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Informed consent is documented by means of a written, signed, and dated informed consent form. [33] In medical research , the Nuremberg Code set a base international standard in 1947, in response to the ethical violation in the Holocaust .
Dynamic consent is an approach to informed consent that enables on-going engagement and communication between individuals and the users and custodians of their data. It is designed to address the many issues that are raised by the use of digital technologies in research and clinical care that enable the wide-scale use, linkage, analysis and integration of diverse datasets and the use of AI and ...
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 research began with the selection of 22 subjects from a veterans' orphanage in Iowa. None were told the intent of the research, and they believed that they were to receive speech therapy. The study was trying to induce stuttering in healthy children. The experiment became national news in the San Jose Mercury News in 2001, and a book was ...
In social science research, issues of research ethics, informed consent, and research protocols often arise, and research of Wikipedia is no exception. Rules and laws established after controversial studies like the Milgram experiment and Stanford prison experiment require researchers to design their studies such that they do no harm to participants.
Havasupai Tribe of Havasupai Reservation v. Arizona Board of Regents was brought to court on April 20, 2010. It was discovered that the DNA samples extracted from the Havasupai tribe members that were initially intended to go towards research regarding the genetic linkage to type 2 diabetes in the 1990s, were being used for additional studies. [2]
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'.
The sponsor sets informed consent requirements, as does the IRB. Each local IRB must review and approve the informed consent, but the CRC is responsible for communication between the IRB and the sponsor. §46.116 of the Code of Federal Regulations outlines the basic elements of informed consent as a: [5]
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