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The Belmont Report summarizes ethical principles and guidelines for human subject research. Three core principles are identified: respect for persons, Beneficence, and Justice. The three primary areas of application were stated as informed consent, assessment of risks and benefits, and selection of human subjects in research.
The main points of the 1931 Guidelines for Human Experimentation are as follows: [5] Full unambiguous and informed consent from test subjects is required, except in extreme extenuating circumstances. Risks should be balanced out by potential benefits. Caution should be taken for subjects under 18 years old. Extreme caution should be taken if ...
The Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects of Biomedical and Behavioral Research (1979) These reports contained their recommendations, [ 10 ] the underlying deliberations and conclusions, [ 11 ] a dissenting statement and additional statement by commission members and summaries of materials presented ...
Declaration of Helsinki. The Declaration of Helsinki (DoH, Finnish: Helsingin julistus) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). [1] It is widely regarded as the cornerstone document on human research ethics. [1][2][3][4]
The Nuremberg Code (German: Nürnberger Kodex) 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. Though it was articulated as part of the court's verdict in the trial, the Code would later become significant ...
e. 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]
In 1975, the Department of Health, Education and Welfare (DHEW) created regulation which included the recommendations laid out in the NIH's 1966 Policies for the Protection of Human Subjects. [6] Title 45 of the Code of Federal Regulations, known as "The Common Rule," requires that institutional review boards (IRBs) oversee experiments using ...
The Common Rule is a 1991 rule of ethics (revised in 2018) [2] regarding biomedical and behavioral research involving human subjects in the United States.The regulations governing Institutional Review Boards for oversight of human research followed the 1975 revision of the Declaration of Helsinki, and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services ...