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One of the earliest models for ethical human experimentation, preceding the Nuremberg Code, was established in 1931. [4] In the Weimar Republic of 20th century pre-Nazi Germany, the entity known as Reichsgesundheitsamt [5] (translating roughly to National Health Service), under the Ministry of the Interior [6] formulated a list of 14 points detailing these ethical principles.
Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. [1]
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 ...
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.
It is one of the three basic principles of research ethics stated in the Belmont Report issued by the Office of Human Subject Research; it comprises two essential moral requirements: to recognize the right for autonomy and to protect individuals who are disadvantaged to the extent that they cannot practice this right. [1] [2]
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.
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).
National Research Act; Other short titles: National Research Service Award Act of 1974: Long title: An Act to amend the Public Health Service Act to establish a program of National Research Service Awards to assure the continued excellence of biomedical and behavioral research and to provide for the protection of human subjects involved in biomedical and behavioral research and for other purposes.
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