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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 ...
The research began with the selection of 22 subjects from a veterans' orphanage in Iowa. None were told the intent of the research, and they believed that they were to receive speech therapy. The study was trying to induce stuttering in healthy children. The experiment became national news in the San Jose Mercury News in 2001, and a book was ...
The following are some examples of different types of ethics dumping. Choosing a location or population for research, which is unlikely to benefit in full, or at all, from the research, for instance: Avian influenza research involving Indonesian human blood samples, when Indonesians were unlikely to benefit from the resulting vaccines. [5]
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 protocol should address the ethical issues and indicate that it is in compliance with the Declaration (Article 14). Studies should be discontinued if the available information indicates that the original considerations are no longer satisfied (Article 17). Information regarding the study should be publicly available (Article 16).
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]
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 ...
Medical Code of Ethics is a document that establishes the ethical rules of behaviour of all healthcare professionals, such as registered medical practitioners, physicians, dental practitioners, psychiatrists, psychologists, defining the priorities of their professional work, showing the principles in the relations with patients, other physicians and the rest of community.