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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).
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 ...
The San Antonio Contraceptive Study was a clinical research study published in 1971 about the side effects of oral contraceptives. Women coming to a clinic in San Antonio, Texas to prevent pregnancies were not told they were participating in a research study or receiving placebos. Ten of the women became pregnant while on placebos. [183] [184 ...
Research should be based on a thorough knowledge of the scientific background (Article 11), a careful assessment of risks and benefits (Articles 16, 17), have a reasonable likelihood of benefit to the population studied (Article 19) and be conducted by suitably trained investigators (Article 15) using approved protocols, subject to independent ...
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.
A lesser studied form of exclusion criteria involves an absence of racial, ethnic, or sexual diversity that results in clinical trials that do not reflect the US population. A recent systematic review of the literature of hearing loss in adults, while representative of the US population in terms of sex, does not adequately represent racial or ...
As clinical trials begin to spread to developing countries, ethical concerns emerge regarding the validity of the informed consent process. [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]