WWII A v6d For Release 2001/03/07 CIA-RDP96-00789ROO3000020003-4 pp ro D D c? DEPARTMENT OF DEFENSE T., PROCEDURES GOVERNING THE ACTIVITIES OF Atl@ DOD INTELLIGENCE COMPONENTS THAT AFFECT UNITED STATES PERSONS DECEMBER 1982 Approved For Release 2001/03/07 CIA-RDP96-00789ROO3000020003-4 zpl@ r- aw@ Z,,&T, 4, 1)1,, i"% PoD 5240. 1 -P, (N FITKO SUBJECTS FOP INTELLIGENCE PtIRPOSES A..-' APPLICtiBILITY This procedure applies to cxperimentation on human subjects if such experi- mentation is conducted by or ort behalf of a DoD intvlligence component. This procedure does not apply to experimentption on animal subjects. B. EXI'LkNATION OF UNDEFINED TER-M3 1. Egerimentation in this context means any research or testing activ- ity involving human subjects that may expose such subjects to the possibility of permanent or temporbry injury (iDcluding physical or psychological damage ani damage to the reputation of such persons) beyond the risks of injury to which such subjects are ordinarily exposed in their daily lives. 2. Experimentation is conducteO on behalf oil a DoD intelligence com- ponent if it is conducted under contrai7t_to. th,at.-component or to another DoD component for the benefit of the intelligence component or at the request of such a component tegardless of l.be cxistence of a contractual relationship. 3. H=an subiects in this context includes any person whether or not such person is a United States person. C. PROCEDRES It Experimentation on human subjects conducted by or on behalf of a DoD intelligence com- onent may lie undertaken Only With I he P by §,VUP NAm&Q .Serjaije Lhat safeguaxd 2. DoD intelligence components may rot eugage in or contract for experi- mentation on hum3n subjects without. approval of the Secretary or Deputy Secre- -t&ry of Defense, or th& Secretary or Under Secretary of a Military Departrent, as appropriate. Approved For Release 2001/03/07 : CIA-RDP96-00789ROO3000020003-4 j.-I .1-ebrugl-YA-482 roved For Release 2001/03/07 CIA-RDP96-00789R00306601b0V3-4 IV P I b(, provided 1)), Army intelli- to sInto 'Ind k--al ):I\N ell- or 1w) tKA i. -ill( I-it authol Itius Only when "vitilablu pubh( ly.) livus 11,e (Al- -smint tO .1 requ(!st by Ithe @j. of Arn v inteflivenoo atid onlY ))U1 Qi SL;C11 authority. Such rcquests imi-it be L, 0 W1 1) u 11, A t." Who ;Al", it.S@ Ill(,(] to Worli for and tile SCCI@Ctary 01- Undel' SeervLaY)'f' th l-l- flil@ diroctiorl q,f ;inother a 111 n I -,I,niy. Iiiider fliese circunistance-9o ,,pert e e% cy o gL fililt-1-111 V0VeJ'1L1M!)lt will conduct themselves 1%,ollflel may be provided to such foi. the (1111%jtion (,I' t1loij, jS,,jj@rIjmejlt agency pro- as if they AI j,;iriicij)ation in law enforcenient,, activi- eplph'vee:; of that Any re ionsi- 'nited as follows: . !I Y l , bilitics to provide information to or services (a) Onjy personnel Nvith technical for L)A will be stated expressly and skills made a part J'eudily available to such law enforcementof 0w t(@rms of the assignment. which call be to prevent, C. Pruct durcs. 0,11 serious injury, may be ;,i-ovided (I) A.,4-signment of employees of Army in- (b) Provision of such pul.,unliel components to other avencies within will be arY to preve 'A @rd to that nevess, nt the de th the fuderal @rovernmew is governed by DOD mlfious injury that is threatened, but in no Directix,(! 1000.17. The mernorandum of alree- sliall such assistance be provided ment concerning such assignment and for more ret ired 72 hours; v by Subsection 1) (6) (c) (1) of the Directive shall (c) Such personnel tire not used to irlChide- ap- 'I d en o ns w h o are suspi@c t com- d i f pers j e o . ttj?lj@, or who are about to commit, a crime, (d) Use of such personnel does not vio- the PoAse Comitatus Act. (3) Emergency assistance. In emergency @,,;,tions, where life is endangered, the request .,jujred ill (1) and (2) above may be oral, -100ded that it is reduced to writing and sub _11flod to IIQI)A(DAMI-CIC) within 72 hours. ,Vhere life is endangered, doubt as to the legal and propriety of the requested assista nee qder this procedure should be resolved in favor ProViding, theussistance. -ocedure 17. Assignment of intelli -i Pi gence Pjst)nnel to other agencies. a. Applicability ,.@, scol)c. Thi@s procedure applies to the as giiinent. of DA intelligence personnel to other ,ellcies within tile federal government. This jro,'ed1lI*(! does 'lot apply to- (1) Assignment to state or local govern cur;-wrations or other private organiza (2) Assignment to another agency within intelligence community when part of the @,r;ose Of the assignment is to gain experience ;4 1,nowledge about the activities of the other (Reporting qr report in this context (a) Ail identification of the Army intel- ligence component from which the employee h-as been assigned by DA. (b) A statement deliticating the em- ployee's responsibi I i ties, if any, for reporting to the DA about rnatterl; that come to the em. Pl*ev's attention while on assignment outside the Department. (2) Other than is permitted by the ternv4 Of the memorandum of agreement pursuant to DOD Directive 1000.17, all employee of an Army intelligence component oil assignment to an other agency of the federal government may not report, to any Army component the operations or personnel of the agency to which the em- plo.vu@c is assiJ."lled. (3) After completion of , in assignment to another -111-ellu Of the federal government and return to DA, an employee remains under the .same rc-strictions, as to reporting, that applied when the employee was oil such assignment. 2-18. Procedure 18. Experimentation on htina.,l subjects. a.Applicabilily upd scope. 0 ) This proce(lure applies to experimen- tation on human subjects if such experimenta- lion is conducted by or on behalf of ally Army intelligence component. This procedure (toes not apply to (.xperimentation un aidnial subjects. 2-21 0,4 Approved. ForRelease.2001M.3107 ---CIA,-RJDP96-0.0789.RO03000020QQ~-4- W @:O --Rb'P96; 007.80RO.0-31-0 00 0 .37/07' -20GIA) 06@ Approv6d.:FO:r:Rie .0 IOU -7 do AR 381-10 (2) Experimentation in this context nicans -9 research, developinent, or related activity that may expow@ an individual to the possibility of injury (ircluding physical, 1).,@ *vcholovi,,a), ()I- social injury) that increascs-the ordinary risl@,CA of daily life for the subject (including the rec- ognized risks inherent in a chosen occupation field of Service), or that temporarily ad- versely affects a p@imvn's mental or physical condition. (3) Experinient,,,fion is conducted "on be- half of" an Army intelligence component if it is conducted under contract to Iliat component or to another Army component for the benefit of the intelligence component, or at the request of such a component re.gardless of the existence of a contractual relationship. (4) Human subjects in this context in- cludes any person regardless of whether the person qualifies as a US person. b. Policy. Army intelligence components may conduct experimentation on hurnan subjects only when an important foreign intelligence or CI purpose is to be served -only after the in- formed consent of the subject has been obtained in writing, and only in accordance with guide- lines issued by the Department of Health and Human Services setting out cohditions that safeguard the welfare of the subjects, and other applicable regulations. c. Procedure. Army intelligence components may not engage in or contract for experimen- tation on human subi Iects without prior ap- proval of the Secretar, or Under Secretary of the Army. 15 February 19 The collection and production of i telligence; W Any functions in support of tl collvetion and production inbulligence, or W) The conduct of special activities I the military services in armed conflict or military deception operations target2d, for mi. tary purposes, against a hostile foreign pow(. (2) Conspiracy in this context hag t) same meaning as in the criminal law conte and requires an overt act. Neither I 'he ler 11assassination" rior the term "conspire" i clude military or civilian measures against o going international terrorist activities (whii is a defined term (see glossary) and should 1 construed strictly), aircraft hijRckings, or response to dRnger of substantial physical har to any person. These terms do not apply actions of the military services in the exec tion of lawfully ordered military operations. (3) Diplomatic and military attache acti ities means the representational, informati( gathering, and reporting activities perform( by diplomatic and military attache personri abroad. (4) Production of intelligence means 0 process of developing "intelligence product! which is a defined term. (see glossary). (5) Special activities meani activities co ducted abroad in support of national foreip policy objectives that are designed to -f urth, official US programs and policies abroad; th., are planned and executed so that the role of tl United States Government is not apparent, acknowledged publicly and functions in 8uppo of such activities, but not including diplomat and military attache activities or the collecti( and production of intelligence or related su- pIurt functions. (6) Support, when used in this contex means the provision of assistance in the for of transportation, training, supplies, equipmei or expert personnel. b. Policy. No Army intelligence componen will participate in the conduct or support L special aclivities. No other Army compone) will provide support for special activities exuel upon the specific direction of the Sceretary Undor Secretary of the Army and Ole secre"o 2-19. Procedure 19. Special activities. a. A P- plicability and scope. (1) This procedure applies to the conduct and support of special activities by Army intel ligence components. This proc-edure also applies to other Army components that, provide support tor speci4l activities conducted by DoD intel hgence components and other agencies within die Intelligence Community. These procedures ?Wt apply tom (a) Diplomatic or militao- attache ac- vitles conducted by DOD. Approved, For Release 2001/03/07 : CIA-RDP96-00789ROO3000020003-4 Approved For Release 2001/03/07 : CIA-RDP96-00789ROO3000020003-4 HL%L,N USE REQUIREMEN-4S J U'-@e Oi humac@ 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 h4- best interests, or that increases ordinary risks of daily lite, 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 con.tract. b. The contracto 'r, befure undertaking to perform any study involving @uman. 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 Telasonably achieve the required results. (3) The study must be such as to contribute significantly to scientific knowledge and have reason-able 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 intrusi6n 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 Approved For Release 2001103107 : CIA-RDP96-00789ROO3000020003-4 Approved For Release 2001/03/07 CIA-RDP96-00789ROO3000020003-4 iiate, required 'Dy this contract, anly infoimation obtEined about hum'-n a ELf,,UiL (A participDtion shall be held as confidential @Is ,Lhe law, allo@,,. (8) The study will be conducted so as to avoid all unnece,s-s--ry physical or mental sufferime, 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 labo'r-atory exptriments, or other eValuations,' n)usL have beer, 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 I humanitarian importance of the knowledge to be gained. (11). A physician will be responsible for the medical care of subjects. Even if not the projecr leader, the physician will have authority to Lerminate the study at any time that he believes death, injury or harm is likely to result. (12) Proper preparaLions will be made, and adequate facilities provided to protect the subject against all foreseeable possibi,lities if injury, disability or death. This- includes but is not limited to hospitalization and medical treatment as may be required. In addition, all appa-ratus a@.d instruments necessary to deal-with likely emergency@_situations will be av4ilable. (13) Human subjects will have no physical or mental conditions which will make participation more hazardous for them than it would be for normal he,althy persons, unless such' condition is a necessary prerequis-ite 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 reasorr 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, appropriat ta .methods in accordance with the provisions of this clause. Approved For Release 2001/03/07 : CIA-RDP96-00789ROO3000020003-4 A"axwkh Pule- Approv6d For Release 2001103107 CIA-RDP96-00789ROO3000020003-4 (2) All consenL rl. USi- be voluntary.It must be the knowing consent L11C indiViGUCliol- his legally authorized of representative, so situated to be able of choice without there as to exercise free power i -, - - - V- clll@y u'f fUlLtf, friud, deceit , duress, constraint, 1JC;VJ.LQ; UuCli coerc ion, iniproper inducement. The elements of or lawful or informationnecessary to such consent include: (i) A fair explanation of the procedures to be followed, and Lheir purposes, including identification of any procedures which are experimenta-U. (ii) A description of any attendant discomforts or risks reasonably to be anticipatea. (iii) A description of any benefits reasonably to be anticipated. (iv) A disclosure of any appropriate alternative procedures that might be a6vantageous 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 liabilit.y 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 torm 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 L conduct of the study, the contractor shall submit -or approval to the contracting officer's representative a detailed Uescription of the means ny Wnich informed consent will be Approved For Release 2001103/07 : CIA-RDP96-00789ROO3000020003-4 Approved For Release 2001/03/07 CIA-RDP96-00789ROO3000020003-4 ubLz@i-ed, tu include nt-iY forr.s tc be used. complir::tinn of the 0 @u c; yt 'I -je conLroLLur wii! suL@Diit to the contracting, officer's repreF;---tativc a dc-L-ailcd report demonstrating co[,ipliance wit@j para&iaph (c), to linCIU&C LU-iCS Of the written consent if such was obtained. V 9. The contractor shall not undertake to conduct. either the clinical pharmacology or clinical Lrails of an investigational drug, unless this contract cont6ins the clause entitled "Clinital Study 6f Investigational. Drugs." h. Prisoners of war will not be used under any circumstances. 2. DoD Directive 5240..l-R governing experimentation on human subjects will be fOl 1OWE'd by the conracror. 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 cb------.vcd and analyzed during Lhe conducL of this contract. Approved For Release 2001/03/07 : CIA-RDP96-00789ROO3000020003-4 TA PROCEDURE 13. EXPERIMENTATION ON HUMAN SUBJECTS FOR INTELLIGENCE PURPOSES A. APPLICABILITY This procedure applies to experimentation on human sub- jects if such experimentati-on 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. 1?@Ri@i@iSentation 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. 2. Experimentation is conducted on behalf of a DoD intelligence component if it is conducted under contract to that component: or to another DoD c,omponent for the benefit of t-hAOM-i-JEldfurAelea4e2OOl/G3107I.: CIA-RDP9,6,?-00799ROOSOO000003-4 a Aporovdd For Release 2001/03/07: CIA-RDP96-60789ROO300002'0003-4 3. Human subjects in this context includes any person whether or not such person is a UniLecl SLates persuti. C. PROCEDURES 1. Experimentation on hLunan subjects conducted by or on behalf of a DoD intelligence component may be under-taken 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 fo r such-approval submitted by Army intelligence components will be addressed through command channels to HQDA (DAMI-CIC), WASH DC 20310.1 Approved For Release 2001/03/0,7.,:XIA-RDP96-00789ROO3000020003-4 SGFOIA2 Approved For Release 2001/03/07 : CIA-RDP96-00789ROO3000020003-4 Approved For Release 2001/03/07 : CIA-RDP96-00789ROO3000020003-4