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.
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 an unethical 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 demonstrates 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.
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 at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical. The main goal of IRB reviews is to ensure that study participants are not harmed. Such boards are formally designated to approve, monitor, and review biomedical and behavioral research involving humans, and they are legally required in some countries under certain specified circumstances. Most countries use some form of IRB to safeguard ethical conduct of research so that it complies with 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 Common Rule is a 1991 rule of ethics in the United States regarding biomedical and behavioral research involving human subjects. A significant revision became effective July 2018. It governed Institutional Review Boards for oversight of human research and followed the 1975 revision of the Declaration of Helsinki; it is encapsulated in the 1991 revision to the U.S. Department of Health and Human Services Title 45 CFR 46 Subparts A, B, C and D. Subpart A. The Common Rule is the baseline standard of ethics by which any government-funded research in the US is held; nearly all U.S. academic institutions hold their researchers to these statements of rights regardless of funding.
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 were performed on human test subjects in the United States in the past are now considered to have been unethical, because they were performed without the knowledge or informed consent of the test subjects. Such tests have been performed throughout American history, but have become significantly less frequent with the advent and adoption of various safeguarding efforts. Despite these safeguards, unethical experimentation involving human subjects is still occasionally uncovered.
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 Guatemala syphilis experiments were United States-led human experiments conducted in Guatemala from 1946 to 1948. The experiments were led by physician John Charles Cutler, who also participated in the late stages of the Tuskegee syphilis experiment. Doctors infected 1,300 people, including at least 600 soldiers and people from various impoverished groups with syphilis, gonorrhea, and chancroid, without the informed consent of the subjects. Only 700 of them received treatment. In total, 5,500 people were involved in all research experiments, of whom 83 died by the end of 1953, though it is unknown whether or not the injections were responsible for all these deaths. Serology studies continued through 1953 involving the same vulnerable populations in addition to children from state-run schools, an orphanage, and rural towns. However, the intentional infection of patients ended with the original study.
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.
Analogous to clinical ethics consultation, Research Ethics Consultation (REC) describes a formal way for researchers to solicit and receive expert ethical guidance related to biomedical research. The first REC service was established at the National Institutes of Health (NIH) Clinical Center in 1997. Today, most REC services are found at academic institutions, and the majority of current services were originally launched in response to the 2006 NIH Clinical and Translational Science Award program, as applicants to that program were required to have procedures in place to address ethical concerns raised by their 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.
