Tuesday, July 21, 2009

US Govt Human Experimentation Rpt GAO

United States General Accounting Office
Testimony
Before the Legislation and National Security Subcommittee,
Committee on Government Operations, House of
Representatives
For Release on Delivery
Expected at
l&O0 a.m. EST
Wednesday
September 28.1994
Human Experimentation
An Overview on Co1d.Wa.r
Era Programs
Statement of Frank C. Conahan, Assistant Comptroller General,
National Security and International Affairs Division
Mr. Chairman and Members of the Subcommittee:
We are pleased to be here today to discuss the use of humans in
tests and experiments conducted for national security purposes by
the Department of Defense (DOD) and other agencies between 1940 and
1974. As you requested, we collected information on the scope of
these experiments and their possible impact. We obtained
information on (1) the magnitude and scope of human subject
experimentation, (2) the potential effects of the experiments on
human subjects, (3) government efforts to assist those who may have
been injured or suffered adverse health effects as a result of the
tests or experiments, and (4) measures to ensure that informed
consent is secured and that volunteers are protected in governmentsponsored
experiments.
BACKGROUND
As you requested, we focused our work on defense-affiliated
programs that used human test subjects between 1940 and 1974.
The programs included tests and experiments conducted or sponsored
by the Departments of the Army, the Navy, and the Air Force; the
Defense Nuclear Agency; the Central Intelligence Agency (CIA); the
Department of Energy; and the Department of Health and Human
Services. The tests and experiments involved radiological,
chemical, and biological research and were conducted to support
weapon development programs, identify methods to protect the health
of military personnel against a variety of diseases and combat
conditions, and analyze U.S. defense vulnerabilities.
RESULTS IN BRIEF
During World War II and the Cold War era, DOD and other national
security agencies conducted or sponsored extensive radiological,
chemical, and biological research programs. Precise information on
the number of tests, experiments, and participants is not
available, and the exact numbers may never be known. However, we
have identified hundreds of radiological, chemical, and biological
tests and experiments in which hundreds of thousands of people were
used as test subjects. These tests and experiments often involved
hazardous substances such as radiation, blister and nerve agents,
biological agents, and lysergic acid diethylamide (LSD). In some
cases, basic safeguards to protect people were either not in place
or not followed. For example, some tests and experiments were
conducted in secret; others involved the use of people without
their knowledge or consent or their full knowledge of the risks
involved.
The effects of the tests and experiments are often difficult to
determine. Although some participants suffered immediate acute
injuries, and some died, in other cases adverse health problems
were not discovered until many years later--often 20 to 30 years or
longer.
Federal programs provide benefits to former military and federal
civilian employees who suffer from injuries or adverse health
effects as a result of federal service. However, it has proven
difficult for participants in government tests and experiments
between 1940 and 1974 to pursue claims because little centralized
information is available to prove participation or determine
whether adverse health effects resulted from the testing. To
address these problems, special efforts have been made by some
involved agencies to help groups of test participants obtain the
information necessary to pursue claims. For example, the
Department of Veterans Affairs (VA) relaxed its requirement that
participants link their health problems to those tests or
experiments. Also, since 1978 DOD has had a program to identify
and provide information to participants in atmospheric nuclear
tests that were conducted between the 1940s and 1960s. More
recently, in January 1994, the administration established an
advisory committee to identify participants in other governmentsponsored
radiation research. We are reviewing the efforts of the
committee at the request of the Senate Committee on Governmental
Affairs.
In other areas, however, special efforts to make information
available on test participants are not as far along. For example,
DOD recently recognized a need to identify and assist participants
in chemical tests conducted prior to 1968, but to date limited
resources have been applied. We were told earlier this month that
the VA continues to have difficulty processing claims because it
cannot obtain necessary information from DOD. Some participants or
their survivors have pursed benefits or compensation, outside
existing federal programs, through specific congressional action or
court awards.
Although military regulations in effect as early as 1953 generally
required that volunteers be informed of the nature and foreseeable
risks of the studies in which they participated, this did not
always occur. Some participants have testified that they were not
informed about the test risks. Government testing and
experimentation with human subjects continues today because of its
importance to national security agencies. For example, the Army's
Medical Research Institute for Infectious Disease uses volunteers
in its tests of new vaccines for malaria, hepatitis, and other
exotic diseases. Since 1974, federal regulations have become more
protective of research subjects and, in general, require (1) the
formation of institutional review boards and procedures and
(2) researchers to obtain informed consent from human subjects and
ensure that their participation is voluntary and based on knowledge
of the potential risks and benefits. We are in the process of
reviewing the effectiveness of these measures. A National
Institutes of Health official has stated that no mechanism exists
to ensure implementation of the key federal policies in this area.
2
THE GOVERNMENT HAS SPONSORED EXTENSIVE TESTING, BUT PRECISE
INFORMATION ON TESTS AND PARTICIPANTS IS NOT AVAILABLE
Precise information on the scope and magnitude of government tests
and experiments involving human subjects is not available, and
exact numbers may never be known. However, our review of available
documentation and interviews with agency officials identified
hundreds of tests and experiments in which hundreds of thousands of
people were used as subjects. Some of these tests and experiments
involved the intentional exposure of people to hazardous substances
such as radiation, blister and nerve agents, biological agents,
LSD, and phencyclidine (PCP). These tests and experiments were
conducted to support weapon development programs, identify methods
to protect the health of military personnel against a variety of
diseases and combat conditions, and analyze U.S. defense
vulnerabilities. Healthy adults, children, psychiatric patients,
and prison inmates were used in these tests and experiments.
Documenting the precise number of tests and participants is
difficult because government information is incomplete. Some
records have been lost or destroyed, and existing documentation
contains limited information and often does not identify names of
participants. Moreover, these records are spread throughout the
country at the National Archives, Federal Record Centers, other
government offices, and the military commands or organizational
units that created them. Some of the records measure thousands of
linear feet, and the availability and quality of indexes to the
records vary widely.
I will describe a few of the radiological, chemical, and biological
research projects that illustrate the scope and magnitude of
governmental experimentation.
Radioloqical Tests and Experiments
To date, over 200 radiation tests and experiments have been
identified involving over 210,000 test participants.
involved in a test or experiment,
Although not
exposed to radiation through work.
another 199,000 people were
This latter group is of concern
because the effects of the exposure are the same as those incurred
by test participants. The radiation tests are generally recognized
as involving the largest number of test participants.
The largest known test program was the atmospheric nuclear test
program conducted from 1945 to 1962. The purpose of this program
was to develop weapons and to gain a better understanding of the
tactical effect on troops. Over this 17-year period, approximately
210,000 DOD-affiliated personnel, including civilian employees of
DOD contractors, scientists, technicians, maneuver and training
troops, and support personnel,
nuclear tests.
participated in 235 atmospheric
We reported on two of these tests, known as
3
Operation Crossroads, in 1985.l In some tests, participants were
directly exposed to radiation. For example, in one test, five
individuals were located directly beneath a high-altitude test. In
other tests, 37 individuals were located in trenches from 2,000 to
2,600 yards from ground zero, and in others, approximately 26,000
individuals occupied trenches, bunkers, and armored vehicles from
2,500 to 5,500 yards from ground zero. According to DOD officials,
as many as 150,000 of the 210,000 participants may have been
exposed to fallout. In addition, 195,000 U.S. service members may
have been exposed to radiation during the occupation of Hiroshima
and Nagasaki, and over 4,000 other service members may have been
exposed during cleanups at Bikini, Enewetak, and Johnston Atolls
after nuclear tests were conducted. Some participants have alleged
that they were not fully informed or did not understand the
potential health risks of exposure to radiation.
In a series of experiments conducted between the 1940s and 196Os,
the Atomic Energy Commission and the U.S. Public Health Service
funded research of the potential medical effects on people from
fallout after a nuclear attack or accident. In some of the
experiments, university researchers exposed mentally disabled
children to low doses of radiation. Years after the experiments
were completed, a task force found that researchers failed to
satisfactorily inform the subjects' families about the nature and
risk of the experiments in order for them to make an informed
decision when they gave their consent. The president of one of the
universities involved in the experiments later apologized for the
use of children and the failure to provide full information about
the nature and risk. We are not aware of what, if any, further
action was taken in this case.
Chemical Tests and Experiments
During World War II and the Cold War era, the Army and the Navy
conducted two major chemical research experiments in which
thousands of service members were used as test subjects. An
unknown number of other chemical tests and experiments were
conducted under contracts with universities, hospitals, and medical
research facilities. In some of the tests and experiments, healthy
adults, psychiatric patients, and prison inmates were used without
their knowledge or consent or their full knowledge of the risks
involved.
During World War II, the Army conducted tests of protective
clothing and equipment in which thousands of people were exposed to
mustard gas and lewisite agents. In addition, the Army developed
and tested offensive chemical weapons and evaluated the
effectiveness and persistency of mustard agents in different
'Operation Crossroads: Personnel Radiation Exposure Estimates
Should Be Improved (GAO/RCED-86-15, Nov. 8, 1985).
4
environments. In February 1993, we reported that the Army's
records of its mustard test activities were not kept in a manner
that readily identifies the participants.* However, the available
records show that 1,002 soldiers were commended for their
participation in tests in which they subjected themselves to pain,
discomfort, and possible permanent injury for the advancement of
research in protection of the armed services.
Similar to the Army's tests, the Navy conducted tests of clothing
and equipment that exposed thousands to the effects of mustard gas
and lewisite agents. These experiments involved (1) gas chamber
tests, in which service members were completely exposed to mustard
and lewisite agents while wearing protective clothing, and (2) skin
tests, in which amounts of mustard agent and antivesicant ointments
were applied to service members' forearms. The Navy has a list of
the names of approximately 3,200 sailors who participated in
mustard and lewisite agent tests performed by the Naval Research
Laboratory. Additionally, Navy officials told us that between
15,000 and 60,000 Navy recruits had participated in skin tests
conducted by a contractor but that the Navy had no record of the
recruits' names.
From 1952 to 1975, the Army conducted a classified medical research
program to develop incapacitating agents. The program involved
testing nerve agents, nerve agent antidotes, psychochemicals, and
irritants. The chemicals were given to volunteer service members
at the Edgewood Arsenal, Maryland, and four other locations. Army
documents identify a total of 7,120 Army and Air Force personnel
who participated in these tests, about half of whom were exposed to
chemicals. The Army's Medical Research and Development Command in
Fort Detrick, Maryland, has the names and service numbers of all
test participants and a list of the chemicals to which the service
members were exposed. Some service members have testified before
congressional committees that they were not fully informed of the
risks involved.
During the same period, the Army Chemical Corps contracted with
various universities, state hospitals, and medical foundations to
research the disruptive influences that psychochemical agents could
have on combat troops. The Air Force also conducted experiments on
the effects of LSD through contracts at five universities.
According to Air Force officials and records, approximately 100
people received LSD in these experiments. No effort has been made
by the Air Force to determine if the participants' names are
available in the universities' records.
'Veterans Disabilitv: Information From Military Mav Helm VA
Assess Claims Related to Secret Tests (GAO/NSIAD-93-89, Feb. 18,
1993).
5
According to a CIA official, from 1553 to about 1964, the CIA
conducted a series of experiments called MKULTRA to test
vulnerabilities to behavior modification drugs. As a part of these
experiments, LSD and other psychochemical drugs were administered
to an undetermined number of people without their knowledge or
consent. According to the official, the names of those involved in
the tests are not available because names were not recorded or the
records were subsequently destroyed. However, some tests were done
under contract, and no effort has been made by the CIA to determine
if names are available in contractors' records.
Biolocrical Tests and Experiments
The Army conducted a series of biological warfare experiments and
tests between 1949 and 1974. The purpose of these tests was to
determine U.S. vulnerabilities to biological warfare. For example,
between 1949 and 1969, the Army conducted several hundred
biological warfare tests in which unaware populations were sprayed
with bacterial tracers or simulants that the Army thought were
harmless at that time. Some of the tests involved spraying large
areas, such as the cities of St. Louis and San Francisco, and
others involved spraying more focused areas, such as the New York
City subway system and Washington National Airport.
In another Army experiment conducted between 1959 and 1974,
approximately 2,200 volunteers were exposed to biological
pathogens, such as Venezuelan Equine Encephalitis and Tularemia, as
part of research to develop vaccines and antidotes. A list of all
studies and medical records of all volunteers are located at the
Army's Medical Research Institute of Infectious Diseases in Fort
Detrick, Maryland. It appears that the participants were
adequately informed.
EFFECTS OF EXPERIMENTS
ARE OFTEN DIFFICULT TO DETERMINE
The effects of government tests on participants' health have been
difficult to determine. At the time of the tests, some people were
clearly harmed. However, in other cases, possible adverse health
effects related to the substances used were unknown or did not
become apparent until years later.
Available records show that people suffered immediate acute
injuries in some tests and that people died in at least two tests.
For example, available records show that some participants in the
Army's and the Navy's mustard and lewisite tests suffered burns and
required hospitalization. Also, in a highly publicized case, an
Army employee died in 1953, a short time after participating in a
CIA experiment using LSD.
However, for some test participants, the test effects were not
readily apparent. In these cases, claimed adverse health problems
6
did not appear until many years later. For example, in our
February 1993 report on the Army's chemical testing program, we
noted that the first health problems for most of the veterans who
sought assistance appeared many years after their military service
and at a time when these same ailments typically show up in their
general age population. Further, only a few of the veterans
alleged that their health problems were long term in nature, dating
back to their active military duty. We reported that 97 of 145
veterans seeking assistance could not prove that their health
problems were caused by participation in a test or experiment.
Research studies have also shown that exposure to some of the
substances used in the tests may create health problems that often
will not appear for many years. For example, the National Academy
of Sciences concluded in 1993 that exposure to mustard agents could
cause many serious diseases that would not immediately appear, such
as leukemia, emphysema, respiratory and skin cancers, and eye
diseases, and that lewisite agents could cause some of these same
diseases.
INFORMATION AVAILABLE TO ASSIST
TEST PARTICIPANTS VARIES
Two federal agencies, the VA and the Department of Labor, have
programs to provide medical care and disability benefits to former
military and federal civilian personnel who have experienced health
problems as a result of their participation in government tests or
experiments. However, because there is not complete information on
those who participated and the precise adverse health effects of
their participation, it has often proven difficult for former test
participants to pursue claims. To address these problems, special
efforts have been made by some involved agencies to help groups of
test participants obtain the information necessary to pursue
claims. Other involved agencies, however, are not providing the
information test participants need. Apart from the information
issue, some participants or their survivors have sought
compensation or benefits directly through civil or specific
congressional actions.
The largest special information assistance effort is the Nuclear
Test Personnel Review program, established by DOD in 1978. This
program, administered by the Defense Nuclear Agency, has assisted
veterans by compiling data on atmospheric nuclear tests, including
the names of participants, the locations of the tests, and the
amount of radiation administered during the tests.3 This program
also involves an extensive outreach program that provides documents
31n October 1979, DUD eqanded the program to include U.S. service personnel who
hadparticipated inthepostwaroccupationof HiroshimaandNagasaki.
7
about the tests and informs participants of the availability of VAprovided
health care and disability benefits.
Other special actions have also been taken to help some veterans
pursue health claims related to their participation in testing. In
1988, the Congress directed the VA to relax its claims adjudication
procedures for veterans exposed to radiation resulting from
atmospheric nuclear detonations. For veterans with certain
ailments that may be attributable to radiation exposure, the VA
presumes that the ailments are service connected. In 1992, the VA
amended its regulations so that veterans of mustard testing receive
similar treatment if they develop certain diseases. In 1994, the
regulations were further amended to include lewisite.
Earlier this year, the administration initiated a large effort to
gather data on people who participated in experiments involving
intentional exposure to ionizing radiation and intentional
environmental releases of radiation. The Presidential Advisory
Committee on Human Radiation Experiments, established in January
1994, is conducting this review. We are currently reviewing the
efforts of the advisory committee at the request of the Chairman,
Senate Committee on Governmental Affairs.
Let me describe some areas in which information is still needed.
Our February 1993 report stated that the military services lacked
complete information on their chemical test activities and
recommended that DOD aggregate the information and provide a point
of contact within each service to assist veterans in obtaining
information about their test experiences. DOD, in turn,
established the Chemical Weapons Exposure Task Force to identify
chemical test information and tasked the Secretaries of the Army,
the Navy, and the Air Force to provide information related to the
tests to the task force. However, to date (1) the task force
employs only one full-time investigator, (2) the Army and the Navy
have not designated points of contact to lead this effort, and (3)
the services have not conducted a complete and thorough search of
their records. Without this assistance, the VA continues to have
difficulty assisting former test participants. For example, we
were told in September 1994 that VA claims adjudicators misdirect
over 100 test information requests monthly because they do not know
which agency should receive them.
A similar situation exists with some other groups. For example,
some agencies have made little effort to assist test participants
by identifying test locations and participants in experiments
conducted by contractors. The CIA, in fact, has not released the
names of 15 of the approximately 80 organizations that conducted
experiments under the previously discussed MKULTRA program because
the organizations do not want to be identified.
8
Conclusive information on the effects of some biological simulants
used in the Army's testing is not available. Recently, the Army
had the Centers for Disease Control review its risk assessments for
one simulant used in some of its biological warfare tests. The
Center determined that adverse health effects from the levels of
exposure to the simulant, zinc cadmium sulfide, at those sites were
very unlikely. However, the Fiscal Year 1995 Defense Appropriation
Bill provides $1 million to further study possible adverse health
effects of exposure to this simulant.
Finally, in the case of civilian government employees, whose claims
for compensation are processed through the Department of Labor, we
were told that the rules have not been relaxed in the same way as
they have been at the VA. In some cases, civilian employees
participated in the same testing as military service members.
In selected cases, test and experiment participants have received
compensation as a result of a civil action or specific
congressional action. For example, in 1976 the President signed
legislation providing $750,000 to the family of an LSD test
participant who died in 1953 shortly after being administered LSD.'
Also, the Justice Department settled a suit brought by another
group of LSD test participants for $750,000. Another example of a
specific congressional action is the establishment of a $100
million fund to cover claims from individuals who lived downwind
from locations where above-ground nuclear tests were conducted.5
Similarly, another act authorized $184 million for Marshall Islands
citizens who may have been exposed during nuclear testing.6 These
funds are distributed to individual islands and disbursed by the
local governments.
GOVERNMENT EFFORTS TO STRENGTHEN THE
PROTECTION OF HUMAN PARTICIPANTS
Although guidance for protecting human subjects has existed since
the post-World War II Nuremberg trials, the principles were not
always followed by U.S. government researchers. It was not until
the 1970s that the Congress and some agencies became actively
involved in examining human research ethics and establishing laws
and regulations that became progressively more protective of human
subjects. In 1974, the Department of Health, Education, and
Welfare issued a regulation strengthening the Department's informed
consent procedures and institutional review requirements. In 1991,
the Department of Health and Human Services issued a revised,
uniform regulation for the protection of human subjects that was
'Private Law 94-126.
'The Radiation Exposure Compensation Act (P.L. 101-426).
6The Compact of Free Association Act of 1985 (P.L. 99-239).
9
adopted by 16 federal agencies, including DOD, CIA, and other
national security agencies.
The 1947 Nuremberg Code of Ethics established the fundamental
principles for scientists and physicians involved in using people
as subjects in experiments and tests. In the Nuremberg Code, the
respect for the human rights of patients, including their voluntary
consent and their safety from undue physical or psychological harm,
was of paramount consideration. A 1953 memorandum from the
Secretary of Defense to the secretaries of the military services
directed them, in essence, to adopt the Nuremberg Code as a guide
for human experimentation. However, according to defense
officials, some of the rules, including those related to the
quality of informed consent and the capability of the subjects to
withdraw without prejudice, were not followed in the 1950s and
1960s.
In 1964, the Declaration of Helsinki emphasized that clinical
research using people as subjects should be (1) based on laboratory
and animal experiments or on scientifically established facts, (2)
conducted by scientifically qualified medical persons, (3) preceded
by a careful assessment of the inherent risks versus benefits, and
(4) generally done with disclosure of the risks to the subjects and
with the subjects' free consent. In November 1966, the American
Medical Association adopted the ethical principles of the Helsinki
Declaration to guide physicians engaged in clinical research and
investigations of new drugs and procedures.
The federal regulation issued in 1974 by the Department of Health,
Education, and Welfare covers the protection of humans in
experiments and tests and requires all institutions carrying out
research funded by the department to have an Institutional Review
Board. The boards are to review the risks and benefits of the
proposed research, the specific procedures to be followed, and the
process of informing the human subject and obtaining consent. The
regulation also requires institutions to describe the test
procedures and the foreseeable risks or discomforts and explain
that subjects can refuse to participate at any time. In general,
federal departments incorporated parts or all of this regulation in
their policies on human experimentation.
The Department of Health and Human Services' 1991 regulation
replaced previous federal policies and regulations and clarified
requirements for researchers to obtain informed consent from human
subjects and ensure that their participation is voluntary and based
on knowledge of the potential risks and benefits. The regulation
was subsequently adopted by 16 other federal agencies.
10
This concludes my prepared statement, Mr. Chairman. I will be
happy to answer any questions.
(709096)
11
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