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The categories of individuals that constitute Vulnerable Populations are outlined under The Common Rule (45 CFR 46, Subparts A-D). These include individuals who are minors, prisoners, pregnant, physically disabled, mentally disabled, old, economically disadvantaged, educationally disadvantaged, or subordinates in hierarchical groups (e.g. a ...
Example of informed consent document from the PARAMOUNT trial. Informed consent is a principle in medical ethics, medical law, media studies, and other fields, that a person must have sufficient information and understanding before making decisions about accepting risk, such as their medical care.
The Centers for Disease Control and Prevention acknowledges that "the design and conduct of the studies was unethical in many respects, including deliberate exposure of subjects to known serious health threats, lack of knowledge of and consent for experimental procedures by study subjects, and the use of highly vulnerable populations."
In the Havasupai case, researchers from Arizona State University failed to gather informed consent and debrief their participants following the study, which are major ethical violations in medical research. Lastly, this case emphasized the importance of providing proper education and protection to vulnerable populations, instead of exploiting them.
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 ...
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 World Medical Association's Declaration of Helsinki requires researchers to take special care with consent involving vulnerable subject populations which have barriers to informed consent. These groups include minors , prisoners, and the mentally ill.
Informed consent; Ethics of public health; ... health needs of the underserved and vulnerable, are included in the right to health. ... of improving population health ...