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Research Subject Information

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.

Contents

Definition of a human subject

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)

History

Roman

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.

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 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.[1]

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.[2]

Infamous cases of human subjects abuse in the 20th century were conducted by (Unit 731) in Imperial Japan 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.

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-experimentation.

World War II

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.[3] 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).[4]

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.[5] 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.[6]

After World War II

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.[7]

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.[8]

United States

Main article: Unethical human experimentation in the United States

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.

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.

Beecher Paper

In a 1966 paper noted anesthesiologist Henry K. Beecher described 22 published medical studies where patients had been experimented on with no expected benefit to the patient.[9] 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.[9][10] 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.[10][11] The paper has been described as "the most influential single paper ever written about experimentation involving human subjects."[12] The Office for Human Research Protections credits this paper as "ultimately contributing to the impetus for the first NIH and FDA regulations."[13]

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.[10] 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 boards as an additional layer of oversight regarding research protocols.[10][11]

Guatemalans used for STD experiments

Main article: Syphilis experiments in Guatemala

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 State Hillary Clinton issuing an official apology.[14] President Barack Obama apologized to President Álvaro Colom who had called these experiments 'a crime against humanity'.[15]

Surgical research

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.[16] 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.[17]

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.[18] 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.[19]

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.[20]

Tuskegee syphilis experiment

Main article: Tuskegee syphilis experiment

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 consent have been tightened.

Ongoing human subject abuse

Guidelines

This section may require cleanup to meet Wikipedia's quality standards. (Consider using .) Please improve this section if you can. The talk page may contain suggestions. (February 2010)

Declaration of Helsinki

Main article: Declaration of Helsinki

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.[21]

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 published in 1979. It identifies three basic ethical principles that underlie human experimentation (the Belmont Principles):

APA Ethics Code

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.[22]

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.[23][24] It defines the laws, criteria for exemption, as well as definition and formulation of institutional review boards, 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.

See also

Notes

  1. ^ Rothman, DJ (1992). Strangers at the bedside: a history of how law and bioethics transformed medical decision making. Basic Books. pp. 21. ISBN 0465082106.
  2. ^ Brady, JV; Jonsen AR (1982). "The Evolution of Regulatory Influences on Research with Human Subjects". In Greenwald RA et al.. Human Subjects Research: A Handbook for Institutional Review Boards. New York: Plenum Press. pp. 4.
  3. ^ Gold, H (2003). Unit 731 Testimony (5 ed.). Tuttle Publishing. pp. 109. ISBN 0804835659.
  4. ^ Mitscherlich, A; Mielke F (1992). "Epilogue: Seven Were Hanged". In Annas GJ & Grodin MA. The Nazi Doctors And The Nuremberg Code - Human Rights in Human Experimentation. New York: Oxford University Press. pp. 105-107.
  5. ^ "Report: Britain Tested Chemical Weapons on Indian Colonial Troops". Voice of America. 2007-09-02. http://www.voanews.com/english/news/a-13-2007-09-02-voa11.html. Retrieved 2011-06-02.
  6. ^ "Hidden history of US germ testing". BBC News. 2006-02-13. http://news.bbc.co.uk/2/hi/programmes/file_on_4/4701196.stm. Retrieved 2010-05-04.
  7. ^ "Nigerians angered by drugs trial delay". BBC News. July 30, 2001. http://news.bbc.co.uk/1/hi/world/africa/1465532.stm. Retrieved May 4, 2010.
  8. ^ "Ex-staffer at Dimona nuclear reactor says made to drink uranium". Haaretz.com. 2009-01-01. http://www.haaretz.com/hasen/spages/1107980.html. Retrieved 2009-08-19.
  9. ^ a b Beecher, HK (1966). "Ethics and Clinical Research" (pdf). New England Journal of Medicine 274 (24): 1354–1360. doi:10.1056/NEJM196606162742405. PMID 5327352. http://www.who.int/docstore/bulletin/pdf/2001/issue4/vol79.no.4.365-372.pdfReprint in Harkness, Lederer & Wikler, 2001, PMID 11357216
  10. ^ a b c d Rothman, D. J. (1987). "Ethics and Human Experimentation" (pdf). New England Journal of Medicine 317 (19): 1195–1199. doi:10.1056/NEJM198711053171906. PMID 3309660. http://tracerkinetics.engr.iupui.edu/emorris_web/Ethics%20Course%2009/Journal%20articles/Ethics%20and%20Human%20Experimentation%20Henry%20Beecher%20revisited.pdf.
  11. ^ a b Kopp, V. (1999). "Henry Knowles Beecher and the development of informed consent in anesthesia research". Anesthesiology 90 (6): 1756–1765. PMID 10360876. http://journals.lww.com/anesthesiology/Fulltext/1999/06000/Henry_K__Beecher__The_Introduction_of_Anesthesia.34.aspx.
  12. ^ Harkness, J.; Lederer, S.; Wikler, D. (2001). "Laying ethical foundations for clinical research" (pdf). Bulletin of the World Health Organization 79 (4): 365–366. PMC 2566394. PMID 11357216. http://www.who.int/docstore/bulletin/pdf/2001/issue4/vol79.no.4.365-372.pdf.
  13. ^ "History of the Human Subjects Protection System". Institutional Review Board Guidebook. Office for Human Research Protections. 1993. http://www.hhs.gov/ohrp/archive/irb/irb_introduction.htm. Retrieved 2011-06-03.
  14. ^ "U.S. Apologizes for Syphilis Experiment". The New York Times. 1 October 2010. http://www.nytimes.com/reuters/2010/10/01/world/americas/news-us-usa-guatemala-experiment.htm. Retrieved 2 October 2010.
  15. ^ "US medical tests in Guatemala 'crime against humanity'". BBC News. 1 October 2010. http://www.bbc.co.uk/news/world-us-canada-11457552. Retrieved 2 October 2010.
  16. ^ Tertullian (in Latin), De Anima, The Latin Library, http://www.thelatinlibrary.com/tertullian/tertullian.anima.shtml#10.4 chapter 10.4. Also Peter Holmes, D.D., ed. (in English), A Treatise on the Soul, Early Christian Writings, http://www.earlychristianwritings.com/text/tertullian10.html, retrieved 10 July 2011
  17. ^ Barenblatt, Daniel (2003). A Plague Upon Humanity. London: HarperCollins. ISBN 0060933879.
  18. ^ "Japanese doctor admits POW abuse". BBC News. 26 November 2006. http://news.bbc.co.uk/2/hi/americas/6185442.stm.
  19. ^ Hongo, Jun. "Vivisectionnist recalls his day of reckoning". The Japan Times. http://search.japantimes.co.jp/cgi-bin/nn20071024w1.html. "I was afraid during my first vivisection, but the second time around, it was much easier. By the third time, I was willing to do it."
  20. ^ http://www.health.vic.gov.au/ethics/downloads/module1f_march05.doc
  21. ^ Shamoo, A.; Irving, D. (1993). "Accountability in research using persons with mental illness". Accountability in Research 3 (1): 1–17. doi:10.1080/08989629308573826. PMID 11659726.
  22. ^ "Ethical Principles of Psychologists and Code of Conduct". American Psychological Association. 2010-06-01. http://www.apa.org/ethics/code/index.aspx. Retrieved 2011-06-01.
  23. ^ "Regulations". Office for Human Research Protections. http://www.hhs.gov/ohrp/humansubjects/index.html. Retrieved 1 June 2011.
  24. ^ "Human Subjects Research (45 CFR 46)". Office for Human Research Protections. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. Retrieved 1 June 2011.

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