Various organizations have created guidelines for human subject research for various types of research involving human subject research and for various situations.
Video Guidelines for human subject research
instructions for Clinical Directors, Outpatient Clinics and Other Medical Facilities
In 1892 Albert Ludwig Sigesmund Neisser, a German doctor credited with the discovery of Neisseria gonorrhoeae, performed two sets of clinical trials trying to find a preventive method for syphilis. Neisser first inserted serum obtained from one patient who had begun to show early signs of syphilis under the skin of four female patients, similar to the procedure for inoculation of smallpox. Neisser did not get approval from these patients, but none of them developed the disease. Neisser then conducted a second test of four prostitutes. This time, the serum is injected intravenously and each serum is obtained from different syphilis patients, each at different stages of the disease. Prostitutes from the second trial group also disagreed or were notified of the experiment. In contrast to the first trial, the four subjects experienced syphilis at various times after the injection.
In 1898, Neisser published the results of his clinical experiment, sparking a public outcry in which Neisser was accused of "innocent children injecting with syphilis poison." Neisser defended his actions, arguing that prostitutes contracted syphilis from their work rather than experiments, and received general support from academic doctors. One notable exception is the German psychiatrist Albert Moll, who believes informed consent is needed in human trials.
Later that year, the Royal Court of Disciplinary fined Neisser, ruling that he was negligent in obtaining the consent of the patient. In 1899, Prussia's minister for religious, academic, and medical affairs sought advice on the ethics of Neisser's experiment in response to a request from the Prussian parliament to take action on the scandal, and to assign a report from the Office of Scientific Medical Health. In 1900, the minister issued "Guidelines for Clinical Directors, Outpatient Clinics and Other Medical Facilities" to all medical directors on medical procedures "in addition to diagnosis, therapy, and immunization".
The instructions state that medical experiments will be prohibited if:
- subject is minor.
- the subject has not given clear consent.
- the possibility of negative consequences has not been explained.
- there is no authorization from the medical director.
These instructions are not committed to the law and thus are not legally binding. To this day, it remains unclear whether the Prussian directive has any effect on human experimentation; However, this is still the first rule regarding human medical experiments in Western medicine.
Maps Guidelines for human subject research
Guidelines for Human Experiment
One of the earliest models for ethical human experiments, ahead of the Nuremberg Code, was established in 1931. In the pre-Nazi Weimar Republic of Germany, an entity known as the Reichsgesundheitsamt (roughly translated to the National Health Service), under the Interior Ministry formulate a list of 14 points detailing these ethical principles.
The main points of the 1931 Guidelines for Human Experimentation are as follows:
- Detailed and fully informed consent of the test subject is required, except in extreme special circumstances.
- Risk must be balanced with potential benefits.
- Caution must be taken for subjects under 18 years of age.
- Be very careful if microorganisms are involved.
- Disadvantaged or socially disadvantaged subjects should not be exploited.
- Animal testing should be done first, and human experiments should be avoided if other data collection methods are still available.
This guide was established under the context of criminal law reform in Germany and in a partial response to public criticism of human experimentation. They also outlined specific definitions for both therapeutic and non-therapeutic research on human subjects (nicknamed "innovative therapies" and "scientific experiments"), and set detailed boundaries for both. However, most physicians who discussed the rules before their instantiation were primarily concerned with the advancement of medical science rather than the protection of vulnerable patients.
These guidelines share similarities with the 1900 Prussian Directive for Directors in which both contain clauses for approval and for underage subjects. The Nuremberg Code will also specify the requirements for informed consent, and contains other additional similarities with the Guidelines - for example, both require risks to be balanced by potential benefits, and both prevent the use of human experiments if other means of obtaining the desired results are available. While both are similar, the Guide contains more clauses and requirements regarding human experimentation. For example, the Guidelines also require the creation of reports detailing experimental objectives and justifications. Ravindra Ghooi criticized the Nuremberg Code, arguing that it was too strong of a resemblance to the 1931 Guideline to pass as a coincidence, and that the 1931 Guidelines should have been used as a reference in creating the Code. However, the Nuremberg Code does contain provisions not found in the Guidelines - clauses that require subjects to be given the freedom to leave an experiment at any time is one such example.
Guidelines for Human Experimentation remained in force through the end of the Third Reich in 1945, and continued to exist in law until 1948. In particular, the Nazi human experiment took place under the existence of this law.
Nuremberg Code
In the early 1940s in Germany, doctors conducted Nazi human experiments on subjects that did not want to be examined; one way to describe the procedure could be to call it medical torture. After the Allied Forces won World War II, US authorities holding the Nuremberg Palace of Justice used the building to organize a Doctor's Examination in which Nazi researchers were charged with crimes against humanity for unethical research practices. After Nuremberg Trials Next, many people feel compelled to enact legislation to codify some research guidelines to protect study participants and determine acceptable relationships between researchers and study participants.
In 1949, the Nuremberg Code was published into a set of guidelines to guide researchers working with human subjects. Among the code points are the following concepts: the participants must continue to give their voluntary consent, the research should have a good generating goal for the community, and consideration should be taken to protect the participant from the possibility of being away from the injury.
Helsinki Declaration
In 1964, the World Medical Association published a research ethic code, the Helsinki Declaration. It's based on the Nuremberg Code, focusing on medical research with therapeutic intentions. Furthermore, medical professionals and researchers are beginning to demand that research follow the principles outlined in the Declaration. This document is one of the milestones leading to the implementation of the institutional review process (IRB). Many IRBs review ethical ethical research clinics based on the Declaration of Helsinki code.
Belmont Report
The Tuskegee syphilis experiment was an experiment started in 1932 by the United States Public Health Service. The trial design involves the recruitment of 400 poor blacks with syphilis and tracking their health. In the 1940s, penicillin was identified as a standard treatment for syphilis, but the goal of this experiment was to track long-term syphilis and the researchers did not tell the participants that they were curable. In 1972 the press reported on this research for public anger for neglecting the health of the participants. This research is influential in shaping public perceptions of research involving human subjects.
After the press exposes the research, the US Congress appoints a panel that stipulates that research should be stopped immediately and that supervision of human research is inadequate. The Panel recommends that federal regulations be designed and implemented to protect human research subjects in the future. Furthermore, the National Research Act of 1974 leads to the creation of General Regulations, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the Office for the Protection of Human Research.
All of these reactions led to the creation and publication of the Belmont Report of 1979. This report identifies respect for people, goodness and justice as the ethical principle that should underlie the research of the human subject.
Code of Conduct WHAT
The American Psychological Association (APA) has a documented code of ethics relating to the practice of psychology and related research. This document contains guidelines for fraudulent use in research. For APA members, this is a hard requirement imposed on their membership. They are also a requirement for any research project undertaken, funded, or managed by APA.
Research funded by the United States government
Title 45 of the Federal Code of Regulations, Section 46 (45 CFR 46) is a central set of Federal regulations concerning the protection of human subjects in research and is often referred to as the Common Rule. It defines legislation, criteria for exceptions, as well as the definition and formulation of the institutional review board, although some agencies have established their own implementation of this code that replaces the sections or all 45 CFR 46. The Department of Defense uses CFR 46 but has different exclusion criteria. The Food and Drug Administration also applies modified codes that are associated with research on the development of food, drugs, or medical equipment.
The Code specifies what it takes to be considered a research activity, and for participants to be considered the subject of human research. Definitions are written in such a way as to include situations in which humans are the subjects of experimentation, their environment manipulated by researchers, and data on their responses are collected. If the project does not meet this definition (or there is minimal risk to participants) then this project is exempt from IRB review and informed consent requirements. Generally these decisions are made and documented by IRB. The general rule also provides a definition of whether the agency is engaged in research, the interaction between the researcher and the subject, what interventions, and what information the subject can expect to remain private.
References
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