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ETHICAL FOUNDATION OF HUMAN RESEARCH PROTECTION The Ethical Principles and Guidelines for the Protection of Human Subjects of Research was written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to identify the basic ethical principles underlying the conduct of research involving human subjects. More commonly known as the “Belmont Report”, this report identified three fundamental ethical principles that must be carefully considered in the IRB decision-making process to ensure the ethical practice of research involving human participants. The University of Kentucky (UK) Institutional Review Board (IRB) applies the following ethical principles of the Belmont Report when conducting protocol/study review:
Other historically significant sources from which ethical principles originated:
The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.
Nuremberg Code: Directives for Human Experimentation. Directives established from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10 to ensure that human research subjects are protected from unreasonable risks, participate of their own free will, and make their decisions only after they have been informed fully about the potential risks and possible benefits, if any, of their participation. |