The Nuremberg Code is a set of ethical research principles for human experimentation created by the court in U.S. v Brandt, one of the Subsequent Nuremberg trials that were held after the Second World War.
Informed consent is a principle in medical ethics and medical law and media studies, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclose a person's medical information.
The Tuskegee Study of Untreated Syphilis in the Negro Male was a study conducted between 1932 and 1972 by the United States Public Health Service (PHS) and the Centers for Disease Control and Prevention (CDC) on a group of nearly 400 African American men with syphilis. The purpose of the study was to observe the effects of the disease when untreated, though by the end of the study medical advancements meant it was entirely treatable. The men were not informed of the nature of the experiment, and more than 100 died as a result.
Human subject research is systematic, scientific investigation that can be either interventional or observational and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and focus groups.
The Little Albert experiment was a study that mid-20th century psychologists interpret as evidence of classical conditioning in humans. The study is also claimed to be an example of stimulus generalization although reading the research report shows that fear did not generalize by color or tactile qualities. It was carried out by John B. Watson and his graduate student, Rosalie Rayner, at Johns Hopkins University. The results were first published in the February 1920 issue of the Journal of Experimental Psychology.
The regulation of science refers to use of law, or other ruling, by academic or governmental bodies to allow or restrict science from performing certain practices, or researching certain scientific areas.
The Animal Welfare Act was signed into law by President Lyndon B. Johnson on August 24, 1966. It is the main federal law in the United States that regulates the treatment of animals in research and exhibition. Other laws, policies, and guidelines may include additional species coverage or specifications for animal care and use, but all refer to the Animal Welfare Act as the minimally acceptable standard for animal treatment and care. The USDA and APHIS oversee the AWA and the House and Senate Agriculture Committees have primary legislative jurisdiction over the Act. Animals covered under this Act include any live or dead cat, dog, hamster, rabbit, nonhuman primate, guinea pig, and any other warm-blooded animal determined by the Secretary of Agriculture for research, pet use or exhibition. Excluded from the Act are birds, rats of the genus Rattus, mice of the genus Mus, farm animals, and all cold-blooded animals.
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Along with developed countries, many developing countries have established national, regional or local Institutional Review Boards in order to safeguard ethical conduct of research concerning both national and international norms, regulations or codes.
The Belmont Report is a 1978 report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.
An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was the first public national body to shape bioethics policy in the United States.
Animal testing regulations are guidelines that permit and control the use of non-human animals for scientific experimentation. They vary greatly around the world, but most governments aim to control the number of times individual animals may be used; the overall numbers used; and the degree of pain that may be inflicted without anesthetic.
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH).
Numerous experiments which are performed on human test subjects in the United States are considered unethical, because they are performed without the knowledge or informed consent of the test subjects. Such tests have been performed throughout American history, but some of them are ongoing. The experiments include the exposure of humans to many chemical and biological weapons, human radiation experiments, injections of toxic and radioactive chemicals, surgical experiments, interrogation and torture experiments, tests which involve mind-altering substances, and a wide variety of other experiments. Many of these tests are performed on children, the sick, and mentally disabled individuals, often under the guise of "medical treatment". In many of the studies, a large portion of the subjects were poor, racial minorities, or prisoners.
Human subject research legislation in the United States can be traced to the early 20th century. Human subject research in the United States was mostly unregulated until the 20th century, as it was throughout the world, until the establishment of various governmental and professional regulations and codes of ethics. Notable – and in some cases, notorious – human subject experiments performed in the US include the Tuskegee syphilis experiment, human radiation experiments, the Milgram obedience experiment and Stanford prison experiments and Project MKULTRA. With growing public awareness of such experimentation, and the evolution of professional ethical standards, such research became regulated by various legislation, most notably, those that introduced and then empowered the institutional review boards.
The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research was a bioethics organization in the United States.
Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations.
In research ethics, justice regards fairness in the distribution of burdens and benefits of research. For example, justice is a consideration in recruiting volunteer research participants, in considering any existing burdens the groups from which they are recruited face and the risks of the research, alongside the potential benefits of the research.
Unethical human experimentation is human experimentation that violates the principles of medical ethics. Such practices have included denying patients the right to informed consent, using pseudoscientific frameworks such as race science, and torturing people under the guise of research. Around World War II, Imperial Japan and Nazi Germany carried out brutal experiments on prisoners and civilians through groups like Unit 731 or individuals like Josef Mengele; the Nuremberg Code was developed after the war in response to the Nazi experiments. Countries have carried out brutal experiments on marginalized populations. Examples include American abuses during Project MKUltra and the Tuskegee syphilis experiments, and the mistreatment of indigenous populations in Canada and Australia. The Declaration of Helsinki, developed by the World Medical Association (WMA), is widely regarded as the cornerstone document on human research ethics.
