Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
.
24’ February 1984
USAINSCOM Regulation 15-3
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
terra
does
not
include
individual
or group training
of personnel
such
as
combat read-
iness,
effectiveness,
proficiency
or
fitness
exercises.
This
definition
is
unique
to
this regulation and
is
not
intended
to
identify an effort
for
funding
under
appropriations
intended
for
Research,
Development,
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)
.
A-
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
Appro
USAXNSCOM
ACS I
/ed For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
J
T
j
•
j
J
-i.
«i
Regulation
15-3
24 February 1984
^
Section II - Abbreviations
i
amed
“
—
Department
of the Army Assistaat
Chief
of Staff,
Intelligence
ARI
Army Medical Department
CENTEX
"
US Army Research Institute
for
the
Behavioral and Social Sciences
CFR
The INSCOM Center for Excellence
DA
DARCOM
Department
of
the Army
DCSPER
US Army Materiel Development and
Research Command
DCSPPM
'
——
The INSCOM Deputy Chief
of Staff
for
Personnel
DCSOPS
The INSCOM Deputy Chief of Staff
for Plans, Programs and Modernization
w w
DHHS
.—
The INSCOM Deputy Chief
of Staff
for Operations
HPTF—
Department
of Health and Human Services
HTRB
The INSCOM High Performance Task
Force
(no longer constituted)
INSCOM
The INSCOM Human Technology Review Board
MACOM
US Army Intelligence
and Security
Command
SJA
TSG
—
The INSCOM Staff Judge Advocate
TT<5
The Surgeon General
of the Army
united scates
A-4
m
Approved 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
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 P0C).
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).
7.
Objectives .
(State
briefly
but
specifically
the
objectives
of
the
pro-
ject.
Include items below,
where applicable).
a.
Study design.
(Double-blind,
crossover,
etc.).
B-l
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
b *
Technologies
to
be employed .
(List
the
generic
technologies
to
be
em-
ployed
in the project).
,
J,
c *
yPe
of
population
involved .
(List
the
subject
population
to
be
ob-
served) .
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.
Bibli graphy .
(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.
11.
Gene:
Section III
PROTOCOL PLAN
al approach .
a.
(yutline
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).
^2*
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
.
T
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).
B-2
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
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) .
i.
Subject
identification .
(Describe
code
system,
if
any,
which
will
be
used
in
the
project).
j.
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)
l.
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).
e.
(Describe
in detail accompanying devices
amd
their
intended use.
Iden-
tify whether
these
are
classified
as
medical
devices
and whether
the
medical
devices amendment
to
the Federal Food, Drug and Cosmetic Act applies).
f.
(Discuss
labeling
to medical devices,
where applicable).
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).
B-3
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7