Most differences, shortcomings and contradictions regarding voluntary informed consent for participation in clinical research relate to the South African-specific guidance documents, i.e. South African Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa (2006) and Ethics in Health Research: Principles, Structures and Processes (2004). These doc...

Informed consent is a foundational concept necessary for ethical conduct of clinical research and practice. It is a technical tool that shifts the autonomy to decide whether a medical procedure should be performed-from the doctor to the patient. However there is an ongoing discussion in bioethical circles on the level of comprehension of the informed consent process by the patients and research...

The rule that a patient should give a free, fully-informed consent to any therapeutic intervention is traditionally thought to express merely a right of the patient against the physician, and a duty of the physician towards the patient. On this view, the patient may waive that right with impunity, a fact sometimes expressed in the notion of a right not to know. This paper argues that the rule a...

For at least 50 years informed consent in medicine has focused on the principle of autonomy. Recently, attention has been given to informed consent being a shared decision. A primary mandate to do what is in the best interest of the patient still remains. The shared view looks to expand beyond the dyadic image of doctor and patient, to acknowledge the essential contribution to be made to inform...

The American physician is today besieged by economic and societal forces which conspire to weaken whatever equanimity he or she could once bring to the practice of medicine. In the latter realm, the threat of malpractice actions is ever-present. In this regard, negligence has long been the theory whereupon plaintiffs' attorneys seek to recover damages for patients' misfortunes in the medical sy...

Physicians and other professionals in the field of medicine have to perform invasive and non-invasive procedures on patients as part of their duties. There is a legal basis upon which these procedures are done; this is called 'informed consent.' Sociocultural factors have strong influence on the sick role. These factors influence the application of informed consent in Nigeria.

Kihlbom has recently argued that a system of seeking negatively informed consent might be preferable in some cases to the ubiquitous informed consent model. Although this theory is perhaps not powerful enough to supplant informed consent in most settings, it lends strength to Evans' and Hungin's proposal that it can be ethical to prescribe placebos rather than "active" drugs. This paper present...

BACKGROUND Treatment informed consent aims to preserve the autonomy of patients in the clinician - patient relationship so as to ensure valid consent. An acceptable method of evaluating understanding of consent information is by assessing the extent of recall by patients of the pieces information believed to have been passed across. When concerns are not satisfactorily addressed from the patien...

INTRODUCTION In settings with low literacy levels ensuring that participants are fully-informed before they consent to participate in clinical trials is a challenge. We explored the experiences and concerns of key actors in the informed consent process in two HIV clinical trials. METHOD Semi-structured interviews were conducted with 46 respondents including trial participants, research study ...