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HUMAN USE REQUIREMENTS
1.
Use of human subjects
a.
The following definitions are used:
(1)
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) 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.
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)
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)
The number of human subjects used will be kept to the
minimum number that will reasonably achieve the required results.
(3)
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)
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)
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) 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) 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)
The study will be conducted so as to avoid all
unnecessary physical or mental suffering or injury.
(9)
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)
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) 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)
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)
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)
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.
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)
Legally effective informed consent will be obtained by
adequate and appropriate methods in accordance with the provisions of
this clause.
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(2) 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:
(i) A fair explanation of the procedures to be followed, and
their purposes, including identification of any procedures which are
experimental.
(ii)
A description of any attendant discomforts or risks
reasonably to be anticipated.
(iii)
A description of any benefits reasonably to be
anticipated.
(iv) A disclosure of any appropriate alternative procedures
that might be advantageous to the subject.
(v) An offer to answer any questions concerning the procedure.
(vi)
An instruction that the subject is free to revoke his
consent and to discontinue participation at any time without prejudice
to himself.
d.
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 .
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 .
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 .
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.
Prisoners of war will not be used under any circumstances.
2. 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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PROCEDURE 13.
EXPERIMENTATION ON HUMAN SUBJECTS FOR
INTELLIGENCE PURPOSES
A.
APPLICABILITY
This procedure applies to experimentation on human sub-
jects if such experimentation is conducted by or on behalf of
a DoD intelligence component. This procedure does not apply
to experimentation on animal subjects.
B.
EXPLANATION OF UNDEFINED TERMS
1.
Experimentation in this context means any research or
testing activity involving human subjects that may expose such
subjects to the possibility of permanent or temporary injury
(including physical or psychological damage and damage to the
reputation of such persons) beyond the risks of injury to
which such subjects are ordinarily exposed in their daily
lives.
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2.
Experimentation is conducted on behalf of a DoD
intelligence component if it is conducted under contract to
that component or to another DoD component for the benefit of
the intelligence component or at the request of such a com-
ponent regardless of the existence of a contractual rela-
tionship.
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3.
Human subjects in this context includes any person
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whether or not such person is a United States person.
c.
PROCEDURES
1. Experimentation en human subjects conducted by or on
behalf of a DoD intelligence component may be undertaken only
with the informed consent of the subject, and in accordance
with guidelines issued by the Department of Health and Human
Services, setting out conditions that safeguard the welfare of
such subjects.
2. DoD intelligence components may not engage in or
contract for experimentation on human subjects without appro-
val of the Secretary or Deputy Secretary of Defense, or the
Secretary or Under Secretary of a Military Department, as
appropriate. [Requests for such approval submitted by Army
Intelligence components will be addressed through command
channels to HQDA (DAMI-CIC), WASH DC 20310. ]
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