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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 ...
Informed consent is "the legal principle that governs the patient's ability to accept or reject individual medical interventions designed to diagnose or treat an illness". Informed consent can only be obtained before the procedure and after potential risks have been explained to the participant.
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 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.
[20] [21] When working with vulnerable populations, researchers must be sure to fully engage with potential patients and clearly explain the research to obtain valid informed consent. [21] It is a legal requirement in some countries to obtain assent from children before they can participate in a study but this may be inappropriate if children ...
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 ...
Certain populations are considered to be vulnerable, and in addition to informed consent, special protections must be made available to them. These include persons who are incarcerated, pregnant women, persons with disabilities, and persons who have a mental disability. Children are considered unable to provide informed consent. [22]: 51–55
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'.