An Extended Doctrine of Implied Consent – A Digital Mediator?
Georgia Jenkins
International Review of Intellectual Property and Competition Law, 23 March 2021
Open Access
Abstract
This article explores whether an extended doctrine of implied consent can better balance copyright interests in the digital environment, particularly users’ access to digital content. Implied licences are analysed from a variety of jurisdictions including the United Kingdom, the European Union, Germany, the United States and Australia to submit that the role of implied consent emerges as a fundamental legal principle in both common and civil law jurisdictions. Given the significance of consent within the doctrine of exhaustion, the article also evaluates its application in the digital environment and the extent to which this could impact the proposal for an extended doctrine of implied consent. The boundaries of the extended doctrine along with its practical impact will be assessed through an example illustrating users’ access and interaction with digital content. It then becomes clear from the discussion that follows, that an extended doctrine of implied consent has the potential to balance copyright interests in the digital environment due to its status as a fundamental legal principle and inherent flexibility to consider a range of factors regarding users’ subsequent use of digital content.

Deceased by default: Consent systems and organ-patient mortality
Research Article
Bart H. H. Golsteyn, Annelore M. C. Verhagen
Plos One, 17 March 2021
Abstract
Previous research shows that countries with opt-out consent systems for organ donation conduct significantly more deceased-donor organ transplantations than those with opt-in systems. This paper investigates whether the higher transplantation rates in opt-out systems translate into equally lower death rates among organ patients registered on a waiting list (i.e., organ-patient mortality rates). We show that the difference between consent systems regarding kidney- and liver-patient mortality rates is significantly smaller than the difference in deceased-donor transplantation rates. This is likely due to different incentives between the consent systems. We find empirical evidence that opt-out systems reduce incentives for living donations, which explains our findings for kidneys. The results imply that focusing on deceased-donor transplantation rates alone paints an incomplete picture of opt-out systems’ benefits, and that there are important differences between organs in this respect.

A Step in the Wrong Direction: Florida Lawmakers’ Interference with Informed Consent for Pelvic Examinations
Commentary
David Alfandre, Cynthia Geppert, Jennifer Goedken, Toby Schonfeld
Women’s Health Issues, 11 March 2021
Excerpt
    Over the last two decades, several states have passed laws regulating informed consent for pelvic examinations. Much of the change has been positive, reflecting bipartisan state-supported legislation enforcing stringent informed consent requirements when health professions students perform pelvic examinations while a patient is under anesthesia. These stronger laws have helped to ensure that patients are included in, and make decisions about, any additional pelvic examinations performed for a student’s educational benefit rather than for the patient’s care (Friesen, 2018; Greene, 2020).

More recently, however, the state of Florida passed a strict consent law that requires a patient’s written consent before any pelvic examination, not just for those performed while under anesthesia. This law signals an ethically concerning trend in women’s health care that would create a more burdensome and unnecessary written consent processes for a broader range of low-risk interventions. In this commentary, we describe the ethical concerns the law raises and discuss more productive ways to empower patients while maintaining strong informed consent practices…

Deemed consent for organ donation: a comparison of the English and Scottish approaches
Jordan A. Parsons
Journal of Law and the Biosciences, 4 March 2021
Open Access
Abstract
Deemed consent for organ donation has long been discussed as a potential solution to the shortage of organs for transplantation, with several countries having implemented it. In Great Britain, Wales was the first nation to introduce such a system, having done so in 2015. Now, the other two nations are following suit. In this paper, I compare the approaches of England and Scotland in moving to systems of deemed consent for organ donation. After outlining both sets of legislation, I focus on three points on which the two nations differ. First, the role of those close to the deceased in the consent process and the extent to which clinicians are required to consult them ahead of consent being deemed. Second, the role of government ministers in ensuring widespread public awareness. Third, the ways in which the two nations responded to the challenge of the COVID-19 pandemic in relation to the implementation of deemed consent. I conclude that on all three points, the Scottish approach is preferable.

Heterogeneity of national legislation and practice on clinical trials with vulnerable patients based on the EU Clinical Trials Directive by the example of adults permanently incapable of giving informed consent
Research Article
Janna K. Schweim, Michael Nonnemacher, Karl-Heinz Jöckel
German Medical Science, 2 March 2021; 19
Open Access
Abstract
    In principle, persons wishing to participate in a clinical trial must give informed consent in advance after comprehensive information has been provided. Under certain conditions, it is possible to deviate from this requirement in the European Union (EU) in order to enable the participation of so-called vulnerable persons who are incapable of giving their informed consent. Kuthning et al. [1] have already dealt with general and specific aspects of vulnerable patients and the principle of informed consent in clinical trials. One group of vulnerable persons, for example, are adults temporarily or permanently incapable of giving consent due to their state of health. For a long period of time, no systematic and uniform legal basis for clinical trials existed in the EU as a whole. The Clinical Trials Directive (CTD) [2], adopted in 2001, aimed to change this by harmonizing all legal regulations on clinical trials applicable in the EU, but nevertheless allowing national deviations in implementation into national laws through opening clauses and aspects that were left unregulated. In view of the Clinical Trials Regulation (CTR) [3] which, according to the current status, will with high probability be applied from 2022 on, and which in future will be the legal basis for clinical trials with medicinal products in humans, applied directly in all EU member states, the necessity to take stock of the effects of the CTD was evident.
The national deviations with regard to the participation of patients incapable of giving informed consent were investigated qualitatively and quantitatively by means of a systematic analysis of legislation in 16 EU countries and a retrospective database analysis of a European clinical trial registry over a ten-year observation period. Although the analysis initially showed a predominantly homogeneous picture, the differences between the EU member states became apparent in a detailed examination. The database analysis yielded a clear result, since in some countries the majority of clinical trials are carried out. The clearest difference was found between the legal analysis and the results of the evaluated clinical trials concerning adults who are permanently incapable of giving informed consent. A presumed association between the “degree of liberality” of the national law and the frequency of clinical trials conducted in the respective country could not be confirmed. In the past, the selection of countries for conducting a clinical trial was based less on legal requirements and more on experience and financial considerations.