Informed Consent Form (ICF)
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An Informed Consent Form (ICF) is a Medical Document/Form that is signed by a patient that authorizes a healthcare provider to perform an intervention, conduct clinical research, or disclose a medical records.
- AKA: Informed Consent Document, Informed Consent Waiver.
- Context:
- It can also require a dynamic consent.
- Example(s):
- a Clinical Direct Access,
- an eConsent,
- an Informed Consent to Research,
- …
- Counter-Example(s):
- See: Research Ethics, Medical Law, Clinical Research, Research Participant, Clinical Trial, Patient Participation.
References
2022
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/informed_consent Retrieved:2022-6-8.
- Informed consent is a principle in medical ethics and medical law that a patient should have sufficient information before making their own free decisions about their medical care. A healthcare provider is often held to have a responsibility to ensure that the consent that a patient gives is informed, and informed consent can apply to a health care intervention on a person, conducting some form of research on a person, or for disclosing a person's information. Informed consent is, in fact, a fundamental principle in the field of health protection, obviously wanting to mark the very close and unavoidable connection between the need for consent and the inviolability of the right to health. [1] A health care provider may ask a patient to consent to receive therapy before providing it, a clinical researcher may ask a research participant before enrolling that person into a clinical trial, and a researcher may ask a research participant before starting some form of controlled experiment. Informed consent is collected according to guidelines from the fields of medical ethics and research ethics. Free consent is a cognate term enshrined in the International Covenant on Civil and Political Rights. The covenant was adopted in 1966 by the United Nations, and intended to be in force by 23 March 1976. Article seven prohibits experiments conducted without the "free consent to medical or scientific experimentation" of the subject. , the covenant has 173 parties and six more signatories without ratification. Informed consent can be said to have been given based upon a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and be in possession of all relevant facts. Impairments to reasoning and judgment that may prevent informed consent include basic intellectual or emotional immaturity, high levels of stress such as post-traumatic stress disorder or a severe intellectual disability, severe mental disorder, intoxication, severe sleep deprivation, Alzheimer's disease, or coma. Obtaining informed consent is not always required. If an individual is considered unable to give informed consent, another person is generally authorized to give consent on his behalf, e.g., parents or legal guardians of a child (though in this circumstance the child may be required to provide informed assent) and conservators for the mentally disordered, or consent can be assumed through the doctrine of implied consent, e.g., when an unconscious person will die without immediate medical treatment. In cases where an individual is provided insufficient information to form a reasoned decision, serious ethical issues arise. Such cases in a clinical trial in medical research are anticipated and prevented by an ethics committee or institutional review board.
Informed consent form templates can be found on the website of the World Health Organization.
- Informed consent is a principle in medical ethics and medical law that a patient should have sufficient information before making their own free decisions about their medical care. A healthcare provider is often held to have a responsibility to ensure that the consent that a patient gives is informed, and informed consent can apply to a health care intervention on a person, conducting some form of research on a person, or for disclosing a person's information. Informed consent is, in fact, a fundamental principle in the field of health protection, obviously wanting to mark the very close and unavoidable connection between the need for consent and the inviolability of the right to health. [1] A health care provider may ask a patient to consent to receive therapy before providing it, a clinical researcher may ask a research participant before enrolling that person into a clinical trial, and a researcher may ask a research participant before starting some form of controlled experiment. Informed consent is collected according to guidelines from the fields of medical ethics and research ethics. Free consent is a cognate term enshrined in the International Covenant on Civil and Political Rights. The covenant was adopted in 1966 by the United Nations, and intended to be in force by 23 March 1976. Article seven prohibits experiments conducted without the "free consent to medical or scientific experimentation" of the subject. , the covenant has 173 parties and six more signatories without ratification. Informed consent can be said to have been given based upon a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and be in possession of all relevant facts. Impairments to reasoning and judgment that may prevent informed consent include basic intellectual or emotional immaturity, high levels of stress such as post-traumatic stress disorder or a severe intellectual disability, severe mental disorder, intoxication, severe sleep deprivation, Alzheimer's disease, or coma. Obtaining informed consent is not always required. If an individual is considered unable to give informed consent, another person is generally authorized to give consent on his behalf, e.g., parents or legal guardians of a child (though in this circumstance the child may be required to provide informed assent) and conservators for the mentally disordered, or consent can be assumed through the doctrine of implied consent, e.g., when an unconscious person will die without immediate medical treatment. In cases where an individual is provided insufficient information to form a reasoned decision, serious ethical issues arise. Such cases in a clinical trial in medical research are anticipated and prevented by an ethics committee or institutional review board.
- ↑ Salerno, Francesco (2014), Consenso informato in medicina e qualità soggettive del paziente, Giurisprudenza italiana, 2014, pp. 275-281
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-12-4.
- Informed consent
- A process in which a person is given important facts about a medical procedure or treatment, a clinical trial, or genetic testing before deciding whether or not to participate. It also includes informing the patient when there is new information that may affect his or her decision to continue. Informed consent includes information about the possible risks, benefits, and limits of the procedure, treatment, trial, or genetic testing. (NCI)
- The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. (NLM)
- A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. 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 in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time. (NLM)
- Informed consent