In Defence of Consent and Capacity Boards for End-of-Life Care

In Cuthbertson v. Rasouli, the Supreme Court of Canada (SCC) found that, in Ontario, it is the Consent and Capacity Board (CCB) and not the courts per se who will resolve conflicts between substitute decision-makers (SDMs) and health practitioners regarding the withdrawal of lifesustaining treatment from incapable patients. This finding was based on the SCC’s interpretation of the Ontario Health Care Consent Act (HCCA). Hawryluck et al. express concern about the SCC’s determination that the CCB is charged with resolving such conflicts since, in their view, this body is ill-equipped to fulfill this role. Instead, they take the position that these disputes should be adjudicated by the courts. We disagree with this position and, for the reasons set out in this editorial, take the position that provincial and territorial legislators across the country should follow the lead of the Ontario legislature, revise their health care consent legislation to clarify the law with respect to the unilateral withholding and withdrawal of potentially life-sustaining treatment, and establish open and transparent consent and capacity tribunals to deal with irreconcilable conflicts in this context

The Therapeutic Misconception: A Threat to Valid Parental Consent for Paediatric Neuroimaging Research

Neuroimaging research has brought major advances to child health and well-being. However, because of the vulnerabilities associated with neurological and developmental conditions, the parental need for hope, and the expectation of parents that new medical advances can benefit their child, pediatric neuroimaging research presents significant challenges to the general problem of consent in the context of research involving children. A particular challenge in this domain is created by the presence of therapeutic misconception on the part of parents and other key research stakeholders. This article reviews the concept of therapeutic misconception and its role in pediatric neuroimaging research. It argues that this misconception can compromise consent given by parents for the involvement of their children in research as healthy controls or as persons with neurological and developmental conditions. The article further contends that therapeutic misconception can undermine the research ethics review process for proposed and ongoing neuroimaging studies. Against this backdrop, the article concludes with recommendations for mitigating the effects of therapeutic misconception in pediatric neuroimaging research

Developing Product Label Information to Support Evidence-Informed Use of Vaccines in Pregnancy

Background: Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy. Purpose: To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels. Methods: We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) meeting, followed by a Delphi survey, and then a consensus workshop with a subset of Delphi participants. We developed a methodological tool to analyse data for consensus. Principal results: Stakeholders (N = 14) at the NGT meeting drafted product label statements for evaluation in the Delphi survey. Survey participants (N = 41) provided feedback on statements for five hypothetical vaccines. Workshop participants (N = 27) initiated discussions that demonstrated a lack of awareness that the regulatory purpose of product labels is to provide a scientific summary of product-specific preclinical and clinical trial data. Each stage of this project built on earlier stages until we achieved strong consensus on the language, structure, and types of data that stakeholders wanted to include in inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine product labels in Canada. Conclusions: The revised statements for IIV and Tdap aligned with workshop participants’ goals that the product label be evidence-based, with a consistent structure and language that is easily understood by healthcare providers. Emergent methods uncovered stakeholder concerns about the regulatory purpose, content, and evidence used in product labels. Involving healthcare providers in the development and regular updating of product information could prevent interpretations of that information that contribute to vaccine hesitancy

A Critique of Canadian Jurisprudence on the Therapeutic Privilege Exception to Informed Consent

The Supreme Court of Canada’s landmark decisions in Hopp v Lepp and Reibl v Hughes furnished a general analytical framework for informed consent actions that remains fully intact today. This article sets its gaze on a specific aspect of the framework, dubbed “therapeutic privilege,” that permits physicians to deviate from their general duty to disclose material, treatmentrelated risks to competent patients. Specifically, the privilege allows information about material risks to be withheld or generalized if physicians believe their patients are “unable to cope” with receiving such information. It is argued that the Supreme Court’s terse and vaguely-articulated exception to truth telling disempowers patients by depriving them of their decisional autonomy and undermines the trust relationship that lies at the heart of the physician-patient relationship. In view of these hazards, the article explores the post-Hopp and post-Reibl jurisprudence to determine how therapeutic privilege has been interpreted and applied by Canadian courts. It finds that the contours of the privilege continue to be ill defined, the Supreme Court’s formulation of the privilege has been interpreted by some courts in a manner that is disrespectful of patient autonomy, and no judicial action has been taken to meaningfully narrow the scope of the privilege. While the privilege may be needed in truly exceptional cases, the courts must establish stringent limitations on its application in order to minimize intrusion on patients’ right of medical selfdetermination and reduce the potential harm to the covenant of trust between patients and physicians. Specific recommendations regarding such limitations are provided

A Critique of Canadian Jurisprudence on the Therapeutic Privilege Exception to Informed Consent

The Supreme Court of Canada’s landmark decisions in Hopp v Lepp and Reibl v Hughes furnished a general analytical framework for informed consent actions that remains fully intact today. This article sets its gaze on a specific aspect of the framework, dubbed “therapeutic privilege,” that permits physicians to deviate from their general duty to disclose material, treatmentrelated risks to competent patients. Specifically, the privilege allows information about material risks to be withheld or generalized if physicians believe their patients are “unable to cope” with receiving such information. It is argued that the Supreme Court’s terse and vaguely-articulated exception to truth telling disempowers patients by depriving them of their decisional autonomy and undermines the trust relationship that lies at the heart of the physician-patient relationship. In view of these hazards, the article explores the post-Hopp and post-Reibl jurisprudence to determine how therapeutic privilege has been interpreted and applied by Canadian courts. It finds that the contours of the privilege continue to be ill defined, the Supreme Court’s formulation of the privilege has been interpreted by some courts in a manner that is disrespectful of patient autonomy, and no judicial action has been taken to meaningfully narrow the scope of the privilege. While the privilege may be needed in truly exceptional cases, the courts must establish stringent limitations on its application in order to minimize intrusion on patients’ right of medical selfdetermination and reduce the potential harm to the covenant of trust between patients and physicians. Specific recommendations regarding such limitations are provided

In Defence of Consent and Capacity Boards for End-of-Life Care

In Cuthbertson v. Rasouli, the Supreme Court of Canada (SCC) found that, in Ontario, it is the Consent and Capacity Board (CCB) and not the courts per se who will resolve conflicts between substitute decision-makers (SDMs) and health practitioners regarding the withdrawal of lifesustaining treatment from incapable patients. This finding was based on the SCC’s interpretation of the Ontario Health Care Consent Act (HCCA). Hawryluck et al. express concern about the SCC’s determination that the CCB is charged with resolving such conflicts since, in their view, this body is ill-equipped to fulfill this role. Instead, they take the position that these disputes should be adjudicated by the courts. We disagree with this position and, for the reasons set out in this editorial, take the position that provincial and territorial legislators across the country should follow the lead of the Ontario legislature, revise their health care consent legislation to clarify the law with respect to the unilateral withholding and withdrawal of potentially life-sustaining treatment, and establish open and transparent consent and capacity tribunals to deal with irreconcilable conflicts in this context

In Defense of Consent and Capacity Boards for End-of-Life Care

In Cuthbertson v. Rasouli, the Supreme Court of Canada (SCC) found that, in Ontario, it is the Consent and Capacity Board (CCB) and not the courts per se who will resolve conflicts between substitute decision-makers (SDMs) and health practitioners regarding the withdrawal of lifesustaining treatment from incapable patients. This finding was based on the SCC’s interpretation of the Ontario Health Care Consent Act (HCCA). Hawryluck et al. express concern about the SCC’s determination that the CCB is charged with resolving such conflicts since, in their view, this body is ill-equipped to fulfill this role. Instead, they take the position that these disputes should be adjudicated by the courts. We disagree with this position and, for the reasons set out in this editorial, take the position that provincial and territorial legislators across the country should follow the lead of the Ontario legislature, revise their health care consent legislation to clarify the law with respect to the unilateral withholding and withdrawal of potentially life-sustaining treatment, and establish open and transparent consent and capacity tribunals to deal with irreconcilable conflicts in this context

Informed consent comes to Britain

Michael Hadskis points out that Halushka was decided prior to the affirmation of the patient-centered disclosure test in 1980, and can thus be situated as a reaction against the existing professional practice standard, which seems indeed even less appropriate in the context of non-therapeutic research on healthy subjects (2011: 471–2). He suggests that it was more important for the court in that context to indicate how the research standard was ‘different.’ It seems indeed logical that research subjects would generally want to engage in a fuller risk assessment in those circumstances. But this more detailed risk assessment would now also fit under the ‘reasonable patient in the same circumstances’ standard, making this simply an application of the same test

In Defense of Consent and Capacity Boards for End-of-Life Care

In Cuthbertson v. Rasouli, the Supreme Court of Canada (SCC) found that, in Ontario, it is the Consent and Capacity Board (CCB) and not the courts per se who will resolve conflicts between substitute decision-makers (SDMs) and health practitioners regarding the withdrawal of lifesustaining treatment from incapable patients. This finding was based on the SCC’s interpretation of the Ontario Health Care Consent Act (HCCA). Hawryluck et al. express concern about the SCC’s determination that the CCB is charged with resolving such conflicts since, in their view, this body is ill-equipped to fulfill this role. Instead, they take the position that these disputes should be adjudicated by the courts. We disagree with this position and, for the reasons set out in this editorial, take the position that provincial and territorial legislators across the country should follow the lead of the Ontario legislature, revise their health care consent legislation to clarify the law with respect to the unilateral withholding and withdrawal of potentially life-sustaining treatment, and establish open and transparent consent and capacity tribunals to deal with irreconcilable conflicts in this context