Approved For Release 2001/03/07
: CIA-RDP96-00788R001 500160j0J-Jj N
igg0
Development Command
(USAMRDC)
is
of
utmost concern
to the Command,
and
is primarily the responsibility
of
the contractor
or recipient
who receives
or
is accountable
to USAMRDC
for
the
funds awarded
for
the support of
the
project.
However,
the
sensitivity
of such
research
necessitates
that
the
Command exercise prudence
in
its
oversight
responsibilities.
The
procedures
employed
shall
be
flexible and
tailored
to
the requirements
of
the specific acquisi-
tion.
2.
It
is
the policy of USAMRDC
that
the
Department of Health
and
Human
Services
( HHS )
Regulation on Protection of Human Sub-
jects,
Food
and Drug Administration Regulations
on
Investigational
Drugs
and
Vaccines
and
Investigational
Medical
Devices,
.
and
Advertisement Guidelines
for
the
Recruiting
of
Research Subjects
shall
be adhered
to by USAMRDC contractors
and
recipients,
with
the
addition of
the
following specific DOD/USAMRDC requirements.
a.
Informed consent must
be obtained
in advance
from the
subject,
or
in
the
case of
research
intended
to
be beneficial
to
the subject,
the
informed
consent
of
the
subject
or
a legal
representative
of
the subject must
be obtained
in
advance.
b.
Contractors
and recipients
shall provide all neces-
sary medical
care
to research subjects
for
injury
or disease which
is
the proximate result
of participation
in
the
research.
c.
Anatomical
Substances
(organs,
tissues,
or tissue
fluids)
obtained
from autopsy
shall
not
be used
for research or
investigational purposes
without
the expressed consent
of
the next
of
kin.
It should
be noted
that
a general autopsy consent may not,
in
itself,
be
sufficient.
If
autopsy tissue
is
to be used,
the
protocol should
include
a copy of
the consent
form used
to obtain
the
tissue.
d.
Anatomical
Substances
(organs,
tissues,
or tissue
fluids)
obtained
from
a
surgical procedure
shall
not
be used
for
research or
investigational purposes without
the expressed consent
of
the
patient or
patient's
legal
representative.
It should
be
noted
that
a
consent
to
perform surgery may not,
in
itself,
be
sufficient.
If excised tissue
is
to
be
used,
the
protocol
should
include
a copy of
the consent
form used
to obtain
the
tissue.
e.
Anatomical
substances
linked
by identifiers
to
a
particular person
and used
for research
shall
be
donated
for
the
purpose of
research,
and
shall
be
lawfully acquired.
The donor
shall
be
the person
from whom the substance
is
removed
or,
in the
event
of
death
or
legal
disability of
the person from whom the
substance
is
removed,
the
next of
kin or
legal
representative
of
such person.
Donation
shall
be
made by
written consent and the
donor shall relinquish all
ownership
and/or
rights
to
the
sub-
stance.
If excised
or autopsy tissue
is
to be
used,
the protocol
should
include
a copy
of
the
consent
form
used
to
obtain the
tissue
.
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: CIA-RDP96-00788R001 5001 60007-3
o£
war
shall
not
be used
as research
f#
Prisoners
of
war
subjects.
research subjects
shall follow
g.
use
Of prisoners
as
CFR
46,
Subpart
C.
.
n
s
»
its territories
.
ctudies
conducted outside
the
citizens
as
h.
stu^
e ®
Evolve
the
use
of
non
4g
and above
or possessions,
whxch
Qn ^
compliance
with^45^ ^
tbe
laws,
subjects
r
in
a
_
.
mpdC requirements r
shal
^
study
is
to be
special DoD and USAMRDC
req ^ count
y in which the^
i?
customs,
and-wS “inimum standards
to be adher®
research proposal
conducted.
The mi
mu“
elsinki
(Tab
D).
in exceptional
the
Declaration
of
docuinent
this
; s
q£
the country
submitted
for
aPP
laws,
customs
or
P
.
i
requirements of
circumstances
where
particular
procedura
t
^
informed
involved take except ion
to
bbe documentation^
_
this
provision
,
s
by
which
it
^
n
q
Army Medical
consent or
the
proce?^
Lorn
the Commander
^S.
JJMT
the
approval
«11 ^® elopment
Command
as
an
Research
and
approval process.
proposal review and appro
f
‘
4 — 1
"
aPPrOVal
P
.
apply
to epidemiological
4=
these
provisions
aPP
Y
i-
l
?one
°L r e than minimal
risk.
surveys
involving
no more
•
_ ^ a. 1*
n
i
ring
n° m
.
t contractor records concerning
The USAMRDC may inspect
human use
.
IV .
Goals,:
The
Human
Use.
affair s Office
Review
an d
Regulatory
___— he
usapikuZ
1.
Tne
numo—
-~
r, g i hi e—for
all
aspects
research and
(SGRD-HR)
shall
be
feiponsible
the
use
of humans m
re
or.cn-HR
is
( SuKu niw
ram
involving
t“.
._,i
substances,
extramural
P^ogra
hunan
anatomical
testing,
and
use
SGRD-HR
is
anatomical
*»«““
testing,
anu
n c ihle
for:
specifically
re p
.
consent
form,
contract,
f
anv
proposal
and consen
order,
or
a .
Review
of
a y
P
en t a i
transfer
of
fun
toinlca l
subcontract, grant,
intrago
^
q£
humans or huma
modification
wh.ich
invol
eoBut0 ,
substances.
Rev
-Hues
Army Regulations,
(1)
that aPP^Cpubliflaws
r
will be' complied with,
FDA and HHS regulations,
valldatlon
of
the human use
(2 )
that
appropriate
process has occurred,
and;
contractor has an assurance
(3)
that
^
he
C pR
C1
en satisfactory
to the HHS^ or
as
of
compliance
with.
n
4S
OT
CRR
on
or negotiatlon wlth
the
PC^ic
e
itl
S
assirance
of compliance.
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Z 6 JUN
1990
b.
Development ,
in
coordination
with
the
U.S.
Army
Medical
Research
Acquisition
Activity
(SGRD-RMA),
of
special
provisions
to
be
included
in RFPs ,
contracts,
and grants.
Develop-
ment,
in
coordination
with
the
Acquisition
Management
Office
( SGRD-ACQ)
,
of
special provisions
to be
included
in
the BAA and
intragovernmental
transfer of
fund orders.
c.
Participating
in
negotiations
(in conjunction with
SGRD-RMA or SGRD-ACQ)
with prospective contractors
for
the develop-
ment of
special assurance
of compliance
with HHS
45 CFR
46.
The
SGRD-HR shall
be
the final approval authority for
special assuran-
ces .
d.
Review
and
approval
of
proposals
recommended
for
inclusion
in
the competitive
range
as
a result
of
solicitations,
and
its
accompanying consent
form.
Where applicable,
advertise-
ments used
to recruit subjects will
be reviewed.
e.
Assuring
that
all
parties
(e.g.,
contracting
officer's representative
(COR),
Project Manager and Product Manager
(PM),
SGRD-ACQ,
AMLO,
and
SGRD-RMA)
are
kept
informed regarding
issues relative
to the use of humans.
f.
Monitoring
contracts,
grants,
and orders
funded by
LJSAMRDC by means
of documentation review
or site
survey
(pre-
and
post-award)
as
required.
g.
Receiving
reports
of
research related
illnesses or
injuries
from principal
investigators.
2.
The
SGRD-RMA
shall
be
responsible
for
the
following
concerning
the
use
of
humans
as
research subjects
or
the use
of
human anatomical
substances:
a.
Negotiation,
in conjunction with
SGRD-HR,
of
special
assurances of compliance with regulations with prospective contrac-
tors
.
b.
Development,
in coordination with SGRD-HR,
of
special
provisions
to
be
included
in RFPs
and contracts.
c.
When
assigned
contract
administration,
assuring
compliance with contract
terms.
d.
Approval
of
use
of
prisoners
as
research
subjects,
after
review
and
approval
of
the
Command
Judge
Advocate
and
SGRD-HR.
3.
The
SGRD-ACQ
shall
be
responsible
for
the
following
concerning
the use of humans
as research subjects:
a.
Issuing required changes
to this procedure.
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1950
b.
Negotiation,
in
conjunction with SGRD-HR,
of special
assurances
of compliance
with
regulations
with
other Government
agencies
.
c.
Development,
in coordination with SGRD-HR,
of special
provisions
to be
included
in
intragovernmental
transfer
of
fund
orders
.
d.
Approval
of
use
of prisoners
as
research subjects,
after
review
and
approval
of
the
Command
Judge
Advocate
and
SGRD-HR.
e.
Administration of
intragovernmental orders
to assure
compliance with
the order.
4.
The
U.S.
Army Medical Materiel Development Activity shall
assist and
participate with SGRD-HR,
SGRD—RMA,
and SGRD—ACQ on all
matters pertaining
to
the
use
of
humans
as
research subjects
in
programs under their cognizance.
5.
The
Office
of
the
Command Judge Advocate
shall advise
SGRD-HR,
SGRD-RMA,
and SGRD-ACQ on all
legal matters
pertaining
to
the use
of humans
as research
subjects
or
the
use
of anatomical
substances
.
6.
The appointed COR through
the AMLO or PM shall assist and
participate with
SGRD—RMA,
SGRD-HR,
and SGRD—ACQ
in administration
of contracts,
grants,
and
intragovernmental orders.
V.
Procedures :
1.
Proposed contracts,
RFPs,
and
proposals
received under
the
BAA,
and
proposals
from other Government
agencies which
are
recommended
for
funding shall
be
reviewed
by SGRD-HR prior
to.
submission
to SGRD-RMA* for
procurement or
to SGRD-ACQ
for intra-
government transfer
of
funds.
a.
Clarifications
or
changes
to
proposals
received
in
response
to
the
BAA
or
from
other
Government
agencies
is
the
responsibility of
SGRD-HR.
Copies
of
all
correspondence will
be
provided
the affected AMLO.
b.
Clarification or changes
in RFPs
and contracts
is
the
responsibility of
SGRD-HR.
All communications with
the contractor
will
be through SGRD-RMA.
2.
To permit
timely award
of
the contract,
the
USAMRDC
Form
and
documentation
may
be
submitted by SGRD-HR to SGRD-RMA or
SGRD-ACQ,
even though all
issues
relating
to
the
use
of human
subjects have
not been resolved,
on
the condition
that
the Prohibi-
tion of Use of
Human Subjects
provision will
be
included
in
the
contract,
grant,
or order.
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a.
Comments
on
proposals
submitted
in
response
to
specific
RFPs
shall
be
provided by
SGRD—HR to
SGRD—RMA prior
to
negotiation
by
SGRD-RMA
with
organizations
in
the competitive
range.
SGRD-HR shall provide SGRD-RMA recommendations
for negotia-
tion
of provisions
to be
included
in contracts
to be awarded
as
the
result of other than
full and open competition,
and provisions
for
changes or tasks after contract award.
b.
Upon receipt
of
required
information,
SGRD-HR shall
review and
approve
the
appropriate
provision
in
the contract,
grant,
or order.
c.
SGRD-HR
will review and approve
task order protocols
in accordance with
the provisions
of
the contract.
d.
Upon resolution
of all
issues
involving
the use
of
humans
in
research,
the
clause entitled
"Use
of Human Subjects,
Investigational
Drugs,
and Investigational Medical
Devices"
(TAB
B)
will
be included
in
the contract.
3.
Compliance
by
subcontractors
with
CFR
and
these
procedures
is
the
responsibility
of
the
prime contractor,
subject
to
the following:
a.
Subcontracts shall
contain
the prime contract clause
Prohibition of Use
of
Human
Subjects
(Tab
A)
or
Use
of Human
Subjects,
Investigational
Drugs,
and
Investigational
Medical
Devices
(Tab
B)
.
The
proposed
subcontract
and
assurance
of
compliance with
45 CFR
46 satisfactory
to
the HHS ,
or sufficient
information for negotiation with USAMRDC of
a special
assurance of
compliance,
shall
be submitted
to SGRD-RMA for review and approval
by SGRD-HR prior
to award
of
the subcontract,
or use
of humans
as
research subjects.
b.
The
SGRD-RMA
will
obtain
comments
and
approval
of
SGRD-HR prior
to SGRD-RMA
approval
of
the subcontract
or use
of
humans,
or
negotiation of
a special assurance with
the subcontrac-
tor.
c.
The
prime
contractor
shall
be
involved
with
and
participate
in all discussions
and
negotiation.
Responsibility for
compliance with
45 CFR
46 and
this procedure
shall
be
the
responsibility
of
the
prime
contractor
and
subcontractor s
)
utilizing humans
as research
subjects.
Subcontractors shall have
Institutional
Review Boards and
follow
CFR
46,
except under
unusual
circumstances
where
SGRD—HR
and
SGRD-RMA
(or SGRD—ACQ)
approve
the prime's assuming
responsibility
for
the subcontractor
in
this regard.
4.
The
requirement
for site visits,
extent
of examination
of
records,
and discussions with researchers and research subjects
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1990
shall,
except
under
unusual
circumstances,
be coordinated between
SGRD-HR,
the assigned administrative
contracting office
(ACO)
(or
SGRD-ACQ) ,
AMLO,
and
the
COR or
PM.
Copies
of correspondence and
telephone memoranda
shall
be
exchanged
between
SGRD-HR,
ACO
(or
SGRD-ACQ)
and
the
COR
and AMLO
or
PM
to assure awareness
of human
use
issues.
If
the
ACO,
in
consultation with
SGRD-HR,
determines
that
the
contractor
is
not
in compliance with
the requirements
of
the provisions
in Tab
B,
the
ACO
may
suspend
work
and further
payment
until
corrections
are made by the contractor.
5.
All
contracts,
grants,
and intragovernmental orders which
involve
the
use
of humans shall:
a.
Contain
the provision
(Tab
A)
to prohibit
the
use of
humans
as
research
subjects,
or
b.
Contain
the
provision
(Tab
B)
governing
the use of
human subjects,
investigational drugs
or
vaccines,
and
investiga-
tional medical
devices,
and/or
c.
Contain
the
provision
(Tab
C)
governing
the
use
of
donated anatomical
substances,
d.
Be
reviewed and approved
by SGRD-JA prior
to award,
e.
Be
reviewed and approved by SGRD-HR prior
to award.
6.
Due
to
the
fact
that
DA policy requires
the contractor
to
I
provide necessary
medical care
of
research subjects,
requests may
be made by prospective contractors
for assurance of
future funding
for certain
liabilities,
as
set
out
in
FAR
52. 228-7 (c
)
( 2
)
.
Since
the Government's
liability
is
subject
to
the availability
of
funds
at
the
time
the contingency occurs,
to
cover
such
a contingency,
an
advance agreement
(pursuant
to
FAR
31.109)
may
be
negotiated
to
recognize costs,
associated with
such medical
care,
which exceed
those
covered
by
the
contractor's
insurance
required
by
the
contract.
Such
allowable costs,
however,
may not
exceed
the
total
amount
of
funds obligated
by the Government
to
the contract.
It
is
the responsibility of
the contractor
to
initiate
a specific
request
for
funds
to
pay premiums
for additional
insurance coverage,
or
the
costs of
medical
care
required
as
a
result
of
research performed
under
the contract.
Approval
of
the
Secretary
of
the
Army
to
indemnify
a
contractor
against
unusually hazardous
risks may be
requested pursuant
to
DOD FARS
235.070.
Such
requests
shall
only
be made
after
receipt
of proof
the
risk cannot
be compensated by
insurance or otherwise.
7.
a.
It
is
the policy
of
the USAMRDC
that whenever
the use
j
of volunteers exists
in USAMRDC sponsored
research,
data sheets are
to be completed
on
all volunteers
for
entry
in
the USAMRDC's
Volunteer Registry data
base.
SGRD-HR may,
on
request,
exempt
this
requirement
for
studies which
the
IRB has determined
to be minimal
risk.
The
intent
of
the data base
is
two
fold:
first,
to readily
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5 JUN
1S9G
answer
questions
concerning
an
individual's
participation
in
research conducted or sponsored
by
the
USAMRDC;
and
second,
to
ensure
that
the USAMRDC
can exercise
its
"duty
to warn.”
The
"duty
to warn"
is
an
obligation
to
ensure
that
research volunteers are
adequately
informed
concerning
the
risks
involved
with
their
participation
in
research,
and
to
provide
them
with
any newly
acquired
information
that
may
affect
their well-being when
that
information becomes available.
The duty
to warn
exists even after
the volunteer
has completed
his
or
her participation
in
research.
To accomplish this,
a system must
be established
which will permit
the
identification
of volunteers who
have participated
in
research
conducted
or sponsored by the USAMRDC.
The data base
must contain
items of
personal
information,
for
example,
name,
Social Security
number,
etc., which subjects
it
to the provision of
the Privacy Act
of
1974
(Reference
11.).
b.
For
each
subject
enrolled
in
a study
a Volunteer
Registry Data
Sheet
(USAMRDC
Form 60-R),
TAB
E,
is
to
be completed.
The
principal
investigator
is
to
complete Part
A of
Form 60-R;
after which.
Form 60-R
is
to be provided
to volunteers
for comple-
tion at
the
time
of consent.
The
information collected
is
then
sent
to SGRD-HR upon completion of
the
research
or
upon expiration/
termination of
the contract,
whichever occurs
first.
Data sheets
collected on volunteers participating
in
task
orders
are
to be
submitted
to
SGRD-HR
upon
completion
of
each
task
order.
The
information
is stored
in
the USAMRDC
Headquarters data
base
for
a
minimum of
75 years.
c.
Information
stored
in
the
Volunteer Registry data
base will
be disclosed
in accordance
with Reference
10,
and
the
privacy Act
of
1974.
Upon
written
or
oral
requests,
persons
on
whom data
is collected,
or
his
or
her
designated agent
or
legal
guardian may
have access
to
the
record pertaining
to
that
individ-
ual contained
in
the Volunteer
Registry data base.
Only authorized
staff
of
the HURRAO
may have
access
to
information entered
in
and
information selected from the Volunteer Registry data base.
d.
The
record system
name
and
notice
number
for
the
Volunteer Registry
data base
is
Medical
Research Volunteer Regist-
ry,
AD 1304-22a
DASG,
as published
in
the
Federal
Reqister /VOL.
51,
No.
125/Monday,
June
30,
1986.
8.
Research and development conducted outside
the
U.S.
utilizing
investigational drugs,
vaccines,
and devices
is subject
to
the same
safety reviews
and
regulatory
procedures as
research
and develop-
ment conducted within the
U.S.
Initial dose
ranging,
toxicity and
safety studies
(Phase
I
studies)
will only
be conducted within
the
U.S.
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%
6 JUN
1990
Prohibition of Use of Human Subjects
Notwithstanding
any
other
provisions
gained
*n
this
contract
or
incorporated
by
reference herein,
the contractor
is
expressly forbidden
to use or
subcontract
for
the
us ®
°^ f
h^g
subiects
in
any
manner
whatsoever.
In
the performance
of
thi
contract,
the contractor agrees
not
to come
into
c°^act with,
us
or
employ,
or
subcontract
for
the
use
or employ of any human
subjects
for research, experimentation,
tests
or
°^her treatmen
under
the
scope of work
as
set out m
the contract without express
written approval
from the contracting officer.
Tab A
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: CIA-RDP96-00788R001 5001 60007-3
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: CIA-RDP96-00788R001500160(&fS
IUN
1990
Use
of Human Subjects,
Investigational
Drugs
and Vaccines,
and
Investigational Medical
Devices
a.
Definitions
(1)
Subject at
risk
means
any
individual
who
may
be
exposed
to
the possibility
of
injury,
including physical,
psycho-
logical,
or social
injury,
as
a
consequence of
participation as
a
subject
in
any
research,
development,
or related activity which
departs from the
application
of
those
established
and accepted
methods
necessary
to
meet
his
needs,
or
which
increases
the
ordinary
risks
of
daily
life,
including
the
recognized
risks
inherent
in
a chosen occupation or
field
of service.
(2)
Investigational
drugs
and
vaccines means
a drug or
vaccine
that may be considered
investigational when
the composition
is such
that:
(a)
Its proposed
use
is
not recognized
for
the
use
under
the
conditions
prescribed?
or
its
proposed
use
is
not
recommended
or
suggested
in
its
approved
labeling.
Experts
qualified by scientific training and experience evaluate
the safety
and effectiveness of drugs and vaccines
to make
this determination.
(b)
Its use has become
recognized
as
investigation-
al,
as
a result
of studies
to determine
its safety
and effective-
ness
for use under such conditions
(21 CFR
312).
(3)
Investigational medical
devices means
a device
that
is
not generally used
in the diagnosis,
cure, mitigation,
treatment
or
prevention
of
disease
in
humans,
and recognized
as
safe and
effective.
Research
is usually,
but
not necessarily,
initiated
to
determine
if
the device
is
safe or effective
(21
CFR 812).
b.
None
of
these
provisions
applies
to
epidemiological
surveys which
involve
no more
than minimal
risk.
c.
Requirements
for
the
Use
of Humans
(1)
Safeguarding
the
rights
and
welfare
of
subjects
at
risk
in
activities
supported
by
this contract
is primarily
the
responsibility of
the contractor.
Compliance
with
this
contract
will
in
no
way
render inapplicable pertinent
federal,
state,
or
local
laws or regulations.
In order
to provide
for
the adequate
discharge of
this
institutional
responsibility,
it
is
the policy of
the
U.S.
Army Medical
Research
and
Development Command
(USAMRDC)
that
no activity
involving human subjects under
this contract shall
be
undertaken
unless
an
Institutional
Review
Board
(IRB)
has
reviewed and approved such activity.
TAB
B
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