The process of gaining consent, retrospectively, when the institution has closed down
Research Article
Lida Anagnostaki
Journal of Child Psychotherapy, 17 October 2022
Abstract
The paper has a twofold aim. First, it describes the complex process of gaining consent retrospectively for the publication of clinical material after the institution, where therapy was taking place, had closed down. The clinical material was derived from the psychotherapeutic work with an autistic young boy and his family. Details of the complicated process of gaining consent to publish this material are provided. The second aim of this paper is to discuss the important role of ‘trust’ when asking or granting consent for publication of clinical material. It is argued that trust at different levels (and amongst various people) plays a pivotal role in gaining consent for publication.

Is the Current Informed Consent Model Flawed?
Book Chapter
Bert Heinrichs, Serap Ergin Aslan
Integrity of Scientific Research, 14 October; pp 549–557 [Springer]
Abstract
Informed consent is a widely acknowledged ethical principle that plays a crucial role, both in research ethics and medical ethics. However, empirical findings as well as theoretical considerations suggest that the current model of informed consent might be flawed. In particular, the understanding of information disclosed to patients and research participants during the consent process proves to be limited. This, in turn, casts serious doubt on the validity of the consent. In this paper, we will review the current state of research on informed consent and discuss the charge of inadequacy. Subsequently, we will examine some suggestions that have been presented in the literature to improve the current model of informed consent. At the end, we will summarize the current state of the discussion and give a brief outlook on future developments.

The Ethics of Advocacy and Consent
Book Chapter
Jill Pluquailec
Dis/orientating Autism, Childhood, and Dis/ability, 13 October 2022; pp 103–121 [Springer]
Abstract
This chapter, though short, is presented discretely between the end of the methodology chapter and before the analytical chapters because it is both methodological and analytical. It explores ethical issues, particularly in relation to advocacy and consent, which were necessary in developing, delivering and writing an ethical project. At the heart of the project is a queering of normative conceptualisations of autistic childhood which, as has already been discussed, requires a queering of traditional, theoretical and methodological orientations.

Editor’s note: Chapter bibliography available at title link above.

Autonomy and Liberty: An Ethical Focus on Human Consent
Jenia Kakchingtabam
International Journal of Arts Humanities & Social Sciences, 8 October 2022
Abstract
This paper aims to examine the problematic relation between autonomy and liberty from the ethical aspect of human consent. The term consent is derived from the Latin conjunction where “con” mean ‘together’ with “sentire” meaning to ‘feel’, ‘think’ or ‘judge’. We feel safe and secure when we participate in the collective life consensually. This idea of protection is provided by the liberal tradition thereby bringing a new complex form of human relation on the basis of consent and informed life. In fact, this new complex relation claims to provide us the benefit of protection from harms and constraints. Autonomy, on the other, indicates self-ruling capacities of a person to make certain plans or goals wherein the significance of consent protects from external wrongful coercion. And, here the question is, how can we discover the significance of autonomous consent of an individual within the sphere of liberty? This paper discusses the ethical issue of consent that seems to be interwoven in the concept of liberty and autonomy in three different sections. The first section examines the question that how and why consent occupies an important place in the social and the political relations of human beings? Further, the second section argues that the meaning of consent is not implied only in the sphere of social and political relation. Consent expresses a person’s sensitivity and experiences by allowing others to perceive the importance of human autonomy across the different areas of life. And, the third section addresses the crucial ethical crux of consent from the aspect of care and concern.

Informed Consent: A Monthly Review
_________________

October 2022 :: Issue 46

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_October 2022

Concepts in Emergency Research Exception from Informed Consent
Book Chapter
Christine S. Cocanour, Isabelle A. Struve
The Acute Management of Surgical Disease, 16 September 2022; pp 113–123 [Springer]
Abstract
Informed consent is an ethical concept, codified in the law, and is in daily practice at every healthcare institution. It is the process of communication between patients and treating physicians that results in an agreement that allows the treating physician to perform a specific medical intervention. A valid informed consent requires disclosure, capacity, and voluntariness. In the emergency setting this consent process is not possible. Ethical concerns involving subjects who cannot provide consent was a barricade to emergency research. Standard, accepted medical therapy was not tested for either safety or efficacy in the emergency setting. In recognition of this potential harm, the government eventually permitted exception from informed consent in certain emergency research trials in order to (1) provide individuals in life-threatening situations access to potentially life-saving therapies, (2) advance knowledge through collection of information about effectiveness and safety, and (3) improve therapies used in emergency medical situations that currently have poor clinical outcomes. This chapter will explore the history behind informed consent, informed consent for human subject research, and exception from informed consent (EFIC)/waiver of informed consent (WIC).

Towards a Design Toolkit of Informed Consent Models Across Fields: A Systematic Review
Original Research/Scholarship
Iris Loosman, Philip J. Nickel
Science and Engineering Ethics, 30 August 2022; 28(42)
Open Access
Abstract
In the 60+ years that the modern concept of informed consent has been around, researchers in various fields of practice, especially medical ethics, have developed new models to overcome theoretical and practical problems. While (systematic) literature reviews of such models exist within given fields (e.g., genetic screening), this article breaks ground by analyzing academic literature on consent models across fields. Three electronic research databases (Scopus, Google Scholar, and Web of Science) were searched for publications mentioning informed consent models. The titles, abstracts, and if applicable, full publications were screened and coded. The resulting data on fields, models, and themes were then analyzed. We scanned 300 sources from three databases to find 207 uniquely named consent models, and created a network visualization displaying which models occur primarily in one field, and which models overlap between fields. This analysis identifies trends in the consent debate in different fields, as well as common goals of consent models. The most frequently occurring consent models are identified and defined. The analysis contributes toward a cross-disciplinary “consent design toolkit” and highlights that there are more interrelationships between models and fields than are acknowledged in the literature. Where some models are designed to solve distinctively field-specific issues and are specific to biomedical ethics, some may be adaptable and applicable for other fields including engineering and design.

Informed Consent: A Monthly Review
_________________

September 2022 :: Issue 45

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_September 2022

“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
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.