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,
p
b *
Serve
as
the DoD representative on matters
relating
to
implementation
oi
rood and Drug Administration
(FDA)
regulatory
requirements.
3*
The Heads
of DoD Components,
or designees,
shall:
.
a ‘
Protect
the
rights and welfare
of human subjects
in research spon-
sored
or conducted by or among the members of
the respective DoD Components.
When more
than one DoD Component
is
involved,
determine primary
responsibility based upon consideration of whether
the subjects
are inpatients
or outpatients
of
a DoD medical treatment
facility
(MTF)
; whether the research
is
conducted m-house
or
by contract;
or whether
the prospective human subjects
are members of
a DoD Con.jonent.
U)
When
the
research,
regardless
of in-house
or contract
status,
involves
use
of patients
of
a DoD MTF,
the Component
to which
the MTF belongs
organizationally
shall
have primary responsibility,
except as provided
in sub-
section E.5.,
below.
(2)
For research not involving
the
use
of patients
at
a DoD MTF
primary responsibility
rests
as
follows:
’
( a )
If
the
research
is
done on grant or contract,
primary
responsibility rests with
the DoD Component providing
funds.
.
(k)
If
the research
is
conducted
in-house,
primary responsibility
rests with the DoD Component
to which the principal
investigator
is assigned.
,
If
f
h
e research
is not
funded by
a DoD Component and
there
is no DoD principal
investigator,
primary responsibility rests with the
uou Component
to which the prospective human subject
is
assigned.
c *
Establish procedures
to maintain adequate documentation of humpn
subjects used
in research,
including resulting adverse reactions.
d.
Establish procedures
for responding to
reports
of improper
?
use of human subjects.
e.
Establish review committees as provided
for
in subsection F.2..
below.
4.
The
Se cretaries of the Military Depa rtments
shall approve in-house and
contract research involving human subjects,
conducted at
or funded by
a DoD
Component for which the Military Department has been designated executive agent.
'is responsibility includes
research that
is classified for reasons of national
security.
When more than one Military Department
is
involved
in the same
research,
the first review committee
to which the research
is submitted shall
perform the human use review and make
recommendations
to
the Military Department
Secretaries concerned.
Each Secretary may accept these
reconmendations or may
require additional
reviews.
5.
The President,
Uniformed Services University of the Health Sciences,
•nd the Director, Defense Nuclear Agency
(DNA)
,
shall have primary responsibil-
*•—
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responsibility for research conducted in-house or by contract when the
research
involves patients of
a DoD MTF or other U.S.
Government health care
facility,
and USUHS directly funds
the
research,
has
received
a grant or gift,
or has
received
some other non-DoD form of support
for the research.
However,
in
these instances,
the MTF review committee shall perform the human use review
and make recommendations
to
the President,
USUHS,
and
to the DoD Component or
other U.S.
Government institution concerned.
The President,
USUHS, may accept
these recommendations or may require additional reviews.
F.
PROCEDURES
1.
Delegation of Authority
a.
The Secretaries
of Military Departments are authorized
to delegate
all or part of their authority under section
E.
within the military chain of
command
to
the lowest level operating
a human- subjects
review process.
b.
In addition,
the Secretaries
of Military Departments
are authorized
to make
the determination that unique military requirements dictate the use of
drugs or devices not officially approved by the FDA.
The Secretaries of the
Military Departments may delegate this authority to
the respective Surgeon
General or designee.
c.
The President,
USUHS, may delegate the authority specified in
subsection E.5.,
above
to
the Dean or Associate Deans.
d.
Requests for approval of the use of human subjects
in research funded
by DoD Components other than Military Departments,
DNA,
and USUHS shall be sub-
mitted to USDR&E for final determination.
e.
Authority not delegated above
to specific officials
is retained by
the Secretary of Defense.
2.
Review Committees
.
Each official having approval authority for research
involving human subjects
shall establish one or more committees
to provide
initial and continuing review of the use of human subjects
in such research.
a.
The review committeee
is similar functionally to the Institutional
Review Board
(IRB) established under 45 CFR part 46
(reference
(a)).
The IRB
performs protocol review and protocol approval.
Within the Department of Defense
these functions are separated.
Review Committees exercise only protocol
review
and recommend approval, modification,
or disapproval
to an approving authority.
Approval authority
is vested
in the approving official
to whom the review com-
mittee
reports.
b.
The review committee shall be constituted
in accordance with reference
(a)
standards for
IRBs,
and paragraph E.3.d.
above, with the following exceptions:
(1)
The prohibition in reference
(a)
of all-male or all-female member
ship may be waived by the approving official when compliance
is impractical.
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Approved For Release 2000/08/08
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(2)
The
requirement
in reference
(a)
for a nonaf filiated member may
be met by appointment of
a member of an institution or organizational unit not
subject to the immediate authority of the approving official.
(3)
When the approving authority,
or the review committee itself,
has reason to believe
a
given proposal includes more than minimal
risk,
a
physician should be included
as an ad hoc member of the consaittee
(see also
paragraph D.l.e.
,
above).
(4)
The approving official may not be
a member.
c.
The review committee must retain records of research reviewed for at
least 3 years after the completion of the
research,
or at the option-of the
approving official,
forward
records
to
that official for longer retention.
d.
An approving official may not approve research for which the official
is also
a principal or coinvestigator.
Such research must be reviewed and
approved at
a higher echelon of command.
e.
Research that involves the use of human subjects may not be initiated
until all necessary approvals and the informed consent of the subjects have been
obtained.
f.
If a review committee recommends safeguards or special conditions
to a protocol it
is recommending for approval, Jthe approving official may not
reduce the safeguards or conditions upon approving the protocol.
The approving
official may require additional safeguards, may disapprove the protocol, or may
refer it to a higher approving authority and review committee.
G.
INFORMATION REQUIREMENTS
The memorandum of understanding betweeen FDA and DoD (reference
(e)),
requires that the FDA be informed whenever the use of human subjects in new
drug or device research that
is classified for reasons of national security,
has been approved.
The FDA must also be informed when a determination has been
made that unique military requirements dictate the use of drugs or devices that
have not been approved by the FDA.
Such notification should also be provided to
USDR&E and ASD(HA)
.
H.
EFFECTIVE DATE
This Directive
is effective immediately.
Forward two copies of implementing
documents to the Under Secretary of Defense for Research and Engineering within
180 days.
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.
Approved For Release 2000/08/08
: CIA-RDP96-00788R001 5001 40001-1
DEPARTMENT OF DEFENSE
DIRECTIVES SYSTEM TRANSMITTAL
u
1 S Tft
I BUT
I ON
3216.2,
Ch
January 31,
1983
3000 series
INSTRUCTIONS FOR RECIPIENTS
The following administrative correction to DoD Directive 3216.2,
"Protection of
Human Subjects
in DoD-Supported Research," January
7,
1983,
is authorized:
PEN CHANGE
First page under "References:"
(c)
DoD Instruction 5030.19,...
should be corrected to read DoD
Instruction
5030.2,9
Change is underlined.
EFFECTIVE DATE
Th is change
is effective immediately.
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