Human experimentation
Encyclopedia
Human subject research includes experiments (formally known as interventional studies) and observational studies. Human subjects are commonly participants in research on basic biology
, clinical medicine
, nursing
, psychology
, and all other social sciences
. Humans have been participants in research since the earliest studies. As research has become formalized the academic community has developed formal definitions of "human subject research", largely in response to abuses of human subjects.
or psychological statistics
, a research subject is any object or phenomenon that is observed for purposes of research. In survey research
and opinion polling, the subject is often called a respondent. In the United States Federal Guidelines a human subject is a living individual about whom an investigator conducting research obtains 1) Data through intervention or interaction with the individual, or 2) Identifiable private information (32 CFR 219.102.f). (Lim,1990)
, author of an encyclopedia which survived in part as De Medicina
, which introduced the Latin term cancer
, discussed at length the pros and cons of human and animal medical experimentation.
A famous example of such research were the Edward Jenner
experiments, where he tested smallpox
vaccines on his son and neighbourhood children. In an instance of self-experimentation
, European physician Johann Jorg swallowed 17 drugs in various doses to record their properties.
In the 20th century, as the progress of medicine began to accelerate, the concept of the various codes of ethics
of scientific disciplines changed dramatically, and the treatment of research subjects along with it.
Walter Reed
's experiments to develop an inoculation
for yellow fever
led these advances. Reed's vaccine
experiments were carefully scrutinized, however, unlike earlier trials.
Infamous cases of human subjects abuse in the 20th century were conducted by (Unit 731
) in China by Imperial Japanese Army and the Nazis during World War II, an example of research involving prisoners which came to light in the Nuremberg Doctors' Trial
and led to the Nuremberg Code
of ethical conduct for human subjects research. Research in the second half of the 20th century has been characterized by increasing attempts to protect human subjects through national agencies, institutional ethical review boards, and informed consent.
.
, a department of the Imperial Japanese Army
located near Harbin
(then puppet state of Manchukuo
, in northeast China), experimented with prisoner vivisection
, dismemberment, bacteria inoculation and induced epidemics on a very large scale from 1932 onward through the Second Sino-Japanese war
. With the expansion of the empire during World War II
, many other units were implemented in conquered cities such as Nanking (Unit 1644), Beijing
(Unit 1855
), Guangzhou
(Unit 8604
) and Singapore
(Unit 9420
). After the war, Supreme commander of occupation Douglas MacArthur
gave immunity in the name of the United States
to Shiro Ishii
and all members of the units in exchange for all of the results. The United States
blocked Soviet access to this information; some unit members were judged by the Soviets during the Khabarovsk War Crime Trials
.
At the end of the war, 23 Nazi doctors and scientists were put on trial for the unethical treatment of concentration camp inmates, often used as research subjects with fatal consequences (see Nazi human experimentation
). Out of those 23, 15 were convicted, 7 were condemned to death, 9 received prison sentences from 10 years to life, and 7 were acquitted (see the Doctors' Trial
).
De-classified documents of the National Archives revealed that during the 1930s and 1940s, the British Army
allegedly used hundreds of British and native British Indian Army
soldiers as "guinea pigs" in their experiments to determine if mustard gas inflicted greater damage on Indian skin compared to British skin. It is unclear whether the trial subjects, some of whom were hospitalised by their injuries, were all volunteers. Fort Detrick in Maryland was the headquarters of US biological warfare experiments. Operation Whitecoat
involved the injection of infectious agents to observe their effects in human subjects.
were conducted, where mentally handicapped test subjects were exposed to large amounts of sugar
to induce dental caries
. In the United Kingdom (voluntary) human experimentation at Porton Down
in the 1950s, led to the death of Ronald Maddison
.
Pharmaceutical giant Pfizer
came under fire in 2001 for allegedly testing meningitis
drugs on Nigerian children.
In Israel, a former worker of Negev Nuclear Research Center
filed lawsuit, claiming that employees of the Center were given drinks with uranium
without medical supervision and without obtaining written consent.
, and were often performed illegally, without the knowledge, consent
, or informed consent
of the test subjects.
Many types of experiments were performed including the deliberately infecting people with deadly or debilitating diseases, exposing people to biological and chemical weapons, human radiation experiments
, injecting people with toxic and radioactive chemicals, surgical experiments, interrogation
/torture
experiments, tests involving mind-altering substances, and a wide variety of others. Many of these tests were performed on children and mentally disabled individuals. In many of the studies, a large number of the subjects were poor
racial minorities or prisoners
.
Often, subjects were sick or disabled people, whose doctors told them that they were receiving "medical treatment", but instead were used as the subjects of harmful and deadly experiments, without their knowledge or consent. The ethical, professional, and legal implications of this in the United States medical and scientific community were quite significant, and led to many institutions and policies which attempted to ensure that future human subject research in the United States would be ethical and legal.
Public outcry over the discovery of government experiments on human subjects led to numerous congressional investigations and hearings, including the Church Committee
, Rockefeller Commission
, and Advisory Committee on Human Radiation Experiments
, amongst others. These inquiries have not resulted in prosecutions and not all subjects involved in the trials have been compensated or notified of their participation.
described 22 published medical studies where patients had been experimented on with no expected benefit to the patient. In one study, for example, patients infused with live cancer cells had been told they were receiving "some cells" without specifying that they were cancer. Though identities of the authors and institutions had been stripped, the 22 studies were later identified as having been conducted by mainstream researchers and published in prestigious journals within approximately the previous decade. The 22 cases had been selected from a set of 50 that Beecher had collected, and he presented evidence that studies he considered unethical were even more widespread and represented a systemic problem in medical research rather than exceptions. Though Beecher had been writing about human experimentation and publicizing cases that he considered to be bad practice for nearly a decade, it was a 1965 briefing to science writers and the 1966 paper that finally earned widespread news coverage and stimulated public reaction. The paper has been described as "the most influential single paper ever written about experimentation involving human subjects." The Office for Human Research Protections
credits this paper as "ultimately contributing to the impetus for the first NIH and FDA regulations."
In addition to documenting the extent of problems in human subjects research, Beecher was instrumental in formulating the solutions. One common aspect to many of Beecher's cases was that some experimental subjects, such as military personnel and mentally handicapped children in institutions, were not in a position to freely decline consent. Beecher believed that rules requiring informed consent were not by themselves sufficient, as truly informed consent was an unattainable ideal. He worked both in defining the rules and conditions for informed consent and in establishing institutional review board
s as an additional layer of oversight regarding research protocols.
Hillary Clinton issuing an official apology. President Barack Obama
apologized to President Álvaro Colom
who had called these experiments 'a crime against humanity'.
, the "father of anatomy" and founder of the first medical school
in Alexandria
, was described by the church leader Tertullian
as having performed surgery on at least 600 live prisoners. In recent times, the wartime programs of Nazi
Dr. Josef Mengele
, Shiro Ishii
, founder of the Japan
ese military Unit 731
, and Dr. Fukujiro Ishiyama at Kyushu Imperial University Hospital
, conducted surgery on concentration camp prisoners in their respective countries during World War II
.
In November 2006, Doctor Akira Makino confessed to Kyodo news having performed surgery and amputations on condemned prisoners, including women and children in 1944 and 1945 while he was stationed on Mindanao
. In 2007, Doctor Ken Yuasa
testified to The Japan Times
that he believes at least 1,000 persons working for the Shōwa
regime, including surgeons, did surgical research in mainland China.
The use of the term vivisection when referring to procedures performed on humans almost always implies a lack of consent. Human volunteers can consent to be subjects for invasive experiments which may involve, for example, the taking of tissue samples (biopsies
), or other procedures which require surgery on the volunteer. These procedures must be approved by ethical review, and carried out in an approved manner that minimizes pain and long term health risks to the subject.
have been tightened.
published a code of research ethics, the Declaration of Helsinki
. It was based on the Nuremberg Code, focusing on medical research with therapeutic intent. Subsequently, medical professionals and researches begun requiring that research follows the principles outlined in the Declaration. This document was one of the milestones towards the implementation of the institutional review board
(IRB) process.
In 1974, the United States Congress ordered the creation of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. Its goal was to identify the basic ethical principles that affect the decision to use human research subjects and to develop guidelines to assure that human research is conducted in accordance with those principles.
The result of the National Commission's work was the Belmont Report
published in 1979. It identifies three basic ethical principles that underlie human experimentation (the Belmont Principles):
(APA) has a documented ethics code pertaining to the practice of psychology
and associated research. This document contains great guidelines for the use of deception in research. For members of the APA, these are hard requirements levied against their membership. They are also requirements for any research project conducted, funded, or managed by the APA.
s, though some agencies have established their own implementation of this code that supersedes portions or all of 45 CFR 46. The Department of Defense
uses CFR 46 but has different exemption criteria. The Food and Drug Administration
also applies a modified code that is associated with research into development of any food, drug, or medical devices.
The code establishes what is required to be considered research activities, and for participants to be considered human subjects of research. The definitions are written as such to include situations where the human is the subject of the experiment, their environment is manipulated by the researchers, and data regarding their responses are collected. If the project does not meet these definitions (or there is minimal risk to participants) then the project is exempt from IRB review and the requirements of informed consent
. Generally this decision is made and documented by an IRB. The common rule also provides definitions regarding whether institutions are engaged in research, interaction between investigators and subjects, what an intervention is, and what information subjects can expect to remain private.
Biology
Biology is a natural science concerned with the study of life and living organisms, including their structure, function, growth, origin, evolution, distribution, and taxonomy. Biology is a vast subject containing many subdivisions, topics, and disciplines...
, clinical medicine
Medicine
Medicine is the science and art of healing. It encompasses a variety of health care practices evolved to maintain and restore health by the prevention and treatment of illness....
, nursing
Nursing
Nursing is a healthcare profession focused on the care of individuals, families, and communities so they may attain, maintain, or recover optimal health and quality of life from conception to death....
, psychology
Psychology
Psychology is the study of the mind and behavior. Its immediate goal is to understand individuals and groups by both establishing general principles and researching specific cases. For many, the ultimate goal of psychology is to benefit society...
, and all other social sciences
Social sciences
Social science is the field of study concerned with society. "Social science" is commonly used as an umbrella term to refer to a plurality of fields outside of the natural sciences usually exclusive of the administrative or managerial sciences...
. Humans have been participants in research since the earliest studies. As research has become formalized the academic community has developed formal definitions of "human subject research", largely in response to abuses of human subjects.
Definition of a human subject
In biostatisticsBiostatistics
Biostatistics is the application of statistics to a wide range of topics in biology...
or psychological statistics
Psychological statistics
Psychological statistics is the application of statistics to psychology. Some of the more common applications include:#psychometrics#learning theory#perception#human development#abnormal psychology#Personality test#psychological tests...
, a research subject is any object or phenomenon that is observed for purposes of research. In survey research
Survey research
Survey research a research method involving the use of questionnaires and/or statistical surveys to gather data about people and their thoughts and behaviours. This method was pioneered in the 1930s and 1940s by sociologist Paul Lazarsfeld. The initial use of the method was to examine the effects...
and opinion polling, the subject is often called a respondent. In the United States Federal Guidelines a human subject is a living individual about whom an investigator conducting research obtains 1) Data through intervention or interaction with the individual, or 2) Identifiable private information (32 CFR 219.102.f). (Lim,1990)
Roman
Aulus Cornelius CelsusAulus Cornelius Celsus
Aulus Cornelius Celsus was a Roman encyclopedist, known for his extant medical work, De Medicina, which is believed to be the only surviving section of a much larger encyclopedia. The De Medicina is a primary source on diet, pharmacy, surgery and related fields, and it is one of the best sources...
, author of an encyclopedia which survived in part as De Medicina
De Medicina
De Medicina is a 1st-century medical treatise by Aulus Cornelius Celsus, a Roman encyclopedist and possibly a practicing physician. It is the only surviving section of a much larger encyclopedia; only small parts still survive from sections on agriculture, military science, oratory, jurisprudence...
, which introduced the Latin term cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
, discussed at length the pros and cons of human and animal medical experimentation.
Post-Enlightenment
Human subject research experiments were recorded during vaccination trials in the 18th century. In these early trials, physicians used themselves or their slaves as test subjects. Experiments on others were often conducted without informing the subjects of dangers associated with such experiments.A famous example of such research were the Edward Jenner
Edward Jenner
Edward Anthony Jenner was an English scientist who studied his natural surroundings in Berkeley, Gloucestershire...
experiments, where he tested smallpox
Smallpox
Smallpox was an infectious disease unique to humans, caused by either of two virus variants, Variola major and Variola minor. The disease is also known by the Latin names Variola or Variola vera, which is a derivative of the Latin varius, meaning "spotted", or varus, meaning "pimple"...
vaccines on his son and neighbourhood children. In an instance of self-experimentation
Self-experimentation
Self-experimentation refers to the very special case of single-subject scientific experimentation in which the experimenter conducts the experiment on her- or himself. Usually this means that the designer, operator, subject, analyst, and user or reporter of the experiment are all the same...
, European physician Johann Jorg swallowed 17 drugs in various doses to record their properties.
In the 20th century, as the progress of medicine began to accelerate, the concept of the various codes of ethics
Ethical code
An ethical code is adopted by an organization in an attempt to assist those in the organization called upon to make a decision understand the difference between 'right' and 'wrong' and to apply this understanding to their decision...
of scientific disciplines changed dramatically, and the treatment of research subjects along with it.
Walter Reed
Walter Reed
Major Walter Reed, M.D., was a U.S. Army physician who in 1900 led the team that postulated and confirmed the theory that yellow fever is transmitted by a particular mosquito species, rather than by direct contact...
's experiments to develop an inoculation
Inoculation
Inoculation is the placement of something that will grow or reproduce, and is most commonly used in respect of the introduction of a serum, vaccine, or antigenic substance into the body of a human or animal, especially to produce or boost immunity to a specific disease...
for yellow fever
Yellow fever
Yellow fever is an acute viral hemorrhagic disease. The virus is a 40 to 50 nm enveloped RNA virus with positive sense of the Flaviviridae family....
led these advances. Reed's vaccine
Vaccine
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
experiments were carefully scrutinized, however, unlike earlier trials.
Infamous cases of human subjects abuse in the 20th century were conducted by (Unit 731
Unit 731
was a covert biological and chemical warfare research and development unit of the Imperial Japanese Army that undertook lethal human experimentation during the Second Sino-Japanese War and World War II. It was responsible for some of the most notorious war crimes carried out by Japanese...
) in China by Imperial Japanese Army and the Nazis during World War II, an example of research involving prisoners which came to light in the Nuremberg Doctors' Trial
Doctors' Trial
The Doctors' Trial was the first of 12 trials for war crimes that the United States authorities held in their occupation zone in Nuremberg, Germany after the end of World War II. These trials were held before U.S...
and led to the Nuremberg Code
Nuremberg Code
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War.-Background:...
of ethical conduct for human subjects research. Research in the second half of the 20th century has been characterized by increasing attempts to protect human subjects through national agencies, institutional ethical review boards, and informed consent.
History of human subjects abuses
Strict policies now exist when a human being is the subject of an experiment. These evolved over time after particularly horrid abuses (and even atrocities) on human subjects: such as research involving prisoners, research on slaves and servants, and research on family members. In some notable cases, doctors have performed experiments on themselves when they have been unwilling to risk the well-being of others. This is known as self-experimentationSelf-experimentation
Self-experimentation refers to the very special case of single-subject scientific experimentation in which the experimenter conducts the experiment on her- or himself. Usually this means that the designer, operator, subject, analyst, and user or reporter of the experiment are all the same...
.
World War II
Unit 731Unit 731
was a covert biological and chemical warfare research and development unit of the Imperial Japanese Army that undertook lethal human experimentation during the Second Sino-Japanese War and World War II. It was responsible for some of the most notorious war crimes carried out by Japanese...
, a department of the Imperial Japanese Army
Imperial Japanese Army
-Foundation:During the Meiji Restoration, the military forces loyal to the Emperor were samurai drawn primarily from the loyalist feudal domains of Satsuma and Chōshū...
located near Harbin
Harbin
Harbin ; Manchu language: , Harbin; Russian: Харби́н Kharbin ), is the capital and largest city of Heilongjiang Province in Northeast China, lying on the southern bank of the Songhua River...
(then puppet state of Manchukuo
Manchukuo
Manchukuo or Manshū-koku was a puppet state in Manchuria and eastern Inner Mongolia, governed under a form of constitutional monarchy. The region was the historical homeland of the Manchus, who founded the Qing Empire in China...
, in northeast China), experimented with prisoner vivisection
Vivisection
Vivisection is defined as surgery conducted for experimental purposes on a living organism, typically animals with a central nervous system, to view living internal structure...
, dismemberment, bacteria inoculation and induced epidemics on a very large scale from 1932 onward through the Second Sino-Japanese war
Second Sino-Japanese War
The Second Sino-Japanese War was a military conflict fought primarily between the Republic of China and the Empire of Japan. From 1937 to 1941, China fought Japan with some economic help from Germany , the Soviet Union and the United States...
. With the expansion of the empire during World War II
World War II
World War II, or the Second World War , was a global conflict lasting from 1939 to 1945, involving most of the world's nations—including all of the great powers—eventually forming two opposing military alliances: the Allies and the Axis...
, many other units were implemented in conquered cities such as Nanking (Unit 1644), Beijing
Beijing
Beijing , also known as Peking , is the capital of the People's Republic of China and one of the most populous cities in the world, with a population of 19,612,368 as of 2010. The city is the country's political, cultural, and educational center, and home to the headquarters for most of China's...
(Unit 1855
Unit 1855
Unit 1855 Unit 1855 Unit 1855 (第一八五五部隊）was a secret Imperial Japanese Army facility that focused on the development of biological weapons during World War II. It was operated by the Kempeitai, the Japanese military police, in Nanjing.-See also:*Japanese war crimes...
), Guangzhou
Guangzhou
Guangzhou , known historically as Canton or Kwangchow, is the capital and largest city of the Guangdong province in the People's Republic of China. Located in southern China on the Pearl River, about north-northwest of Hong Kong, Guangzhou is a key national transportation hub and trading port...
(Unit 8604
Unit 8604
Unit 8604 or Nami Unit was a secret military medical unit of the Imperial Japanese Army that researched biological warfare and other topics through human experimentation during the Second Sino-Japanese War and World War II era...
) and Singapore
Singapore
Singapore , officially the Republic of Singapore, is a Southeast Asian city-state off the southern tip of the Malay Peninsula, north of the equator. An island country made up of 63 islands, it is separated from Malaysia by the Straits of Johor to its north and from Indonesia's Riau Islands by the...
(Unit 9420
Unit 9420
Imperial Japanese ArmyFormed in 1942 to support the Japanese Southern Army, Unit 9420 or Oka Unit consisted of two units; the Umeoka Unit, which specialised in the plague, and the Kono Unit, which specialised in malaria....
). After the war, Supreme commander of occupation Douglas MacArthur
Douglas MacArthur
General of the Army Douglas MacArthur was an American general and field marshal of the Philippine Army. He was a Chief of Staff of the United States Army during the 1930s and played a prominent role in the Pacific theater during World War II. He received the Medal of Honor for his service in the...
gave immunity in the name of the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
to Shiro Ishii
Shiro Ishii
was a Japanese microbiologist and the lieutenant general of Unit 731, a biological warfare unit of the Imperial Japanese Army responsible for human experimentation and war crimes during the Second Sino-Japanese War.-Early years:...
and all members of the units in exchange for all of the results. The United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
blocked Soviet access to this information; some unit members were judged by the Soviets during the Khabarovsk War Crime Trials
Khabarovsk War Crime Trials
Khabarovsk War Crime Trials were a series of hearings held between December 25 - 31st, 1949 in the Soviet Union's industrial city of Khabarovsk situated on the Russian Far East...
.
At the end of the war, 23 Nazi doctors and scientists were put on trial for the unethical treatment of concentration camp inmates, often used as research subjects with fatal consequences (see Nazi human experimentation
Nazi human experimentation
Nazi human experimentation was a series of medical experiments on large numbers of prisoners by the Nazi German regime in its concentration camps mainly in the early 1940s, during World War II and the Holocaust. Prisoners were coerced into participating: they did not willingly volunteer and there...
). Out of those 23, 15 were convicted, 7 were condemned to death, 9 received prison sentences from 10 years to life, and 7 were acquitted (see the Doctors' Trial
Doctors' Trial
The Doctors' Trial was the first of 12 trials for war crimes that the United States authorities held in their occupation zone in Nuremberg, Germany after the end of World War II. These trials were held before U.S...
).
De-classified documents of the National Archives revealed that during the 1930s and 1940s, the British Army
British Army
The British Army is the land warfare branch of Her Majesty's Armed Forces in the United Kingdom. It came into being with the unification of the Kingdom of England and Scotland into the Kingdom of Great Britain in 1707. The new British Army incorporated Regiments that had already existed in England...
allegedly used hundreds of British and native British Indian Army
British Indian Army
The British Indian Army, officially simply the Indian Army, was the principal army of the British Raj in India before the partition of India in 1947...
soldiers as "guinea pigs" in their experiments to determine if mustard gas inflicted greater damage on Indian skin compared to British skin. It is unclear whether the trial subjects, some of whom were hospitalised by their injuries, were all volunteers. Fort Detrick in Maryland was the headquarters of US biological warfare experiments. Operation Whitecoat
Operation Whitecoat
Operation Whitecoat was the name given to a medical research program carried out by the US Army at Fort Detrick, Maryland during the period 1954–1973. The program involved conducting medical research using volunteer enlisted personnel who eventually became nicknamed "White Coats"...
involved the injection of infectious agents to observe their effects in human subjects.
After World War II
In Sweden, the Vipeholm experimentsVipeholm experiments
The Vipeholm experiments were a series of human experiments where patients of Vipeholm Mental Hospital in Lund, Sweden were fed large amounts of sweets to provoke dental caries...
were conducted, where mentally handicapped test subjects were exposed to large amounts of sugar
Sugar
Sugar is a class of edible crystalline carbohydrates, mainly sucrose, lactose, and fructose, characterized by a sweet flavor.Sucrose in its refined form primarily comes from sugar cane and sugar beet...
to induce dental caries
Dental caries
Dental caries, also known as tooth decay or a cavity, is an irreversible infection usually bacterial in origin that causes demineralization of the hard tissues and destruction of the organic matter of the tooth, usually by production of acid by hydrolysis of the food debris accumulated on the...
. In the United Kingdom (voluntary) human experimentation at Porton Down
Porton Down
Porton Down is a United Kingdom government and military science park. It is situated slightly northeast of Porton near Salisbury in Wiltshire, England. To the northwest lies the MoD Boscombe Down test range facility which is operated by QinetiQ...
in the 1950s, led to the death of Ronald Maddison
Ronald Maddison
Leading Aircraftman Ronald George Maddison was a twenty-year-old Royal Air Force engineer who died while acting as a volunteer human "guinea pig" while testing nerve agents at Porton Down, in Wiltshire, England...
.
Pharmaceutical giant Pfizer
Pfizer
Pfizer, Inc. is an American multinational pharmaceutical corporation. The company is based in New York City, New York with its research headquarters in Groton, Connecticut, United States...
came under fire in 2001 for allegedly testing meningitis
Meningitis
Meningitis is inflammation of the protective membranes covering the brain and spinal cord, known collectively as the meninges. The inflammation may be caused by infection with viruses, bacteria, or other microorganisms, and less commonly by certain drugs...
drugs on Nigerian children.
In Israel, a former worker of Negev Nuclear Research Center
Negev Nuclear Research Center
The Negev Nuclear Research Center is an Israeli nuclear installation located in the Negev desert, about thirteen kilometers to the south-east of the city of Dimona. The purpose of Dimona is widely assumed to be the manufacturing of nuclear weapons, and the majority of defense experts have...
filed lawsuit, claiming that employees of the Center were given drinks with uranium
Uranium
Uranium is a silvery-white metallic chemical element in the actinide series of the periodic table, with atomic number 92. It is assigned the chemical symbol U. A uranium atom has 92 protons and 92 electrons, of which 6 are valence electrons...
without medical supervision and without obtaining written consent.
United States
There have been numerous human experiments performed in the United States, which have been considered unethicalMedical ethics
Medical ethics is a system of moral principles that apply values and judgments to the practice of medicine. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology.-History:Historically,...
, and were often performed illegally, without the knowledge, consent
Consent
Consent refers to the provision of approval or agreement, particularly and especially after thoughtful consideration.- Types of consent :*Implied consent is a controversial form of consent which is not expressly granted by a person, but rather inferred from a person's actions and the facts and...
, or informed consent
Informed consent
Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...
of the test subjects.
Many types of experiments were performed including the deliberately infecting people with deadly or debilitating diseases, exposing people to biological and chemical weapons, human radiation experiments
Human radiation experiments
Since the discovery of ionizing radiation, a number of human radiation experiments have been performed to understand the effects of ionizing radiation and radioactive contamination on the human body, specifically with the element plutonium....
, injecting people with toxic and radioactive chemicals, surgical experiments, interrogation
Interrogation
Interrogation is interviewing as commonly employed by officers of the police, military, and Intelligence agencies with the goal of extracting a confession or obtaining information. Subjects of interrogation are often the suspects, victims, or witnesses of a crime...
/torture
Torture
Torture is the act of inflicting severe pain as a means of punishment, revenge, forcing information or a confession, or simply as an act of cruelty. Throughout history, torture has often been used as a method of political re-education, interrogation, punishment, and coercion...
experiments, tests involving mind-altering substances, and a wide variety of others. Many of these tests were performed on children and mentally disabled individuals. In many of the studies, a large number of the subjects were poor
Poverty
Poverty is the lack of a certain amount of material possessions or money. Absolute poverty or destitution is inability to afford basic human needs, which commonly includes clean and fresh water, nutrition, health care, education, clothing and shelter. About 1.7 billion people are estimated to live...
racial minorities or prisoners
Incarceration
Incarceration is the detention of a person in prison, typically as punishment for a crime .People are most commonly incarcerated upon suspicion or conviction of committing a crime, and different jurisdictions have differing laws governing the function of incarceration within a larger system of...
.
Often, subjects were sick or disabled people, whose doctors told them that they were receiving "medical treatment", but instead were used as the subjects of harmful and deadly experiments, without their knowledge or consent. The ethical, professional, and legal implications of this in the United States medical and scientific community were quite significant, and led to many institutions and policies which attempted to ensure that future human subject research in the United States would be ethical and legal.
Public outcry over the discovery of government experiments on human subjects led to numerous congressional investigations and hearings, including the Church Committee
Church Committee
The Church Committee is the common term referring to the United States Senate Select Committee to Study Governmental Operations with Respect to Intelligence Activities, a U.S. Senate committee chaired by Senator Frank Church in 1975. A precursor to the U.S...
, Rockefeller Commission
United States President's Commission on CIA activities within the United States
The U.S. President's Commission on CIA activities within the United States was set up under President Gerald Ford in 1975 to investigate the activities of the Central Intelligence Agency and other intelligence agencies within the United States...
, and Advisory Committee on Human Radiation Experiments
Advisory Committee on Human Radiation Experiments
The Advisory Committee on Human Radiation Experiments was established in 1994 to investigate questions of the record of the United States government with respect to human radiation experiments. The special committee was created by President Bill Clinton in Executive Order 12891, issued January 15,...
, amongst others. These inquiries have not resulted in prosecutions and not all subjects involved in the trials have been compensated or notified of their participation.
Beecher Paper
In a 1966 paper noted anesthesiologist Henry K. BeecherHenry K. Beecher
Henry Knowles Beecher was an important figure in the history of anesthesiology and medicine, receiving awards and honors during his career. His 1966 article on unethical practices in medical experimentation within the New England Journal of Medicine was instrumental in the implementation of...
described 22 published medical studies where patients had been experimented on with no expected benefit to the patient. In one study, for example, patients infused with live cancer cells had been told they were receiving "some cells" without specifying that they were cancer. Though identities of the authors and institutions had been stripped, the 22 studies were later identified as having been conducted by mainstream researchers and published in prestigious journals within approximately the previous decade. The 22 cases had been selected from a set of 50 that Beecher had collected, and he presented evidence that studies he considered unethical were even more widespread and represented a systemic problem in medical research rather than exceptions. Though Beecher had been writing about human experimentation and publicizing cases that he considered to be bad practice for nearly a decade, it was a 1965 briefing to science writers and the 1966 paper that finally earned widespread news coverage and stimulated public reaction. The paper has been described as "the most influential single paper ever written about experimentation involving human subjects." The Office for Human Research Protections
Office for human research protections
The Office for Human Research Protections is a small office within the United States Department of Health and Human Services that deals with ethical oversight of clinical research conducted by the department, mostly through the National Institutes of Health.The office's primary duty is the...
credits this paper as "ultimately contributing to the impetus for the first NIH and FDA regulations."
In addition to documenting the extent of problems in human subjects research, Beecher was instrumental in formulating the solutions. One common aspect to many of Beecher's cases was that some experimental subjects, such as military personnel and mentally handicapped children in institutions, were not in a position to freely decline consent. Beecher believed that rules requiring informed consent were not by themselves sufficient, as truly informed consent was an unattainable ideal. He worked both in defining the rules and conditions for informed consent and in establishing institutional review board
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
s as an additional layer of oversight regarding research protocols.
Guatemalans used for STD experiments
U.S. scientific researchers infected hundreds of Guatemalan mental patients with sexually transmitted diseases from 1946 to 1948. Researchers from the U.S. Public Health Service conducted experiments on 696 male and female patients housed at Guatemala's National Mental Health Hospital. The scientists injected the patients with gonorrhea and syphilis—and even encouraged many of them to pass the disease on to others. The experiments were done in conjunction with the Guatemalan government. The US Public Health Service carried out the experiments under the guise of syphilis inoculations. When some of the inmates did not contract the disease, the researchers created abrasions on the inmate's body and poured the bacteria into the abrasion. When that failed, they injected the disease straight into the inmates' spines. In 2010 these experiments were revealed by Susan Reverby of Wellesley College who was researching a book on Tuskegee experiments. This led to Secretary of StateUnited States Secretary of State
The United States Secretary of State is the head of the United States Department of State, concerned with foreign affairs. The Secretary is a member of the Cabinet and the highest-ranking cabinet secretary both in line of succession and order of precedence...
Hillary Clinton issuing an official apology. President Barack Obama
Barack Obama
Barack Hussein Obama II is the 44th and current President of the United States. He is the first African American to hold the office. Obama previously served as a United States Senator from Illinois, from January 2005 until he resigned following his victory in the 2008 presidential election.Born in...
apologized to President Álvaro Colom
Álvaro Colom
Álvaro Colom Caballeros is the President of Guatemala for the 2008–2012 term and leader of the social-democratic National Unity of Hope .-Early years:...
who had called these experiments 'a crime against humanity'.
Surgical research
HerophilosHerophilos
Herophilos , sometimes Latinized Herophilus , was a Greek physician. Born in Chalcedon, he spent the majority of his life in Alexandria. He was the first scientist to systematically perform scientific dissections of human cadavers and is deemed to be the first anatomist. Herophilos recorded his...
, the "father of anatomy" and founder of the first medical school
Medical school
A medical school is a tertiary educational institution—or part of such an institution—that teaches medicine. Degree programs offered at medical schools often include Doctor of Osteopathic Medicine, Bachelor/Doctor of Medicine, Doctor of Philosophy, master's degree, or other post-secondary...
in Alexandria
Alexandria
Alexandria is the second-largest city of Egypt, with a population of 4.1 million, extending about along the coast of the Mediterranean Sea in the north central part of the country; it is also the largest city lying directly on the Mediterranean coast. It is Egypt's largest seaport, serving...
, was described by the church leader Tertullian
Tertullian
Quintus Septimius Florens Tertullianus, anglicised as Tertullian , was a prolific early Christian author from Carthage in the Roman province of Africa. He is the first Christian author to produce an extensive corpus of Latin Christian literature. He also was a notable early Christian apologist and...
as having performed surgery on at least 600 live prisoners. In recent times, the wartime programs of Nazi
Nazism
Nazism, the common short form name of National Socialism was the ideology and practice of the Nazi Party and of Nazi Germany...
Dr. Josef Mengele
Josef Mengele
Josef Rudolf Mengele , also known as the Angel of Death was a German SS officer and a physician in the Nazi concentration camp Auschwitz-Birkenau. He earned doctorates in anthropology from Munich University and in medicine from Frankfurt University...
, Shiro Ishii
Shiro Ishii
was a Japanese microbiologist and the lieutenant general of Unit 731, a biological warfare unit of the Imperial Japanese Army responsible for human experimentation and war crimes during the Second Sino-Japanese War.-Early years:...
, founder of the Japan
Japan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
ese military Unit 731
Unit 731
was a covert biological and chemical warfare research and development unit of the Imperial Japanese Army that undertook lethal human experimentation during the Second Sino-Japanese War and World War II. It was responsible for some of the most notorious war crimes carried out by Japanese...
, and Dr. Fukujiro Ishiyama at Kyushu Imperial University Hospital
Kyushu University
Kyushu University is one of the most prestigious universities in Japan. It can be seen in the several rankings such as shown below.-General Rankings:The university has been ranked 8th in 2010 and 2009 in the ranking "Truly Strong Universities" by Toyo Keizai...
, conducted surgery on concentration camp prisoners in their respective countries during World War II
World War II
World War II, or the Second World War , was a global conflict lasting from 1939 to 1945, involving most of the world's nations—including all of the great powers—eventually forming two opposing military alliances: the Allies and the Axis...
.
In November 2006, Doctor Akira Makino confessed to Kyodo news having performed surgery and amputations on condemned prisoners, including women and children in 1944 and 1945 while he was stationed on Mindanao
Mindanao
Mindanao is the second largest and easternmost island in the Philippines. It is also the name of one of the three island groups in the country, which consists of the island of Mindanao and smaller surrounding islands. The other two are Luzon and the Visayas. The island of Mindanao is called The...
. In 2007, Doctor Ken Yuasa
Ken Yuasa
Ken Yuasa was a World War II surgeon for the Japanese army. During his service in occupied China he conducted vivisections on Chinese prisoners and civilians, and provided typhoid and dysentery bacillus to the Japanese army for use in biological warfare...
testified to The Japan Times
The Japan Times
The Japan Times is an English language newspaper published in Japan. Unlike its competitors, the Daily Yomiuri and the International Herald Tribune/Asahi Shimbun, it is not affiliated with a Japanese language media organization...
that he believes at least 1,000 persons working for the Shōwa
Showa period
The , or Shōwa era, is the period of Japanese history corresponding to the reign of the Shōwa Emperor, Hirohito, from December 25, 1926 through January 7, 1989.The Shōwa period was longer than the reign of any previous Japanese emperor...
regime, including surgeons, did surgical research in mainland China.
The use of the term vivisection when referring to procedures performed on humans almost always implies a lack of consent. Human volunteers can consent to be subjects for invasive experiments which may involve, for example, the taking of tissue samples (biopsies
Biopsy
A biopsy is a medical test involving sampling of cells or tissues for examination. It is the medical removal of tissue from a living subject to determine the presence or extent of a disease. The tissue is generally examined under a microscope by a pathologist, and can also be analyzed chemically...
), or other procedures which require surgery on the volunteer. These procedures must be approved by ethical review, and carried out in an approved manner that minimizes pain and long term health risks to the subject.
Questionable psychological experiments
Several experiments have been conducted on consenting volunteers whose ethical nature is now considered questionable. Following exposure of these experiments, rules regarding informed consentInformed consent
Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...
have been tightened.
- The Milgram experimentMilgram experimentThe Milgram experiment on obedience to authority figures was a series of notable social psychology experiments conducted by Yale University psychologist Stanley Milgram, which measured the willingness of study participants to obey an authority figure who instructed them to perform acts that...
, in which many subjects were shown they were capable of inflicting discomfort (by electric shock) on other humans if under orders to do so - The Stanford prison experimentStanford prison experimentThe Stanford prison experiment was a study of the psychological effects of becoming a prisoner or prison guard. The experiment was conducted from August 14th-20th, 1971, by a team of researchers led by psychology professor Philip Zimbardo at Stanford University...
, in which many participants became violent and abusive of each other. - The Monster StudyThe Monster StudyThe Monster Study is the name given to a stuttering experiment performed on twenty-two orphan children in Davenport, Iowa in 1939. It was conducted by Wendell Johnson at the University of Iowa. Johnson chose one of his graduate students, Mary Tudor, to conduct the experiment and he supervised her...
that was conducted on orphans in 1939 in an attempt to induce stutteringStutteringStuttering , also known as stammering , is a speech disorder in which the flow of speech is disrupted by involuntary repetitions and prolongations of sounds, syllables, words or phrases, and involuntary silent pauses or blocks in which the stutterer is unable to produce sounds...
.
Declaration of Helsinki
In 1964, the World Medical AssociationWorld Medical Association
The World Medical Association is an international and independent confederation of free professional Medical Associations, therefore representing physicians worldwide...
published a code of research ethics, the Declaration of Helsinki
Declaration of Helsinki
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association . It is widely regarded as the cornerstone document of human research ethics...
. It was based on the Nuremberg Code, focusing on medical research with therapeutic intent. Subsequently, medical professionals and researches begun requiring that research follows the principles outlined in the Declaration. This document was one of the milestones towards the implementation of the institutional review board
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
(IRB) process.
Belmont Report
The Tuskegee syphilis experiment was among the most influential in shaping public perceptions of research involving human subjects. When the press exposed the study, the US Congress appointed a panel that determined that the PHS Syphilis Study should be stopped immediately and that overseeing of human research was inadequate. The panel recommended that federal regulations be designed and implemented to protect human research subjects in the future. Subsequently, the National Research Act of 1974 led to regulations now referred to as the "common rule," a group of similar requirements that cover the various forms of clinical research.In 1974, the United States Congress ordered the creation of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. Its goal was to identify the basic ethical principles that affect the decision to use human research subjects and to develop guidelines to assure that human research is conducted in accordance with those principles.
The result of the National Commission's work was the Belmont Report
Belmont Report
The Belmont Report is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission...
published in 1979. It identifies three basic ethical principles that underlie human experimentation (the Belmont Principles):
- Respect for persons
- Beneficence
- Justice
APA Ethics Code
The American Psychological AssociationAmerican Psychological Association
The American Psychological Association is the largest scientific and professional organization of psychologists in the United States. It is the world's largest association of psychologists with around 154,000 members including scientists, educators, clinicians, consultants and students. The APA...
(APA) has a documented ethics code pertaining to the practice of psychology
Psychology
Psychology is the study of the mind and behavior. Its immediate goal is to understand individuals and groups by both establishing general principles and researching specific cases. For many, the ultimate goal of psychology is to benefit society...
and associated research. This document contains great guidelines for the use of deception in research. For members of the APA, these are hard requirements levied against their membership. They are also requirements for any research project conducted, funded, or managed by the APA.
Research funded by the United States government
Title 45 Code of Federal Regulations, Part 46 (45 CFR 46) is the primary set of Federal regulations regarding the protection of human subjects in research and is often referred to as the common rule. It defines the laws, criteria for exemption, as well as definition and formulation of institutional review boardInstitutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
s, though some agencies have established their own implementation of this code that supersedes portions or all of 45 CFR 46. The Department of Defense
United States Department of Defense
The United States Department of Defense is the U.S...
uses CFR 46 but has different exemption criteria. The Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
also applies a modified code that is associated with research into development of any food, drug, or medical devices.
The code establishes what is required to be considered research activities, and for participants to be considered human subjects of research. The definitions are written as such to include situations where the human is the subject of the experiment, their environment is manipulated by the researchers, and data regarding their responses are collected. If the project does not meet these definitions (or there is minimal risk to participants) then the project is exempt from IRB review and the requirements of informed consent
Informed consent
Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...
. Generally this decision is made and documented by an IRB. The common rule also provides definitions regarding whether institutions are engaged in research, interaction between investigators and subjects, what an intervention is, and what information subjects can expect to remain private.
External links
- Nuremberg Code
- Belmont Report
- Declaration of Helsinki, 6th edition
- Universal Declaration on Bioethics and Human Rights by UNESCOUNESCOThe United Nations Educational, Scientific and Cultural Organization is a specialized agency of the United Nations...