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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.
Informed consent is a principle in medical ethics, medical law, media studies, and other fields, that a person must have sufficient information and understanding before making decisions about accepting risk, such as their medical care.
In April 1947, Alexander submitted a memorandum to the United States Counsel for War Crimes outlining six points for legitimate medical research. [6] An early version of the Code known as the Memorandum, which stated explicit voluntary consent from patients is required for human experimentation, was drafted on 9 August 1947. [7]
Beecher believed that rules requiring informed consent were not alone sufficient, as truly informed consent was an unattainable ideal. He worked both to define the rules and conditions for informed consent, and to establish institutional review boards as an additional layer of oversight regarding research protocols. [73] [74]
Paul Ramsey undertook his doctoral studies at Yale where he was mentored by H. Richard Niebuhr. [2] He subsequently taught Christian Ethics at Princeton.Ramsay has been credited with laying the intellectual foundations of bioethics and informed consent through his book The Patient as Person, which has continued to be a standard text in medical ethics across multiple editions. [3]
The Common Rule is a 1991 rule of ethics (revised in 2018) [2] regarding biomedical and behavioral research involving human subjects in the United States.The regulations governing Institutional Review Boards for oversight of human research followed the 1975 revision of the Declaration of Helsinki, and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services ...
Informed consent was developed further, made more prescriptive and partly moved from 'Medical Research Combined with Professional Care' into the first section (Basic Principles), with the burden of proof for not requiring consent being placed on the investigator to justify to the committee. 'Legal guardian' was replaced with 'responsible relative'.
Jerry Watson Canterbury (1939-2017) was an FBI clerk who suffered a ruptured disk in 1958. [1] He received laminectomy by Dr. William T. Spence, a well-known Washington neurosurgeon, and as a result of the surgery, and a subsequent fall from his bed while hospitalized, he ended up paralyzed below the waist and incontinent.