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ARMY REGULATION!
No. 70-25
HEADQUARTERS,
DEPARTMENT OF THE ARMY
WASHINGTON, DC, 31 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.
Purpose
Definition
Exemptions.
3
Basic principles.
1
Additional safeguards
5
Approval to conduct experiment-
Civilian employees
Recruitment of active duty military volunteers.
Appendix. Legal implications
6
7
8
1. Purpose. These regulations prescribe policies
and procedures governing the use of volunteers
as subjects in Department of the Army resanch
wherein human beings aro deliberately exposed to
unusual or potentially hazardous
conditions.
These regulations are applicable worldwide, 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 hazardous condi-
tions are those which may be reasonably expected
to involve the risk, beyond the normal call of duty, .
of privation, discomfort, distress, pain, damage to
health, bodily harm, physical mjury, or death
8. Exemptions. The following categories 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 exposure of personnel
to potentially hazardous situations encountered as
part of training or other normal duties, e.g., flight
training, jump training, marksmanship training,
ranger training, fire drills, gas drills, and handling
of explosives.
X
b. 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-
sonnel would reveal the artificial nature of
such conditions and defeat the purpose of the
investigation.
c. Ethical medical and clinical investigations
involving the basic disease process or new treat-
ment procedures conducted by the Army Medical
Service for the benefit of patients.
4. Basic principles. Certain basic principles must
be observed to satisfy moral, ethical, and legal
concepts. These are - .
a. Voluntary consent is absolutely essential,
(1) The volunteer will have legal capacity to
give consent, and must give consent freely without.
being subjected to any force or duress. He must
have sufficient understanding of the implications
of his participation to enable him to make an
informed decision, so far as such knowledge does
not compromise the experiment. He will be told as
much of the nature, duration, and purpose of the
experiment, the method and means by which it is
to be conducted, and the inconveniences and
hazards to be expected, as will not invalidate the
results. He will be fully informed of the effects
upon his health or person which may possibly come
from his participation in the experiment.
(2) The consent of the volunteer will be in
writing. A document setting forth substantially
The above requirements will be signed by the
volunteer in the presence of at least one witness
*This regulation supersedes AR 70-25, 26 March 1962.
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not involved in the research study who will attest
to such signature in writing.
(3) The responsibility for ascertaining the
quality of the consent rests upon each person who
initiates, directs, or conducts the experiment. It is
a personal responsibility which 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-
ment 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.
h. 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.
i. The volunteer will be informed that at any
time during the course of the experiment he will
have the right to revoke his consent and withdraw
from the experiment, without prejudice to himself.
7. Volunteers will have no physical or mental
diseases which will make the proposed experi-
inent more hazardous for them than for normal
*
Healthy persons. This determination will be made
by the project leader with, if necessary, competent
medical advice.
TE. 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 likely to result
in injury, disability, or death to the volunteer.
¿. Prisoners of war will not be used under any
circumstances.
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 harm is likely to result.
b. All apparatus and instruments necessary to
deal with likely emergency situations will be
available.
c. 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 anticipated.
6. Approval to conduct experiment. It is the re-
sponsibility of the head of cach major command
and other agency 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 charge, 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 MAKE
will be considered as constructive duty for which Sure
straight time rates are payable. Time spent in
connection with an experiment outside the em-
ploycc's regularly scheduled tour will be consid-
ered as voluntary overtime for which no payment
may bo made nor compensatory time granted.
The employee will be so informed before accop-
tance of his volunteer services.
All KNOW
About
This.
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,
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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.
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.
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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 the procurement of services
that are needed for these programs (10 U.S.C.
4503). The 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 the
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 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 discaso 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 (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 use of employees of
contractors in research and development experi-
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-
pation of these employees. 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 the
terms of cach 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 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 10-551).
6. Irregular or fee-basis employees. Intermittent
services of such employees are authorized. (For
experts and consultants sce 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; Sec. 710 Defense Production
Act of 1960 (64 Stat. 819; 50 U.S.C. App 2160);
and for architects, engineers, and other technical
and 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-
ployces Compensation Act, supra, in all probability
applies with respect to these irregular and fec-
basis employees for any injury or disease resulting
from their employment, although a final deter-
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 he 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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AR 70-25
additional allowance to the employee for financing
such private insurance arrangements as he may
wish to make rather than to undertake direct
negotiations with insurance carriers for the desired
coverage.
7. Conclusion. Subject to the above conditions,
Armed Forces personnel and/or civilians on duty
at installations engaged in research in subject
fields will be permitted to actively participate in
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 :
CREIGIITON W. ABRAMS
General, United States Army
Chief of Staff
Official :
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)
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