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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 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 guidelines that a research study must follow before being approved involves informed consent of the subjects, minimal risk to the subjects, and no abuse of "vulnerable subjects". [19] Informed consent must include all aspects of the research, which include the overall premise, risks, benefits, alternative procedures, confidentiality, and ...
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.
One measure for safeguarding this right is the use of informed consent for clinical research. [36] Researchers refer to populations with limited autonomy as "vulnerable populations"; these are subjects who may not be able to fairly decide for themselves whether to participate.
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 like this deserves the need for informed consent in any type of research in general, and it should prohibit experiments where injury, disability, or death to the participant is reasonably expected. Nevertheless, "science and society should never outweigh the wellbeing of the subject". [36] "The way that this case in Peru was handled ...
Appropriate application of the four principles requires that Stakeholder analysis must first be performed. Thorough stakeholder analysis is important to identify: the correct entity(s) from whom to seek informed consent; the party(s) who bear the burdens or face risks of research; the party(s) who will benefit from research activity; and, the party(s) who are critical to mitigation in the ...