HUMAN USE REQUIREMENTS

• Document Type: CREST
• Collection: STARGATE
• Document Number (FOIA) /ESDN (CREST): CIA-RDP96-00788R001500140006-6
• Release Decision: RIFPUB
• Original Classification: K
• Document Page Count: 6
• Document Creation Date: November 4, 2016
• Document Release Date: May 15, 2000
• Sequence Number: 6
• Content Type: REGULATION

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HUMAN i1SE REQUIREMENTS
1.. Use of human subjects
a. The fal.lawing definitions are used:
(1) At risk means ttfat the human subject may be exposed t:o.
the passibility of harm -, physical, biological, psychalogica].,
sociological, ar ether as a consequence of an act or omission tl.~at
goes beyond tl-~e application of ttaase established and accepted methc,ds
ar pracedures which are in his best interests, ar that increases
ordinary risks of daily l:ife~, c>ccupatian ar field of serviice,
(2) Human subject Ricans any human being who, knowingly or
unknowingly, is subjected to an act or omission, whether at task or
net, the abject. of which is to contribute to knowledge to"be gained a,~
r3 part of work to be performed under the scope of this corr,tract.
b. The cantracto,r, before undertaking to perform any study
a:nvolving human subjects, w}~~ether at risk ar not, shall insure thr~.t
t:he following minimum conditions are complies] with:
(1) The proposed study has been reviewed and approved by a
committee meeting the requirerne~nts set Earth in Cha~~ter 4ES of Title 4~i
of the Code of Federal Regulations.
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(2) The number of 'Human subjects used will be kept to the
minimum number that will reasonably achieve the required results.
(~) 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 wi11 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
canduct.or assist in the study.
(5) The subject will be infor~aed that at any time during the
course of his pa~rticipat:ion he~has the right to revoke his cot7sent and
withdraw from participation ~;ai.thout prejudice to himself.
(ti) Participation by subjects wi11 be immediately terminated
if it subsequently appears that the risk to the subjects is
significantly gr~rater than anticilaated at the: time review and approve].
was granted.
(7) Thence sha].1 be no ~,reater intrusion into the privacy c:~f
the human subject than is absolutely necessary far the conduct of the
study involved. Except for the submission of .reports and other
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c1ata required by this contract, any information obtained about human
subjects as a result of participation shall be held as confidential pis
r.he law allow.
($) The study will. be conducted so as to avoid all
i.innecessary physical or meat?il 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,.
~i~ust have beerx completed to give.assurance of acceptable risks prior
to the use of human subjects.
(10) The degree oi: risk to be taken will never exceed that
which is justified by ~ th~~ benefit to the subject anti/or the
humanitarian importance of the knowledge to be gained.
(11) A physician wi.l1. 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 prep~crations will be made, and adequate
:Facilities provided to protest the subject against all foreseeab:3.e
possibi.Iities if injury, di.sabil.ity or death. This includes but is
~aot limited to hospitalization and medical treatment as tray be
-required. In addition, a1:1 apparatus aid instruments necessary to
deal with likely emergency situations will be available.
(13) 1?iuman 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
ease, the use of human subjects with such pre-existing ccanditians trust
have been specifically described and justified in the scope ~of tl'}e
cork to be pcwrformed under this contract.
(14) 'I'he scientifically. qualified gersor~ conducting the
.study, and each member of hiss research team, will be prepared to
terminate the"subject?s participation at any stage if he has reasot~?t:a
believe, in the exercise of the good faith, superior :=kill, and
careful judgment required r,3f him, that continuation is likely to
result in injury, disability, or death to the human subject.
c. The contract:a~c, before permitting any person to participate
pis a human subject, whether. at risk or not, shall insure that the
`following minimum condition's are complied with:
(1) Legally effective informed consent wi:Ll be obtained by
adequate and; appropriate 'methods in accordance with the provisions of
tFcis clause.
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(2) A11. cansent must be voluntary, It me.ast be the knowing
cansent of the :individual or his legally authorized representative, sa
=situated as to 'be able to exerca.se free power of choice caithout there
~aaving been any uae of force, fraud, deceit, duress, constraint,
coercion, or lawful car improper inducement. The e~lerrsents of
information necEsssary to sucMh r_orrsent include:
{i) A fair exp:lanatian of the procedures to be (allowed, and
their purposes, including idc=ntificatian of any procedures which are
experimental.
(ii) A description of any attendant- discomfar_ts ar risky
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 cancernin~; the procedure.
(vi) An instruction that the subject is free to revoke his
consent and to discontinue ~>articipation at any time without prejudice
to himself. -
d, Excul~:aatory language through which the subject is made to
waive, ar appease to waive, any of his legal rights, including any
release from liability far negligence, is prohibited,
e, Prior consent by a subject ar his legally authorized
representative shall be obtained in all cases. Such consent shall be
in writing whenever it is reasonably passible to da sa. The cansent
farm may be read to the subject or his legally authorized
representative, but in any event he of his legally authorized
representative :rust be given adequate opportunity to read it and to
ask questions they might have. This consent farm should then he
signed by the subject ar 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 perforaned under this contract or approved in
writing by the contracting officer, When so authorized and used, anal
r.onsent is subject to all r_he same standards as apply to written
cansent, 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 l:~y which informed consent will be
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obtained,- to include any forms to be used. Upon completion of the
study, the car,tr.actor will submit to the contracting officer's
representative a detailed repcart de.manstrating compliance with
paragraph (c~, to include copies of the written consent if such was
attained.
g. The contractor shall not undertake to conduce: either the
clinical pharmacology or~ el:inieal trails of an investigational drug;
unless this contract contains the clacase entitled "Clinical Study cif
Investigational. Drugs."
h. Priscfners of war will not to used under any circumstances.
2. 1)oD Directive 5240.1-R governing experimentation an Kumar, subjects
will be followed by thf~ contactor. Informed consent of all subjects
will be obtained in writing in accordance with the guidelines issued
ty the Department of ~iealth, Education and Welfare. All persons
participatgxig cis human subjects, as defined in paragraph 6.1 above
shall to known tca possess the abilities and quala.ties which will be
atserved and analysed during the conduct of this contract.
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I?ROCELIURE 13. EXFERIMt":NTATIt)N ON HUMAN SUBJECTS FOR
INTFLLtGENCE ;PURPOSES
This pracedure applies to experiroentatian an huroan~sub-
jests if such experimentation is conducted by or an behalf of
a 1DoB intelligence component. This procedure daes not apply
to experimentation an animal subjects.
b. EXPLAtdATION OF UN DEFINED TF,'RMS
1. Ex~~rirnentatian in this context means any research or
testing activity involving h,asnan subjects that ,gay expase such
subjects to the possibil~lty oaf permanent or tPmparary injury
(including physical or psych~alagical damage and damage to the
~?eputation of .such persons) beyond the risks of injury to
which such subjects are ordi,~arily exposed in their daily
lives.
2. Experimentation is conducted on behalf of a DaID
intelligence ccsroponent if it is conducted under contract to
that component oar to another L~oD component for the benefit of
t:he intelligence component or at t:he request of such a co~m-
panent regardless of the exi,~tence of a contractual rela~
tianship.
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3. Human sub acts in this c:antext includes any person
whether or nat such person is a United States person,
~;. PROCEDURES
~ ? Experimentation can ha4anan sub,] acts conducted by or ozx
behalf of a L3oL- in tellige~nce co~-ganent may be undertaken oniy
with the informed consent; of the subject, end in eccorderice
4aith guidelines issued by the Department of Health grid Numacx
Services, setting, out conditions that safeguard the welf~-re of
such subjects.
2. DoD inte7.ligence coropons~nts rosy not engage in or
contract fc~r experimentation oix ht~nan subjects without appro-
va1 0# the Secretary or Deputy Secretary o# Defense, or the
Secretary or Under Secretary ?f a Military Department, as
appropriate. [Requests f`or such approval submitted by Arroy
intelligence components will be addressed through command
channels to HQDA (DAMT-CIC) , k1r~SH DC 20310. ]
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