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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 ...
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 ...
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.
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
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.
The indigenous population opposed the idea and said that consent should be needed for mega development in indigenous territories. The result was large protests in La Paz for fear of damage to the vital river system, illegal logging , and the alteration of the habitats of endangered animals in the area. [ 36 ]
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established and was tasked with establishing the boundary between research and routine practice, the role of risk-benefit analysis, guidelines for participation, and the definition of informed consent.
Vulnerable groups such as children, pregnant women, physically disabled or elderly maybe excluded from the process. Nurses must notify the IRB of any ethical or legal violations. It is important to be up to date on all the appropriate state laws and regulations regarding vulnerable populations.