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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 ...
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 informed consent doctrine is generally implemented through good healthcare practice: pre-operation discussions with patients and the use of medical consent forms in hospitals. However, reliance on a signed form should not undermine the basis of the doctrine in giving the patient an opportunity to weigh and respond to the risk.
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.
[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 ...
Informed Consent in Medical Research is a medical textbook on medical ethics, authored by Jeffrey S. Tobias and Len Doyal, and published by Wiley in 2001. It was produced in response to the debates between the authors in 1997, following the response to the 1990's British Medical Journal publications of studies in which consent was not obtained by participants.
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
To assess the shift to rural communities, they surveyed 34 physicians or researchers and 46 research coordinators from states that have "large rural populations and have historically demonstrated limited participation in clinical research." [18] Proper consent forms were provided and signed at the start of the study. Of the physicians and ...