CIA-RDP96-00788R001500120046-4

SG1A
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500120046-4
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Approved For Release 2000/08/08 : CIA-RDP96-00788R001500120046-4

Approved For Release 2000/08/08: CIA-RDP06-00788R001500120046-4
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HUMAN USE REQUIREMENTS
1.
(U) Use of human subjects
a .
(U)
The following definitions are used :
(1) (U)
At risk means
that the human subject may be exposed
to
the possibility of harm - physical, biological, psychological,
sociological, or other as a consequence of an act or omission that
goes beyond the application of those established and accepted methods
or procedures which are in his best interests, or that increases
ordinary risks of daily life, occupation or field of service.
(2) (U)
Human subject means any human being who, knowingly or
unknowingly, is subjected to an act or omission, whether at task or
not, the object of which is to contribute to knowledge to be gained as
a part of work to be performed under the scope of this contract.
b.
(U)
The contractor, before undertaking to perform any study
involving human subjects, whether at risk or not, shall insure that
the following minimum conditions are complied with :
(1) (U)
The proposed study has been reviewed and approved by
a committee meeting the requirements set forth in Chapter 46 of Title
45 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
persons
by
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
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.
,
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
o 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, and adequate
facilities
provided to protect the subject against all foreseeable
possibilities if injury, disability or death.
This includes but is
not limited to 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 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.
(14) (U)
The 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
participate as a human 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
by adequate and appropriate methods in accordance with the provisions
of this clause.
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UNCLASSIFIED
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(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 :
and
(i) (U).
A fair explanation of the procedures to be followed,
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)
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.
(v)
(U)
An
offer to answer any questions concerning the
procedure.
(vi) (U)
An instruction that the subject is free to revoke
and to discontinue participation at any time without
prejudice to himself.
his consent
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.
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
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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.
2.
(U)
Do D
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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Approved For Release 2000/08/08 : CIA-RDP96-00788R001500120046-4