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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, 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. 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)

Ethical Guidelines
Ethical guidelines with regards to the use of human subjects in research are a fairly new construct. It wasn’t until 1906 that specific regulations were put in place to protect subjects from abuses. After 1906, after the passage of the Pure Food and Drug Act, systems were gradually institutionalized such as the Food and Drug Administration (FDA) and Institutional Review Board (IRB). Most notably, these policies were instituted becuase of the necessity to regulate experiments that put a subject's wellbeing at risk both mentally and physically.

Nuremberg Code
In 1948, proceeding the Nuremberg Trials against German physicians who conducted experiments on concentration camp prisoners that had devastating consequences which included deformity and death, the Nuremberg Code was established. It stated, "The voluntary consent of the human subject is absolutely essential (citation).” In establishing individual consent, the Nuremberg Code (which was an international document) was aimed at ensuring that participants were informed of the risk-benefit outcomes of experiments and were given the ability to choose accordingly (citation).

Kefauver-Harris Drug Amendment
In 1962, the Kefauver-Harris Drug Amendment was passed by the United States Congress. This amendment made changes to the Federal Food Drug & Consumer Act by now requiring drug companies to prove both safety and effectiveness of their products. Also, from then on drugs were then required to have FDA approval before they could be marketed to consumers, a requirement of informed participation consent and also rules were established for the investigation of drugs. (citation) This regulation was put in place after the 1950 thalidomide incident in Western Europe where pregnant mothers were prescribed the sedative thalidomide which was marketed as sleeping pills lead to the deformity of over 12,000 newborns. (citation)

Declaration of Helsinki
The Declaration of Helsinki was established in 1964 as a means of governing international research. Established by the World Medical Association, the declaration recommended guidelines for medical biomedical research where human subjects were involved. (citation) Some of these guidelines included the principles that “research protocols should be reviewed by an independent committee prior to initiation and that “research with humans should be based on results from laboratory animals and experimentation” (citation)

National Research Act/Belmont Report
As a consequence of the political outcomes of the Tuskegee Syphilis Project, the National Research Act was passed in 1974. The creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was a direct consequence of this law. It was this governing body that was responsible for drafting the Belmont Report (citation). The Belmont Report laid the foundation for ethical standards in the United States. The three tenants that it established were respect for persons, beneficence, and justice (SOCRA).

Subject Rights
These rights are a culmination of the principles that are governed by the previous ethical guidelines: •Voluntary, informed consent •Respect for persons: treated as autonomous agents (history of) •The right to end participation in research (SOCRA) •Right to safeguard integrity (SOCRA) •Benefits should outweigh cost: fair distribution of cost to benefit ratio •Subjects should not be harmed (physically or otherwise) •Access to information regarding research (SOCRA)

Human Subject 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 ethnic and racial minorities, 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.

Abuses 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.

US Pharmaceutical Outsourcing & Subject Abuses
The passage of ethical guidelines, including the ones named in the ethical guidelines section of this article have made clinical trials and human subject research more complex, time consuming and expensive. (Shah) In response to the red tape that these regulations have imposed, such as FDA approval before drugs can be placed on the market, many American pharmaceutical companies including Pfizer, Eli Lilly, Merck, Novartis and Astra Zeneca have outsourced clinical trials to developing regions including Latin America, Africa and Asia (Shah/Adobor). Pharmaceutical giant Pfizer came under fire in 2001 for allegedly testing meningitis drugs on Nigerian children.

Global Abuses
In Sweden, the Vipeholm experiments 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. 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.

Ongoing human subject abuse

 * North Korea: Alleged North Korean human experimentation

Guidelines
Various guidelines have been proposed for governing different aspects of human subject research. Among the most influential of these guidelines are the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report.