Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
24 February 1984
USAINSCOM Regulation 15-3
Chapter
RESPONSIBILITIES
2-1.
Approving
officials.
The
Commanding
General,
the
Deputy Commander,
In-
telligenceT^it^l^
Commander,
Support,
are
the
designated
INSC0M
ap-
proving officials.
Only
these
officials may approve
the
use
of human subjects
in research.
2-2.
Commanders and
Staff Element Heads
.
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
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
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.
g.
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.
“1
2- ^ *
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
injformed
of
HTRB
activities,
and
recommending
approval/disapproval
of
HTRB 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 *
i*nsur*nS
t *iat
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,
DCS SYS,
SJA,
Command
Chaplain apd DARC0M LNO,
are
each
responsible
for nomination
of
an
individual
to
serve
ps
a
regular
member
of
the HTRB.
Nominees may
be
from
their
respec-
tive
staffp,
subordinate
command
functional
counterpart
staffs,
or
may
be
the
gating, elerat
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.
bominees will
be
identified by name,
earned degrees,
current position
and duties
?
and experience,
such
as board
certifications and
licenses.
The
in-
formation
^Ln
the
nomination
will
be
complete
enough
to
describe
each member's
chief expected
contributions
to HTRB reviews.
2-2
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 15-3
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.
2-7.
Ex
officio
HTRB membership .
The
incumbents
of
the
following
positions
will
serve
as
ex officio, non-voting members
of
the HTRB:
a.
Chief,
CENTEX.
b.
Command Psychologist.
c.
Chief,
Human Technology Office.
d.
Chief, Public Affairs Office.
2-8.
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.
b.
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.
2-3
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
USAINSCOfl Regulation
15-3
d.
24 February 1984
Insuring
that
the
research
has
been approved by
the proper authority
and
the
.CNSC0M 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.
f .
Insuring
that
investigational materials
and
devices
are
administered
only
to subjects under his
or her personal supervision and
that
of a previously
approved associate
investigator.
g.
Insuring
that volunteer recruiting
teams
are briefed
as
to
the nature
of
the research
and
the
ethical principles
in
this
and related regulations.
2“ 10 *
Members
of volunteer recruiting
teams .
Members
of volunteer recruiting
teams are responsible
for —
~
a.
Establishing volunteer requirements
prior
to
recruitment.
b.
Undertaking recruiting
in a morally,
ethically and legally acceptable
manner
.
2-11 •
Mqdlcal monitor .
The medical monitor of each project
is
responsible
for
and
is hereby delegated the authority
to terminate the effort
if —
a.
Subjects are
at
risk of
life
or
limb..
b.
It
appears
the
risk
is
significantly greater
than anticipated
at
the
time
of review and approval
of
the project.
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
24 February 1984
USAINSCOM Regulation 15-3
Chapter
POLICIES
3-1.
General.
Experimentation
involving
human
technology
or
human
subjects
conducted by
or
on behalf
of any INSC0M 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 INSC0M 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.
3-8.
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
3-1
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
Chapter
PROCEDURAL GUIDANCE
4-1.
Technical
reports.
Technical
reports
will
be
prepared
as
prescribed
in
AR 70-31 and follow the
format
of MIL-STD-847A.
When applicable,
these reports
will contain
the
following statement:
For
the
protection
of
human
subjects,
the
investigators
have
adhered
to
the
policies
of AR 70-25 concerning
the use
of volunteers
as research subjects.
4-2.
Advising
the
Medical
Research
and
Development
Command .
Two
copies
of
technical
reports
of
study will
be
forwarded
to
the
Commander,
US Army Medical
Research
and
Development
Command,
ATTN:
SGRD—HR,
Fort
Detrick,
Frederick,
Maryland
21701.
When
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.
a.
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
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
4-1
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
USAINSCO^ Regulation 15-3
24 February ,1984
with
the
! contractor
or vendor.
In all cases,
however,
the INSCOM HTRB must ap-
prove
th?
INSCOM
participation
in
or
utilization
of
such
contractors
or
ven-
dors.
|
^“7*
Request s
for exceptions .
Requests
for exceptions
to
this
regulation will
be submitted
to
the INSCOM HTRB Chairperson (DCSPPM) with
full
justification.
*-8,
ExPedlted
review
categories .
Categories
which
may
be
processed
in
the
expedited
review procedures
are
as
follows:
a.
Recording
of
data
from
subjects
who
are
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 —
I
(1)
The use
of
physical
sensors
that
are
applied
either
to
the
sur-
face
of
the body or
at
a distance
and
do
not
involve
input
of matter
or signif-
icant
amounts
of
energy
into
the
subject
or
an
invasion
of
the
subject’s
pri-
vacy.
(2)
Such procedures
as —
(a)
Weighing.
(b)
Electrocardiography.
(c)
Electroencephalography.
(d)
Thermography.
(e)
Detection of naturally occurring radioactivity.
(f)
Diagnostic echography.
(g)
Electroretinography.
b.
Voice
recordings made
for research purposes
such
as
investigations
of
speech defects,
improvement
in language utilization,
etc.
c.
Moderate exercise
of healthy volunteers.
d.
Study
of
existing
data,
documents,
records,
pathological
specimens,
or diagnostic
specimens.
e.
Minor
changes
in
previously
approved
research
during
the
period
for
which approval has been authorized.
^
Expedited
review
procedures
.
Under
an
expedited
review
procedure,
the
HTRB
C haii-person,
or
one
or more HTRB reviewers
designated
by
the
chairperson,
may carry
out
the
review.
These
reviewers
may
exercise
all
of
the
authorities
4-2
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 15-3
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.
4-3
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
24 February
1984
THIS PAGE INTENTIONALLY LEFT BLANK
4-4
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
24 February
1984
USAINSCOM Regulation 15-3
Chapter
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
is
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 each 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
5-1
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
particular
project,
unless
a
clear
linkage
has
been
established
to
other
pro-
jects.
b,
i
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.
Co)
Already
being
used
on
subjects
for
diagnosis
or
treatment,
when appropriate.
.
(2)
Risks
to
subjects
are reasonable
in relation
to —
j
(a)
Anticipated benefits,
if
any,
to
the
subjects.
(b)
The
importance
of
the
knowledge
that
may
be
expected
to
result.
(3)
In making
an
assessment
for
the
selection
of
subjects,
the
spon-
sor has
adequately considered —
(a)
The purpose
of
the
investigation.
(b)
The setting
in which
the
research investigation will
be con-
(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
vulnerably
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 —
5-2
ducted.
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
T
*.
(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
INSC0M
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.
5-3
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
24 February 1984
THIS
PAGE INTENTIONALLY LEFT BLANK
5-4
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7
24 February 1984
USAINSCOM Regulation 15-3
APPENDIX A
TERMS AND ABBREVIATIONS
Section I - Terms
A-l.
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.
A-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
I
I
A“ 7 '
Huiyan
subject.
Any
person,
whether
or
not
such
person
is
a US citizen,
about whop 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
^ 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
contipuing
review
of
research
involving
the
use
of
human
subjects.
HTRB
fulfills
pll
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
guideline^
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
Cq,
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 palidly constituted HTRBs .
Outside
DOD,
IRBs
tend
to
be
vested with
this
authority.
A”?*
legally
authorized
representative .
A
person
or
judicial
or
other
body
authorize^
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“* 1,
Minimal
risk.
When
used
in
the
context
of
this
regulation,
this
means
that
the
pisks
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 ‘
Principa l investigator .
A person,
regardless
of
title,
who
is primarily
responsible
for
the actual execution
of
the research.
A~^2,
*>iy
t:0C0^*
wr^ tten »
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.
^n assessment
of potential
risks and benefits
to
subjects.
A-
Approyed For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40005-7