Medical therapeutics: mortality effects, uncertainty, and informed consent

Medical treatment, medical research and informed consent.

Informed Consent to Medical Treatment

Informed consent in medical research.

That people should only be enrolled in medical research if they have given free and informed consent is now an unquestioned principle of research ethics. It is however a recent innovation. Prior to the prominence given to consent to participation in research in the condemnation of German doctors arraigned at Nuremberg in 1945, informed consent had appeared in American litigation, but only as an...

Informed Consent in Medical Malpractice

FDA medical device regulation and informed consent.

New medical devices are subject to a regulatory scheme designed to ensure safety and effectiveness that is administered by the United States Food and Drug Administration (FDA). Gaining approval to market a device for a specific clinical indication may be time-consuming and costly, particularly for one that poses a potentially unreasonable risk of patient injury and represents genuinely new medi...