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 that a patient should have sufficient information before making their own free decisions about their medical care. A healthcare provider is often held to have a responsibility to ensure that the consent that a patient gives is informed, and informed consent can apply to a health care intervention on a person, conducting some form of research on a person, or for disclosing a person's information. Informed consent is, in fact, a fundamental principle in the field of health protection, obviously wanting to mark the very close and unavoidable connection between the need for consent and the inviolability of the right to health. A health care provider may ask a patient to consent to receive therapy before providing it, a clinical researcher may ask a research participant before enrolling that person into a clinical trial, and a researcher may ask a research participant before starting some form of controlled experiment. Informed consent is collected according to guidelines from the fields of medical ethics and research ethics.
Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal. It is important to note that these four values are not ranked in order of importance or relevance and that they all encompass values pertaining to medical ethics. However, a conflict may arise leading to the need for hierarchy in an ethical system, such that some moral elements overrule others with the purpose of applying the best moral judgement to a difficult medical situation. Medical ethics is particularly relevant in decisions regarding involuntary treatment and involuntary commitment.
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 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.
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.
Archaeological ethics refers to the moral issues raised through the study of the material past. It is a branch of the philosophy of archaeology. This article will touch on human remains, the preservation and laws protecting remains and cultural items, issues around the globe, as well as preservation and ethnoarchaeology.
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.
The mission of the Council for International Organizations of Medical Sciences (CIOMS) is to advance public health through guidance on health research including ethics, medical product development and safety. CIOMS is an international nongovernmental organization established jointly by World Health Organization (WHO) and United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949. CIOMS represents a substantial proportion of the biomedical scientific community through its member organizations.
The Green report was a report written by Andrew Conway Ivy, a medical researcher and vice president of the University of Illinois at Chicago. Ivy was in charge of the medical school and its hospitals. The report justified testing malaria vaccines on Statesville Prison, Joliet, Illinois prisoners in the 1940s. Ivy mentioned the report in the 1946 Nuremberg Medical Trial for Nazi war criminals. He used it to refute any similarity between human experimentation in the United States and the Nazis.
The National Research Act was enacted by the 93rd United States Congress and signed into law by President Richard Nixon on July 12, 1974, after a series of congressional hearings on human-subjects research, directed by Senator Edward Kennedy. The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to develop guidelines for human subject research and to oversee and regulate the use of human experimentation in medicine. The National Research Act issued Title 45, Part 46 of the Code of Federal Regulations: Protection of Human Subjects. The National Research Act is overseen by the Office of Human Research Protections. The Act also formalized a regulated IRB process through local institutional review boards, also overseen by the Office of Human Research Protections.
The Stateville Penitentiary malaria study was a controlled but ethically questionable study of the effects of malaria on the prisoners of Stateville Penitentiary near Joliet, Illinois in the 1940s. The study was conducted by the Department of Medicine at the University of Chicago in conjunction with the United States Army and the State Department. The Stateville experiment was viewed as coercive because it offered shortened sentences to participants. The study is notable for its impacts on the Nuremberg Medical Trial and subsequent medical experimentation on prisoners.
Andrew Conway Ivy was an American physician. He was appointed by the American Medical Association as its representative at the 1946 Nuremberg Medical Trial for Nazi doctors, but later fell into disrepute for advocating the fraudulent drug Krebiozen.
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).
Nazi human experimentation was a series of medical experiments on large numbers of prisoners, including children, by Nazi Germany in its concentration camps in the early to mid 1940s, during World War II and the Holocaust. Chief target populations included Romani, Sinti, ethnic Poles, Soviet POWs, disabled Germans, and Jews from across Europe.
Numerous experiments which are performed on human test subjects in the United States are considered unethical, because they are illegally performed or they are performed without the knowledge, consent, 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.
Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations.
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.
The Interagency Advisory Panel on Research Ethics was formed in 2001 by three of the research funding agencies of the Government of Canada: CIHR, NSERC and SSHRC. The Panel "develops, interprets and implements the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans" (TCPS), as updated in 2014, and the Tri-Agency Framework: Responsible Conduct of Research, which was updated in 2016, and again in 2021. The Tri-Agency Research Integrity Policy also dictates the conduct of federally-funded researchers.
