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H.C.
USE OF BOHAN SUBJECTS:
a.
DEFINITIONS:
1*
Human Subject:
An individual about whan 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 rail
specifically for
such qualifications such as test pilots and test engineers.
2.
Non-U. S .
Citizens;
Foreign
nationals,
excluding,
personnel
on
active duty.
3*
Research:
The term does not include individual or group training
of military personnel such as contort readiness,
effectiveness, proficiency,
or fitness exercises.
b.
GENERAL GUIDANCE;
1.
The contractor shall conduct research using human subjects at al 1
times
so
as
to be
in
full
compliance with
all
applicable
laws,
federal
regulations and DoD instructions.
Among them are:
a.
CFR
Health
and
Human
Services
(HHS)
Regulation,
"Protection of Human Subjects";
b.
U.S.C.
Section
980,
"Limitations
on
Use
of
Humans
as
Experimental Subjects";
c.
DoD Directive 3216.2
(January
7,
1983)
"Protection of Human
Subjects in DoD-S\pported Research";
2.
Safeguarding
the
ri#its
and
welfare
of
subjects
at
risk
in
activities
supported
by
this
contract
is
the
responsibility
of
the
Contractor.
Compliance
with
this
contract
will
in
no
way
render
inapplicable pertinent
federal,
state,
or
local
laws
car
regulations.
In
order
to
provide
for
the
adequate
discharge
of
this
institutional
responsibility,
no
activity
involving human
subjects
under
this
contract
shall be undertaken unless a
Contractor Human Use Review Board
(CRB)
has
reviewed and approved such activity.
3.
The contractor must provide the Contracting Officer with a written
assurance that
it
is
in
ccrplianoe with all provisions
of 45 CFR 46 HHS
Regulation,
"Protection of Human Subjects", as amended.
4.
The
Contractor
will
assure
the
Contracting
Officer
that
the
identities of all subjects will be protected.
5.
Informed
consent
must
be
obtained
in
writing
from
each
human
subject before research is undertaken.
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6.
Ihc Contractor shall provide all necessary medical care to research
subjects
far
injury
ar
disease
which
is
the
proximate
result
of
participation in the research.
7*
Studies conducted outside the United
States,
its territories
car
possessions,
shall be conducted in occplianoe with all
laws,
customs,
and
practices of the ocwntry in which the study is to be conducted.
c.
REQUIREMENTS FOR REPORTING AND DQCWENIMTCK:
1*
Copies
of
all
documents presented ar
required
far
initial
and
continuing review of the
CRB,
e.g. ,
Board minutes pertaining only to the
contract,
record of subjects consent,
transmittal on actions,
instructions
and conditions resulting frcxn Board deliberations addressed to the activity
director,
are to be retained by the Contractor far at least three
(3) years
after completion of the
research.
All
documents , shall be accessible far
inspection
during
normal
working
hours
by
the
DIA
CCER
ar
authorized
representative
2 .
Except as otherwise provided by law,
information in the records or
possession of the Contractor which refers to or can be identified with a
particular subject may not be disclosed except;
a.
With
the
consent
of
the
subject of his
legally authorized
representative, or
b.
As
may
be
necessary
for
the
DIA
to
carry
out
its
legal
responsibilities
3.
Upon expiration or termination of
this
contract,
a
list of
all
unused test material shall be provided to the DIA Contracting Officer.
4.
The
Contractor
shall
immediately
notify
the
DIA
Contracting
Officer,
by telephone,
of
inquires from sources outside the Department of
Defense concerning the use of human subjects under this contract.
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$SG1D Approved For Release 2000/08/08 : CIA-RDP96-00789R003000460007-2 Approved For Release 2000/08/08 : CIA-RDP96-00789R003000460007-2
Approved For Release 2000/08/08
: CIA-RDP96-00789R003000460007-2
SECTION
I
CONTRACT CLAUSES
1.1
252 • 201-7000
DAC 91-3 57FR179
09/15/92
CONTRACTING OFFICER'S REPRESENTATIVE
(DEC 1991)
(a)
Definition.
"Contracting officer's representative" means an
individual designated in accordance with subsection 201.602-2 of the
Defense Federal Acquisition Regulation Supplement and authorized in writing
by the Contracting Officer to perform specific technical or administrative
functions
(b)
If the Contracting Officer designates a contracting officer's
representative
(COR),
the Contractor will receive a copy of the written
designation.
It will specify the extent of the COR's authority to act on
behalf of the Contracting Officer.
The COR
is not authorized to make any
commitments or changes that will affect price,
quality,
quantity,
delivery,
or any other term or condition of the contract.
(End of clause)
1.2
52.203-6
AL 92-9
RESTRICTIONS ON SUBCONTRACTOR SALES TO THE GOVERNMENT
(JUL 1985)
(a)
Except as provided in
(b)
below,
the Contractor shall not enter into
any agreement with an actual or prospective subcontractor,
nor otherwise
act
in any manner, which has or may have the effect of restricting sales by
such subcontractors directly to the Government of any item or process
(including computer software)
made or furnished by the subcontractor under
this contract or under any follow-on production contract.
(b)
The prohibition
in
(a)
above does not preclude the Contractor from
asserting rights that are otherwise authorized by law or regulation.
(c)
The Contractor agrees to incorporate the substance of this clause,
including this paragraph
(c),
in all subcontracts under this contract.
(End of clause)
1.3
52.215-39
REVERSION OR ADJUSTMENT OF PLANS FOR POSTRETIREMENT BENEFITS OTHER THAN
PENSIONS
(PRB)
(JUL 1991)
The Contractor shall promptly notify the Contracting Officer in writing
when it determines that
it will terminate or reduce a PRB plan.
If PRB
fund assets revert,
or inure,
to the Contractor or are constructively
received by it under a plan termination or otherwise,
the Contractor shall
make
a refund or give
a credit to the Government for its equitable share
as required by FAR 31 . 205-6 (o)
( 5 )
.
The Contractor shall include the
substance of this clause in all subcontracts under this contract which
meet the applicability requirements of FAR 15.804-8(f).
The resulting
adjustment to prior years'
PRB costs will be determined and applied in
accordance with FAR 31.205-6(o).
(End of clause)
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