a apprsidettor Release 2000/08/08 : CIA-RDP96-00788R001500140007-4 “AR 70-25) RMY REG@ULATION HWADQUARTERS, DEPARTMENT OF 'TIITKE ARMY Wasuineron, DC, 8f July 1974 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 duty 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. No, 70-25 Paragraph Purpose... 2-2 2-2 ne Lan 1 Definition... 2222 ee. ---- - 2 Vxemptions.-_-..-22-2---0020 0200-2 eee 3 Basie principles_...2-. 2-22 ee. ce eee eee . wae 4 Additional safeguards...-2-.222222 2-22 eee 5 Approval to conduct experiment.___-_.2 222. |. wenn eee eee _ 6 Civilian employecs._------2---- 2 eee _- 7 Recruitment of active duty military volunteers... _.. a _. . S Appendix. Legal implications 1. Purpose. Theso regulations prescribe policies and procedures governing the use of volupt as subjects in L ent of the : wherein human beings aro deliberate unusua. : murdous condi hese regulations are applicable worldwide, wher- ever volunteers aro used as subjects in Department of the Army rescarch. 2. Definition. For the purpose of these regu- lations, unusual and potentially hazardous condi- © i “| ollowing categorics of activities and investigative programs are exempt from the provisions of these regulations: a. Research and nonresearch programs, tasks, and tests which may involve inherent occupa- tional hazards to health or oxposuro of personnel to potentially hazardous situations encountered as part of training or other normal duties, c.g., flight training, jump training, marksmanship training, ranger training, fire drills, gas drills, and handling of explosives. #, That portion of human factors research which involves normal training or other military duties as part of an experiment, wherein disclosure of experimental conditions to participating por- *This regulation supersedes AR 70-25, 26 March 1962. TAGO 58A—July 580-465-—74 sonnel would reveal the artificial nature of such conditions and defeat the purpose of the investigation. e. Kthical medical and clinical investigations involving the basic diseaso process or new trout- ment procedures conducted by the Army Medical Service for the benefit of patients. 4, Basic principles. Certain basic be observed to satisfy concepts. These are. a Voluntary consent is absolutely essential (1) The volunteer will have legal cupacity lo give consetit, and must give consent freely without being subjected to any foree or duress. He must have suflicicnt understanding of the implications fF his participation to enable him to make an informed decision, so fur as such knowledge does not compromise the experiment. Ho will be told as much of the nature, duration, and purpose of the experiment, the method and meatus by whieh it is to be conducted, aud the inconveniences and hazards to be expected, as will not invalidate the results. He will be fully informed of the effects upon bis health or person which may possibly come from his participation in the experiment, (2) ‘Pho consent. of the volunteer will be in writing, A document setting forth substantially Tho“above requirements will be signed by the inciples must moral, ethica
ae aie she i ae id dae. “ | ———Approved F 108/08 : CIA-RDP96-00788R001500140007-5 _ ~ % ‘AR 70-25 oo Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140007-5 not involved in the research study who will attest to such signature in writing. 14 WAG sahyaly . sravat cl OTEEETT (8) re aesponsi for ascertaining the quality of the consent rests upon each person who Initintes, directs, or conducts the experi personal responsibility Which” may delegated. b. The number of volunteers used will be kept at a minimum consistent with ¢ below. ¢. ‘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 oxperiment 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 expori- ment to believe that death or disabling injury will occur. J. 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. kh. The 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. 4. glunteer will be informed that at an; time during the course of the experiment he wi be TIGHt to revoke DIS consent and withd oa rom the experiment, Without prejudice to lumself, j» Volunteers will have no ph not be sical or mental Tor norma } : SOT is determination will be made bythe propectteador with, if necessary, competent inedical advice. rz. The scientist in charge will be prepared to terminate the experiment at any stage if he has probable cause to believe, in the exercise of the good faith, superior skill, and careful judgment required of him, that continuation is likel y to result in injury, disability, or death to the volunteer. i. Prisoners of war will not be used under any circumstances. 2 5. Additional safeguards. As added protection for volunteers, the following safeguards will be provided: a. A physician approved by The Surgeon General will be responsible for the medical care of volun- teers. The physician may or may not be the project leader but will have authority to terminate the experiment at any time that he believes death, injury, or bodily harin is likely to result. 6. All apparatus and instruments necessary to deal with likely emergency situations will be available. ¢. Required medical treatment 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 antici pated. 6. Approval to conduct experiment. It is the re- sponsibility of the head of each major command and other agency to submit to The Surgeon General a written proposal for studies which como within the purview of this directive. The proposal will include for each study the name of the person to be in charge, name of the proposed. attending physician, and the detailed plan of the experiment. The Surgeon General has final approval authority for all rescarch using volun- tecrs except research with nuclear or chemical warfare agents. Proposals for research with nuclear or chemical warfare agents will bo forwarded by The Surgeon General with recommendations on taecdical aspects to the Secretary of the Army for approval. 7. Civilian employees. Wlicn civilian employ- ces 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 employce’s regularly scheduled tour of duty will be considered as constructive duty for which straight time rates are payable. Time spent in connection with an experiment outside the em- ployee’s regularly scheduled tour will be consid- ered as voluntaryoyvertime for which no payment bo Jo ner_compensator 1¢ cmployee will be so informe tance of his volunteer services. 6. Claims submitted to the Bureau of Em- ployces’ Compensation, U.S. Department of Labor, because of disability or death resulting from an employee’s voluntary participation in oxperiments, will include a citation to title 10, TAGO 568A make. Sv te Alout TWS -
4 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140007; 15; 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, Joave, compensation claims, or application of other civilian personnel regulations to voluntecr om- ployces will be presented through channels to the Deputy Chicf of Staff for Personnel, ATTN: Office of Civilian Personnel. TAGO 58A 8. Recruitment of active duty military volunteers. Some research will require active duty military personnel as volunteers because of the nature of the investigations. Recruiting 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. — : - 6-00788R001500140007-5 + a
« ar Approved 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 partici- pants in research using volunteers: 1. Authority. ‘The Secretary of the Army. is authorized to conduct research and development programs including tho procurement of services that are needed for these programs (10 U.S.C. 4503). Tho Secretary has the authority to “assign detail and prescribe the duties” of both members of the Army and civilian personnel (10 U.S.C. 3012(c)). 2. Military personnel and Department of the Army civilian employees. Compensation for tho disability of death of a civilian employee re- sulting from personal injury or disease proxi- mately caused by his employment is payable under the Federal Employees Compensation Act (39 Stat. 742 et seq.), as amended (5 U.S.C. 751 ot 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 discaso in- cident to service depends upon the individual status of cach member, and is covered by various provisions of law. It may bo 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- ticiputing in experiments by reason of the hazard- ous nature of the oporations. 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 (R.S. 1765; Commissioner of Internal Revenue v. Bonwit, 87 F 2d 764 (2d Cir, 1937); Canaday v. Guitteau, 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 uso of employees of contractors in research and development, experi- ments. It is the responsibility of the contracting officer 10 determine whether the terms of the con- 4 tract are sufficiently broad to permit the partici- pation of these employces. Generally, benefits to which private employees may become entitled by reason of death or disability resulting from their employment 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. tho terms of each contract. These employees are not disqualified from prosecuting claims against the Government under 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 io 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 10-551). 6. Irregular or fee-basis employees. Intermittent services of such employces are authorized. (For experts and consultants see Sec. 15, Act of 2 Aug 1946 (60 Stat. 810; 5 U.S.C. 55a); Sec. 501, DoD Appropriation Act, 1961 (74 Stat. 349); note APP 30-204.1, CPR A7; See. 710 Defense Production Act of 1960 (64 Stat. 819; 50 U.S.C. App 2160); and for architects, engincers, and other technical and professional personnel on a fee basis, see 10 US.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- ployecs Compensation Act, supra, in all probability applies with respect to these irregular and fee- basis employees for any injury or discase resulting from their employment, although a final deter- mination in such cases will have to be made by the Bureau of Mmployees Compensation, Department of Labor. Subject to such restrictions and limita- tions as may appear in the statutory authority under which he is employed, it would appear that the Government may legally bear the expenso of premiums upon tho life of an irrogular or fee- basis omployee whose rate of compensation is not fixed by law or regulations. In this regard, it may be advisable for the Government to provide an TAGO 584 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140007-5
Approved’For Release 2000/08/08 : CIA-RDP96-00788R001500140007-5 R 10-25 additional allowance to the employee for fmancing 7. Conclusion. Subject to tho above conditions, such private insuranco arrangements as ho may — Armed Forces personnel and/or civilians on duty wish to make rather than to undertake direct at installations engaged in research in subject negotiations with insurance carricrs for tho 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 Army: CREIGHTON W. ABRAMS General, United States Army Official : Chief of Staff VERNE L. BOWERS Major General, United States Army The Adjutant General DISTRIBUTION: Active Army, ARNG, USAG: To be distributed in accordance. with DA Form 12-9A_ require- ments for AR, Research and Development—D (Qty Rqr Block No, 112) TAGO 58A a} U.S. GOVERNMENT PRINTING OFFICE: 1974 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140007-5