“What are my options?”: Physicians as ontological decision architects in surgical informed consent

“What are my options?”: Physicians as ontological decision architects in surgical informed consent
Original Article
Stacy S. Chen, Sunit Das
Bioethics, 1 August 2022
Abstract
The aim of a theoretically ideal process of informed consent is to promote the autonomy of the patient and to limit unethical physician paternalism. However, in practice, the nature of the medical profession requires physicians to act as ontological decision architects—based on the medical knowledge that they acquire through their experience and training, physicians ontologically determine a subset of viable courses of action for their patient. What is observed is not an unethical physician limitation or biasing of the patient towards certain treatment options that violates patient autonomy or consciously undermines informed consent, but rather a more foundational paternalism that is necessarily inherent to the physician–patient relationship. In this article we argue for a recognition of this underlying physician paternalism and posit that this necessary paternalism is not a foil to patient autonomy, but rather a foundational aspect of the duties of the medical professional within the physician–patient relationship.

 

Consent — Informed Consent and Requirements of Consent

Consent — Informed Consent and Requirements of Consent
Book
Kumari K. Nirmala
Health Laws in India, 2022 [Routledge]
Abstract
    In the medical treatment, the relationship between the doctor and the patient has been in terms of benevolent paternalism. In ancient times, the obligation of the physician was solely in terms of promoting the welfare of the patient, diagnosing the ailment, and prescribing medicine or surgery, but seldom had they thought about patient’s right. But nowadays this locus of the authority in decision making has been shifted from the physician to the patient. A patient will receive all the information that he or she needs in order to make decision as to take treatment or not or a particular operation. There involves the consent of the patient. Consent to treatment is the principle that a person must give permission before they receive any type of medical treatment, test or examination. This must be done on the basis of an explanation by a clinician. Consent from a patient is needed regardless of the procedure, whether it a physical examination, organ donation or something else. The principle of consent is an important part of medical ethics and the international human rights law.

80 The earliest expression of this fundamental principle, based on autonomy, is found in the Nuremberg Code of 1947. The code makes it mandatory to obtain voluntary and informed consent of human subjects. Similarly, the Declaration of Helsinki adopted by the World Medical Association in 1964 emphasizes the importance of obtaining freely given informed consent for medical research by adequately informing the subjects of the aims, methods, anticipated benefits, potential hazards, and discomforts that the study may entail. Several international conventions and declarations have similarly ratified the importance of obtaining consent from patients before testing and treatment.

In India the principle of autonomy is enshrined within Art. 21 of the Indian Constitution, which deals with the right to life and personal liberty. Sec 88 of IPC, provides- Nothing which is not intended to cause death, is an offence to any person for whose benefit it is done in good faith, and who has given a consent. When a tort is committed, meaning that a defendant’s actions interfered with the plaintiff’s person or property, a plaintiff’s consent will excuse the defendant of the wrongdoing.

In the view of the above background, the present chapter proposes to deal briefly with the aspects of laws concerning consent in medical cases, and their implications. The chapter discusses about the capacity to give consent, ‘Real’ consent in the United Kingdom (UK) and as ‘Informed’ consent in the United States (US). To account for the Indian position, unlike in the West, the courts have assigned immense significance to the requirement of informed consent. The Honorable Court has in different cases summarized principles relating to consent and the necessity to enact full-fledged laws so as to adjust to the need of the day.

Informed Consent: A Monthly Review
_________________

August 2022

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_August 2022

Privacy Behaviour: A Model for Online Informed Consent

Privacy Behaviour: A Model for Online Informed Consent
Original Paper
Gary Burkhardt, Frederic Boy, Daniele Doneddu, Nick Hajli
Journal of Business Ethics, 14 July 2022
Open Access
Abstract
An online world exists in which businesses have become burdened with managerial and legal duties regarding the seeking of informed consent and the protection of privacy and personal data, while growing public cynicism regarding personal data collection threatens the healthy development of marketing and e-commerce. This research seeks to address such cynicism by assisting organisations to devise ethical consent management processes that consider an individual’s attitudes, their subjective norms and their perceived sense of control during the elicitation of consent. It does so by developing an original conceptual model for online informed consent, argued through logical reasoning, and supported by an illustrative example, which brings together the autonomous authorisation (AA) model of informed consent and the theory of planned behaviour (TPB). Accordingly, it constructs a model for online informed consent, rooted in the ethic of autonomy, which employs behavioural theory to facilitate a mode of consent elicitation that prioritises users’ interests and supports ethical information management and marketing practices. The model also introduces a novel concept, the informed attitude, which must be present for informed consent to be valid. It also reveals that, under certain tolerated conditions, it is possible for informed consent to be provided unwillingly and to remain valid: this has significant ethical, information management and marketing implications.

Malpractice Claims and Ethical Issues in Prison Health Care Related to Consent and Confidentiality

Malpractice Claims and Ethical Issues in Prison Health Care Related to Consent and Confidentiality
Review
Oana-Maria Isailă, Sorin Hostiuc
Healthcare, 12 July 2022
Open Access
Abstract
Respecting the consent and confidentiality of a patient is an underlying element in establishing the patient’s trust in the physician and, implicitly, obtaining the patient’s compliance. In particular, cases of inmate patients require increased attention in order to fulfill this goal against a background of institutional interferences, which, in certain situations, may endanger the autonomy of the physician and their respect for the inmate’s dignity. The purpose of this article is to depict the characteristics of consent and confidentiality in a prison environment, in special cases, such as hunger strikes, violent acts, HIV testing, COVID-19 measures, and drug use, bringing into focus the physician and the inmate in the context of the particular situation where the target is disciplining someone in order for them to conform to social and juridical norms. Respecting the dignity of the inmate patient requires an adequate approach of informed consent and confidentiality, depending on each case, considering the potential unspoken aspects of the inmate’s account, which can be key elements in obtaining their compliance and avoiding malpractice claims.

Ethics Considerations Regarding Donors’ and Patients’ Consent

Ethics Considerations Regarding Donors’ and Patients’ Consent
Book Chapter
Jeremy Sugarman
Brain Organoids in Research and Therapy, 10 July 2022; pp 121-130 [Springer]
Abstract
Informed consent is a crucial factor in determining whether particular uses of brain organoids for research and clinical translation are ethically acceptable. In the context of basic research, the consent of donors whose tissues are used to derive brain organoids is of primary concern, whereas in clinical translation the consent of both allogeneic donors and patients may be relevant. In this chapter, I examine key ethics considerations related to informed consent for brain organoid research and clinical translation. In order to do so, I first describe both a standard conceptual approach to informed consent that aims at meeting the ethical goal of respecting the autonomy of persons and some of the other ethically relevant functions of informed consent. This conceptual work provides a foundation for mapping ethics considerations related to informed consent in regard to the decision-making capacity and voluntariness of those being asked to consent, disclosure requirements associated with brain organoids in general and for particular proposed uses that involve morally significant aspects, threats to understanding that must be overcome, and considerations for authorization. Finally, I offer some suggestions for grappling with such informed consent challenges related to brain organoids.

The Scope of Consent

The Scope of Consent
Joseph Millum
The Philosophical Quarterly, 2 July 2022
Extract
Suppose you come to my house and I invite you in. ‘I’m just heading out’, I say, ‘but make yourself at home’. I have consented to you remaining in my house, but what else? In your home, you put your feet up on the coffee table, so may you now do that in mine? If I complain that you’ve left crumbs from eating biscuits in my bed, can you defend yourself on the grounds that I told you to make yourself at home? These questions concern the scope of my consent. How we should ascertain the scope of someone’s consent is the topic of Tom Dougherty’s book. The book is divided into three main parts, each corresponding to a view about what fixes the scope of consent: the mental account, the successful communication account, and the evidential account, which Dougherty favours…

Informed Consent: A Monthly Review
_________________

July 2022

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_July 2022

Animal-informed consent: sled dog tours as asymmetric agential events

Animal-informed consent: sled dog tours as asymmetric agential events
David A. Fennell
Tourism Management, December 2022; 93
Abstract
Standing in the way of a stronger voice for animals used in tourism is Cartesian and contractarian thinking on the part of operators and ontologically and epistemically constructed barriers by theorists. This paper pushes the animal ethics agenda forward by developing a novel, first-of-its-kind animal-informed consent framework in tourism under the assumption that sled dogs do, in fact, consent or deny consent through their emotions, preferences, behaviours, and physical state. The Five Domains model of animal welfare focused on the subjective experiences of animals is used to build the framework. The discussion culminates with a discussion on asymmetric agency, which speaks to the lack of balance between human and animal agents working in the same events.

Mapping consent practices for outpatient psychiatric use of ketamine

Mapping consent practices for outpatient psychiatric use of ketamine
David S. Mathai, Scott M. Lee, Victoria Mora, Kelley C. O’Donnell, Albert Garcia-Romeu, Eric A. Storch
Journal of Affective Disorders, 1 September 2022; 312, pp 113-121
Abstract
Background
Given increasing community-based and off-label use of ketamine for psychiatric indications, we examined current informed consent processes from a convenience sample of outpatient ketamine clinics to identify areas of congruence with current evidence and opportunities for growth.
Methods
Using a rubric developed from existing practice guidelines, we conducted an exploratory analysis of informed consent documents (IC-Docs) from 23 American clinics offering ketamine as a psychiatric treatment. Domains assessed included clinical content, procedures, and syntax.
Results
Participating clinics (23/288) varied widely in their constitution, training, and services provided. We found that IC-Docs addressed a majority of consent elements, though did so variably on an item-level. Areas for improvement included communication around long-term adverse effects, treatment alternatives, medical/psychiatric evaluation prior to treatment, medical/psychological support during treatment, adjunctive psychological interventions, and subjective/dissociative-type effects. All forms were limited by poor readability.
Limitations
Our study was limited by convenience sampling along with possible underestimation of verbal consent processes.
Conclusions
As ketamine continues to emerge as a psychiatric intervention, both patients and providers will benefit from a deliberate consent process informed by scientific, ethical, and pragmatic factors toward the goal of shared decision-making regarding treatment.