Informed Consent and Related Civil Liability in Chinese Law: Focusing on Article 1219 of the Chinese Civil Code
Bai Yuanyuan
International Law Review, November 2023
Abstract
As an important guideline in Chinese medical legal system and a basic professional norm in the clinical practice, the patient informed consent is critical for enhancement of the level of Chinese medical civilization and establishment of a harmonious doctor-patient relationship. Thus, there are some revisions on the provision about the patient informed consent in the new Chinese civil code issued in 2019. In this paper the background, content and impact on medical and judicial practice of these revisions of the provisions are addressed. Article 1219 of the Chinese Civil Code about the informed consent basically follows the legal structure of Article 55 in original Chinese Tort Liability. The modifications and improvement have been made on the medical disclosure duty in three aspects: raising the standard of inform duty, enrichment of the forms of patient consent and the supplement of legal basis for “substituted consent”. The modifications of provisions about informed consent in the CCC reflect the improvement of the legislator’s understanding on patient informed consent, and are also the inevitable results of the requirements of patient informed consent in practice. Moreover, this paper analyzes the civil liability system related to informed consent. In addition, some problems in judicial practice, for example, the inconsistency of the judgment standards of the duty of medical staff to inform, the unclear definition of damage on the patients, and the incomplete analysis of causal connection, have been pointed out. This paper also discusses the special rule about burden of proof in the informed consent claim, and examines why judges tend to heavily rely on medical expertise during the trial of such cases. Finally, the causes of the above problems as well as the corresponding solutions are analyzed.

Early experiences of deemed consent legislation for organ donation in Nova Scotia: a qualitative study
Reports of Original Investigations
Robin Urquhart, Jessica Vickery, Cynthia Kendell, Jade Dirk, Stephen Beed
Canadian Journal of Anesthesia, 20 November 2023
Abstract
Purpose
In 2021, Nova Scotia, Canada, became the first jurisdiction in North America to adopt a deemed consent organ donation system under its revised Human Organ and Tissue Donation Act. This study sought to understand the early experiences of program staff and clinicians involved in implementing this legislation.
Methods
We conducted semistructured interviews with members of the provincial organ donation program and intensive care unit and emergency department clinicians (n = 14). Two investigators coded transcripts of interviews, then categorized the coded data into themes.
Results
We identified four key themes: 1) legislation has limited impact on daily practice; 2) legislation does not address existing barriers; 3) legislation aids conversations with donor families; and 4) legislation should provide more autonomy to patients and families, not less.
Conclusion
Deemed consent legislation had limited impact on clinician’s day-to-day practices, because of lack of infrastructure changes and infrequent donation opportunities. Nevertheless, participants felt the introduction of deemed consent in Nova Scotia eased conversations between families of potential donors and clinicians. These findings should be used to inform ongoing implementation of deemed consent and be considered by those contemplating similar legislative changes.

Our “WMA Declaration of Helsinki”: Opinions and Proposals from Patient and Public for Research Ethics
Book Chapter
Chieko Kurihara, Keiko Inoue, Hiroto Kai, Katsura Suzuki, Haruko Saeki, Yoshikazu Funabashi, Noriko Kishi, Akemi Kuge, Toshie Murakami, Yoshiko Saito, Eiko Uchida, Naoki Tsutsumi, Kyoko Imamura
Ethical Innovation for Global Health, November 2023 [Springer]
Abstract
    The Declaration of Helsinki (DoH) was first issued in 1964 by the World Medical Association (WMA), addressed to physicians, and was amended nine times with the latest version being adopted in 2013. While it has been incorporated into research regulations in many countries and is well known to most researchers, most patients and the public see its title for the first time when they are requested to participate in medical research. We therefore formed a group composed mainly of patients and the public together with experts having perspectives of patients and the public. Our activity was intended to enhance our understanding of the DoH and to have it explained in our own language. In this way, patients and the public would be able to better comprehend its scope and contents.
This chapter is resulting from about 2 years of our monthly web-meetings, during COVID-19 pandemic. We found some discussion points not included in the current version of the DoH, such as the value of research aimed at Sustainable Development Goals (SDGs), patient and public involvement, multidisciplinary collaboration, shared decision-making founded on informed consent, patient-oriented research, diversity and fairness of research ethics committees, assuring the rights of those considered to be “vulnerable populations,” broad informed consent, dynamic consent, and social contract.
We hope that this chapter will contribute to the future revision of the DoH, as well as stimulate discussion for the international research ethics norms being under development, and that can be agreed to uniformly by all relevant stakeholders.

The British Transplantation Society guidelines on ethics, law and consent in relation to deceased donors after circulatory death
Review Article
Greg Moorlock, Ellie Asgari, Chris Callaghan, Heather Draper, Peter Dupont, Patty Gilbert, David Nasralla, Peter Veitch, Chris Watson, Stephen O’Neill
Transplantation Reviews, 26 October 2023
Abstract
The British Transplantation Society (BTS) ‘Guideline on transplantation from deceased donors after circulatory death’ has recently been updated and this manuscript summarises the relevant recommendations from chapters specifically related to law, ethics, donor consent and informing the recipient.

Highlights

• UK nations have moved to deemed consent organ donation systems.
• ‘Overall benefit’ should be the guiding principle for decisions about end-of-life care in relation to organ donation.
• The patient’s wishes, especially strength of those wishes, play a significant role in determining what is of overall

Informed Consent and Medicolegal Aspects
Book Chapter
Bernardo Hontanilla, Andrés Ros Magallón
Post-maternity Body Changes, 20 October 2023 [Springer]
Abstract
    It is not seldom in our trade that one must face litigation, be it against oneself or when testifying for or against something a colleague has done in their practice. Having a working knowledge of the regulations that permeate the doctor-patient relationship is paramount to building a successful practice and reducing the risks associated with patient care.

This is especially relevant in the field of aesthetic surgery, where a patient is not seeking a treatment that is essentially curative, but one to look like a younger version of themselves or improve their appearance. Often due to the aggressive marketing performed by some surgeons or reality TV, such a patient can present with unrealistic expectations or without even knowing the risks surgery entails, which becomes even more harmful when a third party can be affected by the results of the surgery as it is the case when treating a post-maternity patient.

The aims of this chapter are to provide a basic knowledge of the different kinds of regulations that specifically affect our trade, to bring forward the possible pitfalls when treating a post-maternity patient, and to emphasize the importance of the informed consent both to reduce risk and to improve the doctor-patient relationship.

[The presumed consent legislation – A success factor or a disruptive factor for tissue donation? A qualitative study based on multidisciplinary interviews with experts]
Kirchner K, Lauerer M, Nagel E
The Journal of Evidence and Quality in Health Care, 6 October 2023
Abstract
Introduction
Tissue transplantation can improve the quality of life of patients in a very wide range of applications. In 2021, around 900 people in Germany agreed to donate organs after death – the number of tissue donors was significantly higher. Nevertheless, there is a shortage of organs and tissues in Germany. In order to counteract this, the introduction of a presumed consent legislation has been discussed time and again. However, the debates focused on possible positive effects for organ donation, whereas potential consequences for tissue donation have so far not been considered in the political discourse or in research. Using an exploratory approach, this paper aims to contribute to closing this research gap: Multidisciplinary interviews with experts were conducted to investigate whether the presumed consent legislation is a key success factor for increasing the number of tissue donors in Germany and which other approaches might be promising.

Editor’s note: This is a German language publication.

Opt-out, mandated choice and informed consent
Ben Saunders
Bioethics, 4 October 2023
Abstract
A number of authors criticise opt-out (or ‘deemed consent’) systems for failing to secure valid consent to organ donation. Further, several suggest that mandated choice offers a more ethical alternative. This article responds to criticisms that opt-out does not secure informed consent. If we assume current (low) levels of public awareness, then the explicit consent secured under mandated choice will not be informed either. Conversely, a mandated choice policy might be justifiable if accompanied by a significant public education campaign. However, if this entitles us to assume that members of the public are informed, then an opt-out system would also be justified in the same circumstances. The alleged advantages of mandated choice seem to rest on an unfair comparison, between mandated choice with a public education campaign and an opt-out system without one. While it may be that some countries with opt-out systems should do more to inform their publics, I see no reason to assume that this cannot be done. Indeed, advocates of mandated choice seem committed to thinking it possible to raise awareness. If opt-out systems adopt the same methods, such as writing to every individual, this should also address concerns about whether consent is informed.

Principles of consent in trauma and orthopaedics
Christopher Wilson, Qamar Mustafa, Tim Crook
Surgery (Oxford), 9 September 2023
Abstract
Consent is one of the essential elements of daily practice for clinicians working in Trauma and Orthopaedics. Autonomy is the right of competent adults to make informed decisions about their care. GMC guidance has placed a professional burden on surgeons to provide informed decision making. The Montgomery v Lanarkshire Health Board (2015) case set a precedent that has driven the modernization of consenting practice, raising the status of shared decision making from guidance to legal requirement. In a post-Montgomery landscape, consent is often the first focus for lawyers and insurers when medico-legal malpractice suit is concerned. Orthopaedic surgeons are at a higher risk of facing malpractice suites (Gould et al., 2003), yet there is a lack of formal training regarding obtaining and documenting informed consent. In this article we discuss the historical context, the current status of consent within UK medical practice, as well as strategies to ensure that consent is legally obtained within Trauma and Orthopaedics.

Consent for Medical Treatment: What is ‘Reasonable’?
Original Article
Abeezar Ismail Sarela
Health Care Analysis, 19 August 2023
Open Access
Abstract
The General Medical Council (GMC) instructs doctors to act ‘reasonably’ in obtaining consent from patients. However, the GMC does not explain what it means to be reasonable: it is left to doctors to figure out the substance of this instruction. The GMC relies on the Supreme Court’s judgment in Montgomery v Lanarkshire Health Board; and it can be assumed that the judges’ idea of reasonability is adopted. The aim of this paper is to flesh out this idea of reasonability. This idea is commonly personified as the audience that has to be satisfied by the doctor’s justification for offering, or withholding, certain treatments and related information. In case law, this audience shifted from a reasonable doctor to a ‘reasonable person in the patient’s position’; and Montgomery expands the audience to include ‘particular’ patients, too. Senior judges have clarified that the reasonable person is a normative ideal, and not a sociological construct; but they do not set out the characteristics of this ideal. John Rawls has conceived the reasonable person-ideal as one that pursues fair terms of co-operation with other members of society. An alternative ideal can be inferred from the feminist ethic of care. However, the reasonable patient from Montgomery does not align with either theoretical ideal; but, instead, is an entirely rational being. Such a conception conflicts with both real-life constraints on rationality and the doctor’s duty to care for the patient, and it challenges the practice of medicine.

A Systematic Review Of Patient Perspective On The Informed Consent Doctrine: Ethical And Legal Reflections
Alexander Fiifi Ghartey
UCC Law Journal, July 2023; 3(1) pp 32-56
Abstract
Informed consent is an ethical and legal doctrine of patients’ right of acquiescence to treatment and the disclosure of adequate information by the physician to facilitate patients’ medical decisions. The doctrine seeks to expand the scope of potential legal liabilities of medical practitioners and to promote patients’ rights to medical care. A breach of the informed consent doctrine could be actionable in battery or assault when there is bodily trespass without consent and the tort of clinical negligence when there are inadequate disclosures. This article is a desk-top systematic review of primary data from seven independent empirical studies on informed consent from the perspective of the patient in five common law African countries. The publications which were purposively searched and extracted from Google Scholar reveal that though majority of patients (at least 79 percent) granted consent for treatment, there was insufficient disclosure of material complications or risks, treatment alternatives or the right of patients to refuse medical treatment if they so wished. Disclosures on material risks were as low as 21.2 percent of patients. The physician’s competence in providing adequate information disclosure demands continual medical training in the practice of the informed consent doctrine. The application of communication strategies that could enhance patients’ capacity to understand the informed consent process is recommended. Additionally, clear guidelines from relevant regulatory bodies are recommended to promote patient rights to informed consent and to protect medical practitioners from potential legal liabilities.