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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 code establishes what is required to be considered research activities, and for participants to be considered human subjects of research. The definitions are written as such to include situations where the human is the subject of the experiment, their environment is manipulated by the researchers, and data regarding their responses are ...
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 ...
The later revision in 2000 would go on to require monitoring of scientific research on human subjects to assure ethical standards were being met. [20] In 1997 Lurie and Wolfe published their seminal paper on HIV trials, [21] raising awareness of a number of central issues. These included the claims that the continuing trials in developing ...
Protecting Human Subjects (1981) Whistleblowing in Biomedical Research (1981) IRB Guidebook (1981) Compensating for Research Injuries (1982) Splicing Life: The Social and Ethical Issues of Genetic Engineering with Human Beings (1982) Making Health Care Decisions (1982) Deciding to Forego [sic] Life-Sustaining Treatment (1983)
These individuals are entitled to protection, and additional ethical justification is needed to involve such populations in human subject studies. In such cases, a balance should be established between protecting subjects from exploitation and depriving these subjects of access to the potential benefits of research.
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European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]