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In medical research ethics, the term Vulnerable Populations generally refers to individuals whose situations do not allow them to protect their own interests. The categories of individuals that constitute Vulnerable Populations are outlined under The Common Rule (45 CFR 46, Subparts A-D).
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 ...
Research ethics is a discipline within the study of applied ethics. Its scope ranges from general scientific integrity and misconduct to the treatment of human and animal subjects. The social responsibilities of scientists and researchers are not traditionally included and are less well defined. [1] The discipline is most developed in medical ...
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 distinction between therapeutic and non-therapeutic research introduced in the original document, criticised by Levine [19] [38] was removed to emphasize the more general application of ethical principles, but the application of the principles to healthy volunteers is spelt out in Articles 18–9, and they are referred to in Article 8 ...
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).
In research ethics, justice regards fairness in the distribution of burdens and benefits of research. For example, justice is a consideration in recruiting volunteer research participants, in considering any existing burdens the groups from which they are recruited face (such as historic marginalisation) and the risks of the research, alongside the potential benefits of the research.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was the first public national body to shape bioethics policy in the United States. Formed in the aftermath of the Tuskegee Experiment scandal, the commission was created in 1974 as Title II of the National Research Act .