : CTA-RDP96-00788R001500090010-7
DEPARTMENT OF THE ARMY
UNITED STATES ARMY INTELLIGENCE AND SECURITY COMMAND
ARLINGTON HALL STATION
ARLINGTON, VIRGINIA 22212
DEPAR
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
as
HARRY E. SOYSTER
Major General, USA
Commanding
CLASSIFIED BY: CG, INSCOM
DECLAS:
OADR
NOT KEMEAGABLE TO FOREIGN NATIONALS
Approved For Release 2004/07/09 : CIA-RDP96-00788R001500090010-7
SECRET

.
Approved For Release 200
6-00788R001500090010-7
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,
4
subject :
Memorandum of
Agreement.
(Incl 1)
2. (S/CL-3/NOFORN)
Discussions with Defense Intelligence Agency
(DIA) management now indicate that DIA will not be able to accept
the transfer of INSCOM CENTER LANE Project (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 funds 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 accomplish preparation and staffing of a new
.
WARNING NOTICE:
CENTER LANE
SENSITIVE
..
.. 1
THREE (3)
- .
:
2
Approved For Release 2004/07/09 : CIA-RDP96-00788R001500090010-7
SECRET
Incl 1

.
--
Approved For Release 2004/07/09.0 CIA-RDP96-00788R001500090010-7
21 December 1984
IAGPA-F-SD
SUBJECT:
Transfer of CENTER LANE to DIA (S/CL-2/NOFORN)
Memorandum of Agreement delineating the responsibilities of both parties.
The
. .
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.
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.
1 Incl
as
HARRY/ E. SOYSTER
Major General, USA
*Commanding
.
Approved For Release 2004/07/09 : CIA-RDP96-00788R001500090010-7

SECRET
Approved For Release 2004/07/09 CIA-RDP96-00788R001500090010-7
DEPARTMENT OF THE ARMY
OFFICE OF THE ASSISTANT CHIEF OF STAFF FOR INTELLIGENCE
WASHINGTON, DC 20310
REPLY TO
ATTENTION OF
DAMI-ISH
SUBJECT :
Memorandum of Agreement (U)
4 OCT 1901
Commander
USA Intelligence and Security Command
Arlington Hall Station
Arlington, VA 22212
.
1. (S/ CL-2/NOFORN)
Reference memorandum, INSCOM, IAGC,
26 Sep 84, subject:
Memorandum of Agreement, Transfer of INSCOM
CENTER LANE Project (ICLP) 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 personnel 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 a change in
status if the subject becomes an issue.
WILLIAM E. ODOM
Lieutenant General, USA
ACofS for Intelligence
Classified by Cdr, INSCOM
Declassify on: OADR
NOT RELEASABLE TO
FOREIGN NATIONALS
Approved For Release 2004/07/09 : GIA RDP96-00788R001500090010-7
SECRET
CLOSE HOLD/HAND CARRY

Approved For Release 2004/07/09 : CIA-RDP96-00788R001500090010-7
TAB
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1
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Approved For Release 2004/07/09 : CIA-RDP96-00788R001500090010-7

SECRET
Approved For Release 2004/07/09 : CIA-RDP96-00788R001500090010-7
DEPARTMENT OF THE ARMY
UNITED STATES ARMY INTELLIGENCE AND SECURITY COMMAND
ARLINGTON HALL STATION
ARLINGTON, VIRGINIA 22212
REPLY TO
ATTENTION OF
IACG
SUBJECT:
Deactivation of INSCOM CENTER LANE Project (ICLP)
as a Special Access Program (SAP)
(U)
HQDA
ATTN:
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
C
CLASSIFIED BY: CG, INSCOM
DECLAS:
OADR
NOR ALIASABLE TO FOREIGN NATIONALS
Approved For Release 2004/07/09: CIA-RDP96-00788R001500090010-7
SECRET
TAR 6