Presumed Consent for Organ Donation: An Incoherent Justification
Vicente Formoso, Sílvia Marina, Miguel Ricou
Acta Bioethica, 2021; 27(1) pp 27-35
Open Access
Abstract
The difference between supply and demand of transplantable organs is a global problem, and one of the most discussed measures aiming to solve it is the implementation of a presumed consent (opt-out) policy in cadaveric organ donation. This type of system is controversial when it comes to its direct effects on organ donation rates as well as its ethical base. We aim to present the latest perspectives concerning the ethical implications of the policy, especially regarding consent: its need, the coherence of presuming it and the policy’s capacity to fulfill its requirements. From a community perspective, we advocate a default change in societies with an opt-out system, with a strong population education in that direction. The potential rights of family objection are also approached as well as the differences between theoretical discussion and concrete application of public policy.

Will EU’s GDPR Act as an Effective Enforcer to Gain Consent?
Junhyoung Oh, Jinhyoung Hong, Changsoo Lee, Jemin Justin Lee, Simon S.Woo, Kyungho Lee
IEEE, 26 May 2021
Open Access
Abstract
Since the GDPR was implemented in 2018, organizations that collect data from the EU residents are required to receive the user’s consent. Organizational measures to ensure that the organizations are compliant to the recently enacted GDPR are still abstract and ambiguous. Moreover, data subjects and controllers have demanded the practice of obtaining consent from organizations. By observing the case law and guidelines related to the GDPR provisions, we deduced four consent conditions. Then, we examined how online service provider’s websites are making efforts to implement the GDPR framework. For this, we identified key characteristics of these websites, such as the existence of consent buttons. In order to help the data subjects obtain consent, we proposed an automatic tool that can check the consent conditions by checking the websites. Our study examined 10,000 websites for 26 days using the Python libraries with the tool automatically crawling the website information and analyzes the HTML structure according to the specified conditions. In addition, this tool crawls the privacy policy of each website. Moreover, it automatically determines whether it meets the four consent conditions by calculating it according to the formula defined in the consent condition. To evaluate the tool’s accuracy, the researchers manually analyzed 500 websites and compared the manual analysis with the results of the tool’s automatic analysis. We found that this tool differentiates itself through qualitative comparisons with other GDPR meters.

How Has ‘Montgomery’ Changed the Way We Document Risks on Consent Forms for Deceased Donor Kidney Transplantation? A Single-Centre Audit and Re-Audit
A M Hussein, C J Callaghan
British Journal of Surgery, 4 May 2021; 108(Supplement 2)
Abstract
Introduction
The 2015 Montgomery case changed the remit of risk discussions required during the consent process. This audit reviewed single kidney transplant (SKT) consent forms to establish which risks are documented, and whether this legal case affected discussions. Following the audit, we introduced a pre-printed consent form and closed the audit loop by assessing its uptake.
Method
Trust paper consent forms for all patients aged 50+ who received a deceased donor SKT in our centre in 2014 (n = 58; pre-Montgomery) and 2017 (n = 70; post-Montgomery) were reviewed to see if 20 perceived ‘gold standard’ risks were documented. A pre-printed procedure-specific consent form including all gold standard risks was then introduced in July 2019. A re-audit reviewed the case-notes of every alternate recipient aged 50+ of a deceased donor SKT from 01/08/19 to 29/02/20 to check if the pre-printed form was used.
Results
Overall, 53% of the 20 ‘gold standard’ risks were documented in 2014 versus 59% in 2017 (p = 0.55). There was a 91% uptake of the pre-printed consent form.
Discussion
This audit established the importance of using a pre-printed consent form to standardise risk discussions We propose that pre-printed procedure-specific forms should be encouraged throughout the NHS to support ‘Montgomery-appropriate’ consent discussions.

Consent in privacy laws: Analysis of India’s PDPB, ECPA of USA and GDPR of EU
Prashant Mali
International Journal of Law, 25 March 2021; 7(2) pp 142-152
Open Access
Abstract
Consent refers to an affirmative action on the part of the individuals indicating their agreement to the use of their personal data by the collectors or processors for the purpose of processing. Consent has been viewed as an expression of a person‘s autonomy or control, which has the consequence of allowing another person to legally disclaim liability for acts, which have been consented to. Consent has many connotations in various privacy laws, somewhere it tows the line of prevailing international laws and in some laws it gets localized, but largely consent remains individuals’ will to share his / her data. This paper analysis the established privacy laws i.e. EU’s GDPR and ECPA of USA with long awaited India’s proposed Personal Data Protection Bill. The author has been involved in various government consultations on PDPB since 2006.

Towards a coherent model of informed consent : is there, and should there be, a coherent model of informed consent to surgery across medical ethics, medical professional regulation, and medical law? [DISSERTATION]
Louise Austin
University of Bristol, 2021; PhD Thesis
Abstract
Utilising the empirical ethics methodology and method of ‘reflexive balancing’ (RBL), this thesis asks: is there, or should there be, a coherent model of informed consent to surgery across medical ethics, medical professional regulation, and medical law? It concludes that whilst presently there is not a coherent model across these three areas, there should be, and a proposed model is outlined. In reaching this conclusion, the thesis draws upon ethical literature, the medical regulatory and legal standards of informed consent, and my empirical analysis of fitness to practice decisions and court judgments concerning informed consent in the context of surgery. Such a detailed analysis of these decisions and judgments has not been done before and this thesis, therefore, makes an original and significant contribution to existing scholarship. This contribution is developed further by the use of RBL to bring the data together to address the question the thesis asks. RBL has not previously been used to bring together medical ethics, medical professional regulation, and medical law. Chapter One sets out the methodology and methods underpinning the thesis. Chapters Two to Four illustrate there is not a coherent model of informed consent to surgery across medical ethics, medical professional regulation, and medical law. Chapters Five and Six set out the empirical analysis and Chapter Seven draws upon that analysis to develop a model of informed consent to surgery. RBL is then utilised to challenge that model, leading to a coherent model of informed consent to surgery across medical ethics, medical professional regulation, and medical law. This model enables autonomous choices about surgery, utilising objective and subjective perspectives in determining what information should be given to patients, and requiring understanding and reflection. The thesis concludes with recommendations for the model’s implementation, and for further research suggested by the thesis’ findings.

Medical Violence, Obstetric Racism, and the Limits of Informed Consent for Black Women
Colleen Campbell
Michigan Journal of Race and Law, Winter 2021; 26 (Special Issue)
Open Access
Abstract
The United States’ alarmingly high C-section rate and its equally alarming maternal mortality rate make it clear that reproductive healthcare is failing women. But it is especially failing Black women, who are today disproportionately exposed to these and other reproductive health risks just as they have been throughout history. The Michigan Journal of Gender & Law selected this Essay because it traces a direct line from early gynecology’s reliance on the bodies of unconsenting Black women to how medicine and the law’s failure to reckon with this history continues to harm Black women now. While these institutions now purport to embrace ethical principles like bodily autonomy and individual agency, this Essay critically examines why Black women must still navigate reproductive healthcare against a backdrop of both racist medical violence that puts their health at risk and a legal doctrine of informed consent that cannot realistically protect them.

Editor’s note: The Michigan Journal of Race & Law is a legal journal associated with the University of Michigan Law School that serves as a forum for the exploration of issues relating to race and law.

Beyond Montgomery – decision making, consent and the GMC
Anastasia Georgiou, Helen Bolton
Obstetrics, Gynaecology & Reproductive Medicine, 17 April 2021
Abstract
In November 2020 the General Medical Council (GMC) updated its guidance on decision making and consent. This new document reflects significant legal and ethical developments that have occurred in recent years. It is helpful to understand the context from which this guidance has arisen, and imperative to understand the implications it will have on clinical practice. As such, this article will (i) outline the evolution of consent (ii) briefly explain the landmark case of Montgomery and (iii) highlight the key updates in the GMC’s 2020 guidance.

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…