"Informed consent is a principle in medical ethics and medical law and media studies, that a patient must have sufficient information and understanding before making decisions about their medical care."
The process of obtaining a patient's voluntary agreement to undergo medical treatment or participate in research.
Definition and Purpose of Informed Consent: This topic covers the basics of informed consent, its definition, and its importance in medical ethics.
Elements of Informed Consent: This topic covers the essential components of informed consent, such as the disclosure of information, the patient's understanding of the information, and the patient's voluntary consent.
Capacity to Consent: This topic focuses on a patient's capacity to understand and make decisions about their medical treatment. It covers the importance of assessing a patient's capacity to consent and the ethical considerations that arise when a patient lacks capacity.
Implied Consent: This topic deals with the concept of implied consent, which occurs when a patient's actions (such as showing up for an appointment) indicate that they have given their consent for a medical procedure.
Special Considerations for Obtaining Informed Consent: This topic covers special considerations that need to be made when obtaining informed consent, such as dealing with language barriers, cultural differences, and patients with disabilities.
Exceptions to Informed Consent: This topic deals with the circumstances under which informed consent may not be necessary, such as in emergency situations or when a patient lacks capacity.
Informed Consent for Research: This topic focuses on the special considerations that need to be made when obtaining informed consent for research studies, such as the need for a separate consent process and the importance of ensuring that the patient fully understands the risks and benefits of participating.
Informed Consent for Minors: This topic covers the special considerations that need to be made when obtaining informed consent for minors, including the role of parents and guardians in the consent process.
Legal and Ethical Issues Related to Informed Consent: This topic covers legal and ethical issues related to informed consent, such as the role of healthcare professionals in obtaining consent, the consequences of failing to obtain informed consent, and the principles of autonomy and beneficence in medical ethics.
Documentation and Record-Keeping: This topic covers the importance of documenting the informed consent process, including the patient's understanding of the information disclosed, the patient's consent, and any special considerations made during the consent process.
Written Informed Consent: A process in which a participant gives written agreement before taking part in a medical procedure, clinical trial or research study.
Verbal Informed Consent: Consent that is obtained orally without any written documentation.
Implied Consent: Consent inferred from a patient or participant's conduct, such as when a patient presents himself/herself for treatment.
Expressed Consent: An actual communication from the patient indicating assent, like a nod or a "yes" response.
Opt-Out Consent: A type of informed consent where the participant is contacted about an intervention and has the option to decline or opt-out.
Opt-In Consent: A type of informed consent where the participant is contacted for an intervention and has to affirmatively choose to participate.
Substitute or Proxy Consent: Consent given when the patient is unable to provide consent for himself/herself, and an authorized representative or surrogate gives approval.
Presumed Consent: A form of implied consent whereby the patient's silence or failure to object when treatment is proposed is taken as an indication of consent to the treatment.
Broad Consent: A form of informed consent that allows multiple uses of collected data or biospecimens in the future for various research projects.
Specific Consent: A form of informed consent that identifies and specifies the scope, goal, procedures, risks, and benefits of a particular study or treatment.
Continuing Consent: A form of informed consent that enables participants to receive new information, periodically reevaluate the project, and to choose to withdraw their approval at any time.
"Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment."
"Healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed."
"This principle applies more broadly than healthcare intervention, for example to conduct research and to disclose a person's medical information."
"Within the US, definitions of informed consent vary, and the standard required is generally determined by the state."
"Impairments to reasoning and judgment that may preclude informed consent include 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, dementia, 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 their behalf."
"Parents or legal guardians of a child can generally give consent on their behalf, though the child may be required to provide informed assent."
"The doctrine of implied consent permits treatment in limited cases, for example when an unconscious person will die without immediate intervention."
"Cases in which an individual is provided insufficient information to form a reasoned decision raise serious ethical issues."
"When these issues occur, or are anticipated to occur, in a clinical trial, they are subject to review by an ethics committee or institutional review board."
"Informed consent is codified in both national and international law."
"'Free consent' is a cognate term in the International Covenant on Civil and Political Rights, adopted in 1966 by the United Nations."
"Article 7 of the covenant prohibits experiments conducted without the 'free consent to medical or scientific experimentation' of the subject."
"As of September 2019, the covenant has 173 parties and six more signatories without ratification."