Informed consent

consentPrior Informed Consentconsensualconsent formfully informedinformed, consensualmedical consentconsensual sexlack the capacitylegal consent
Informed consent is a process for getting permission before conducting a healthcare intervention on a person, or for disclosing personal information.wikipedia
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Consent

consensualaffirmative consentnon-consensual
A health care provider may ask a patient to consent to receive therapy before providing it, or a clinical researcher may ask a research participant before enrolling that person into a clinical trial.
Types of consent include implied consent, expressed consent, informed consent and unanimous consent.

Informed assent

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.
It is similar to the process of informed consent in adults, however there remains some overlap between the terms.

21st Century Cures Act

The 21st Century Cures Act enacted by the 114th United States Congress in December 2016 allows researchers to waive the requirement for informed consent when clinical testing "poses no more than minimal risk" and "includes appropriate safeguards to protect the rights, safety, and welfare of the human subject."
In section 3024, the 21st Century Cures Act allows researchers to waive the requirement for "informed consent" in cases where clinical testing of drugs or devices "poses no more than minimal risk" and "includes appropriate safeguards to protect the rights, safety, and welfare of the human subject."

Ethics committee

research ethics committeesResearch Ethics Committee
Such cases in a clinical trial in medical research are anticipated and prevented by an ethics committee or Institutional Review Board.
An important element of an ethics committee's oversight is to ensure that informed consent of the subjects has been given.

Institutional review board

Institutional Review BoardsInstitutional Review Board (IRB)IRB
Such cases in a clinical trial in medical research are anticipated and prevented by an ethics committee or Institutional Review Board.
A bona fide process for obtaining informed consent from participants is also generally needed.

Clinical trial

clinical trialsclinical studiesclinical study
A health care provider may ask a patient to consent to receive therapy before providing it, or a clinical researcher may ask a research participant before enrolling that person into a clinical trial. Such cases in a clinical trial in medical research are anticipated and prevented by an ethics committee or Institutional Review Board.
Clinical trials recruit study subjects to sign a document representing their "informed consent".

Montgomery v Lanarkshire Health Board

The UK has since departed from the Bolam test for judging standards of informed consent, due to the landmark ruling in Montgomery v Lanarkshire Health Board.
Montgomery v Lanarkshire Health Board [2015] UKSC 11 is a Scottish delict, medical negligence and English tort law case on doctors and pharmacists that outlines the rule on the disclosure of risks to satisfy the criteria of an informed consent.

Mental disorder

mental illnessnervous breakdownmentally ill
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. Impairments to reasoning and judgment that may prevent informed consent include basic intellectual or emotional immaturity, high levels of stress such as posttraumatic stress disorder (PTSD) or a severe intellectual disability, severe mental disorder, intoxication, severe sleep deprivation, Alzheimer's disease, or being in a coma.
In order for involuntary treatment to be administered (by force if necessary), it should be shown that an individual lacks the mental capacity for informed consent (i.e. to understand treatment information and its implications, and therefore be able to make an informed choice to either accept or refuse).

Bolam v Friern Hospital Management Committee

Bolam testBolam v. Friern Hospital Management CommitteeBolam
Until 2015 in the United Kingdom and in countries such as Malaysia and Singapore, informed consent in medical procedures requires proof as to the standard of care to expect as a recognised standard of acceptable professional practice (the Bolam Test), that is, what risks would a medical professional usually disclose in the circumstances (see Loss of right in English law).
Thus, Bolam applies to all the acts and omissions constituting diagnosis and consequential treatment, and Hedley Byrne applies to all advisory activities involving the communication of diagnosis and prognosis, giving of advice on both therapeutic and non-therapeutic options for treatment, and disclosure of relevant information to obtain informed consent.

Chester M. Southam

Chester M. Southam used HeLa cells to inject into cancer patients and Ohio State Penitentiary inmates without informed consent to determine if people could become immune to cancer and if cancer could be transmitted.
From the mid-1950s to the mid-1960s, Southam conducted clinical research on people without their informed consent, in which he injected cancer cells (HeLa cells) into their skin, to see if their immune system would reject the cancer cells or if the cells would grow.

Consent (BDSM)

Consentconsensualconsensual non-consent
It bears much in common with the concept of informed consent and is simultaneously a personal, ethical and social issue.

Dynamic consent

Researchers are required to obtain informed consent from potential participants before any research begins – this is a fundamental principle of medical research as laid out in the Declaration of Helsinki.

Consensual crime

consentconsensualconsensually
Legislative bodies and interest groups sometimes rationalize the criminalization of consensual activity because they feel it offends cultural norms, or because one of the parties to the activity is considered a "victim" despite their informed consent.

Unethical human experimentation in the United States

Human experimentation in the United Stateshuman experimentationmedical experimentation
Unethical human experimentation in the United States describes numerous experiments performed on human test subjects in the United States that have been considered unethical, and were often performed illegally, without the knowledge, consent, or informed consent of the test subjects.

Tearoom Trade

Tearoom Trade: A Study of Homosexual Encounters in Public PlacesTearoom Trade: Impersonal Sex in Public Placestearooms
Tearoom Trade is the name of a book by American psychologist Laud Humphreys.
Humphreys' study has been criticized on ethical grounds in that he observed acts of homosexuality by masquerading as a voyeur, did not get his subjects’ consent, used their license plate numbers to track them down, and interviewed them in disguise without revealing the true intent of his studies (he claimed to be a health service interviewer, and asked them questions about their race, marital status, occupation, and so on).

Declaration of Helsinki

Helsinki DeclarationHelsinki Committeeethical
The fundamental principle is respect for the individual (Article 8), their right to self-determination and the right to make informed decisions (Articles 20, 21 and 22) regarding participation in research, both initially and during the course of the research.

Nuremberg Code

Nuremberg CodesNuremburg CodeThe Nuremberg Code
In medical research, the Nuremberg Code set a base international standard in 1947, which continued to develop, for example in response to the ethical violation in the Holocaust.
The guidelines were based on beneficence and non-maleficence, but also stressed legal doctrine of informed consent.

Informed refusal

refuse medical treatmentright to refuse treatment
Informed refusal is linked to the informed consent process, as a patient has a right to consent, but also may choose to refuse.

Human subject research

human experimentationhuman experimentsguinea pig
Historians cite a series of human subject research experiments to trace the history of informed consent in research.
Privacy, confidentiality, and informed consent are key concerns, yet it is unclear when social media users qualify as human subjects.

Laud Humphreys

Tearoom Trade is the name of a book by American psychologist Laud Humphreys.
Humphreys' study has been criticized by sociologists and other social and behavioral scientists on ethical grounds in that he observed sexual acts by masquerading as a voyeur, "did not get his subjects’ consent, tracked down names and addresses through license plate numbers, and interviewed the men in their homes in disguise and under false pretenses."

Yellow fever

yellow fever virusyellow-feveryellow plague
The U.S. Army Yellow Fever Commission “is considered the first research group in history to use consent forms.” In 1900, Major Walter Reed was appointed head of the four man U.S. Army Yellow Fever Commission in Cuba that determined mosquitoes were the vector for yellow fever transmission.
He is also credited for using the first type of medical consent form during his experiments in Cuba, an attempt to ensure that participants knew they were taking a risk by being part of testing.

Minors and abortion

parental notificationconsent lawparental consent
However, she must give informed consent, meaning that if she is unable to understand the consequences of an abortion she cannot consent to one without the assistance of her parents or guardian.

Privacy for research participants

protect subjects' identitiesresearch participant privacyresearch participant's privacy
In conducting this research he never sought consent from his research subjects and other researchers raised concerns that he violated the right to privacy for research participants.

Mature minor doctrine

medical emancipationdoctrine of the mature minormedically emancipated
His doctor required written consent, which Smith provided, and the surgery was performed.

Respect for persons

Respectvulnerable populations
The doctrine of informed consent relates to professional negligence and establishes a breach of the duty of care owed to the patient (see duty of care, breach of the duty, and respect for persons).
In practice, respect for persons is operationalized by obtaining Informed Consent from all individuals who are going to be research subjects.