USE OF VOLUNTEERS AS SUBJECTS OF RESEARCH

• Document Type: CREST
• Collection: STARGATE
• Document Number (FOIA) /ESDN (CREST): CIA-RDP96-00788R001500140007-5
• Release Decision: RIFPUB
• Original Classification: K
• Document Page Count: 6
• Document Creation Date: November 4, 2016
• Document Release Date: May 15, 2000
• Sequence Number: 7
• Publication Date: July 31, 1974
• Content Type: REGULATION

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11HEADQUARTERS,
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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.
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(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
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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.
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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
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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:
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