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- Theory of Informed Consent
By Hub staff report. Fully informed consent is not ethically required for some types of health research , leading bioethics experts contend in an article published in the latest issue of the New England Journal of Medicine. The experts—including Ruth Faden , director of the Berman Institute of Bioethics at Johns Hopkins, and Nancy Kass , the Berman Institute's deputy director for public health—advocate for a more nuanced approach to consent, noting that in some cases a time-consuming consent process is unnecessary for patient protection and could actually impede improvements in patient care.
Their position is a considerable break from principles that have guided research ethics and regulation for decades. The commentary is published in the Feb. The commentary's authors are thought leaders in the field of bioethics: Faden and Georgetown University philosophy professor Tom L. Beauchamp , co-authored A History and Theory of Informed Consent , and Kass is an innovator in public health ethics and author of the widely referenced "Kass framework" for ethics analysis of public health programs.
Beauchamp was also the principal author of The Belmont Report, which established the ethical principles that have formed the foundation of national and professional policy regarding research with human subjects in the decades since its release. Tagged bioethics , berman institute of bioethics , ruth faden. Patient consent to research not always necessary, leading bioethicists say Faden, Beauchamp, Kass author 'New England Journal of Medicine' article. Share on Twitter. Competency is presumed in law in the case of adults see Chapter 7 on mental health for a detailed discussion of competency issues.
Questions of competency arise in the context of mental health, and healthcare or research involving children, to which common law jurisdictions generally apply the mature minor rule, which allows children and adolescents to provide consent when they are deemed mature enough to understand and appreciate the consequences of doing so.
Competency is connected to comprehension: competency is treatment specific, so that a person with borderline competency can be competent to make one decision, but incompetent to decide in more complex situations. The act of consenting can in many circumstances be explicit or implicit, verbal or written. Consent does not always have to be formalized and can be expressed in different ways.
Written consent provides stronger — yet not conclusive — evidence that consent has been obtained and that specific information has been shared. Regulations often prescribe that a written consent form must be used, particularly in the research context. Written consent forms are also used for complex medical procedures, such as invasive surgeries, that involve more elevated levels of risk.
Yet courts can still rule that notwithstanding the signed consent form, there was no informed consent Tremblay v. Inversely, the absence of a written consent form should not be equated with the absence of consent. Rather, when regulations require written consent as a norm, they will often specify exceptions where written consent may be impractical or impossible to obtain. Obviously, informed consent procedures should be adjusted to the circumstances. Specific situations may require shorter informational exchanges, and in exceptional circumstances it will be impossible to obtain even the most minimal form of consent prior to a healthcare intervention.
The exchange of information at that point may also be necessary for follow-up interventions. A final note is warranted here about another another exception that is often mentioned and has strong historical roots: therapeutic privilege. As mentioned before, physicians were traditionally given much discretion about hiding information that could distress the patient.
While the exception is still often mentioned, it is doubtful when physicians could still invoke it to justify a failure to disclose relevant information. Physicians have a duty of care in how they transfer information, and a patient may also express a desire not to receive further information, but the concept of therapeutic privilege clearly no longer allows physicians to make their own judgment about what to tell patients. In some situations, the inability of a patient to comprehend and deal with information may be associated with competency issues.
In that case, other protective measures apply based on substitute decision-making see Chapter 7 on mental health.
Book review essays
Different normative foundations of informed consent may result in different interpretations of its various components in law. Yet, even though courts and legislators often ground the need for informed consent with references to autonomy and the importance of self-determination, they do not engage in a detailed philosophical discussion of what type of autonomy or other ethical norm is the real basis for informed consent, or how various challenges to autonomy impact on meaningful consent. The legal notion of informed consent has its own meaning. For Jessica W. The legal concept of informed consent is driven in part by pragmatic concerns about clarity, feasibility, and certainty.
A History and Theory of Informed Consent.pdf
The legal rules surrounding the institutional practice of informed consent will often explicitly refer to the ideals discussed earlier. Common law and civil law jurisdictions generally start from the premise that a person has the right to make his or her own healthcare decisions, and that some level of information-sharing is needed to enable this McLean But legal and institutional rules aim to clarify what level of information is to be provided; how it is to be provided e. These rules vary among jurisdictions. The discussion here aims at offering a picture of some of the key legal concepts, questions, and tests that have emerged, with particular attention to Canadian common law.
This will be followed by a brief discussion of the regulation of informed consent in various jurisdictions. When patients or research subjects feel that they have not been properly informed about a medical procedure or about the research project they were enrolled in and they feel harmed, what type of legal action is available to them at common law?
Two common law actions can be used, depending on the nature of the violation: battery or negligence. Battery involves the intentional touching of a person without his or her consent. The action in battery, a form of trespass on the person, seemed a logical tool for courts, once it became accepted that the right to self-determination required medical professionals to obtain consent from patients prior to any physical interference with their body.
As Katz points out , battery offers a more robust protection of the concept of self-determination underlying informed consent: the mere fact of bodily intrusion suffices for a claim of battery.
No physical or psychological harm has to be proven as the harm resides in the violation of the dignitary interest people have in the integrity of their body Katz Battery also offers the advantage that it is up to the defendant to provide evidence of consent Peppin : Nonetheless, courts became hesitant to allow actions in battery, fearing the use of the action every time that there was a potential problem with the consent given for a medical procedure. Consequently, battery became restricted to cases where there was no disclosure as to the nature of the procedure, notably where patients consented to one operation and surgeons performed another Mulloy v.
Curry 3 DLR ; Murray v. McMurchy  2 DLR Katz locates this development in the judicial and societal deference to the medical profession. For McLean, other factors favored the introduction of a remedy based on negligence: some healthcare practices do not involve physical touching, such as the prescription of medication; and some failures to obtain informed consent, such as the failure to discuss alternatives, are hard to qualify as battery Other Canadian cases have broadened the scope of battery: the earlier mentioned Ontario case of Gerula v.
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Flores where a surgeon performed a second operation under a false pretext to correct an earlier mistake; Malette v. Schulman et al. Wynrib , discussed above; Nightingale v. Weisner and South Fraser Health Region , BCSC 15, involving the vaccination of a minor without parental consent, even though the nurse vaccinating the child believed the parents had consented.
While battery protects the right of patients to be free from physical intrusion in extreme cases of failure to consent, negligence protects more widely the right of patients to have all relevant information before making healthcare decisions. Negligence has become the more common claim in cases of failure to provide adequate informed consent.
To establish negligence, a plaintiff must overcome several hurdles associated with traditional tort claims.
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Patients must establish a duty of care, a breach of that duty, harm suffered, and causation between the breach and the harm. In the context of informational negligence, there are three key issues: the content of the informational duty of care, and particularly how the standard of care will be determined; the nature of the harm suffered; and causality between the failure to inform and the harm suffered.
Courts have developed different standards to determine what constitutes sufficient information. As pointed out before, English common law has been more reluctant than other jurisdictions to fully embrace the doctrine of informed consent. Even though English courts have long recognized the importance of providing information to enable patients to make self-regarding decisions, how that information is to be provided and how much information should be shared is still largely measured according to the so-called professional standard McLean : 73—6. The Sidaway case and Gold v.
Haringey Health Authority  QB both confirmed that the traditional test for negligence in medical practice from Bolam v. Bethlem Royal Hospital Governors et al. Sheila McLean notes, however, that more recent cases, while not rejecting outright the Bolam test, move prudently away from mere reliance on professional judgment 79— In Chester v. Afshar , p. Without explicitly abandoning Sidaway , the English Lords promoted patient autonomy through a remarkable interpretation of the causation test. Canadian, Australian, and US courts have since long adopted a test that appears more in line with the concept of self-determination underlying informed consent.
Theory of Informed Consent
In Canada, a duo of Supreme Court cases, Hopp v. Lepp  2 SCR and Reibl v. Hughes , rejected the professional standard and emphasized that the duty of disclosure has to be assessed from what a reasonable patient in the same position would want to know in order to make a properly informed decision.