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.

The Current Practice and Medico Legal Aspects of Informed Consent in Obstetrics and Gynaecology in a Teritary Care Hospital, Can We Improve?: An Interventional Study
Shreen R., Kagne R.N., Jayasree M
Indian Journal of Forensic Medicine and Toxicology, October-December 2022; 16(4)
Open Access
Abstract
The Informed Consent plays major role in both Patients and the Doctors to carry out various aspects in the surgical procedures. This paper was an interventional study it was conducted in the Department of Forensic Medicine and Toxicology, Sri Manakula Vinayaga Medical College and Hospital, Madagadipet, Puducherry to audit and to improve it was conducted in the Department of Obstetrics and Gynaecology. The deficiencies were identified and it was analysed. The results of both pre-interventional and post-interventional were recorded, which showed the significant improvement in the consent form of the major and minor procedures. This study results will give importance on documenting the Informed Consent day to day life practice.

Informed Decision-Making and Capabilities in Population-based Cancer Screening
Ineke L L E Bolt, Maartje H N Schermer, Hanna Bomhof-Roordink, Danielle R M Timmermans
Public Health Ethics, 3 October 2022
Abstract
Informed decision-making (IDM) is considered an important ethical and legal requirement for population-based screening. Governments offering such screening have a duty to enable invitees to make informed decisions regarding participation. Various views exist on how to define and measure IDM in different screening programmes. In this paper we first address the question which components should be part of IDM in the context of cancer screening. Departing from two diverging interpretations of the value of autonomy—as a right and as an ideal—we describe how this value is operationalized in the practice of informed consent in medicine and translate this to IDM in population-based cancer screening. Next, we specify components of IDM, which is voluntariness and the requirements of disclosure and understanding. We argue that whereas disclosure should contain all information considered relevant in order to enable authentic IDM, understanding of basic information is sufficient for a valid IDM. In the second part of the paper we apply the capability approach in order to argue for the responsibility of the government to warrant equal and real opportunities for invitees for IDM. We argue that additional conditions beyond mere provision of information are needed in order to do so.

Towards a technologically assisted consent in the upcoming new EU data laws?
Andrés Chomczyk Penedo
Privacy in Germany, 2 September 2022
Abstract
The European Commission (Commission) put forward an ambitious proposal package of new legislation for the digital economy, including the Digital Markets Act, the Digital Services Act, or the Data Governance Act. Despite their different scopes, they all share a recurring topic: the relevance of (personal) data in enabling a data-intensive economic model around data sharing and the role of data subjects in granting permission to do so. As such, the purpose of this article is to explore how the Commission and other EU institutions intended to strengthen consent in these novel data regulations through technological tools but also novel assistance duties, but also the potential shortcoming around this approach.

Psychiatric advance directives and consent to electroconvulsive therapy (ECT) in Australia: A legislative review and suggestions for the future
Kay Wilson, Subramanian Purushothaman, Uday Kolur
International Journal of Law and Psychiatry, November–December 2022; 85
Abstract
Psychiatric Advance Directives (PADs) have been adopted in many jurisdictions around the world and in most Australian states and territories. They are seen as a less restrictive and patient-centered approach to the provision of mental health care. Electroconvulsive therapy (ECT) is a restricted treatment in most jurisdictions in Australia and across the world. This paper explores the history, regulation and use of ECT and PADs and the intersections between them. It provides an overview of the legislative framework in each Australian state and territory and explores some of the issues which have arisen such as complexity of the regulatory framework, making PADs binding for refusing and consenting to ECT, involving treating teams in how PADs are made, using restrictive interventions to implement PADs, and the role of the Tribunal. While PADs are often framed as an important legal tool for allowing patients to refuse psychiatric treatment (especially ECT), the paper emphasizes that they can also be an innovative way for people to consent to psychiatric treatment in advance and an empowering option to access mental health care. It then makes some suggestions for future reform.

What Cookie Consent Notices Do Users Prefer: A Study In The Wild
Ashutosh Kumar Singh, Nisarg Upadhyaya, Arka Seth, Xuehui Hu, Nishanth Sastry, Mainack Mondal
EuroUSEC ’22: Proceedings of the 2022 European Symposium on Usable Security, 29 September 2022; pp 28 – 39
Abstract
Laws like GDPR in the EU mandated all websites operating in their jurisdiction to obtain users’ informed consent before tracking those users and collecting their data. Today, this is achieved by showing users cookie consent notices. These notices are ubiquitous (often permeating the geographical boundaries of GDPR enforcement), even though their exact user interface (UI) designs vary. These designs are provided by Consent Management Platforms (CMPs) to different websites, effectively resulting in a handful of cookie consent notice designs being shown to a majority of internet users. Naturally, not all designs are uniformly liked by the users. Thus the first step of improving cookie consent notice UI design and moving to a better consent mechanism is to understand whether users prefer one design over another in the wild and why. To answer these questions, in this work, we conduct an in the wild comparative survey with 98 participants where 64.3% of the participants were from the EU (i.e., GDPR is applicable), and the rest were self-reported to be located outside of the EU. In this within-subjects study, our participants ranked five different popular cookie consent UI designs (leveraged by CMPs used in Alexa UK Top500 websites) and gave rationale for their choices. Our analysis found that the slider design is statistically significantly better ranked (and thus most liked) than all other designs. Our further qualitative analysis identifies and unpacks five key design factors which impacted our participants’ liking/disliking of consent notice UI designs (as captured by the ranks given to these designs by our participants) – ease of use, amount of information, customisability, decision-making time, and clarity/transparency. We conclude this work by discussing the implications of our findings on future cookie consent notice UI designs.

Physicians’ legal knowledge of informed consent and confidentiality. A cross-sectional study
Research
Maria Cristina Plaiasu, Dragos Ovidiu Alexandru, Codrut Andrei Nanu
BMC Medical Ethics, 16 September 2022; 23(93)
Open Access
Abstract
Background
Only a few studies have been conducted to assess physicians’ knowledge of legal standards. Nevertheless, prior research has demonstrated a dearth of medical law knowledge. Our study explored physicians’ awareness of legal provisions concerning informed consent and confidentiality, which are essential components of the physician-patient relationship of trust.
Methods
A cross-sectional study assessed attending physicians’ legal knowledge of informed consent and confidentiality regulations. The study was conducted in nine hospitals in Dolj County, Romania. Physicians were given a questionnaire with ten scenarios and instructed to select the response that best reflected their practice. We assessed the responses of physicians who claimed their practice to be entirely legal. Their legal knowledge was evaluated by comparing their answers to applicable laws. We also calculated a score for the physicians who admitted to committing a legal breach.
Results
Of the 305 respondents, 275 declared they never committed any law violation. However, their median correct answer score was 5.35 ± 1.66 out of 10. The specialty was the strongest predictor of legal knowledge, with emergency physicians rating the lowest and non-surgical physicians scoring the highest. Physicians who worked in both private and public sectors were better knowledgeable about legal issues than those who worked exclusively in the public sector. Results indicate that physicians are aware of the patient’s right to informed consent but lack comprehensive understanding. While most physicians correctly answered simple questions, only a tiny minority identified the correct solution when confronted with ethical dilemmas. The physicians who acknowledged breaching the law, on the other hand, had a slightly higher knowledge score at 5.45 ± 2.18.
Conclusion
Legal compliance remains relatively low due to insufficient legal awareness. Physicians display limited awareness of legal requirements governing patient autonomy, confidentiality, and access to health data. Law should be taught in all medical schools, including undergraduate programs, to increase physicians’ legal knowledge and compliance.

Informed Consent in Medical Law in the Romanian Legal System: A Comparative Perspective
Camelia Mihăilă
Journal of Intercultural Management and Ethics, 2022
Open Access
Abstract
This paper aims to analyse the principle of consent in the medical act from a comparative law perspective. While the introduction gives a brief presentation of the definition of consent from the perspective of legal doctrine, the content of the paper analyses some legislative landmarks in the Romanian legal system, as well as in the French and Spanish legal systems. Consent is one of the basic principles of modern medical bioethics and an essential element of the validity of the medical contract, ensuring respect for human dignity and protection of the patient’s bodily integrity. While Romanian law is based more on the idea of information, Spanish law analyses consent from the point of view of a personalist right, including it in the short list of personal rights enshrined in Law 1/1982 on the protection of honour, image and privacy. French law, on the other hand, has a long history of case law regulating consent in medical acts, with the Teysier and Mercier cases being worth mentioning.

Cameroon: New Law on Medical Research Involving the “Human Person” Adopted
Article
Nicolas Boring
The Global Legal Monitor, Library of Congress, 2022
Excerpt
On April 27, 2022, the Parliament of Cameroon adopted a law providing a new framework for medical research involving the “human person.” This law places a particular emphasis on the right to information and the free, informed, and written consent of the participants. It also provides guarantees regarding respect for privacy and confidentiality of personal data and respect for human integrity, dignity, and vulnerability…
Background to the Law
According to Cameroonian press reports, the new law was drafted in reaction to a scandal involving the trial of a preventive treatment for AIDS conducted in 2004 by the American NGO Family Health International on sex workers in Douala “in violation of [their] ethical and deontological rights.” The new law also represents a response to the recent proliferation in Cameroon of clinical trials of COVID-19 treatments conducted without rigorous controls.
Content of the Law
The newly enacted law delimits the scope of consent for medical research involving minors (articles 15 and 16), disabled persons (articles 17 and 18), and pregnant women (articles 19 and 20). It also provides a framework for medical research on in vivo fetuses and in vivo embryos (articles 19 to 22). Finally, the law addresses research conducted on stillborn children (articles 23 and 24) and on the dead (articles 27 and 28)…

The Legal Requirements for—and Limits to—the Donor’s and the Patient’s Consent
Book Chapter
Silvia Deuring
Brain Organoids in Research and Therapy, 10 July 2022; pp 131-190 [Springer]
Abstract
Research with and on brain organoids implicates well-known problems of consent: under which circumstances is consent required, when is it valid, and how far does it reach? In some cases, these problems are exacerbated by the applicability and complex interplay of specific statutes such as the Transplantation Act, the Transfusion Act, and the regulations on medicinal products. For that reason, this article seeks to provide an overview of the problems of consent within the various contexts of brain organoid use.