Approved For R«|)ggse^000/08/08
: CIA-RDP96-00788R001 5001 40001-1
FlNfct
January 7,
1983
NUMBER
321
* 2
Department of Defense Directive
SUBJECT
Protection of Human Subjects
in DoD-Supported Research
References
:
(a)
Department of Health and Human Services Regulation
"Protection of Human Subjects"
(45 CFR Part 46)
(b)
Food and Drug Administration Regulation
(21 CFR subchapters
A,
D,
and H)
(c)
DoD Instruction 5030.^9,
"Investigational Use of
Drugs by the Department of Defense," May
12,
1964.
(hereby canceled)
(d)
DoD Directive 6000.4 "Clinical Investigation
Program," April
16,
1976
(e)
Memorandum of Understanding Between the Food and
Drug Administration and the Department of Defense,
"Investigational Use of Drugs by the Department of
Defense," November 21,
1974
A.
PURPOSE
This Directive, under references
(a)
and
(b),
establishes policy,
assigns
responsibility,
and specifies authority for protecting the
rights and welfare of humans used as subjects of study in DoD-sup-
ported research,
development,
test,
and evaluation (RDT&E) and
clinical investigation activities
(hereafter referred to as
"research");
and cancels
reference
(c).
B.
APPLICABILITY AND SCOPE
1.
This Directive applies
to the Office of the Secretary of Defense
(OSD),
the Military Departments,
the Organization of the Joint Chiefs of
Staff,
the Unified and Specified Commands,
the Defense Agencies,
and the
Uniformed Services University of Health Sciences
(hereafter referred
to
as "DoD Components")
,
and contractor or grantee activities supported by
the Department of Defense.
2.
Its provisions encompass the following:
a.
Clinical investigations as established by reference
(d),
bio-
medical research,
and behavioral studies.
b.
RDT&E involving new drugs, vaccines, biologicals, or investi-
gational medical devices.
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c.
Inclusion of human subjects, whether
as
the direct object of research,
or as
the indirect object of research involving more than minimal
risk in the
]
development and testing of military weapon systems,
vehicles,
aircraft,
and other
|
®*teriel.
The determination of whether
a
research protocol
involves more than
minimal
risk shall be made by review committees established in accordance with
section F.
Nothing
in this Directive
is intended
to supersede requirements
for
health hazard or other safety reviews required by other DoD issuances or other
i
DoD Component regulations.
3.
Its provisions do not apply to epidemiological surveys which are of no
more than minimal
risk as
set forth in the human protection regulations issued
by the Department of Health and Human Services
(reference
(a)).
4.
Nothing in this Directive
is
intended to limit the authority of
a health
care practitioner
to provide emergency medical care under applicable
law of the
jurisdiction in which the
care
is provided,
or of commanders
in the discharge of
assigned duties or responsibilities.
C.
DEFINITIONS
Terms used
in this Directive are as defined in reference
(a)
except for the
following:
Human Subject .
A living individual about whom an investigator conducting
research obtains data through interaction with the individual,
including both
physical procedures and manipulations of the subject or the subject's environment.
The term does not include military or civilian personnel who are qualified to test
by assignment to duties that call specifically for such qualifications such as
test pilots and test engineers.
2.
Non-U. S.
Citizens .
Foreign nationals,
excluding,
for the purposes of this
Directive, personnel on active
duty.
3.
Research .
A systematic investigation as described
in paragraph B.2.a.,
b.,
and
c.
of this Directive that
is designed
to develop or contribute to
generalizable knowledge.
The
term does not include
individual or group training
of military personnel such as
combat readiness,
effectiveness,
proficiency,
or
fitness exercises.
D.
POLICY
1.
It
is the policy of the Department of Defense
that:
a.
The fundamental
rights and welfare of human subjects
in research
funded by DoD Components shall be protected
to
the maximum extent possible.
This protection
is meant
to encompass basic respect
for human dignity and
to
P ro^ec ^- subjects
from actual harm.
Responsibility
for the protection of human
subjects
is
a command responsibility.
b.
Except as provided elsewhere in this Directive,
the human protection
regulations issued by the Department of Health and Human Services
for the pro-
tection
of human subjects,
45 CFR part
46,
(reference
(a))
shall apply to research
supported by
the Department of Defense.
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Jan
7,
83 if
3216.2
c.
Contractors or grantees
(and elements
of DoD Components)
holding an
assurance of compliance with
the human use
regulations
of
the Department
of
Health and Human Services
(45 CFR
46,
reference
(a))
shall be considered
in com-
pliance with
the
terms of
this Directive.
In
the absence of such an assurance,
a
special assurance
that meets
the minimum requirements
of reference
(a)
shall
be negotiated between
the contractor or grantee
and
the DoD Component concerned.
d.
Only persons who are
informed
fully and voluntarily agree
to partici-
*
pate may be used
as
human subjects
in
research.
The only exception
to
the policy
*
is
that consent
to participate may be obtained
from
a
legal
representative of the
*
subject when the measures
used are
intended
to be beneficial
to
the
subject.
(1)
In
research conducted outside
the United States
involving
non-U. S.
citizens
as
human subjects,
the
laws,
customs,
and practices
of the
country
in which
the
research
is
conducted,
or those required by this Directive,
whichever are more
stringent,
shall
take precedence.
The
research shall meet
the same standards
of ethics
and safety that apply
to
research conducted within
the United States
involving U.S.
citizens.
(2)
The
use of prisoners
of war
as human subjects of
research
is
prohibited.
e.
For any research involving human subjects,
a medical monitor shall
be appointed by name
if
the approving official determines
that
the
risk
is more
than minimal.
2.
Requests
for exceptions
to policy as stated above shall be submitted with
full justification
to
the Under Secretary of Defense
for Research and Engineering
(USDR&E)
by heads
of DoD Components.
E.
RESPONSIBILITIES
1.
The Under Secretary of Defense
for Research and Engineering ,
or designee,
shall
:
a.
Develop policies
in coordination with
the Assistant Secretary of
Defense
(Health Affairs)
(ASD(HA))
to protect human subjects
in DoD-funded
research.
b.
Coordinate DoD Component activities
in the protection of human subjects.
c.
Serve as
the point of contact within the Department of Defense and
act
as the principal DoD liaison with civil or
federal agencies outside the
Department of Defense on matters pertaining to protection of humans
in research.
d.
Serve as
the
final DoD approval authority
for all research involving
actual exposure of human subjects
to nuclear weapons effect or chemical warfare
agents.
2.
The Assistant Secretary of Defense
(Health Affairs)
shall:
a.
Provide policy guidance regarding medical safety and standards of
professional medical
care and conduct as they relate
to
the use of humans
in
research.
Appftfa&i ^5?
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: CIA-RDP96-00788R001 5001 40001-1