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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).
Examples include American abuses during Project MKUltra and the Tuskegee syphilis experiments, and the mistreatment of indigenous populations in Canada and Australia. The Declaration of Helsinki , developed by the World Medical Association (WMA), is widely regarded as the cornerstone document on human research ethics .
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 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 ...
One of the earliest models for ethical human experimentation, preceding the Nuremberg Code, was established in 1931. [4] In the Weimar Republic of 20th century pre-Nazi Germany, the entity known as Reichsgesundheitsamt [5] (translating roughly to National Health Service), under the Ministry of the Interior [6] formulated a list of 14 points detailing these ethical principles.
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 ...
Informed consent was developed further, made more prescriptive and partly moved from 'Medical Research Combined with Professional Care' into the first section (Basic Principles), with the burden of proof for not requiring consent being placed on the investigator to justify to the committee. 'Legal guardian' was replaced with 'responsible relative'.