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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]
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.
The three primary areas of application were stated as informed consent, assessment of risks and benefits, and selection of human subjects in research. It was named the Belmont Report , for the Belmont Conference Center , where the National Commission met when first drafting the report.
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 ...
Informed consent is documented by means of a written, signed, and dated informed consent form. (ICH E6) Informed consent document A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained ...
Unethical human experimentation is human experimentation that violates the principles of medical ethics.Such practices have included denying patients the right to informed consent, using pseudoscientific frameworks such as race science, and torturing people under the guise of research.
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'.