(Lim, 1990)[2] As defined by HHS regulations (45 CFR 46.102): In 2010, the National Institute of Justice in the United States published recommended rights of human subjects: The term research subject has traditionally been the preferred term in professional guidelines and academic literature to describe a patient or an individual taking part in biomedical research.
In recent years, however, there has been a steady shift away from the use of the term 'research subject' in favour of 'research participant' when referring to individuals who take part by providing data to various kinds of biomedical and epidemiological research.
[9] In 1947, German physicians who conducted deadly or debilitating experiments on concentration camp prisoners were prosecuted as war criminals in the Nuremberg Trials.
A portion of the verdict handed down in the doctors' trial became commonly known as the Nuremberg Code, the first international document to clearly articulate the concept that "the voluntary consent of the human subject is absolutely essential".
[14] The selection process of the subject is supposed to be fair and not separate due to race, sexual orientation or ethnic group.
[citation needed] Ann Cook and Freeman Hoas from the University of Montana's Department of Psychology conducted a study[18] to gain more understanding about what influences potential candidates to consent to participation in any given clinical trial.
"[18] Cook and Hoas found that most of the physicians and coordinators could not explain directly if they actually told their patients or subjects about any financial compensation they received.
Respondents worry that discussing funding or compensation would affect enrollment, effectively swaying participants from joining a research study.
When asked if information about funding or compensation would be important to provide to patients, one physician replied "...certainly it may influence or bring up in their mind questions whether or not, you know, we want them to participate because we're gonna get paid for this, you know, budget dollar amount.
"[18] Typical ethical issues that arise in this type of research trials include participant enrollment, the question of coercion if a physician refers their own patients, and any misunderstandings regarding treatment benefits.
[citation needed] Most of the coordinators and researchers showed some hesitation when they were asked if they would enroll as a subject in a clinical trial, not necessarily their own, but any study.
Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory.
For example, a clinical drug trial case at the University of Minnesota that was under investigation in 2015[23] for the Death of Dan Markingson was funded by AstraZeneca, a pharmaceutical company headquartered in the United Kingdom.
[25] In 1961, Yale University psychologist Stanley Milgram led a series of experiments to determine to what extent an individual would obey instructions given by an experimenter.
[26][27] Although many participants questioned the experimenter and displayed various signs of discomfort, when the experiment was repeated, 65 percent of subjects were willing to obey instructions to administer the shocks through the final one.
[28] Psychologist Solomon Asch's classic conformity experiment in 1951 involved one subject participant and multiple confederates; they were asked to provide answers to a variety of different low-difficulty questions.
[30] A classic advocate of realistic conflict theory, Muzafer Sherif's Robber's Cave experiment shed light on how group competition can foster hostility and prejudice.
[32] Human subjects have been commonly used in experiments testing the theory of cognitive dissonance after the landmark study by Leon Festinger and Merrill Carlsmith.
All the subjects had to do was simply inform the next "student" waiting outside the testing area (who was secretly a confederate) that the tasks involved in the experiment were interesting and enjoyable.
A subsequent survey showed that, by a large margin, those who received less money for essentially "lying" to the student came to believe that the tasks were far more enjoyable than their highly paid counterparts.
Privacy, confidentiality, and informed consent are key concerns, yet it is unclear when social media users qualify as human subjects.
It is nevertheless a matter of concern that the collection of the data by Facebook may have involved practices that were not fully consistent with the principles of obtaining informed consent and allowing participants to opt out.
"[38] Moreno et al.'s recommended considerations for social media research are: 1) determine if the study qualifies as human subject research, 2) consider the risk level of the content, 3) present research and motives accurately when engaging on social media, 4) provide contact information throughout the consent process, 5) make sure data is not identifiable or searchable (avoid direct quotes that may be identifiable with an online search), 6) consider developing project privacy policies in advance, and 7) be aware that each state has its own laws regarding informed consent.
It has been performed by countries including Nazi Germany, Imperial Japan, North Korea, the United States and the Soviet Union.
Examples include Project MKUltra, Unit 731, Totskoye nuclear exercise,[43] the experiments of Josef Mengele, and the human experimentation conducted by Chester M. Southam.
[44] During the Nuremberg Trials, 23 Nazi doctors and scientists were prosecuted for the unethical treatment of concentration camp inmates, who were often used as research subjects with fatal consequences.
[45] Unit 731, a department of the Imperial Japanese Army located near Harbin (then in the puppet state of Manchukuo, in northeast China), experimented on prisoners by conducting vivisections, dismemberments, and bacterial inoculations.
Millions of people, especially women, underwent sterilization surgeries without their informed consent, often under pressure from local authorities or in exchange for government services.
[52] Some pharmaceutical companies have been accused of conducting clinical trials of experimental drugs in Africa without the informed consent of participants or without providing adequate access to healthcare.
[53] Psychological experiments have also faced ethical criticism due to their manipulation of participants, inducing stress, anxiety, or other forms of emotional distress without informed consent.