Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
DEPARTMENT OF THE ARMY
UNITED STATES ARMY INTELLIGENCE AND SECURITY COMMAND
Arlington Hall Station
Arlington, Virginia
22212
USAINSC0M 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
(INSC0M)
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
GENERAL
INFORMATION
Paragraph
Page
Purpose
Applicability
References
Scope
Exemptions
Explanation
of
terms
and abbreviations
CHAPTER
RESPONSIBILITIES
Approving officials
Commanders
and Staff Element Heads
INSCOM Human Technology Review Board
(HTRB)
Chairperson of
the HTRB
Executive Secretary
of
the HTRB
Regular HTRB
Membership —
Ex Officio HTRB Membership
Ad
hoc HTRB Membership
Principal
investigator
—
Members
of volunteer recruiting
teams
Medical monitor
1-1
1-1
1-2
1-1
1-3
1-1
1-4
1-1
1-5
1-2
1-6
1-3
2-1
2-1
2-2
2-1
2-3
2-1
2-4
2-2
2-5
2-2
2-6
2-2
2-7
2-3
2-8
2-3
2-9
2-3
2-10
2-4
2-11
2-4
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
USAINSCOM Regulation
15-3
CHAPTER
POLICIES
General
Approval
Risk determinations
——
—
Risk versus benefit
•
Moral,
ethical and
legal concepts
—
Fully informed subjects —
—
Use
of non-US citizens
Use
of prisoners
of war and detainees
Medical
care
Stated objectives
——
Physical and mental
suffering
——
Qualifications
of
Investigators
Minors
Recruiting
of volunteers
Protocol guidance
24 February
, 1984
Paragraph
Page
-
3-1
3-1
-
3-2
3-1
-
3-3
3-1
-
3-4
3-1
-
3-5
3-1
-
3-6
3-1
-
3-7
3-1
-
3-8
3-1
-
3-9
3-1
-
3-10
3-1
-
3-11
3-1
-
3-12
3-2
-
3-13
3-2
-
3-14
3-2
-
3-15
3-2
CHAPTER 4
PROCEDURAL GUIDANCE
Technical reports
Advising
the Medical Research
and Development Command
Informed consent
Minimum standards
More
than minimal
risk
Contractors
or vendors
Requests
for exceptions
Expedited review categories
-
Expedited
review procedures
-
4-1
4-1
4-2
4-1
4-3
4-1
4-4
4-1
4-5
4-1
4-6
4-1
4-7
4-2
4-8
4-2
4-9
4-2
CHAPTER
INSC0M HUMAN TECHNOLOGY REVIEW BOARD
(HTRB) ACTIVITIES
Composition of
the HTRB
5-1
General criteria
for membership
5-2
General
committee activities
5-3
Avoiding possible conflicts
of
interest
—
5-4
Criteria
for INSC0M HTRB approval
5-5
Special considerations
of
sensitivity
5-6
Suspension
or termination
of
a project
5-7
Records
5_g
APPENDICES
5-1
5-1
5-1
5-1
5-1
5-2
5-2
5-3
A - Terms and Abbreviations
——
B - Format
for Preparation
of
a Research Protocol
C - Volunteer Agreement
, Part A
D
- Volunteer Agreement,
Part
B
A-l
B—
C-l
D-l
ii
Approi/ed For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
24 February 1984
USAINSCOM Regulation 15-3
Chapter
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
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
Approi/ed For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
USAINSCOM Regulation
15-3
24 February 1984
the
INSCpM,
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—
and
individual
excellence
where
such
investigation
involves
the
in-
clusion
<jf human subjects
as
their object.
1-5 .
Exemptions
.
izatlona
a.
Research,
testing and
studies
in which human subjects are
involved in
one
or mere
of
the following categories
are exempt
from this
regulation.
(1)
Bonafide
activities
under
the
sponsorship
of
another Department
of
the
Ai^my 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 hpw 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
Hufnan
Technology
Review
Board
as
prescribed
elsewhere
in
this
regula-
tion.
1-2
Approi/ed For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7