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$ $ JUN
19QQ
PROCEDURES
FOR USE
OF HUMANS AS RESEARCH SUBJECTS
IN THE EXTRAMURAL RESEARCH PROGRAM
I.
Purpose
;
This
is
to establish uniform procedures and
respon-
sibility
for
review of
the
use
of
humans
as
research subjects,
negotiation of
provisions,
and administration
of
research projects
in
the extramural
program.
Wherever
the
term
•’contractor" appears
it
shall also mean grantee and other Government agency.
I I .
References
1.
45 CFR
HHS Regulation
on Protection
of
Human Subjects;
2.
U.S.C.
Section
980 Limitations
on
Use
of
Humans
as
Experimental
Subjects;
3.
CFR
312 Investigational
Drugs and Vaccines?
4.
CFR
812
Investigational
Medical
Devices;
5.
CFR
56.111(a)(3)
Advertisement
Guidelines
for
the
Recruiting of Research Subjects;
6.
DOD
Directive
6465.2
Organs and Tissues Obtained from
Autopsy;
7.
DOD Directive
3216.2
Protection
of
Human
Subjects
in
DOD-Supported Research;
8.
Federal
Acquisition
Regulation
(FAR)
52.228-7
Insurance
Liability
to Third Persons and
FAR
31.109 Advance Agreements?
9.
USAMRDC
Regulation
70-25
Use
of
Human
Subjects
in
Research,
Development,
Testing and Evaluation;
10.
USAMRDC Broad Agency Announcement
(BAA);
11.
Army Regulation
340-21
The Army Privacy Program?
and
12.
Federal Acquisition
Regulations
(FAR)
Part
Protection
of
Privacy
and
Freedom
of
Information,
52.224-1
Privacy
Act
Notification,
and 52.224-2 Privacy Act.
III.
Objectives
;
1.
Safeguarding
the
rights
and welfare
of human subjects
participating
in
research
and
development supported
by contracts,
grants and orders awarded
by
U.S.
Army Medical
Research and
SOP
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1990
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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f.
Prisoners
of
war
shall
not
be used
as research
subjects
g.
Use
of prisoners
as
research subjects
shall
follow
CFR
46,
Subpart
C.
h.
Studies
conducted outside
the
U.S.,
its territories
or possessions,
which
involve
the
use
of
non-U. S.
citizens
as
subjects,
in
addition
to
compliance
with
CFR
46 and above
special
DoD and USAMRDC requirements,
shall
comply with
the
laws,
customs,
and
practices of
the country
in which
the
study
is
to be
conducted.
The minimum standards
to be adhered
to are contained
in
the
Declaration
of
Helsinki
(Tab
D)
.
The
research proposal
submitted
for approval will document
this
action.
In exceptional
circumstances
where
laws,
customs
or
practices
of
the country
involved
take exception
to
particular
procedural
requirements
of
this
provision
(as,
for
example,
the documentation of
informed
consent or
the
procedures
by
which
it
is
obtained),
specific
approval
will
be
obtained
from
the Commander,
U.S.
Army Medical
Research
and
Development
Command
as
an
integral
part
of
the
proposal review and approval process.
i.
None
of
these
provisions
apply
to epidemiological
surveys
involving
no more
than minimal
risk.
j.
The USAMRDC may inspect contractor
records concerning
human use.
IV.
Goals :
1.
The
Human
Use
Review
and
Regulatory
Affairs Office
(SGRD-HR)
shall
be
responsible
for
all
aspects
of
the USAMRDC
extramural
program
involving
the
use
of humans
in research and
testing,
and
use
of
human
anatomical
substances.
SGRD-HR
is
specifically responsible
for:
a.
Review
of
any
proposal
and consent
form,
contract,
subcontract,
grant,
intragovernmental
transfer
of
funds
order,
or
modification
wh,ich
involve
the
use
of
humans
or human anatomical
substances.
Review shall ensure:
(1)
that applicable
DOD directives.
Army Regulations,
FDA and HHS regulations,
and public laws will
be complied with;
(2)
that
appropriate
validation
of
the human
use
process has occurred,
and;
(3)
that
the recipient or contractor has
an assurance
of
compliance
with
CFR
satisfactory
to
the
HHS,
or has
provided sufficient
information
for negotiation with
the USAMRDC of
a special assurance of compliance.
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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
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
USAMRDC 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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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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1990
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
45 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
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
. 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
of volunteers exists
in
CJSAMRDC 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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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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1990
Prohibition of Use of Human Subjects
Notwithstanding
any
other
provisions
contained
in
this
contract
or
incorporated
by
reference herein,
the contractor
is
expressly forbidden
to use or
subcontract
for
the
use
of human
subjects
in
any
manner
whatsoever.
In
the performance
of
this
contract,
the contractor agrees
not
to come
into
contact with,
use
or
employ,
or
subcontract
for
the
use
or employ of any human
subjects
for research, experimentation,
tests
or
other treatment
under
the
scope of work
as
set out
in
the contract without express
written approval
from the contracting officer.
Tab A
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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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2 6 JUN 19au
(2)
The
institution
shall
have
provided
to USAMRDC
a
written assurance
that
it
will
abide
by
the
policy
for
the pro-
tection
of
human
subjects
as
contained
in
45 CFR
46.
When
an
institution has
an assurance
of compliance satisfactory
to
the
Department
of Health
and
Human
Services
( HHS )
,
evidence
of
IRB
approval
of
the study shall have been accomplished by submission
to
USAMRDC of
an executed HHS Form
596.
For
an
institution
without
a
HHS approved
assurance
of
compliance/
an assurance concerning
the
protection of human subjects
shall have
been negotiated
with
the
USAMRDC contracting officer,
and
IRB approval given.
(3)
In addition
to
the requirements
of Title
45,
Part
of
the
CFR,
the
following
shall
apply
to
all
USAMRDC contracts
supporting
research,
development,
and related activities:
(a)
Informed consent must be obtained
in advance
from
a
subject
at
risk,
or
in
the
case
of
research
intended
to
be
beneficial
to
the
subject,
a
legal
representative of
the subject
may give
informed consent
in advance
of
the
research.
(b)
The contractor shall
provide
for
all
necessary
medical
care of subjects
at
risk
for
injury or disease which
is
the
proximate result
of participation
in
the research.
(c)
Prisoners
of war
shall
not
be
used
under any
circumstances
.
(d)
Use
of prisoners
as
research subjects shall
have
been specifically approved by the USAMRDC contracting officer.
(e)
Studies conducted outside
the United
States,
its
territories
or
possessions,
which
involve
the
use
of
non-U. S.
citizens
as
subjects,
in addition
to compliance with
45 CFR
and
special
DOD
requirements,
shall comply with all
laws,
customs,
and
practices
of
the country
in which
the study
is
to
be conducted.
The
minimum
standards
to
be
adhered
to
are
contained
in
The
Declaration
of
Helsinki.
The
research
proposal
submitted
for
approval will
document
this
action.
In exceptional circumstances
where
laws,
customs
or
practices
of
the
country
involved
take
exception
to
particular procedural
requirements
of
this provision
(as,
for example,
the
documentation
of
informed
consent
or
the
procedures
by
which
it
is
obtained),
specific approval will be
obtained
from
the
Commander,
U.S.
Army
Medical
Research
and
Development Command
as
an
integral part of
the proposal review and
approval process.
(4)
In accordance
with
CFR
56.111(a)(3),
IRBs are
responsible
for
reviewing
the
methods
used by investigators
to
recruit subjects.
One method
of
recruiting
subjects
is
through
advertisements which should be
seen as
an extension of
the
informed
consent.
IRB review of advertisements
is necessary
to ensure
that
the
information
is
not misleading
to subjects.
The
FDA has
established guidelines on advertisement
for research subjects.
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1990
Generally,
the
FDA
believes
that
any
advertisement
to recruit
\
subjects should
be
limited
to:
(a)
The
name
and
address
of
the principal
investi-
gator?
(b)
The purpose
of
the
research
and,
in
summary form,
the eligibility criteria that will
be
used
to
admit subjects
into
the
study;
(c)
A straightforward
and
truthful description
of
the
benefits
(e.g.,
payments or
free
treatment)
to
the
subject
from
participation
in
the
study;
(d)
The
location
of
the research
and
the person
to
contact
for further
information.
(5)
In addition
to
the
requirements
noted
above,
a copy
of
the protocol
and
informed consent
for each phase of
a study will
be
forwarded
to
the
Commander,
U.S.
Army
Medical
Research and
Development
Command,
ATTN:
SGRD-HR,
Fort
Detrick,
Frederick,
MD
21701-5012.
If available,
a
copy
of
the
local
IRB
review and
approval should
be provided.
Research
involving
the
use of human
subjects
may
not
commence
until
approved
by
the
contracting
officer.
d .
Requirements
for
the
Use
of
Investigational Drugs
and
Vaccines
The contractor shall comply with
21 CFR
312
for
the study
and evaluation of
those new drugs
restricted by
the
Federal
Food,
Drug,
and
Cosmetic Act.
The drug
shall
be used
by,
or under
the
supervision of an
investigator
pursuant
to
an
Investigational New
Drug Application
(IND).
A copy of
the current applicable
forms
as
related under Part
312 shall
have
been provided
with
the contrac-
tor's proposal.
e
.
Requirements
for
the
Use
of
Investigational
Medical
Devices
The contractor shall comply with
21 CFR
812
for
the study
and evaluation,
of
those devices which are not generally recognized
as
safe and/or effective,
intended
for use
in
the diagnosis,
cure,
mitigation,
treatment,
or prevention of disease
in,
or research on
humans.
Should
the contractor
propose
to
use an
investigational
device
in
the
research,
he
shall provide with his proposal
a copy
of
Food and
Drug Administration
(FDA)
approval
of,
or
grant
of
waiver
for,
use of
an investigational device exemption
(IDE).
f
Requirements
for Reporting
and Documentation :
(1)
Immediate
telephone
notification
shall
be given
to
the USAMRDC Human
Use Review and
Regulatory Affairs
Office of any
significant adverse reactions.
(Telephone weekdays,
Area
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5 JUN
1990
Code
301/663-2165;
nights,
weekends,
and holidays,
the Duty Officer
Telephone Area Code
301/ 663-7114.)
(2)
Copies of all
documents
presented
or
required
for
initial
and
continuing
review
by
the
IRB,
e.g.,
Board minutes
pertaining only
to
the
contract,
record
of
subject’s consent,
transmittals
on
actions,
instructions,
and conditions resulting
from
IRB deliberations addressed
to
the
activity director,
are
to
be
retained
by
the
contractor
for
at
least
three years
after
completion of
the research.
All documents shall
be
accessible
for
inspection during
normal working hours,
by the USAMRDC contracting
officer or authorized representative.
(3)
Information on volunteers used
in research sponsored
by USAMRDC
will
be
entered
in the USAMRDC Volunteer Registry data
base.
The data base
is required
to ensure
that USAMRDC can readily
exercise
its
"duty
to
warn"
individuals
of
any newly acquired
information which may affect
their well-being,
even after partici-
pation
in
the
research.
The
SGRD-HR
may,
on
request of
the
contractor,
exempt
the
research
from
this
requirement;
such
exemption may
only be
granted
for studies which the
local
IRB has
determined
to
be minimal
risk.
The Volunteer
Registry Data Sheet
USAMRDC
Form
60-R
(Tab
E)
is
to
be completed
at
the
time
the
subject consents
to participate and
is entered
into
the study.
The
forms
shall
be
submitted
to
the
HURRAO upon completion of
the
research project or upon
expirat ion/terraination
of
the contract,
whichever occurs
first.
The USAMRDC will
retain
information
in
the
data base
for 75 years.
Persons on
whom data
is collected,
or
a
designated representative or legal guardian, may have access
to
the
record pertaining
to that
individual.
(4)
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
or his
legally
authorized representative,
or
(b)
as may be necessary
for
the USAMRDC
to carry out
its
legal
responsibilities.
(5)
Upon
expiration
or
termination of
this contract,
a
list
of all unused
test material
shall
be
provided
to
the USAMRDC
contracting officer.
(6)
The contractor
shall
immediately
notify the USAMRDC
contracting
officer,
by
telephone,
of
inquiries
outside
the
Department
of Defense concerning
the use
of human subjects
under
this contract.
In addition,
the contracting officer shall
be
notified
as
soon
as possible
of
inspections
of
the
facility
or
contract protocols by
the
FDA.
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g.
Subcontracts.
Compliance
by subcontractors with Code of
Federal Regulations
45 CFR
and
this contract
provision
is
the
responsibility of
the prime contractor.
All subcontracts which
contain this
contract provision shall
be approved
by the contract-
ing officer prior
to award.
The
requirements
of
paragraph c(2)
above shall apply
to subcontractors.
h.
If
at
any time
during performance
of
this contract,
the
contracting officer determines,
in
consultation
with
the USAMRDC
Human Use Review and Regulatory Affairs Office,
that
the contractor
is
not
in compliance with any of
the
requirements and/or standards
stated
in paragraphs
c,
d,
and
e
above,
the contracting officer may
immediately suspend,
in whole
or
in part,
work
and
further payments
under this
contract until
the contractor corrects
such noncompli-
ance.
Notice
of
the
suspension may
be communicated
by telephone
and
confirmed
in
writing.
If
the contractor
fails
to complete
corrective action within
the
period
of
time
designated
in the
contracting officer's written notice
of
suspension,
the contracting
officer may terminate
this contract
in
whole or
in part,
and
the
contractor's
name may be removed
from
the
list
of
those contractors
with approved policies on
the
use
of human subjects.
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Use
of Anatomical Substances
%
5 JUN 1990
Any anatomical
substance
(organs,
tissues,
or
tissue
fluids)
linked by
identifiers
to
a particular person and used
for research
under this
^ contract
shall
be donated
for
the purpose of research or
investigation.
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 shall relinquish all ownership and/or rights
to
the substance.
All human
anatomical
substance
used
in research
under
this contract shall
be lawfully acguired.
It should be noted
that
a general autopsy consent
form or
a consent
to perform surgery
in and
of themselves,
may not
be adequate.
If excised or autopsy
tissue
is
to
be
used,
the
protocol
should
include
a
copy of
the
consent form used
to obtain
the
tissue.
Tab
C
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1990
THE DECLARATION OF HELSINKI
1.
BASIC PRINCIPLES
a.
Biomedical research
involving
human subjects must conform
to generally accepted scientific principles
and should
be based
on adequately performed
laboratory and animal experimentation
and
on
a thorough
knowledge
of
the scientific
literature.
b.
The design and performance
of
each experimental procedure
involving human subjects
should
be clearly formulated
in an
experimental protocol which
should
be transmitted
to
a specially
appointed
independent committee
for consideration,
comment,
and
guidance.
c.
Biomedical
research
involving human subjects should
be
conducted only by scientifically qualified persons
and
under
the
supervision of
a clinically competent medical person.
The
responsibility
for
the human subject must always
rest with
a
medically qualified person
and
never
rest on
the subject of
the
research,
even though
the subject has given his
or
her consent.
d.
Biomedical research
involving human subjects cannot
legitimately be carried
out unless
the
importance of
the
objective
is
in proportion
to
the
inherent
risk
to
the subject.
e.
Every biomedical
research project
involving human
subjects should
be preceded
by careful assessment of predictable
risks
in comparison with
foreseeable benefits
to
the subject
or
to others.
Concern
for
the
interests
of
the subject must always
prevail over
the
interests of
science and
society.
f.
The
right of
the
research subject
to safeguard
his
or her
integrity must always
be
respected.
Every precaution should
be
taken
to
respect
the privacy
of
the
subject,
and
to minimize
the
impact of
the
study on
the subject's physical and mental
integrity
and on
the personality of
the subject.
g.
Doctors
should abstain from engaging
in research projects
involving
human subjects unless
they are satisfied
that
the
hazards
involved
are believed
to
be predictable.
Doctors should
cease any
investigation
if
the hazards are
found
to outweigh
the
potential benefits.
h.
In publication
of
the
results of
his or
her
research,
the
doctor
is obliged
to preserve
the accuracy of
the
results.
Reports
of experimentation not
in accordance with
the principles
laid down
in
this Declaration should not be accepted
for
publication
.
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i.
In
any
research on human beings,
each potential subject
must
be adequately
informed of
the
aims,
methods,
anticipated
benefits
and potential hazards
of
the study and
the discomfort
it
may entail.
He or
she
should
be
informed
that he
or
she
is
at
liberty
to abstain
from participation
in
the study and
that
he
or
she
is
free
to withdraw his
or
her consent
to participation
at
any
time.
The doctor
should
then obtain
the
subject's given
informed
consent,
preferably
in writing.
j.
When obtaining
informed consent
for
the research project,
the doctor
should
be particularly cautious
if
the subject
is
in
a
dependent
relationship
to him or
her
or may consent under duress.
In
that case
the
informed consent should
be obtained
by
a doctor
who
is
not engaged
in
the
investigation
and who
is completely
independent of
this official relationship.
k.
In case of
legal
incompetence,
informed consent should
be
obtained
from the
legal guardian
in accordance with national
legislation.
Where physical or mental
incapacity makes
it
impossible
to obtain
informed consent,
or when
the
subject
is
a
minor,
permission from
the responsible
relative
replaces
that
of
the
subject
in accordance with national legislation.
l.
The
research protocol should always contain
a statement
of
the ethical considerations
involved and should
indicate
that
the principles enunciated
in
the present Declaration
are complied
with
.
2.
MEDICAL RESEARCH COMBINED WITH PROFESSIONAL CARE
(CLINICAL
RESEARCH)
a.
In
the
treatment of
the
sick person,
the doctor must
be
free
to use
a new diagnostic
and
therapeutic measure,
if
in his
or
her
judgment
it offers
hope
of
saving
life,
reestablishing
health,
or alleviating suffering.
b.
The potential benefits,
hazards and discomforts
of
a
new
method should
be weighed against
the advantages
of
the
best
current diagnostic
and
therapeutic methods.
c.
In any medical study,
every patient— including
those
of
a
control group,
if
any— should
be assured
of
the best proven
diagnostic
and therapeutic methods.
d.
The
refusal
of
the patient
to participate
in
a study must
never
interfere with
the doctor-patient relationship.
e.
If
the doctor considers
it essential not
to obtain
informed
consent,
the specific reasons
for
this proposal should
be
stated
in
the experimental protocol
for
transmission
to
the
independent committee.
D-2
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Approved For Release 2003/09/16
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5 JUN
1990
f.
The doctor can combine medical research with professional
care,
the objective being
the acquisition of new medical
knowledge,
only
to
the extent
that medical research
is
justified
by
its potential diagnostic or
therapeutic
value
for
the patient.
3.
NON-THERAPEUTIC BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS
(NON-CLINICAL BIOMEDICAL
RESEARCH)
a.
In
the purely scientific application
of medical
research
carried
out on
a human being,
it
is
the duty of
the doctor
to
remain
the protector of
the
life and health of
that person on
whom biomedical research
is being carried
out.
b.
The subjects should be volunteers— either healthy persons
or patients
for whom the experimental design
is
not
related
to
the patient's
illness.
c.
The
investigator
or
the
investigating
team should
discontinue
the research
if
in his
or
her
or
their
judgment
it
may,
if continued,
be harmful
to
the
individual.
d.
In
research on man,
the
interest of science
and society
should never
take precedence
over considerations
related
to
the
well-being of
the subject.
D-3
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: CIA-RDP96-00788R001 100440082-3
Approved For Release 2003/09/16
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lim
1ftnn
VOLUNTEER REGISTRY DATA SHEET
5 JUN
1990
l; AUTHORITY:
ifitJSC;30l5
2.
Principal and Routine Purposes: To do<nmi«u: pitrtirip«tiim:to
or sponsored by the U.S. An^ Mcidi^i
Research-
:^;^?foptncnt:ffimma^.::||i^^
3.
Mandatory or Voluntary Disclosure: The furnishing q£ the SSN is mandatory and necessary to provide identification
•
•
and- to: contact -you; if future:^
:.frwKcot»
I
'
:
; Faflure :.tn?
nj^
PART A-INVESTIGATOR INFORMATION
(To Be CompletedBy Investigator)
PLEASE PRINT, USING INK OR BALLPOINT PEN
1.
Study NR:
2. Protocol Title:
3. Contractor (Laboratory/Institute Conducting Study):
4. Study
Period: From:
01/
/
To: 15/
/
(DA/MO/YR)
(DAJMO/YR)
5. Principal/Other Investigators) Names(s)
( 1)
(Last)
(First)
(MI)
(2)
(3)
6. Location/Laboratory
/
/
/
PART B-VOLUNTEER INFORMATION
(To Be CompletedBy Volunteer)
PLEASE PRINT, USING INK OR BALLPOINT PEN
7. SSN:
L
8. Name:
(Last)
(First)
(MI)
9. Sex: M_F_
10. Date of Birth:
/
/
11. *MOS/Job Series:
12. *Rank/Grade:
13. Permanent Home Address (Home of Record) or Study Location Address:
(Street)
(P.O. Box!Apartment No.)
(City)
(
)
{Country
)
(State)
(Zip Code)
(Perm Home Phone No)
14. *Local Address (If Different From Permanent Address):
(Street)
(P.O. Box!Apartment No.)
(City)
(
)
( Country
)
(State)
(Zip Code)
(Local Phone No)
5.* Military Unit
Zip Code:
Organization:
Post:
Duty Phone No.
(
)
USAMRDC Form 60-R AppltfUd4rl$6l{&ptea&a £ftQaiQ9Z46oh£IA-RDP9b-UU788KUUl 1UU44ub8^-3
TAB E
Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440082-3 - PART C-ADDITIONAL INFORMATION. (To Be Completed By Investigator) SS A Se SSS sR SSS SS SSS SSS PLEASE PRINT, USING INK OR BALLPOINT PEN — 16. Location of Study: 17. Is Study Completed: Y__. N__ Did voluntee? finish participation: Y__N____If YES, Date finished: a _ (DA/MOIYR) If NO, Date withdrawn: ff eason wi : (DAIMO/YR) 7 siemaiien 18. Did Any Serious or Unexpected Adverse Incident or Reaction Occur: Y__N____ If YES, Explain: 19.* Volunteer Followup: Purpose: Date: ___/___/____ Wascontact made: Y__N___ If No action taken, explain: (DAIMOIYR) 20.*Hard Copy Records Retired: Place: FileNR:_ 21.*Product Information: Product: Manufacturer: Lot NR: Expiration Date:. NDA NR: IND/IDE NR: *Indicates that item may be left blank if information is unavailable or does not apply. Entries must be made for all other items. Approved For Release 2003/09/16 : CIA-RDP96-00788R001100440082-3