Ethics of the fiduciary relationship between patient and physician: the case of informed consent

Ethics of the fiduciary relationship between patient and physician: the case of informed consent
Sophie Ludewigs, Jonas Narchi, Lukas Kiefer, Eva C Winkler
JME, 8 December 2022
Open Access
Abstract
This paper serves two purposes: first, the proposition of an ethical fiduciary theory that substantiates the often cited assertion that the patient–physician relationship is fiduciary in nature; and second, the application of this theory to the case of informed consent. Patients’ decision-making preferences vary significantly. While some seek fully autonomous decision-making, others prefer to delegate parts of their decision. Therefore, we propose an ethical fiduciary theory that allows physician and patient to jointly determine the physician’s role on a spectrum from fiduciary as advisor to fiduciary as agent. Drawing on legal concepts of the fiduciary relationship and on phenomenological accounts of obligation by Lévinas and Løgstrup, our theory relies on the key attributes of trust, vulnerability and otherness. Finally, practical implications of this theory for the informed consent process are developed: we propose a preassessment of patients’ risk and value profiles as well as a restructuring of the oral consent interview and the written consent materials.

A Comparative Analysis of Informed Consent Legistlation in Ukrainian and Latvia Legislation and Case Law

A Comparative Analysis of Informed Consent Legistlation in Ukrainian and Latvia Legislation and Case Law
Anatoliy A. Lytvynenko, Iryna Ya. Senyuta, Tatjana I. Jurkeviča, Volodymyr S. Makarchuk
International Comparative Jurisprudence, 18 October 2022; 8(2)
Open Access
Abstract
Informed consent is one of the key principles in safeguarding human rights in the sphere of healthcare. It presupposes the expression of the patient’s free will relating to his medical examinations, treatment and diagnostic procedures, as well as the physician’s duty to inform the patient on the forthcoming medical interventions, including the facts regarding the potential risks of these medical interventions. This principle is one of the elements of contemporary medical law, which has marked the transfer from paternalistic medicine to a modern model of medicine, where the patient is an active participant in the process of medical treatment. In this paper, the authors illustrate the legal aspects of safeguarding the patient’s right to informed consent in the legislation and legal practices of Ukraine and the Republic of Latvia. The institute of informed consent, which needs to be safeguarded, as a key element of the legitimacy of a medical intervention (such as surgery, or vaccination), requires a specific form of fulfillment, which is conducted in writing. A medical intervention, excluding cases of emergency, is legitimate only when the consent of the patient is provided; unconsented medical interventions frequently cause lawsuits, where plaintiffs seek to recover damages for performance of a medical intervention without their informed consent. The authors have highlighted these issues while commenting on the recent case law of the Supreme Court of Ukraine and the Supreme Court of the Republic of Latvia.

Age-of-consent requirements and adolescent HIV testing in low-and middle-income countries: multinational insights from 51 population-based surveys

Age-of-consent requirements and adolescent HIV testing in low-and middle-income countries: multinational insights from 51 population-based surveys
Joseph G Rosen, Elizabeth M Stone, Michael T Mbizvo
International Journal of STD & AIDS, 16 December 2022
Abstract
Background
Pervasive social and structural barriers—including national policies—inhibit HIV testing uptake among priority populations, including adolescents. We assessed the relationship between age-of-consent policies for HIV testing and adolescent HIV testing coverage in 51 low- and middle-income countries.
Methods
We pooled data from household surveys (2010–2020) and calculated the weighted country-level prevalence of lifetime HIV testing separately for adolescent girls and boys (ages 15–19). We then abstracted age-of-consent requirements for HIV testing across countries. Using multivariable linear regression, we estimated the average difference in national HIV testing coverage estimates for adolescent girls and boys by age-of-consent restrictions for HIV testing.
Results
National HIV testing coverage estimates ranged from 0.7% to 72.5% among girls (median: 18.0%) and 0% to 73.2% among boys (median: 7.5%) in Pakistan and Lesotho, respectively. In adjusted models, HIV testing coverage in countries requiring parental consent for individuals <18 years was, on average, 9.4 percentage-points (pp) lower (95% confidence interval [95%CI] −17.9pp to −0.9pp) among girls and 9.3pp lower (95%CI: −17.3pp to −1.2pp) among boys, relative to countries with less restrictive policies (age-of-consent: ≤16 years). Compared to countries with less restrictive (age-of-consent: ≤14 years) policies, HIV testing prevalence was significantly lower among girls (β −10.5pp, 95%CI: −19.7pp to −1.3pp) and boys (β −10.5pp, 95%CI –19.2pp to −1.8pp) in countries with more restrictive (age-of-consent: 18 years) parental consent requirements.
Conclusions
Age-of-consent policies are persistent obstacles to adolescent HIV testing. Repealing parental consent requirements for HIV testing is needed to expand coverage and accelerate progress towards global HIV treatment and prevention targets.

Body donation in Italy and the issue of consent: Operational suggestions

Body donation in Italy and the issue of consent: Operational suggestions
Gianluca Montanari Vergallo, Vittoria Masotti, EnricoMarinelli
Legal Medicine, February 2023; 60
Abstract
The authors aimed to analyze the Italian law of 10 February 2020, n. 10, which governs the post mortem donation of one’s body and tissues for training, educational and scientific research purposes. The different models of consent set forth in this set of norms are discussed, reaching the conclusion that the most suitable option for balancing the interests at stake is the one that authorizes all uses of the body for the sole purposes expressly permitted by the donor. After briefly laying out the current legislation on the subject, particularly regarding the ways of expressing consent, the authors highlight how the legislation enacted by Italian lawmakers is meant to codify the absolute preeminence to the donor’s right to self-determination.

Italian law n. 219/2017 on consent and advance directives: survey among Ethics Committees on their involvement and possible role

Italian law n. 219/2017 on consent and advance directives: survey among Ethics Committees on their involvement and possible role
Research
Corinna Porteri, Giulia Ienco, Edda Mariaelisa Turla, Carlo Petrini, Patrizio Pasqualetti
BMC Medical Ethics, 16 November 2022; 23(114)
Open Access
Abstract
Background
On December 2017 the Italian Parliament approved law n. 219/2017 “Provisions for informed consent and advance directives” regarding challenging legal and bioethical issues related to healthcare decisions and end-of-life choices. The law does not contain an explicit reference to Ethics Committees (ECs), but they could still play a role in implementing the law.
Methods
A questionnaire-based survey was performed among the ECs of the Italian Institute for Research and Care belonging to the Network of neuroscience and neurorehabilitation, with the aim of (1) knowing whether the ECs participated and, if so, how in the process of implementation of law n. 219/2017 in the referring institutes; (2) investigating the point of view of the ECs regarding their possible involvement in the process; (3) exploring the contribution ECs can provide to give effective implementation to the law principles and provisions.
Results
Seventeen ECs out of thirty took part in the survey; the characteristics of the responding and non-responding committees are similar, so the responding ECs can be regarded as representative of all ECs in the Network. Nine ECs did not discuss the law in anyway: the main reason for this is that the referring institutions (6) and the health care professionals (3) did not ask for an EC intervention. Nevertheless, the large majority of the ECs believe that their involvement in the implementation of the law as a whole is appropriate (8) or absolutely appropriate (6), while 3 of them are neutral. No EC believes that the involvement is inappropriate. The aspect of the law on which the 14 ECs converge in considering the EC involvement appropriate/absolutely appropriate is the one related to the health facilities obligation to guarantee the full and proper implementation of the principles of the law.
Conclusions
Our survey confirms that ECs believe they can play a role in the implementation of law n. 219/2017, although this does not entirely correspond to what the committees have actually done in reality. This role could be better exercised by ECs specifically established for clinical practice, which would have a composition, functioning and a mandate better suited to the purpose. This supports the call for a national regulation of ECs for clinical practice.

Attitudes of European students towards family decision-making and the harmonisation of consent systems in deceased organ donation: a cross-national survey

Attitudes of European students towards family decision-making and the harmonisation of consent systems in deceased organ donation: a cross-national survey
Research
Alberto Molina-Pérez, Gabriele Werner-Felmayer, Kristof Van Assche, Anja M. B. Jensen, Janet Delgado, Magdalena Flatscher-Thöni, Ivar R. Hannikainen, David Rodriguez-Arias, Silke Schicktanz, Sabine Wöhlke
BMC Public Health, 15 November 2022; 22(2080)
Open Access
Abstract
Background
European countries are increasingly harmonising their organ donation and transplantation policies. Although a growing number of nations are moving to presumed consent to deceased organ donation, no attempts have been made to harmonise policies on individual consent and the role of the family in the decision-making process. Little is known about public awareness of and attitudes towards the role of the family in their own country and European harmonisation on these health policy dimensions. To improve understanding of these issues, we examined what university students think about the role of the family in decision-making in deceased organ donation and about harmonising consent policies within Europe.
Methods
Using LimeSurvey© software, we conducted a comparative cross-sectional international survey of 2193 university students of health sciences and humanities/social sciences from Austria (339), Belgium (439), Denmark (230), Germany (424), Greece (159), Romania (190), Slovenia (190), and Spain (222).
Results
Participants from opt-in countries may have a better awareness of the family’s legal role than those from opt-out countries. Most respondents opposed the family veto, but they were more ambivalent towards the role of the family as a surrogate decision-maker. The majority of participants were satisfied with the family’s legal role. However, those who were unsatisfied preferred to limit family involvement. Overall, participants were opposed to the idea of national sovereignty over consent policies. They favoured an opt-out policy harmonisation and were divided over opt-in. Their views on harmonisation of family involvement were consistent with their personal preferences.
Conclusions
There is overall division on whether families should have a surrogate role, and substantial opposition to granting them sole authority over decision-making. If European countries were to harmonise their policies on consent for organ donation, an opt-out system that grants families a surrogate decision-making role may enjoy the widest public support.

The Completeness of Informed Consent Form Filling and Protection of Consumer Rights in Hospital Healthcare Services

The Completeness of Informed Consent Form Filling and Protection of Consumer Rights in Hospital Healthcare Services
Anggra Yudha, Ramadianto Barkah, Rosadi Hindun, Nafiah Sindy, Risa Nandiesty, Rulli Saqinah, Nur Windah Fadillah, Frisca Mahrunissa
HIV Nursing, 30 October 2022
Open Access
Abstract
Fulfillment the completeness of filling out the informed consent form is one of the minimum service standards in hospitals, but until now there are some hospitals that have not complied this obligation. This study aims to understand the legal protection of patients’ rights as consumers related to the completeness of filling out an informed consent form in medical record services in hospitals. This research uses a normative legal approach through descriptive analysis. The secondary data used in this study were obtained through a study of the literature. The results of the analysis in this study show that the fulfillment of the completeness of filling out the informed consent form is a form of obligation of business actors to fulfill consumer rights which include the right to be treated or served correctly and honestly and not discriminatory and the right to obtain advocacy, protection, and consumer protection dispute resolution efforts properly. The violation of the patient’s right to obtain a minimum standard of health services in the form of incomplete filling of the informed consent form is a violation of consumer rights in health services. According to the provisions of the Consumer Protection Law, the settlement of disputes regarding violations of these rights can be carried out through providing compensation to patients by business actors, filing lawsuits by patients, and even criminal charges against business actors. The conclusion obtained in this study is that the completeness of filling out the informed consent form in the medical record service at the hospital contains protection of consumer rights in the form of the right to obtain health services in accordance with the standards in legislation and legal rights. As a protection for the rights of these patients, consumer protection legal instruments in Indonesia require business actors to provide compensation to patients. Consumers are also given the authority to file claims and lawsuits. Based on these conclusions, it can be said that this study provides a new formulation regarding the protection of patient rights as consumers regarding the completeness of filling out an informed consent form in medical record services in hospitals.

Information Privacy in Healthcare — The Vital Role of Informed Consent

Information Privacy in Healthcare — The Vital Role of Informed Consent
Roy McClelland, Colin M. Harper
European Journal of Health Law, 27 October 2022
Abstract
The use and disclosure of patient information is subject to multiple legal and ethical obligations. Within European human rights law the differences relating to consent are reflected in the separate requirements of data protection law, the common law, and professional ethics. The GDPR requires explicit consent. This contrasts with the ethical and common law availability of reliance on implied consent for the use of patient information for that patient’s care and treatment. For any proposed use of patient information for healthcare purposes other than direct care, even where GDPR may be satisfied if the patient refuses to consent to disclosure, the information should not normally be disclosed. For any proposed use or disclosure outside healthcare the justification should normally be consent. However, consent is often not possible or appropriate and an overriding public interest can be relied upon to justify the use or disclosure, both legally and ethically.

A Qualitative Content Analysis of Comments on Press Articles on Deemed Consent for Organ Donation in Canada

A Qualitative Content Analysis of Comments on Press Articles on Deemed Consent for Organ Donation in Canada
Danielle E. Fox, Maoliosa Donald, Christy Chong, Robert R. Quinn, Paul E. Ronksley, Meghan J. Elliott, Ngan N. Lam
Clinical Journal of the American Society of Nephrology, October 2022
Abstract
Background and objectives
In 2019, two Canadian provinces became the first jurisdictions in North America to pass deemed consent legislation to increase deceased organ donation and transplantation rates. We sought to explore the perspectives of the deemed consent legislation for organ donation in Canada from the viewpoint of individuals commenting on press articles.
Design, setting, participants, & measurements
In this qualitative descriptive study, we extracted public comments regarding deemed consent from online articles published by four major Canadian news outlets between January 2019 and July 2020. A total of 4357 comments were extracted from 35 eligible news articles. Comments were independently analyzed by two research team members using a conventional content analysis approach.
Results
Commenters’ perceptions of the deemed consent legislation for organ donation in Canada predominantly fit within three organizational groups: perceived positive implications of the bills, perceived negative implications of the bills, and key considerations. Three themes emerged within each group that summarized perspectives of the proposed legislation. Themes regarding the perceived positive implications of the bills included majority rules, societal effect, and prioritizing donation. Themes regarding the perceived negative implications of the bills were a right to choose, the potential for abuse and errors, and a possible slippery slope. Improving government transparency and communication, clarifying questions and addressing concerns, and providing evidence for the bills were identified as key considerations.
Conclusions
If deemed consent legislation is meant to increase organ donation and transplantation, addressing public concerns will be important to ensure successful implementation.

An ex-ante cost-utility analysis of the deemed consent legislation compared to expressed consent for kidney transplantations in Nova Scotia

An ex-ante cost-utility analysis of the deemed consent legislation compared to expressed consent for kidney transplantations in Nova Scotia
Research
Prosper Koto, Karthik Tennankore, Amanda Vinson, Kristina Krmpotic, Matthew J. Weiss, Chris Theriault, Stephen Beed
Cost Effectiveness and Resource Allocation, 6 October 2022; 20(55)
Open Access
Abstract
Background
This study was an ex-ante cost-utility analysis of deemed consent legislation for deceased organ donation in Nova Scotia, a province in Canada. The legislation became effective in January 2021. The study’s objective was to assess the conditions necessary for the legislation change’s cost-effectiveness compared to expressed consent, focusing on kidney transplantation (KT).
Method
We performed a cost-utility analysis using a Markov model with a lifetime horizon. The study was from a Canadian payer perspective. The target population was patients with end-stage kidney disease (ESKD) in Atlantic Canada waitlisted for KT. The intervention was the deemed consent and accompanying health system transformations. Expressed consent (before the change) was the comparator. We simulated the minimum required increase in deceased donor KT per year for the cost-effectiveness of the deemed consent. We also evaluated how changes in dialysis and maintenance immunosuppressant drug costs and living donor KT per year impacted cost-effectiveness in sensitivity analyses.
Results
The expected lifetime cost of an ESKD patient ranged from $177,663 to $553,897. In the deemed consent environment, the expected lifetime cost per patient depended on the percentage increases in the proportion of ESKD patients on the waitlist getting a KT in a year. The incremental cost-utility ratio (ICUR) increased with deceased donor KT per year. Cost-effectiveness of deemed consent compared to expressed consent required a minimum of a 1% increase in deceased donor KT per year. A 1% increase was associated with an ICUR of $32,629 per QALY (95% CI: − $64,279, $232,488) with a 81% probability of being cost-effective if the willingness-to-pay (WTP) was $61,466. Increases in dialysis and post-KT maintenance immunosuppressant drug costs above a threshold impacted value for money. The threshold for immunosuppressant drug costs also depended on the percent increases in deceased donor KT probability and the WTP threshold.
Conclusions
The deemed consent legislation in NS for deceased organ donation and the accompanying health system transformations are cost-effective to the extent that they are anticipated to contribute to more deceased donor KTs than before, and even a small increase in the proportion of waitlist patients receiving a deceased donor KT than before the change represents value for money.