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Document Creation Date: 
November 4, 2016
Document Release Date: 
May 15, 2000
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PDF icon CIA-RDP96-00788R001500140006-6.pdf401.43 KB
,Approved For Release 2000/08/08 :CIA-RDP96-007888001500140006-6 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. .- (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 oo BB Approved For Release 2000/08/08 :CIA-RDP96-007888001500140006-6 I~v~ ~ e "Approved For Release 2000/08/08: CIA-RDP96-007888001500140006-6 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. Approved For Release 2000/08/08: CIA-RDP96-007888001500140006-6 ~, 1 . Approved For Release 2000/08/08: CIA-RDP96-007888001500140006-6 (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 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 Approved For Release 2000/08/08: CIA-RDP96-007888001500140006-6 .Approved For Release 2000/08/08: CIA-RDP96-007888001500140006-6 obtained,- to include any forms to be used. Upon completion of the study, the car, 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. Approved For Release 2000/08/08 :.CIA-RDP96-007888001500140006-6 L; ~ a _, Approved,For Release 2000/08/08 :CIA-RDP96-00788800150014,0006-6 ~,. _ 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. Approved For Release 2000/08/08: C96-007888001500140006-6 ~~,,,~ ~ . Approved For Release 2000/08/08 :CIA-RDP96-007888001500140006-6 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. ] Approved For Release 2000/08/08 : ~I~-~j~P96-007888001500140006-6 v