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Example of informed consent document from the PARAMOUNT trial. 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.
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.
Right to know is a human right enshrined in law in several countries. UNESCO defines it as the right for people to "participate in an informed way in decisions that affect them, while also holding governments and others accountable". [1]
Consent is not defined but is granted or withheld after a process that involves consultation and participation. However, mere consultation by itself is not a substitute for actual consent. [5] The UN Working Group on Business and Human Rights notes that Indigenous Peoples "should determine autonomously how they define and establish consent." [6]
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 ...
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 ...
An informed consent clause, although allowing medical professionals not to perform procedures against their conscience, does not allow professionals to give fraudulent information to deter a patient from obtaining such a procedure (such as lying about the risks involved in an abortion to deter one from obtaining one) in order to impose one's belief using deception.
Informed refusal is where a person has refused a recommended medical treatment based upon an understanding of the facts and implications of not following the treatment. [ 1 ] [ 2 ] Informed refusal is linked to the informed consent process, as a patient has a right to consent, but also may choose to refuse.