PREPARED STATEMENT BY LIEUTENANT GENERAL RICHARD R. TAYLOR, M.D.

• Document Type: CREST
• Collection: STARGATE
• Document Number (FOIA) /ESDN (CREST): CIA-RDP96-00788R001500160011-8
• Release Decision: RIFPUB
• Original Classification: K
• Document Page Count: 17
• Document Creation Date: November 4, 2016
• Document Release Date: May 17, 2004
• Sequence Number: 11
• Publication Date: September 8, 1975
• Content Type: STATEMENT

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yt ~' r
It (J't I
PREPARE D
STATEMENT'
BY
..LIEUTENANT GENERAL RICHARD R. TAYLOR, M.D.
its
THE SURGEON GENERAL
DEPARTMENT OF THE ARMY
BEFORE THE
SUBCOMMITTEE ON INVESTIGATIONS
OF THE
ARMED SERVICES COMMITTEE
HOUSE OF REPRESENTATIVES
FIRST SESSION, 94th CONGRES
8 September 1975
NOT FOR PUBLICATION
UNTIL RELEASED BY THE
HOUSE SUBCOMMITTEE ON
INVESTIGATIONS
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BIOGRAPHICAL SKETCH.OF WITNESS: Lieutenant General Richard R. Taylor, M.D.,
was born in Israirie urg, Iowa, on November 21, 1922. After completing premedical
studies at the University of Chicago in 1944, he graduated in 1946 with a doctor of
medicine degree.
General Taylor attended the Army Medical Department officer's basic course, after corn
pleting an internship at the Highland Alameda County Hospital,. Oakland, California,
in 1947. His first medical assignment was as a general medical officer at the Army-Na-,
General Hospital in Hot Springs, Arkansas. After attending the company grade medical
officer's course, he completed his residency training at Letterman General Hospital in
internal medicine and cardiology.
In 1953, General Taylor was assigned to Korea, first as Assistant Division Surgeon, then
as Commander, 7th Medical Battalion, 7th Infantry Division, later serving as an interni,
at the Hemorrhagic Fever Center, 45th Evacuation Hospital.. In 1955, General Taylor
returned to the United States as a resident in pulmonary disease at Fitzsimons General
Hospital and later became Chief, Non-TB Chest Disease Service.
In 1957, he became Commanding Officer, US Army Medical Research and Development
Unit, Fitzsimons General Hospital.
Following a fellowship in tropical medicine at Louisiana State University in 1959, Gene
Taylor became Chief, Biophysics and Astronautics Research Branch of the US Army Medi
Research and Development. Command. After successive staff assignments, he was named
Deputy Commander of the Command in 1963.
September 1964 saw General Taylor serving as Staff Surgeon of the Joint US Military
Assistance Group in Thailand and Command Surgeon of the Military Assistance Comman Thailand. After attending the Army War College at Carlisle Barracks, Pennsylvania, he
served in the Office of the Secretary of Defense as Chief, Biological and Medical Scier
Division, Office of the Director of Defense Research and Engineering:..
He served as Command Surgeon, Headquarters, Military Assistance Command, Vietnam,
from 1969-70, where he was promoted to Brigadier General on October 1, 1969. In
September 1970, he became Commanding General of the US Army Medical Research
and Development Command. He was sworn in as the Deputy Surgeon General on March
1, 1973, and became The Surgeon General, US Army, on October I, 1973.
He is certified by the American Board of Internal Medicine, and is a Fellow of both
the American College of Physicians and the American College of Chest Physicians.
He is a member of the American Medical Association, the Association of Military
Surgeons of the US (Past President), and the New York Academy of Science.
His awards and decorations include the Distinguished Service Medal, the Legion of
Merit with oak leaf cluster, the Bronze Star Medal, the Joint Services Commendation
Medal with oak leaf cluster and the Army Commendation Medal with oak leaf cluster.
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Mr. Chairman:
I am pleased to appear before you to review Department of Defense policies and
procedures to protect the rights and welfare of human subjects of biomedical and
behavioral research conducted under its sponsorship. I believe that your invitation
was based upon a desire to know whether the Department of Defense has sponsored or
is now sponsoring medical research which exposes human beings to unreasonable risks.
I refer to the risks of death or likely permanent damage to the mind, personality, or
physical well -being as a result of research. I assure you that Department of Defense
policy prohibits research carrying this degree of risk as well as research on humans
who have not given their free and informed consent. I believe that you also wish
to know whether the Department of Defense meets current standards for conduct of
research in human subjects. The Department of Defense and the military departments
today follow standards for protection of research subjects which equal or exceed those
followed by other Federal agencies and the medical community at large.
The basic Department of Defense policy governing medical experiments was
promulgated by the Secretary of Defense on 26 February 1953 (lncl 1). This policy
is based on the Nuremberg Code of 1947, which followed the war crimes trials (Incl 2).
The Chief of Staff published an implementing Memorandum in 1953. The departmental
regulations implementing the tightening Federal controls of studies using investigational
drugs, use of volunteers in medical research, and clinical investigations are listed
at Ind 3. Copies of these regulations are available to your staff.
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Some impacts of these various regulations are that an individual participating
as a subject is required to be fully informed of the nature, purposes, and the effects
of the experimentation; he must give voluntary written informed consent without
coercion; and he must be allowed to withdraw at any point from the experiment.
These basic moral, ethical, and legal principles, identified above, are common
to the regulations of the military departments. The Department of Defense has
demonstrated a continuing concern in this area and has reviewed the procedures
and taken corrective action where it was needed.
In 1964, HEW and DOD entered into a Memorandum of Understanding related
to new regulatory authority and responsibilities of the FDA concerning investigational
drugs. This Memorandum and subsequent DOD Directives and service regulations
established Investigational Drug Review Boards within the Offices of the Surgeons
General. The boards provide professional review of proposed investigations with
new drugs and biologicals. With these boards, the DOD was permitted certain
exceptions from ordinary FDA review, including military requirements work which
was classified, for reasons of national security. The DOD agreed to discuss its
classified investigations of drugs periodically with FDA personnel who had proper
security clearance and to report to FDA findings associated with such studies
which FDA should be aware of to make a sound evaluation of non-classified studies
proposed on the same or similar drugs.
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In May 1974, the Army staff responsibility for research involving life sciences
was transferred from the Army Research Office, Office of the Chief of Research
and Development, to The Surgeon General. In July of 1974, the approval authority
for all research involving human subjects in the Army, except for nuclear and
chemical warfare related studies, was transferred from the Office of the Chief of
Research and Development to The Surgeon General, Proposals for research with
nuclear or chemical warfare agents are forwarded by The Surgeon. General with
recommendations on the medical aspects to the Secretary of the Army for approval.
In October 1974, The Surgeon General established the Human Use Review Office
under the direction of the Assistant Surgeon General for Research and Development.
The Human Use Review Office was charged with administering and coordinating
activities of the Army Investigational Drug Review Board, the US Army Medical
Research and Development Command Contract Review Board, and The Surgeon
General's Human Use Committee and Clinical Investigation Committee to insure
uniform application of ethical standards for human research studies conducted within
or sponsored by the Army Medical Department and other Army agencies.
The Human Use Review Committee is the central Army processing point for
all extramural and intramural human subjects research which require approval under
provisions of Army Regulations. The staff includes a full time physician, two pharmacists
with advanced training in pharmacology and a biostatistician. Legal advice is provided
by attorneys in the Army Medical Research and Development Command. This medical,
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scientific, and legal staff identifies problem areas and requests review by expert
professional consultants, clarifications and/or revision before protocols are submitted
to appropriate committees for review and recommendations to The Surgeon General.
The Deputy Surgeon General has been delegated authority for-final approval. The
Human Use Review Office is the authorized channel through which Army investigators
communicate with the Food and Drug Administration (FDA). The Army committees on
human subjects research reviewed and made recommendations on over 300 research
proposals during fiscal year 1975. Provisions for the protection of human subjects
and the detailed content of consent agreements were the primary concern of the
members. The careful review is reflected by the fact that a large number of proposals
were disapproved or deferred pending revision of the consent procedures. The Human
Use Review Office staff and committees apply the standards contained in current
Department of Defense and Department of Health, Education, and Welfare (DHEW)
regulations. For example, when the recent HEW moratorium on fetal research was
promulgated, the files were searched to be sure such research was not being conducted
within the Army Clinical Investigation Program. The Human Use Review committees
have paid particular attention to special classes of subjects involved in Army research
i.e. children, pregnant women, and prisoners, and have often required special consent
procedures appropriate to a particular project.
Within the Army, increased emphasis has been placed on insuring that agencies
outside he Army Medical Department follow the same high standards as those within
it. We have insisted that other Army agencies interpret the language of AR 70-25
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broadly to include all experiments which may expose participants to risk even though
the project proponents may consider the testing to be primarily an operational exam-
ination of prototype machinery or equipment. If a test of a new uniform or vehicle,
for example, may expose subjects to risks from heat stress, noise, or fumes,. the
protocol is examined in detail to be sure that the subjects are fully informed volunteers
and to reduce risk as much as possible. A large amount of time and effort is often
required to adequately review tests of this type since their uniquely military setting
sometimes makes it difficult to distinguish clearly what tasks are reasonably "in the
Ii ne of duty
Scope of Department of Defense Research Involving Human Subjects
Within this context, I would like to discuss in broad terms the present Department
of Defense research effort involving human subjects. Military missions expose troops
to extremely diverse hazards and stresses, including "exotic" infections such as
malaria and scrub typhus, great pressure variations, as in deep diving, and crash
forces; and high and low velocity missile combat wounds. The effectiveness of even
our most "automated" military systems still is intimately linked to proper human
performance. The rising cost of defense manpower means that efforts to decrease
non-effectiveness of military personnel are increasingly important. Within our
military health care systems we must conserve the fighting strength, and maintain
quality health care. It should not be surprising that a defense environment of this
kind generates requirements for research and investigation which can only be met by
the use of human subjects.
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All Department of Defense work using human subjects is conducted to meet
requirements of the Department of Defense. There are two main divisions of this
work. First, and by far ;he largest, is the RDTE funded program. The second, and
newer program is that of clinical investigations funded in operations and maintenance
accounts.
The RDTE program is reviewed by the Director of Defense Research and Engineering
and conducted by the Military Departments. Its requirements are generated by military
unique needs of the Department of Defense and the Military Departments.
The Assistant Secretary of Defense (Health and Environment) is the DOD proponent
of the clinical investigation program. The requirement for this program is generated
by the Department of Defense mission of providing health care and training of medical
personnel. The work here more nearly resembles civilian (university) research programs.
Professional postgraduate medical training requires the experience of research or clinical
investigation, while the opportunity to participate in clinical investigations remains
an important career incentive. While the work may not be unique to the Military
Departments, it is usually of considerable relevance and aimed at improving the care
in military hospitals.
Some examples of military medical research are:
Casualty Care
a. Use of electrical anesthesia in surgery.
b. Tissue (bone) transplantation in the treatment of severe maxillofacial wounds,
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Infectious Disease. This area is one of great importance and interest in the
Department of Defense and accounts for the largest use of human subjects, chiefly
in vaccine development.
a. Development and testing of a meningococcal meningitis vaccine to protect
recruit populations.
b. Development and testing of new antimalarial drugs against malaria resistant
to conventional medications.
Following tests for safety and effectiveness in experimental animals, humans
must be involved initially in small and later larger scale tests.
Hazard Protection
Human testing of physiological techniques to improve tolerance to sustained
high acceleration forces encountered in combat aircraft.
Evaluation of body heat loss encountered in cold-water diving in various protective
This area of research is primarily performed by active duty military personnel
who are skilled in operating in these unusual environments and who have volunteered:
for hazardous duty, for which they receive extra pay. This area of research is
potentially the most hazardous of Department of Defense research and the one with
the most highly trained subjects.
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Defense Against Chemical Weapons
This research is conducted in service and under contract by Edgewood Arsenal,
which is a part of the US Army Materiel Command. Research involving defense
against chemical and biological weapons was authorized by the Secretary of the
Army in 1953 and has been governed by Department of Defense and Army directives
originally written in 1953 containing the language of the Nuremberg Code which l
referred to earlier. This work was reviewed in open hearings before the House
Committee on Science and Astronautics, 16 and 22 June 1959, and on several later
occasions by Congressional Committees. The major research effort is involved with
frying to find more effective antidote drugs to counteract chemical weapons that we
know are in the arsenals of potential enemies. Many of the drugs that are used do
temporarily affect performance and ability to do complex tasks but this is a side effect
and not an intended purpose of using the drug. I am sure you may have many questions
about the history of this type of research and I will do my best to answer them. I: would
like to point out, however, that no drug is tested if there is any suspicion from pre-
chemical testing in animals that it will have serious adverse or long fasting effects.
Furthermore, the review mechanisms applied to Edgewood have been tightened over
the last two years so that protocols are reviewed by the Army Investigational Drug
Review Board and Human Subjects Research Review Board and relevant Department of
Defense and Food and Drug Administration regulations are followed. A case in point
is the newly developed antidote called "TAB" which will replace the traditional
atropine antidote carried by US Armed Forces. A meeting was held with the FDA in
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November 1974 regarding the deployment of this new drug. Since that time, further
clinical studies have been postponed pending submission of further data to FDA.
Other Work with Investigational Drugs
There is presently no classified work with investigational drugs being conducted
in the Department of Defense. The large majority of this work has always been open
and reported fully to the Food and Drug Administration.
Presumably all use of
investigational drugs in the Department of Defense is formally on file with the FDA
and projects are subject to that agency's review before projects are begun. In addition
to the 1974 meeting, mentioned above, representatives of the Food and Drug Administration
reviewed the Medical Research activities at Edgewood Arsenal in 1967, pursuant to the
HEW/DOD agreement, and a liaison visit by FDA was made to the Biomedical
Laboratory, Edgewood Arsenal in 1972. More detailed information about Department
of Defense research involving human subjects will be provided for the record.
Historical information which you may desire will be promptly retrieved.
As you have heard, there is evidence that the sound ethical principles directed
in past and present DOD regulations appear not always to have been followed,
particularly in the 1950's. Where this has been true, I believe that the problem has
not been lack of guidelines but lack of compliance with them. We all deplore any
instances in which the welfare of human subjects was not property protected.
Procedures have been implemented that tighten control of this work so that the
future will not provide more incidents. I assure you that no contract or in service
prcectscalling for experimentation upon human beings will be done in the future by
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any part of the Department of Defense without the proper safeguards. In addition,
action has been taken to insure that any participation in volunteer studies under the
sponsorship of Fort Detrick or Edgewood Arsenal by service personnel will be carefully
documented in individual medical records.
My aim has been to give you an overview of the subject. I assure you that when
we ask people to assume any degree of risk as part of a Department of Defense medical
or behavioral research project, we do it in the context of a long tradition of ethical
responsibility. I believe our past efforts to protect subjects have been vigorous but
we are always striving to improve.
10
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 C O P, Y
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Was hi ngt on
MEMORANDUM FOR THE SECRETARY OF THE ARMY
SECRETARY OF THE NAVY
SECRETARY OF THE AIR FORCE
SUBJECT: Use of Human Volunteers in Experimental Research
1. Based upon a recommendation of the Armed Forces Medical
Policy Council, that human subjects be employed, under recognized
safeguards, as the only feasible means for realistic evaluation
and/or development of effective preventive measures of defense
against atomic, biological'or chemical agents, the policy set
forth below will govern the use of human volunteers by the
Department of Defense in experimental research in the fields
of atomic, biological and/or chemical warfare.
2. By reason of the basic medical responsibility in connection
with the development of defense of all types against atomic,
biological and/or chemical warfare agents, Armed Services personnel
and/or civilians on duty at installations engaged in such research
shall be permitted to actively participate in all phases of the
program, such participation shall be subject to the following
conditions:
a. The voluntary consent of the human subject is
absolutely essential.
(1) This means that the person involved should
have legal capacity to give consent; should be so
situated as to be able to exercise free power of
choice, without the intervention of any element of
force, fraud, deceit, duress, over-reaching, or other
ulterior form of constraint or coercion;.and should
have sufficient knowledge and comprehension of the
elements of the subject matter involved as to
enable him to make an understanding and enlightened
decision. This latter element requires that before
the acceptance of an affirmative decision by the
experimental subject there should be made known
to him the nature, duration, and purpose of
the experiment; the method and means by
Downgraded to
UNCLASSIFIED 22 Aug 75
per S. Clements
DDR&E OSD(PA)
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which it is to be conducted; all inconveniences
and hazards reasonably to be expected; and the
effects upon his health or person which may possibly-
come from his participation in the experiment.
(2) The concept of the human subject shall be in
writing, his signature shall be affixed to a written
instument setting forth substantially the afore-
mentioned requirements and shall be signed in the
presence of at least one witness who shall attest to
such signature in writing.
(a) In experiments where personnel from more
than one Service are involved the Secretary of the
Service which is exercising primary responsibility
for conducting the experiment is designated to pre-
pare such an instil.iment and coordinate it for use
by all the Services having human volunteers involved
in the experiment.
(3) The duty and responsibility for ascertaining
the quality of the consent rests upon each individual
who initiates, directs or engages in the experiment.
It is a personal duty and responsibility which may
not be delegated to another with impunity.
b. The experiment should be such as to yield fruitful
results for the good of society, unprocurable by other methods
or means of study, and not random and unnecessary in nature.,
c. The number of volunteers used shall be kept at a
minimum consistent with item b., above.
d. The experiment should be so designed'and based on the
results of animal experimentation and a knowledge of the natural
history of the disease or other problem under study that the
anticipated results will justify the performance of the experiment.
U i
e. The experiment should be so conducted as to avoid all
unnecessary physical and mental suffering and injury.
f. No experiment should be-conducted where there is an
a priori reason to believe that death or disabling injury will
occur,
g. The degree of risk to be taken should never exceed
that determined by the humanitarian importance of the problem
to be solved by the experiment.
?,- -.0e Downgraded to
UNCLASSIFIED 22 Aug 75
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 X o. P Y
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h. Proper preparation should be made and adequate
facilities provided to protect the experimental subject against
even remote possibilities of injury, disability, or death.
i. The experiment should be conducted only by scientifi-
cally qualified persons. The highest degree of skill and care
should be required through all stages of the experiment of those
who conduct or engage in the experiment.
j. During the course of the experiment the human subject
should be at liberty to bring the experiment to an end if he has
reached the physical or mental state-where continuation of the
experiment seems to him to be impossible.
k. During the course of the experiment the scientist in
charge must 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 a
continuation of the experiment is likely to result in injury, dis-
ability, or death to the experimental subject.
1. The established policy, which prohibits the use of
prisoners of war in human experimentation, is continued and they
will not be used under any circumstances.
3. The Secretaries of the Army, Navy and Air Force are
authorized to conduct experiments in connection with the development
of.defenses of all types against atomic, biological and/or chemical
warfare agents involving the use of human subjects within the
limits prescribed above.
4. In each instance in which an experiment is proposed pur-
suant to this memorandum, the nature and purpose of the proposed
experiment and the name of the person who will be in charge of
such experiment shall be submitted for approval to the Secretary
of the military department in which the proposed experiment is to
be conducted. No such experiment shall be undertaken until such
Secretary has approved in writing the experiment proposed, the
person who will be in charge of conducting it, as well as informing
the Secretary of Defense.
.5. The addresses will be responsible for insuring compliance
with the provisions of this memorandum within their respective
Services.
/signed/
G.E. WILSON
Copies furnished:
Joint Chiefs of Staff
Research and Development Board
Downgraded to UNCLASSIFIED
22 Aug.75
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NUREMBERG CODE*
1. The voluntary consent of the human
subject is absolutely essential.
This means that the person involved' should
have legal capacity to give consent; should be
*:Copied from Experimentation with
Human Beingsby Jay Katz, Russell
Sage Foundation, New.York 1972.
ment of force, fraud, deceit. duress. over-reat;h-
in4, or other ulterior foruf of cuns.traint or co-
crcion; and should liaoie sutiicivnt knuwicdge
and comprehensic;a of th,: elements of the sub-
_ ject.rnatter involved as to enable hun to make
an understanding and entt'htened decision. This
latter element requires that betore the accept-
ance of an affirmative decision by the e'tperi-
Emcmadsubject there should be made known tc
him. the nature, duration, and purpose. of the
experiment: the method and means by which it
is to be conducted; all inconveniences and hea-
Ards reasonably to be expected; and the effects
-upon *his health or person which may possibly
come from his participation in the experiment.
The duty and responsibility for ascertain-
ing the quality of the consent rests upon each
individual who initiates, directs, or engages in
the experiment.- It is a personal duty and re-
sponsibility which may not be delegated. to an-
other with impunity.
2. The'cxperiment should be such as to
yield fruitful results for the good of society,
unprocurable by other methods or means of
study. and not random and unnecessary in na-
ture.
3. The experiment should be so designed
and based on the results of animal experimenta-
tion and ;t knowledge of the natural history of
the disease or other problem under study that
the anticipated results will justify the perform-
ance of the experiment.
4. The experiment should be so conducted
as to avoid all unnecessary physical and mental
suffering and injury.
5. No experiment should be conducted
where there is an a priori reason to believe that
death or disabling injury will occur; except.,
perhaps, in those experiments where the experi-
mental physicians also serve as subjects.
6. The degree of risk to be takeh should
never exceed that determined by- the humani-
tarian importance of the problem to be solved
by the experiment.
Proper preparations should be made and
adequate facilities provided to protect the ex-
perimental subject against even remote possi-
bilities of injury, disability. or death.
8. The experiment should be conducted
only by scientifically qualified persons. The
highest degree of skill and care should be re-
quired through all stages of the experiment of
those who conduct or engage in the experiment.
9. During the course of the experiment the
bu=n subject should be at liberty to bring the
experiment to an end if he has reached the phys-
ical or mental .state where continuation of the
experiment seems to hint to be impossible.
10. During the course of the. experiment
the scientist in charge must he prepared to
terminate the experiment-at any stage, if he has
probabl4cause to believe, in the exercise; of the
good faith, superior skill, and careful judgment
required of him that a continuation of the ex-
ptriment is likely to result in injury, disability,
or death to the experimental subject.
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 CURRENT REGULATIONS
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Army
AR 40-7
AR 40-38 Clinical Investigation Program, 23 Feb 73
Use of Investigational Drugs in Humans and
the Use of Schedule I Controlled Drug
Substances; 4 Apr 75
Use of Volunteers as Subjects of Research,
15 Sep 74
N1
BUMEDINST 6000.4B Clinical Investigation Program, 15 Jan 75
BUMEDINST 6710.49D Investigational Use of New Drugs in Human
Beings, 9 Jul 73
SECNAVINST 3900.39 Use of Volunteers as Subjects in Research,
Development, Test and Evaluation,. 28 Apr 69
Air Force
AFR 169-6 Clinical Investigation, 26 Jun 74
AFR 1.69-8 Use of Human Test Subjects in the Medical
Service, 19 Aug 74
AFR 80-33 Use of Volunteers in Aerospace Research,
28 Aug 69
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