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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, 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.
Contents |
In biostatistics 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)
Systematic experimentation and quantification were introduced into the study of physiology in 1025, by the influential Persian Muslim physician, Avicenna (Ibn Sina), in The Law of Medicine (Al-qanun fi al-tibb).[1] He also introduced the use of biomedical research,[2] clinical trials,[3] randomized controlled trials,[4][5] drug tests[2] and efficacy tests[6][7] on human subjects.
Human dissections were carried out by Ibn Zuhr (Avenzoar),[8] who introduced the use of experimentation in surgery during the 12th century,[9][10] as well as Ibn Tufail[11] and Saladin's physician Ibn Jumay in the 12th century, Abd-el-latif in 1200,[12] and Ibn al-Nafis in the 13th century.[13]
HSR experiments were recorded during vaccination trials in the 1700s. 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 experiments, in which he first tested smallpox vaccines on his son and neighbourhood children. In an instance of self-experimentation, Johann Jorg swallowed 17 drugs in various doses to record their properties. Conversely, the famous scientist Louis Pasteur "agonized over treating humans," though he was confident of previous results obtained through extensive animal trials. He consented to treat a human only when he was convinced that the death of his first test subject, the child Joseph Meister, "appeared inevitable." (Rothman 1993)
In the 1900s, 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 well-known experiments to develop an inoculation for yellow fever led these advances. Reed's vaccine experiments were carefully scrutinized, however, unlike earlier trials. (Brady 1982)
The infamous cases of human subjects abuse in the 20th century was Nazi experimentation, an example of research involving prisoners which came to light in the Nuremberg Doctors' trial and led to the Nuremberg Code of ethical human subjects research conduct. 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.
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-experimentation.
Unit 731, a department of the Imperial Japanese Army located near Harbin (Manchukuo), 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 Ishii and all members of the units in exchange for all of the results.[14] The United States blocked Soviet access to this information. However, some unit members were judged by the Soviets during the Khabarovsk War Crime Trials.
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.[15][16][17][18]
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.[19]
In Sweden, the Vipeholm experiments were conducted, where retarded 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 African children.[20] 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.[21]
There have been numerous human experiments performed in the United States, which have been considered unethical, 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.
Many of these experiments were funded by the United States government, especially the Central Intelligence Agency and the United States military. The human research programs were usually highly secretive, and in many cases information about them was not released until many years after the studies had been performed.
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. However, as of 2010, not a single U.S. government researcher has been prosecuted for human experimentation, and many of the victims of U.S. government experiments have not received retribution, or in many cases, even acknowledgement of what was done to them.
Herophilos, 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.[citation needed] In recent times, the wartime programs of Nazi Dr. Josef Mengele, Shiro Ishii, founder of the Japanese 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.[22]
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.[23] 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.[24]
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.[25] Despite this, the term is generally recognized as pejorative: one would never refer to life-saving surgery, for example, as "vivisection."[citation needed]
Several experiments have been conducted on consenting volunteers whose ethical nature is now considered questionable. Following exposure of these experiments, rules regarding informed consent have been tightened.
In 1964, the World Medical Association developed a code of research ethics that came to be known as the Declaration of Helsinki. It was a reinterpretation of the Nuremberg Code, with an eye to medical research with therapeutic intent. Subsequently, journal editors required that research be performed in accordance with the Declaration. This document set the stage for the implementation of the Institutional Review Board (IRB) process. (Shamoo & Irving 1993)
In 1966, anaesthesiologist Dr. Henry K. Beecher wrote an article, "Ethics and Clinical Research," describing 22 examples of research studies with controversial ethics that had been conducted by reputable researchers and published in major journals. Beecher wrote, "Medicine is sound, and most progress is soundly attained..." He believed, however, that if unethical research were not prohibited it would "do great harm to medicine." Beecher provided estimates of the number of unethical studies and concluded "unethical or questionably ethical procedures are not uncommon." (Beecher 1966)
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 authorised the formation of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, known to most people in research ethics as the National Commission. Congress charged the National Commission with the task of identifying the basic ethical principles that affect the decision to use, or to not use, human research subjects. To accomplish this task, the National Commission looked at writings and discussions that had taken place to date and asked, "What are the basic ethical principles that are used to judge the ethics of human subject research?" Congress also asked the National Commission to develop guidelines to assure that human research is conducted in accordance with those principles.
In 1979, the National Commission met and published the Belmont Report. The Belmont Report is required reading for everyone involved in human experimentation. The Belmont Report identifies three basic ethical principles that underlie human experimentation. These principles are commonly called the Belmont Principles. The Belmont Principles include:
The Council for International Organizations of Medical Sciences (CIOMS) has written an International Ethical Guidelines for Biomedical Research Involving Human Subjects. .....
The American Psychological Association (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.
The following policies codify requirements that must be followed for any research conducted or supported by the US Federal Government.
This is the US codifitation of regulated policy based on the guidelines of the Belmont Report. It combines and supersedes previous disparate regulatory codes.
Just because a project involves the use of human participants does not mean it constitutes human subject research. The activities must meet the definition of research, and the use of the human participants must meet the definition of human subjects. 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 the definition of Human Subject Research, then the requirements do not apply, and the project does not require an IRB review or informed consent. However, it is best to have an IRB make this determination and document the decision.
If a project is defined as Human Subject Research, it may still be considered Exempt. This generally means that the project is minimal risk, and the requirements do not apply. The protocol for the project must meet one of the exempt categories defined in the Common Rule. By definition then, an IRB does not need to perform a full review on the project, and informed consent is not required. However, again, an IRB needs to make this determination and document the decision. In these situations, the guidelines in the Belmont Report should still be followed since it is still Human Subject Research.
"Students of the history of medicine know him for his attempts to introduce systematic experimentation and quantification into the study of physiology".
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, 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.
Contents |
In biostatistics 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)
Aulus Cornelius Celsus, 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.
| This section may contain inappropriate or misinterpreted citations that do not verify the text. Please help improve this article by checking for inaccuracies. (help, talk, get involved!) (September 2010) |
The influential Persian Muslim physician, Avicenna (Ibn Sina) introduced the use of biomedical research,[1] clinical trials,[2] randomized controlled trials,[3][4] drug tests[1] and efficacy tests[5][6] on human subjects.
Human dissections were carried out by Ibn Zuhr (Avenzoar),[7] who introduced the use of experimentation in surgery during the 12th century,[8][9] as well as Ibn Tufail[10] and Saladin's physician Ibn Jumay in the 12th century, Abd-el-latif in 1200,[11] and Ibn al-Nafis in the 13th century.[12]
HSR 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 experiments. where he tested smallpox vaccines on his son and neighbourhood children. In an instance of self-experimentation, Johann Jorg swallowed 17 drugs in various doses to record their properties. Conversely, the famous scientist Louis Pasteur "agonized over treating humans" and consented to treat a human only when he was convinced that the death of his first test subject, the child Joseph Meister, "appeared inevitable."[13]
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.[14]
Infamous cases of human subjects abuse in the 20th century were conducted by 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.
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-experimentation.
Unit 731, a department of the Imperial Japanese Army located near Harbin (Manchukuo), 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.[15] The United States blocked Soviet access to this information. However, some unit members were judged by the Soviets during the Khabarovsk War Crime Trials.
At the end of 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 by, 8 received prison sentences from 10 years to life, and 8 were acquitted (see the Doctors' Trial).[16]
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.[17][18][19][20]
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.[21]
In Sweden, the Vipeholm experiments were conducted, where retarded 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.[22]
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.[23]
There have been numerous human experiments performed in the United States, which have been considered unethical, 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.
Many of these experiments were funded by the United States government, especially the Central Intelligence Agency and the United States military. The human research programs were usually highly secretive, and in many cases information about them was not released until many years after the studies had been performed. Human subject research of children by the government and others have been alleged by several survivors.[24][25][26]
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.
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 lead to Secretary of State Hillary Clinton issuing an official apology.[27] President Barack Obama apologized to President Álvaro Colom who had called these experiments 'a crime against humanity'.[28]
Herophilos, 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.[citation needed] In recent times, the wartime programs of Nazi Dr. Josef Mengele, Shiro Ishii, founder of the Japanese 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.[29]
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.[30] 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.[31]
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.[32] Despite this, the term is generally recognized as pejorative: one would never refer to life-saving surgery, for example, as "vivisection."[citation needed]
Several experiments have been conducted on consenting volunteers whose ethical nature is now considered questionable. Following exposure of these experiments, rules regarding informed consent have been tightened.
| This section may require cleanup to meet Wikipedia's quality standards. Please improve this section if you can. The talk page may contain suggestions. (February 2010) |
In 1964, the World Medical Association 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.[33]
In 1966, anesthesiologist Dr. Henry K. Beecher published an article, "Ethics and Clinical Research". Beecher estimated that "unethical or questionably ethical procedures are not uncommon" and in detail outlined 22 examples of controversial studies that have been published in major journals. Beecher wrote, "Medicine is sound, and most progress is soundly attained..." He believed that unethical research is not "sound" and instead it can "do great harm to medicine."[34]
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 published in 1979. It identifies three basic ethical principles that underlie human experimentation (the Belmont Principles):
The Council for International Organizations of Medical Sciences (CIOMS) has written an International Ethical Guidelines for Biomedical Research Involving Human Subjects. .....
The American Psychological Association (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.
The following policies codify requirements that must be followed for any research conducted or supported by the US Federal Government.
This is the US codifitation of regulated policy based on the guidelines of the Belmont Report. It combines and supersedes previous disparate regulatory codes.
Just because a project involves the use of human participants does not mean it constitutes human subject research. The activities must meet the definition of research, and the use of the human participants must meet the definition of human subjects. 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 the definition of Human Subject Research, then the requirements do not apply, and the project does not require an IRB review or informed consent. However, it is best to have an IRB make this determination and document the decision.
If a project is defined as Human Subject Research, it may still be considered Exempt. This generally means that the project is minimal risk, and the requirements do not apply. The protocol for the project must meet one of the exempt categories defined in the Common Rule. By definition then, an IRB does not need to perform a full review on the project, and informed consent is not required. However, again, an IRB needs to make this determination and document the decision. In these situations, the guidelines in the Belmont Report should still be followed since it is still Human Subject Research.
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