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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).
In adult medical research, the term informed consent is used to describe a state whereby a competent individual, having been fully informed about the nature, benefits and risks of a clinical trial, agrees to their own participation. National authorities define certain populations as vulnerable and therefore unable to provide informed consent ...
Research should be based on a thorough knowledge of the scientific background (Article 11), a careful assessment of risks and benefits (Articles 16, 17), have a reasonable likelihood of benefit to the population studied (Article 19) and be conducted by suitably trained investigators (Article 15) using approved protocols, subject to independent ...
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 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.
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).
A lesser studied form of exclusion criteria involves an absence of racial, ethnic, or sexual diversity that results in clinical trials that do not reflect the US population. A recent systematic review of the literature of hearing loss in adults, while representative of the US population in terms of sex, does not adequately represent racial or ...