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Document Number (FOIA) /ESDN (CREST): 
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Document Creation Date: 
November 4, 2016
Document Release Date: 
May 15, 2000
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July 31, 1974
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PDF icon CIA-RDP96-00788R001500140007-5.pdf426.99 KB
n App~i&ie or Release 2000/08/08 : CIA-RDP96-00788R001500140007- 11HEADQUARTERS, lll+P,1lI'iti1LN'I' Oi+' 'l'+. Al ~L 1' o. 70-25 RMY REGULATION ...I kri vlv, .L~i, JL NUty 1Uj1j RESEARCH AND DEVELOPMENT USE OF VOLUNTEERS AS SUBJECTS OF RESEARCH Effective 15 September 1974 This revision transfers the final approval authority from the Chief of Research and Develop- ment to The Surgeon General for all research using volunteers, except research involving nuclear and chemical warfare agents and identifies the requirement for use of active ditty military personnel as volunteers and instructs major commanders to provide assistance in their recruitment. Local limited supplementation of this regulation is permitted, but is not required. If supplements are issued, Army Staff agencies and major Army commands will furnish one copy of each to HQDA (DASG-RDZ), Washington, DC 20310. Other commands will furnish one copy each to the next higher headquarters. Purpose ------------------------------Paragraph 1 De.finition ------------------2 Exemptions --------------------------------------- 3 Basic principles------------------------- ---- - - Additional safeguards -------------------- 4 A5 pproval to conduct experiment -----___-..- f; Civilian employees ---------------------- of active duty military volunteers- _. Appendix. Legal implications activities and investigative programs are exempt from the provisions of these regulations: a. Research and nonresearcli programs, tasks, and tests which may involve inlierent occupa- tional hazards to health or exposure of personnel to potentially hazardous situations encountered as part of training or other normal duties, e.g., flight training, jump training, inarksma.nsl.tip training, ranger training, fire drills, gas drills, and handling of explosives. b r X , )or~id.n of human factors research which invo vl es normal training or other military duties as part of an experiment, wherein disclosure of experimental conditions to participating per- Exemptions. The o owing categories of health, bodill; tirtn i ]ys1Ca Injury' tit These regulations are apl'liica) o wor divide, wher- ever volunteers are used as subjects in Department; of the Army research. 2. Definition. For the purpose of these regu- lations, unusual and potentially hazarduus tions arc those 1iie i may 1e reasonably expeciw~ to involvo the risl., eyonc ie norma C1 11t a irivation disco m:or (Ts tress, pain, clam . to wherein human beings are do i crate ea ) o.? d to unusual potentially hazardous condoms. 1. Purpose. These regulations piescribo policies and procedures overnin the use of voluuttnr,r:. sonnet woir](1 royal the artificial nuUue of such con(lition5 and defeat the purpose of the invest:iga lion. e. F 1liical medical and clinical invest.i!ations involving the basic (li case proses, or new treat-- meut procedures conducted by tiro Army Medical Service for the bcllrfit. of pt(ticlita. 4. Basic principles. ('ertain basic prinei )1rs inu.,t be observed to satisfy moral, et iI!cal, an( e~r.(1 concepts. to c It - a. Voltiutarv consent is absolutely es eiitial (1) The vu (tutor wi iave legal capacity to give consent, and must give consent freely vwithout. being subjected to any force or duress. lie must have sufficient understandilrm of the inlpli, at.ion; of us participation to (liable hint to inuke an informed decision, so far as such knowledge doe, not, compromi-,c th(' experiment. Ilo NN-111 be.. told a, Inucli of (ho nature, duration, and purpose of 111 expet?iinellt, the method and meauts by which it, i, to be conducted, ;uid the ittcotIVentetices and hazards to be eXprcird, as will not invalidate the results. He will be fully inforrnrd of the. efl'ecl-~ upon his hrall-h or per-oil which n(ay possibly conrr 110111 his Imrti(Ipa(i0n in the experiuterit. (2) '1'ho consrnl of the volunteer will be in writing. ~~ docunien se ding fort Ii substatitial]y -. is -t i ve requirements will be signed by the volunteer ill the presence of at Icas one 1%I ne'; it r ,1~~~.~; ?~ti. ~..~~...~..appreued For R9I9as 2000IQ8/fR - (IA RDP96 00788R001500140007 5 rr AR 70-25 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140007-5 (3) The ;flail for ascertaining the not involved in the research study who will attest to such signature in writing. 5. Additional safeguards. As added protection for volunteers, the following safeguards will be provided: a. A physician approved by TheSurgoon General i\ ill be responsible for th.e medical care of volun- Leers. The physician may or inay not be, the project quality of t let cIL rests upon each iwrson who ff personaf responsibility w ncT1 may not be delegated. b. The number of volunteers used will be kept at a minimum consistent with c below. c. The experiment must be such as to contribute significantly to approved research and have rea- sonable prospects of yielding militarily important results essential to an Army research program which are not obtainable by other methods or means of study. d. The experiment will be conducted so as to avoid all unnecessary physical and mental suffering and injury. e. No experiment will be conducted if there is any reason inherent to the nature of the experi- Inent to believe that death or disabling injury will occur. f. The degree of risk to be taken will never ex- ceed that determined to be required by the urgency or importance of the Army program for which the experiment is necessary. g. Proper preparations will be made and ade- quate facilities provided to protect the volunteer against all foreseeable possibilities of injury, dis- ability, or death. 1z. '.fife experiment will be conducted only by scientifically qualified persons. The highest de- gree of skill and. care will be required during all stages of the experiment of persons who conduct or engage in the experiment. i. The volunteer will be informed that at any time during the course o _1e experiment lie W-111 tMve Ie right to revoke 17.t1 consent anc wtLhcUaw from the experiment, My-M-1-5-Tiff- prejudice to umself. ~. Volunteers will have no h sical or mental diseases which will Ina ke the proposed experi- I more Iazarc ous -or than tan or nol ma I Is determination will be-made by the project '3eador with, if necessary, corn Ietent medical a vice. I k. The scientist in charge will be prepared. to terminate the experiment at any stage if lie has probable cause 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 volunteer. 1. Prisoners of war will not be used under any circumstances. leader but will have authority to terminate the experiment at any time that he believes death, injury, or bodily harm is likely to result. b. All apparatus and instruments necessary to deal with likely emergency situations will be available. c. Required medical treatuien.t and hospitaliza- tion will be provided for all casualties. d. The physician in charge will have consultants available to him on short notice throughout the experiment who are competent to advise or assist with complications which can be anticipated. 6. Approval to conduct experiment. It is the re- sponsibility of the head of each major command and other fugeucy to submit to The Surgeon General a written proposal for studies which come within the purview of this directive. The proposal will include for each study the name of the person to be in chfu?ge, name of the proposed attending physician, and the detailed plan of the experiment. The Surgeon General has final approval authority for all research using volun- teers except research with nuclear or chemical warfare agents. Proposals for research with nuclear or chemical warfare agents will be forwarded by The Surgeon General with recommendations on medical aspects to the Secretary of the Army for approval. 7. Civilian employees. When civilian employ- ees of the Department of the Army volunteer under this program, the following instructions will be observed: a. Any duty as a volunteer performed during the employee's regularly scheduled tour of duty will be considered as constructive duty for which straight; time rates are payable. Time spent in connection with all experiment outside the em- ployee's regularly scheduled tour will be consid- ered as Voluntliry u.,ii 'f.ilyin for which no payment may be iuade nor compensatory ti 10 granted. III e employee will be so mforlnedicforo accep- tance of his voluruteer services. b. Claims submitted to the Bureau of Em- ployees' Compensation, U.S. Department of Labor, because of disability or death resulting from an employee's voluntary participation in experiments, will include a citation to title 10, F approved For Release 000/08/08 : CIA-RDP96-00788 R001500140007-5 Approved for Release 2000/08/08 : CIA-RDP96-00788RO01500140007AA 70-25 United States Code, section 4503 as the Depart- ment of the Army authority for the use of such volunteer services. c. All questions concerning hours of duty, pay, leave, compensation claims, or application of other civilian personnel regulations to volunteer em- ployees will be presented through channels to the Deputy Chief of Staff for Personnel, ATTN: Office of Civilian Personnel. S. Recruitment of active duty military volunteers. Some research will require active duty ncilitar'%, personnel as volunteers because of the nature of the investigations. Recruitiug is best accom- plished by research personnel responsible for conduct of the research. Major commanders will provide assistance to recruiting teams. At all times recruiting will be conducted in a morally, ethically, and legally acceptable manner. Approved Fnr Releagp 2000/08/08 0 CIA RDP96-00788R001500140007-5 AR Ap roved for Release 2000/08/08 : CIA-RDP96-00788R001500140007-5 APPENDIX LEGAL IMPLICATIONS The following opinions of The Judge Advocate General furnish specific guidance for all 1)Rrtlcl- pants in research using volunteers: 1. Authority. The Secretary of the Arniv is authorized to conduct research and development programs including the procurement of services that are needed for these programs (10 U.S.C. 4503). The Secretary has the authority to "assign detail and proscribe the duties" of both members of the Army and civilian personnel (10 U.S.C. 3012(0)). 2. Military personnel and Department of the Army civilian employees. Compensation for the disability of death of a civilian employee re- sulting from personal injury or disease proxi- mately caused by his employment is payable tinder the Federal Employees Compensation Act, (39 Stat. 742 et seq.), as amended (5 U.S.C. 751 et seq.), regardless of whether his employment was of a hazardous nature. The amount and type of disability compensation or other benefits payable by reason of the death or disability of a member of the Army resulting from injury or disease in- cident to service depends upon the individual status of each member, and is covered by various provisions of law. It may be stated generally that under present laws no additional rights against the Government will result from the death or dis- ability of military and civilian personnel par- ticipating in experiments by reason of the hazard- ous nature of the operations. 3. Private citizens. It is the policy of the United States to prohibit the acceptance of voluntary services particularly when they may provide a basis for a future claim against the Government. (R.S. 3679, as amended; 31 U.S.C. 665(b)). 4. Use of appropriated funds for the purchase of insurance. As the payment of insurance pre- miums on the life of an officer or employee of the United States is a form of compensation which is not currently authorized, payment of those premiums is prohibited (ItS. 1765; Comrnissioner of Internal Revenue v. 13onevit, 87 F 2d 764 (2d. Cir. 1937) ; Canaday v. Gaitteau, 86 F 2d 303 (6th Cir. 1936); 24 Comp Gen. 648 (1945)). 5. Contractor's employees. There appears to be no legal objection to the use of employees of contractors in research and development 0xpeei- ments. It is the responsibility of the contracting officer to determine whether the terms of the con- tract are sufficiently broad to permit the partici- pa.tion of these employees. Generally, benefits to which private employees may become entitled by reason of death or disability resulting from their eniploylnent are payable under State law except persons covered by the survivors insurance pro- visions of the Social Security Act (49 Stat. 623, as amended (42 U.S.C. 402)). Reimbursement of the employer for additional costs by reason of this liability of his employees will depend upon the terms of each contract. These employees are not disqualified from prosecuting claims against the Government ruder the Federal Torts Claims Act (28 U.S.C. 2671 et seq., see AR 25-70). In cost reimbursement type research contracts with com- mercial organizations the cost of maintaining group accident and life insurance may be reim- bursed to the contractor (subject to certain ex- ceptions) under ASPR 15-205.16 provided that the approval of the head of the Procuring Activity is obtained (APP 1.0-551). 6. Irregular or fee-basis employees. Intermittent , services of such employees are authorized. (For experts and consultants see Sec. 15, Act of 2 Aug 1.946 (60 Stat. 810; 5 U.S.C. 55a); Sec. 501, DOD Appropriation Act, 1961 (74 Stat. 349); note APP 30-204.1, CPR A7; Sec. 710 Defense Production Act of 1960 (64 Stat. 819; 50 U.S.C. App 2160); and for architects, engineers, and other technical an(j. professional personnel on a fee basis, see 10 U.S.C. 4540.). Whether these employees can be detailed or assigned to the proposed experiments will depend upon the statutory authority for employment and the provisions of their employ- ment agreement in each case. The Federal Em- ployees Compensation Act, supra, in all probability applies with respect to these irregular and fee- basis employees for any injury or disease resulting from their employment, although a final doter- mination in such cases will. have to be made by the Bureau of Employees Compensation, Department of Labor. Subject to such restrictions and limita- tions as may appear in the. statutory authority under which be is employed, it would appear that the Government may legally bear the expense of premiums upon the life of an irregular or fee- basis employee whose rate of compensation is not fixed by law or regulations. in this regard, it may be advisable for the Government to provide an Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140007-5 Approved'For Release 2000/08/08 : CIA-RDP96-00788R001500140007-5 AR 70-2'5 additional allowance to the employee for financing 7. Conclusion. Subject to the above conditions, such private insurance arrangements as he may Armed Forces personnel. and/or civilians on duty wish to make rather than to undertake direct at installations enraged in research in subject negotiations with insurance carriers for the desired fields will be permitted to actively participate in coverage. all phases of the program. The proponent agency of this regulation is the Office of The Surgeon General. Users are invited to send comments and suggested improve- ments on DA Form 2028 (Recommended Changes to Publications and Blank Forms) to HQDA (DASG-RDZ), WASH DC 20310. By Order of the Secretary of the Array : Official : VERNE L. BOWERS Major General, United States Army The Adjutant General CREIGIITON W. ABRAMS General, United States Army Chief of Staff DISTRIBUTION: Active Army, AR[VG, USAG: To be distributed in accordance wih DA Form 12-9A require- ments for All, Research and Development-D (Qty Rqr ]lock No. 112)' Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140007-5 f~'-, `R oAp r vdd or Release 2000/08/08 : CIA-RDP96-00788R091500140007-5 A I A T A I A I CI4 t / O P f?- C r2? 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I,' AR' 70-25 f10FS NOT 14EFLECT THE CU1RFNT POLICY CONTAINED In THE DRAFT DOn oJRvcr)v,: st!PJECT: PROTECTION OF 14IJ14AAI St!AJECTS I--! 00n R0T'F & ? t) CLINICAL I''.`VEST IGATTON ACTIVITIFS wHIC4 I S CURRENTLY 60,1707, STAFFED AND FINALIZE n-. 2 . THE NEW 00D O 1 RE C T I UE IS CO NST5 TENT WITH }to DA LTR REF-EP NCCO I N 0ADA12RAGu It AMr, Cun?..r. n T "" "2'-S SGRp_A.1 SUBJECT: HUMes* TESTThlf3 3.? P. 70-25 IS PkES1+-I TLY fl FI NG 1REtQRITTEN TO REFLECT THE PE MM')TNG 00!3 DIRECTIVE AND SHOULD wE AVAILABLE DURING THE FIRST ?hIARTER FYR20 4. IN THE MFANTI$E.' THE ANNfUNCEO POLICIES OF H) DA LTR UITI) 16 JUN 60 Sfl JECT: t-a;FLAN TESTIrg REMAIN VALID PENDING PUf)LICATION OF REV! cE0 tR 70-25. U$ OF V'oLL uN Tl:C,tJr , -s ' E HOR Y 6. COORr)INATEr, RY: o5A(GC )r OASA(R?DA)? CDCSOPS. DEfCSPCR, Or CSROA, xu4 t! r o P A E3 E1~e c H . PAGE 02 Rt-FAf W-6279- Vt%CLAS' 5. VISSE"I N'A Tu TO ALL HUMAN TESTTRG FACILITIES. W6274 Approved For Release 2000/08/08: CIA:RDP96-00788R001500140007-5