Informed consent

Principle of biomedical research stating that study participants have the right to know the risks and benefits involved in participating in a research study and that they may not be included in such studies without their explicit written consent.


Permission by the patient for a medical procedure based on understanding the nature of the procedure, the risks involved, the consequences of withholding permission, and alternative procedures.


Agreement based on full knowledge.


Consent, preferably in writing, obtained from a patient for performance on the patient of specific medical, surgical or research procedures after the proposed procedure and risks involved have been fully explained in non-technical terms and understood. If the patient is minor, or is incapable of under-standing or communicating, such consent must be obtained from a close adult relative or legal guardian.


An agreement to allow a procedure to be carried out, given by a patient, or the guardian of a patient, who has been provided with all the necessary information.


Formal written permission to be obtained from a patient by medical personnel before invasive and possibly risky medical tests or other medical procedures, such as operations, are performed. By law, the doctor is required to tell patients, in language they can understand, the risks as well as the benefits of the test or procedure to be performed and to give patients information about possible alternative tests to find the same or similar information. Before certain types of procedures, the patient may be asked to sign a document outlining that information in language understandable to nonprofessionals, often before a witness and generally a specified number of hours or days ahead of time. Because children, as minors, are usually not legally able to sign such documents, parents must obtain and analyze the information and give consent for them.


Permission obtained from a patient for the performance of a particular procedure or test, after being told fully the risks, options, and expected results. Informed consent, usually in a signed statement, is generally required before any invasive procedure (e.g., surgery or diagnostic procedures in which instruments are inserted into the body), before admission to any experimental or research study, and in certain other situations. The legal standard for informed consent varies from state to state. Most states have the “reasonable patient” standard, meaning that the health care provider must tell the patient what the reasonable lay patient would want to know. A few states use the “reasonable provider” standard, meaning that the health care provider is only required to tell the patient what the provider feels is important for the patient know to make an informed decision.


Patients’ rights are a growing concern for doctors and patients. A vital aspect of their relationship is consent: doctors need signed agreement from patients before carrying out operations or procedures; before entering patients in clinical trials; and before publishing clinical details or photographs of patients for medical education in print or electronic media. Consent is said to be informed when patients are fully aware of the consequences and risks of the procedure in question. For example, doctors and other health professionals should tell patients of the complications of a treatment and the likelihood of its success. They should make sure that the patients understand the information given; they should be given the opportunity to ask questions and, where appropriate, immediate relatives should be involved in the process. Doctors are often inclined to highlight the benefits of a treatment, while downplaying the risks, but the General Medical Council in the United Kingdom has shown its willingness to discipline doctors who go beyond the consent that they were given by patients.


A voluntary agreement made by a well-advised and mentally competent patient to be treated by a health care provider or institution, or randomized into a research study. The health care provider should provide full disclosure of information regarding the material risks, benefits of the proposed treatment, alternatives, and consequences of no treatment, so that the patient can make an intelligent, or informed, choice.


An informative interaction taking place between healthcare providers and patients with the aim of educating the patient about the characteristics and objectives of a medical procedure or treatment, the potential risks and advantages associated with it, as well as alternative options, including the choice of not undergoing the test or treatment. This process is commonly known as patient education or informed consent.


 


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