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Jun 1, 2019 · The requirement for free decision-making has been formalized as the principle of respect for persons, and in the regulatory requirements of informed consent. We must resist the temptation to argue these as terms-of-art, and remember their common-sense meaning and visceral truth. Free and voluntary consent (which is not free if it is given ...
The U.S. federal regulations known as the “Common Rule,” which govern research with human subjects, lists several conditions for waiving consent. However, neither guidance documents on the ethics of clinical research nor the literature in bioethics contains a general justification of research without consent.
The second major argument often mentioned in the literature for making an exception to the rule of informed consent in specific situations is that a consent procedure might lead to unnecessary distress or confusion on the participants’ part . The informed consent procedure itself may generate such distress or confusion.
1. The Structure, Definition, and Limits of Informed Consent. As Gerald Dworkin points out, the doctrine of informed consent is a ‘creature of law’; 1 it has been developed in various legal domains in which one party sanctions another to perform ‘… some course of action to which the consented to party would otherwise have no moral right’. 2 The fundamental idea that we aim to capture ...
- Jonathan Pugh
- 2020
- 2020
Sep 20, 2011 · Informed consent is currently treated as the core of bioethics. In clinical practice, the doctrine of informed consent rose to dominance during the course of the 20th century. It replaced a medical ethos founded on trust in physicians’ decisions, often on the assumption that “doctor knows best”, with an ethos that sought to put patients ...
In this issue of Mayo Clinic Proceedings, Paterick et al1 provide a balanced summary of the moral and legal underpinnings of the doctrine of informed consent and identify its essential role in the patient-physician relationship. The authors further explain that procuring informed consent will limit the potential for negligence cases. The risk-management benefits of informed consent warrant ...
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Voluntary informed consent is essential to conducting ethical research with human participants. Valid consent rests on three pillars: the absence of coercion or undue influence, providing participants with information relevant to the decision at hand, and ensuring that participants have the capacity to use that information to make an authentic decision on whether to participate.