Human subject research is systematic, scientific investigations that may be either intervention ("experiment") or observation (no "test articles") and involve humans as research subjects. Human subject research can be either medical (clinical) or non-medical (eg, social studies) research. Systematic investigations combine data collection and analysis to answer specific questions. Research on human medical subjects often involves the analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. (The type of research on specific human medical subjects, and especially highly regulated, is "clinical trials", in which medications, vaccines and medical equipment are evaluated.) On the other hand, human subject studies in social science often involve surveys consisting of questions to a group certain people. Survey methodologies include questionnaires, interviews, and focus groups.
Research on human subjects is used in a variety of fields, including basic biology research, clinical medicine, nursing, psychology, sociology, political science, and anthropology. When research has become formal, the academic community has developed a formal definition of "human subject research", largely in response to violations of human subjects.
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The Department of Health and Human Services of the United States (HHS) defines the subject of human research as a living individual on whom the researcher (whether a professional or a student) obtains data through 1) intervention or interaction with the individual, or 2) identifiable personal information > 32 CFR 219.102 (f) ). (Lim, 1990)
As defined by HHS regulations:
"Interventions" - the physical procedures by which data are collected and the manipulation of their subject and/or environment for research purposes [ 45 C.F.R. 46.102 (f) ]
"Interaction" - communication or interpersonal contact between the investigator and the subject [ 45 C.F.R. 46.102 (f) ])
"Personal Information" - information about behavior occurring in contexts in which an individual can reasonably expect that no observation or record-keeping takes place, and information provided for a particular purpose by an individual and which may be expected by an individual will not be made public [ 45 CFR 46.102 (f) ])]]
"Identified information" - specific information that can be used to identify individuals.
Humanity rights
In 2010, the National Institute of Justice in the United States published the rights recommended for human subjects:
- Volunteerism, informed consent
- Respect for people: treated as autonomous agents
- Right to terminate participation in research anytime
- Right to maintain integrity
- Benefits must be greater than cost
- Protection from physical, mental and emotional disturbance
- Access to research information
- Privacy and welfare protection
Maps Human subject research
Ethics guidelines
The ethical guidelines that govern the use of human subjects in research are fairly recent constructions. In 1906 some regulations were enacted in the United States to protect the subject from infringement. After the passage of the Food and Drug Act in 1906, regulatory bodies such as the Food and Drug Administration (FDA) and the institutional review board (IRB) were introduced gradually. The policies adopted by these institutions serve to minimize the physical and/or physical harm of participants.
Nuremberg Code
In 1947, German doctors who conducted lethal or debilitating experiments on concentration camp prisoners were prosecuted as war criminals in the Nuremberg Trials. That same year, the Allies established the Nuremberg Code, the first international document to support the concept that "the voluntary consent of human subjects is of paramount importance". Individual consent is emphasized in the Nuremberg Code to prevent prisoners of war, patients, prisoners, and soldiers from being forced into human subjects. In addition, it is emphasized to inform participants about the benefit-risk outcome of the experiment.
Helsinki Declaration
The Helsinki Declaration was established in 1964 to organize international research involving human subjects. Established by the World Medical Association, this declaration recommends guidelines for physicians conducting biomedical research involving human subjects. Some of these guidelines include the principle that "research protocols should be reviewed by an independent committee before initiation" and that "research with humans should be based on the results of laboratory animals and experiments".
The Helsinki Declaration is widely regarded as a grounding document on the ethics of human research.
Belmont Report
The Belmont report was created by the National Commission for the Protection of Human Subjects of Biomedical Research and Behavior to describe ethical behavior that involves the study of human subjects. By looking primarily at biomedical and behavioral research involving human subjects, a report was made to promise that ethical standards were followed during the study of human subjects. There are three standards that serve as the basis for the report and how human subjects should be examined.. The three guidelines are goodness (ethics), justice, and respect for people. Beneficence (ethics) is described as protecting people's well-being and respecting their decisions by being ethical and protecting the subject from harm. Two good rules are to maximize the benefits of research and minimize the risks that may occur. It is the researcher's job to inform people about the benefits and risks of human subject research. Justice is important because it causes researchers to be fair in their research findings and share what they find, whether the information is good or bad. The subject selection process should be fair and not separate because of race, sexual orientation or ethnic groups. Lastly, respect for people explains that at some point someone involved in the research can decide whether they want to participate, not participate or withdraw from the study at all. Two rules of respect for people involve autonomous people and people with reduced autonomy and are entitled to protection. The sole purpose of these guidelines is to ensure autonomy and to protect against those who have lower chances to remain autonomous because something is out of their control..
Clinical test
Clinical trials are experiments conducted in clinical studies. Biomedical research studies or prospective behaviors such as human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as new vaccines, drugs, dietary options, dietary supplements, and medical devices) and known interventions that guarantee research Furthermore. and comparison. Clinical trials yield data on safety and efficacy. They are performed only after they receive the approval of the health authority/ethics committee in the country where treatment approval is sought. These authorities are responsible for checking the risk/benefit ratio of their trial - their approval does not mean that the therapy is 'safe' or effective, only that a trial can be conducted.
Depending on the product type and development stage, the researchers initially enrolled volunteers and/or patients into small pilot studies, and then conducted a larger, progressive scale comparison study. Clinical trials may vary in size and cost, and they may involve a research center or multiple centers, in one country or in several countries. The design of clinical research aims to ensure scientific validity and reproducibility of results.
Experiments can be very expensive, depending on a number of factors. Sponsors may be government organizations or pharmaceutical companies, biotechnology, or medical devices. Certain functions required for the experiment, such as monitoring and practicum, may be managed by an outsourced partner, such as a contract research organization or a central laboratory.
The human subject in psychology and sociology
Stanford prison experiment
A study conducted by Philip Zimbardo in 1971 examined the effect of social roles on students at Stanford University. Twenty-four male students were assigned to the random role of a prisoner or guard to imitate a mock prison in one of Stanford's basements. After just six days, the guards' abusive behavior and the psychological suffering of the prisoners proved significant enough to stop the two-week trial. Human subjects play a role in this experiment. This study will show whether prisoners and guards have conflicts that make conflict unavoidable. This conflict may be due to the sadistic behavior of the guard (dispositional) or because of an unfriendly (positional) prison environment. Due to the fact that detainees may lack respect for the law and the guards may behave in a hostile manner because of the social environment power structure that is in jail. However, if prisoners and guards act in a non-aggressive manner, this will support the dispositional hypothesis. If the prisoner only behaves in the same way that people in real life do, this will support the positional hypothesis. Using human subjects for this experiment is very important because the results are based on the way humans react, with behaviors that only humans gain. The human subject is the best way to get successful results from this type of experiment. The results of this experiment show that people will be ready to adjust to the particular social role they are supposed to play. The prison environment plays a role in making guard behavior more brutal, due to the fact that no participants have shown this behavior before. Most of the troublemakers believe they have acted in that way. This evidence concludes this to be a positional behavior, which means that behavior is caused by an unfriendly prison environment.
Milgram Experiments
In 1961, Yale University psychologist Stanley Milgram led a series of experiments to determine the extent to which an individual would obey the instructions given by an experiment. Placed in a room with experiments, the subject plays the role of a "teacher" for "learners" located in a separate room. Subjects are instructed to give electric shocks to learners when students answer wrong for a set of questions. The intensity of this electric shock should be increased for every wrong answer. The learner is a confederation (ie an actor), and the shock is falsified, but the subject is directed to believe otherwise. Both electric shock sound recordings and confederation requests to stop the termination were heard by "teachers" during the experiment. When the subject asks a question or pauses, the experiment insists that the experiment should continue. Despite widespread speculation that most participants will not continue to "surprise" the learner, 65 percent of participants in Milgram's initial experiment meet until the end of the experiment, continuing to provide shocks to the confederation with a claimed intensity of up to "450 volts". Although many participants questioned the experiment and displayed various signs of discomfort, when the experiment was repeated, 65 percent of subjects were willing to obey instructions to manage shocks through the latter.
Sync adjustment experiments
The classical conformity experiment of Solomon Asch psychologists in 1951 involved one subject participant and several confederations; they are asked to provide answers to different low-difficult questions. In each scenario, some confederations give their answers in turn, and subject subjects are allowed to answer the latter. In the participant control group, the error percentage is less than one percent. However, when the unanimous confederation chose the wrong answer, 75 percent of the subject participants agreed with the majority at least once. This study has been considered as significant evidence for the power of social influence and conformity.
Cave Studies Robber
A classic supporter of the theory of Realistic conflict, The Robber Cave Trial Muzafer Sherif explains how group competition can encourage hostility and prejudice. In a 1961 study, two groups of ten non-hostile boys were naturally grouped together unbeknownst to each other at Robber's Cave State Park, Oklahoma. The twelve-year-olds are tied to their own group for a week before the groups compete in games like tug and football. In light of this competition, these groups use name calling and display other hatreds, such as burning flags of other team teams. Hostilities continue and worsen until the end of the three-week study, when groups are forced to work together to resolve the problem.
Bystander Effect
The observer effect is shown in a series of well-known experiments by Bibb Latane and John Darley. In each of these experiments, participants were confronted with emergency types, such as witnessing seizures or smoke entering through the air vents. A common phenomenon is observed that when the number of witnesses or "viewers" increases, so does the time required for the individual to respond to an emergency. This effect has been shown to promote the diffusion of responsibility by concluding that, when surrounded by others, the individual expects others to take action.
Cognitive dissonance
Human subjects have been commonly used in experiments testing the theory of cognitive dissonance after important studies by Leon Festinger and Merrill Carlsmith. In 1959, Festinger and Carlsmith set up a situation where participants would undergo tasks that were too boring and monotonous. Upon completion of these tasks, subjects are instructed to assist the ongoing trial in exchange for varying amounts of money. All the subjects must do is to inform the next "student" who is waiting outside the testing area (confidentially confederate) that the task involved in the experiment is interesting and fun. It is expected that the participants will not completely agree with the information they provide to the students, and after fulfilling, half of the participants are given $ 1, and the other is given $ 20. The next survey shows that, by a large margin, those who receive less money because basically "lying" to the students came to believe that the task was much more enjoyable than their highly paid counterparts.
Vehicle security
Over the years, much research has been done on human subjects that help toward larger goals. Human subject research is used in many industries, with one of them being the automotive industry. Research has shown that civilian volunteers decided to participate in vehicle safety research to help car designers create more impact and sustainable safety barriers for vehicles. This research allows designers to inquire more data about human body tolerance in the event of a car accident to further improve safety features in the car. Several tests performed ranged from sled surgeries that evaluated head-neck injuries, airbag tests, and even tests involving military vehicles and their constraint systems. It is important to note that out of thousands of tests involving human subjects, the results show no persistent serious injury. This fact is largely due to the preparation efforts of researchers to ensure all ethical guidelines are followed and to ensure the safety and well-being of their subjects. Although this research contributes positively, there are some weaknesses and resilience to human subject research for accident testing due to injury responsibility and lack of facilities that have the right machinery to conduct such experiments. Overall, experiments have helped contribute to the knowledge of human tolerance for injury in collisions. This study is additional data from which testing with sound or crash test dummies will prevent us from discovery. The cadaver's body and crash tests still provide meaningful purpose when testing for higher tolerance tests beyond human capabilities.
Social media
Increasing use of social media as a source of data for researchers has led to new uncertainties about the definition of human subject research. Privacy, confidentiality, and informed consent are the main concerns, but it is not clear when social media users qualify as human subjects. Moreno et al. concludes that if access to social media content is public, information can be identified but not personal, and the collection of information does not require interaction with the person who posted it online, this study will not qualify as a human research subject. Determining human subject research features, according to federal regulations, is that the researchers interact directly with the subject or obtain identifiable personal information about the subject. Social media research may or may not meet this definition. The institutional review institutional review board (IRB) is often responsible for reviewing potential research on human subjects, but the IRB protocol on social media research may be unclear or outdated.
Concerns about privacy and informed consent have emerged over several social media studies. A research project by the sociologist Harvard, known as "Tastes, Ties, and Time," uses data from a student's Facebook profile at an anonymous "North American university" that is quickly identified as Harvard, potentially putting the privacy of human subjects at risk. The data set has been removed from public access as soon as the problem is identified. This issue is complicated by the fact that the research project is partly funded by the National Science Foundation, which mandates projects financed to engage in data sharing.
A study by Facebook and researchers at Cornell University, published in Proceedings of the National Academy of Sciences in 2014, collects data from hundreds of thousands of Facebook users after temporarily removing some kind of emotional content from their News Feed. Many consider this a violation of the requirements for informed consent in human subjects research. Because data is collected by Facebook, private companies, in a manner consistent with the Data Usage Policy and its user terms and agreements, the Cornell IRB board stipulates that research is not included in its jurisdiction. It has been argued that this study violates the law by violating state laws regarding informed consent. Others have noted that speaking against these research methods can be counterproductive, since private companies will likely continue to experiment on users, but will be disincentived from sharing their methods or findings with scientists or the public. In the "Editorial Expression of Concern" added to the online version of the research paper, PNAS stated that while they "consider it feasible to publish a paper... Nevertheless it remains a matter of concern that Facebook's data collection may have involved practices that are not entirely consistent with the principle - the principle of getting informed consent and allowing participants to opt out. "
Recommended considerations Moreno et al. For social media research are: 1) determining whether research qualifies as human subject research, 2) considering content risk levels, 3) accurately presenting research and motives when engaging in social media; 4) providing contact information throughout the approval process; ) ensuring data can not be identified or searched (avoiding direct identifiable citation with online search), 6) considering the development of the project privacy policy in advance, and 7) recognizing that each state has its own law on informed consent. Social media sites offer great potential as a source of data by providing access to unreachable subjects and research groups, capturing the natural, "real-world" responses of the subject, and providing an affordable and efficient data collection method.
Unethical human experiment
Unethical human experiments violate the principles of medical ethics. This has been done by countries including Nazi Germany, Imperial Japan, North Korea, the United States, and the Soviet Union. Examples include the MKUltra Project, Unit 731, Totskoye nuclear training, the Josef Mengele experiment, and the human experiments conducted by Chester M. Southam.
Nazi Germany conducted human experiments on a large number of prisoners (including children), mostly Jews from all over Europe, but also Romani, Sinti, Polish, Soviet POW and German defects, by Nazi Germany in concentration camps mainly in early 1940s, during World War II and the Holocaust. Prisoners are forced to participate; they are unwilling to volunteer and no consent is given for the procedure. Usually, the experiment produces death, trauma, disability or permanent disability, and is thus considered an example of medical torture. After the war, these crimes were tried on what is known as the Doctor's Trial, and the offenses committed led to the development of the Nuremberg Code. During the Nuremberg Trial, 23 Nazi doctors and scientists were sued for unethical treatment of concentration camp prisoners, often used as research subjects with fatal consequences. Of those 23, 15 were convicted, 7 were sentenced to death, 9 received imprisonment of 10 years for life, and 7 were released.
Unit 731, a department of the Imperial Japanese Army located near Harbin (later in Manchukuo puppet state, in northeastern China), experimented on detention by performing live, cutting, and bacterial inoculation. This induced a very large scale epidemic from 1932 onwards through the Second Sino-Japanese War. It also conducts biological and chemical weapons tests on detainees and captures prisoners of war. With imperial expansion during World War II, similar units were established in conquered cities such as Nanking (Unit 1644), Beijing (Unit 1855), Guangzhou (Unit 8604) and Singapore (Unit 9420). After the war, Supreme Commander Douglas MacArthur gave immunity on behalf of the United States to Shir? Ishii and all members of the unit in exchange for all the results of their experiments.
During World War II, Fort Detrick in Maryland was the headquarters of US biological warfare experiments. The Whitecoat surgery involves injecting infectious agents into military force to observe their effect on human subjects. Further human experiments in the United States are also characterized as unethical. They are often done illegally, without the knowledge, consent, or informed consent of the test subjects. Public condemnation of the discovery of government experiments on human subjects led to numerous congressional inquiries and hearings, including the Church Committee, the Rockefeller Commission, and the Human Radiation Experiment Advisory Committee, among others. The Tuskegee syphilis experiment, widely regarded as "the most famous biomedical research study in US history," was conducted from 1932 to 1972 by the Tuskegee Institute contracted by the United States Public Health Service. The study followed more than 600 African-American men who were not informed that they suffered from syphilis and were denied access to known penicillin treatment. This led to the National Research Act of 1974, to provide for the protection of human subjects in experiments. National Commission for the Protection of Human Subjects Biomedical and Behavioral Research is established and assigned the task of setting boundaries between research and routine practice, the role of risk-benefit analysis, guidelines for participation, and the definition of informed consent. Its Belmont Report sets forth three principles of ethical research: respect for people, kindness, and justice.
From the 1950s to the 60s, Chester M. Southam, an important virologist and cancer researcher, injected HeLa cells into cancer patients, healthy individuals, and prison inmates from the Ohio Penitentiary. She wants to see if the cancer can be transmitted as well if people can become immune to cancer by developing an acquired immune response. Many believe that this experiment violates the bioethics principle of informed consent, non-maleficence, and beneficence.
See also
References
Further reading
External links
- "Human Research Report" - monthly bulletin to protect human subjects
- Nuremberg Code
- Belmont Reports
- Declaration of Helsinki, 6th ed.
- Universal Declaration of Bioethics and Human Rights by UNESCO
- Hungry Hungry Aboriginal Children Used in Government Experiments During the 1940s Toronto Star, 2013
Source of the article : Wikipedia
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