CIA-RDP96-00788R001100440007-6

Approved For Release 2003/09/16 : CJA-ROP96-00788R001100440007-6
FORM
DET. OF HUMAN SUBJECTS
( 1978 AUG)
((a) The following definitions are used in this clause:
(1) At risk means that the human subject may be exposed to the
possibility of herm - physical, biological, psychological, sociological,
or other - as a consequence of an act of 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, including the recognized risks inherent in his chosen occu-
parion or field of service.
(2)
Human Subject means any human being who, knowingly or un-
knowingly, is subjected to an act or omission, whether at risk 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 in-
volving human subjects, whether at risk or not, shall insure that the
following minimum conditions are complied with:
subje
auth(
(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 impor-
tant 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 con-
duct or assist in the study.
(5)
The human 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 further participation without prejudice to himself.
(6) Participation by subjects will be immediately terminated if
it subsequently appears that the risk to the subjectr is significantis
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 data required
Inclosure 2
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by this contract, ar; information obtained about Women forlects as a
result of their participation shall be held at confidencial as the law
allows .
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(8)
The study will be conducted so as to avoid all unnecessary
physical or mental suffering of injury.
(9) No study will be conducted if there is any inherent reason to
believe that death of 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
of 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, dis-
ability, or death to the human subject.
(c) The Contractor, before permitting any person to participate
as & human subject, whether at risk or not, shall insure that the
following minimum conditions are complied with:
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(1) Legally effective informed consent will be obtained by adequate
and appropriate methods in accordance with the provisions of this clause.
(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, of 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 experi-
mental.
(ii)' A description of any attendant discomforts or risks reasonably
to be anticipated.
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A description of any benefits reasonably to be anticipated.
(iii)
(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 represen-
tative 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 any 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 of his legally
authorized representative is not required.
(f) Prior to conduct of the study, the contractor shall submit for
approval to the contracting officer a detailed description of the means
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by which ancoraed consent will
be obtained, to include any forms to be
USEe.
Upon completion of the : tedy, the contractor will submit to the
contracting CHEde: detailed Report demonstrating compliance vil
paragraph (c), Le chlode expdet of the written consent is 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 cheuse entitled "Clinical Study of
Investigational brugs."
(h)
Prisoners of war will not be used under any circumstances.
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