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(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
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
sab^ts
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
subjectsas
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.
(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.
(12)
(U)
Proper
preparations
will
be
made
facilities
provided
to
protect
the
subject
against
possibilities
if
injury,
disability
or
death.
This
,
and
adequate
all
foreseeable
includes
but
is
Approved For Release 2001/04/02
: CIA-RDP96-00788R001 5001 10003-2
Approved For Release 2001/04/02
: CIA-RDP96-00788R001 5001 10003-2
reauiVJd
b
d
Tn
fc
tallZ^tl0n
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
for
them
than
it
would
be
for
normal
healthy
persons,
unless
such
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,
0 .,.
( i4)
(uu)
T
Lhe
scientifically qualified
person
conducting
the
study,
and
each
member
of
his
research
team,
will
be
prepared
to
terminate
the subject's participation
at any
stage
if
he
has
reason
to
believe,
in
the
exercise
of
the
good
faith,
superior
skill,
and
careful
. judgment
required
of
him,
that
continuation
is
likely
to
result
in
injury,
disability,
or
death
to
the human
subject.
_
(c)
(u)
The
contractor,
before
permitting
any
person
to
? s
?
huraan
subject,
whether
at
risk
or
not,
shall
insure
that
the following minimum conditions
are complied with:
(1)
(U)
Legally
effective
informed
consent
will
be
obtained
y adequate
and appropriate methods
in
accordance
with
the provisions
of
this
clause.
(2)
(U)
All
consent
must
be
voluntary.
It
must
be
the
knowing
consent
of
the
individual
or
his
legally
authorized
representative,
so
situated
as
to
be
able
to
exercise
free
power
of
choice
without
there
having
been
any
use
of
force,
fraud,
deceit,
duress,
constraint,
coercion,
or
lawful
or
improper
inducement.
The
elements
of
information necessary
to such consent
include:
a
,
4-u
^
A
f
.air
explanation
of
the procedures
to
be
followed,
and
their
purposes,
including
identification
of
any
procedures
which
are experimental.
(ii)
(U)
A description
of
any attendant
discomforts
or
risks
reasonably
to
be anticipated.
( iii )
(U)
anticipated
.
A
description
of
any
benefits
reasonably
to
be
(iv)
(U)
A
disclosure
of
any
appropriate
alternative
procedures
that might
be advantageous
to
the subject.
(v)
(U)
procedure
.
An
offer
to
answer
any
questions
concerning
the
Approved For Release 2001/04/02
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(vi)
(U)
An
instruction
that
the
subject
is
free
to
revoke
his
consent
and
to
discontinue
participation
at
any
time
without
prejudice
to himself.
(d)
(U)
Exculpatory
language
through
which
the
subject
is
made
to waive,
or
appear
to
waive,
any
of
his
legal
rights,
including
any release from liability
for
negligence,
is prohibited.
(e)
(U)
Prior
consent by
a
subject
or
his
legally authorized
representative
shall
be
obtained
in
all
cases.
Such
consent
shall
be
in writing whenever
it
is
reasonably possible
to
do
so.
The
consent
form
may
be
read
to
the
subject
or
his
legally
authorized
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.
Approved For Release 2001/04/02
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This consent
form should
then
be
signed
by
the
subject
or
his
legally
authorized
representative
and
by
a
witness
not
directly
involved
in
the
study.
Oral
consent
may
be
used
only
when
it
has
been
specifically
described
and
justified
in
the
scope
of
the
work
to
be
performed
under
this
contract
or
approved
in
writing
by
the
contracting
officer.
When
so
authorized
and
used,
oral
consent
is
subject
to
all
the
same
standards
as
apply
to written
consent,
except
that
the
signature
of
the
subject
or
his
legally
authorized
representative
is
not
required.
(f)
(U)
Prior
to
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
used.
Upon
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
.
(g)
(U)
The contractor
shall
not
undertake
to
conduct
either
the
clinical
pharmacology
or
clinical
trails
of
an
investigational
drug unless
this contract
contains
the
clause entitled
"Clinical
Study
of Investigational Drugs."
(h)
(U)
Prisoners
of
war
will
not
be
used
under
any
circumstances
.
6.2
(U)
DoD
Directive
5240. 1-R
governing
experimentation
on
human subjects will
be followed
by
the contactor.
Informed consent
of
all
subjects
will
be
obtained
in
writing
in
accordance
with
the
guidelines
issued
by
the Department
of
Health,
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.
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