Approved For Release 2001/04/02
: CIA-RDP96-00788R001 5001 10030-2
(1)
(U)
The
proposed
study
has
been
reviewed
and
approved
by
a
committee
meeting
the
requirements
set
forth
in
Chapter
of Title
of
the Code
of Federal Regulations.
(2)
(U)
The
number
of
human
subjects
used
will
be
kept
to
the
minimum
number
that
will
reasonably
achieve
the
required
results.
(3)
(U)
The
study
must
be
such
as
to
contribute
significantly
to
scientific
knowledge
and
have
reasonable
prospects
of
yielding
important
results
essential
to
an
Army
research program.
(4)
(U)
The
study
will
be
conducted
only
by persons
possessing
the
requisite
scientific
qualifications.
The
highest
degree
of
skill
and
care
will
be
required
during
all
stages
of
study
of persons
who conduct
or
assist
in
the
study.
(5)
(U)
The subject will
be
informed
that
at
any
time
during
the
course
of
his
participation
he
has
the
right
to
revoke
his
consent
and
withdraw
from
participation
without
prejudice
to himself.
(6)
(U)
Participation
by
subjects
will
be
immediately
terminated
if
it
subsequently
appears
that
the
risk
to
the
subjects
is
significantly greater
than
anticipated
at
the
time
review and approval
was
granted.
(7)
(U)
There
shall
be
no
greater
intrusion
into
the
privacy
of
the
human
subject
than
is
absolutely
necessary
for
the
conduct
of
the
study
involved.
Except
for
the
submission
of
reports
and
other
data
required
by
this
contract,
any
information
obtained
about
human
subjects
as
a
result
of
participation
shall
be
held
as
confidential
as
the
law allow.
(8)
(U)
The
study
will
be
conducted
so
as
to
avoid
all
unnecessary physical
or
mental suffering
or
injury.
(9)
(U)
No
study
will
be
conducted
if
there
is
any
inherent
reason
to
believe
that
death
or
disabling
injury
is
likely
to
occur.
Sufficient
animal
or
laboratory
experiments,
or
other
evaluations,
must
have
been
completed
to
give
assurance
of
acceptable
risks
prior
to
the
use
of
human
subjects
.
(10)
(U )
The
degree
of
risk
to
be
taken
will
never
exceed
that
which
is
justified
by
the
benefit
to
the
subject
and/or
the
humanitarian
importance
of
the
knowledge
to
be
gained.
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.
(11)
(U)
A
physician
will
be
responsible
for
the
medical
care
of
subjects.
Even
if
not
the project
leader,
the
physician
will
have
authority
to
terminate
the
study
at
any
time
that
he believes death,
injury
or harm
is
likely
to result.
(
(
U!
Proper
preparations
will
be
made,
and
adequate facilities provided
to protect
the
subject against
all
foreseeable possibilities
of
injury,
disability
or
death.
This
treit^nf
l'0t
lim
.ited
t0 '
hospitalization
and
medical
treatment
as
may
be
required.
In
addition,
all
apparatus
and
instruments necessary
to
deal
with
likely
emergency
situations
will
be available.
(13)
.
(U)
Human
subjects
will
have
no
physical
or
mental
conditions
which
will
make participation
more
hazardous
fchem
than
it
would
be
for
normal
healthy
persons,
unless
condition
is
a
necessary prerequisite
for
the
particular
study
involved.
In
any
such
case,
the
use
of
human
subjects
with
such
pre-existing
conditions
must
have
been
specifically
described
and
justified
in
the
scope
of
the
work
to
be
performed
under
this
contract.
(U)
The
scientifically
qualified
person
conducting
the
study,
and
each
member
of
his
research
team
anv stL ff
re?\
red
K
t0
terminate
the
subject's
participation
at
ny stage
if
he
has
reason
to
belie ve,
in
the
exercise
of
the
9?°d
suPer ior
skill,
and
careful
judgment
retired
of
him,
that
continuation
is
likely
to
result
in
iniurv
disability,
or
death
to
the human subject.
y '
to
narti
Tt:ie
contractor ,
before permitting
any person
Psl ticipate
as
a
human
subject,
whether
at
risk
or
not,
shall
insure
that
the
following minimum conditions
are
complied
ohi-ai
a
i
(U)
Legally
effective
informed
consent
will
be
the provisLn^
e
af
a
^f
t aPPr °Priate methods
in
accordance with
inc provisions
of
this
clause
.
f 2
^
AH
consent
must
be
voluntary.
It
must
be
representative
03^ °K ^
1individual
or
his
legally authorized
representative ,
so
situated
as
to
be
able
to
exercise
free
°
\
C
?t° e
W ^ tll0ut
there
having
been
any
use
of
force/
fj"f
ad '
deceit,
duress ,
constraint,
coercion,
or
lawful
or
improper
inducement.
The
elements
of
information
necessarv
to
such consent
include:
lon
necessary
to
foil owed* Hnri
• A
fair
explanat ion
of
the
procedures
to
be
followed,
and
their
purposes,
including
identification
of
anv
procedures which
are experimental.
cacion
any
Approved For Release 2001/04/(j
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Approved For Release 2001/04/02
: CIA-RDP96-00788R001 5001 10030-2
UNCLASSIFIED
(ii)
(U)
A
description
of
any
attendant
discomforts
or
risks reasonably
to
be anticipated.
(iii)
(U)
A description
of
any benefits
reasonably
to
be anticipated.
(iv)
(U).
A disclosure
of
any
appropriate
alternative
procedures
that might
be advantageous
to
the subject.
the procedure ^
offer
to
answer
any
questions
concerning
(vi)
An
instruction
that
the
subject
is
free
to
revoke his
consent
and
to discontinue participation
at
any
time
without prejudice
to himself.
y
(U)
Exculpatory
language
through
which
the
subject
is
made
to
waive,
or
appear
to
waive,
any
of
his
legal
prohibited
ClU<3ln9 3nY
release
from liability
for
negligence,
is
.
Prior
consent
by
a
subject
or
his
legally
h ° ri
'ZQ
i representative
shall
be
obtained
in
all
cases.
Such
consent
shall
be m writing whenever
it
is
reasonably possible
f?i®°’
f^he
. co«sent
form may
be
read
to
the
subject
or
his
i J!l!y
authorised
representative,
but
in
any
event
he
or
his
legally
authorized
representative
must
be
given
adequate
opportunity
to
read
it
and
to
ask questions
they might have?
consent
form should
then
be
signed
by
the
subject
or
his
legally authorized representative
and
by
a witness
not
directly
involved m
the
study.
Oral
consent
may
be
used
only when
it
£he
tTrk K
eC
H
l£iCal
Ply
de
,Ecribed
ana
justified
in
the
scope
of
the
work
to
be
performed
under
this
contract
or
approved
in
nqpd
lng
b
T
thG
cont f ac ting
officer.
when
so
authorized
and
?
°^ Sen
subject
to
a11
the
same
standards
as
?nhiLt-
n
i
C ° nff nt '
except
that
the
signature
of
the
required
hlb
legally
authorized
representative
is
not
shall
(UeL Pri ° r
t0
conduct
of
the
study,
the
contractor
shall
submit
for
approval
to
the
contracting
officer’s
representative
a
detailed
description
of
the
means
by
which
informed
consent
will
be
obtained,
to
include
any
forms
to
be
“
d '
Upor
i completion
of
the
study,
the
contractor
will
submit
to
the
contracting
officer's
representative
a
detailed
report
demonstrating
compliance
with
paragraph
(c),
to
include
copies
of
the written consent
if
such was obtained.
P
Approved For Release 2001/04/02
: CIA-RDP96-00788R001 5001 10030-2
Approved For Release 2001/04/02
: CIA-RDP96-00788R001 5001 10030-2
ii
. ..
J P ^
contractor
shall
not
undertake
to
conduct
.
the
f
,
clinical
pharmacology
or
clinical
trails
of
an
oPf Pf
d5 ug
unless
this
contract
contains
the
clause
entitled
Clinical Study
of
Investigational Drugs,"
( h
)
( U
)
circumstances
.
Prisoners
of
war
will
not
be
used
under
any
6.2
(U)
DoD
Directive
5240. 1-R
governing
experimentation
on
human
subjects
will
be
followed
by
the
contactor
.
Informed
onsent
of
all
subjects
will
be
obtained
in
writing
in
1%
W\
th
thS
guidelines
issued
by
the
Department
of
-alth,
Education
and
Welfare.
All
persons
participating
as
human
subjects,
as
defined
in
paragraph
6.1
above
shall
be
known
to
possess
the
abilities
and
qualities
which
will
be
observed
and analyzed during
the conduct
of
this
contract.
Approved For Release 2001 /04/y||jg^|8iH6-00788R001 5001 10030-2