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.

Security and Privacy Requirements for Electronic Consent: A Systematic Literature Review
Research Article
Stef Verreydt, Koen Yskout, Wouter Joosen
ACM Transactions on Computing for Healthcare, March 2021; 2(2)
Abstract
Electronic consent (e-consent) has the potential to solve many paper-based consent approaches. Existing approaches, however, face challenges regarding privacy and security. This literature review aims to provide an overview of privacy and security challenges and requirements proposed by papers discussing e-consent implementations, as well as the manner in which state-of-the-art solutions address them. We conducted a systematic literature search using ACM Digital Library, IEEE Xplore, and PubMed Central. We included papers providing comprehensive discussions of one or more technical aspects of e-consent systems. Thirty-one papers met our inclusion criteria. Two distinct topics were identified, the first being discussions of e-consent representations and the second being implementations of e-consent in data sharing systems. The main challenge for e-consent representations is gathering the requirements for a “valid” consent. For the implementation papers, many provided some requirements but none provided a comprehensive overview. Blockchain is identified as a solution to transparency and trust issues in traditional client-server systems, but several challenges hinder it from being applied in practice. E-consent has the potential to grant data subjects control over their data. However, there is no agreed-upon set of security and privacy requirements that must be addressed by an e-consent platform. Therefore, security- and privacy-by-design techniques should be an essential part of the development lifecycle for such a platform.

A Modern History of Informed Consent and the Role of Key Information
Lydia A. Bazzano, Jaquail Durant, Paula Rhode Brantley
Ochsner Journal, March 2021; 21 pp 81–85
Open Access
Abstract
Background
The concept of informed consent has evolved significantly with regard to both the practice of medicine and research conducted with human volunteers. Yet the process of informed consent used in clinical research and the lengthy consent documents that are difficult to comprehend have been criticized.
Methods
We review the history of informed consent as a legal and regulatory concept and the intended impact of the new key information section, a requirement that was introduced in the 2017 revisions to the Common Rule.
Results
The key information section is intended to be a concise and focused presentation at the beginning of the informed consent document that facilitates potential participants’ comprehension of the research. However, the lack of regulatory guidance regarding content and length has been problematic. To avoid the risk of noncompliance, many institutions have sought safe harbor by following the limited format guidelines included in the preamble to the revisions to the Common Rule.
Conclusion
Research examining formats for the key information section and aids to increasing potential participants’ understanding of a research project should be conducted to ensure that the new regulations achieve the original intent rather than simply lengthening an already lengthy paper document. In addition, the human research protections community should evaluate whether the key information section increases research participants’ understanding of what they will be undertaking in a particular study.

Editor’s note: The Ochsner Journal is a peer-reviewed quarterly medical journal published by the Academic Division of Ochsner Clinic Foundation.

Comparison of notice requirements for consent between ISO/IEC 29184:2020 and General Data Protection Regulation
Harshvardhan J. Pandit, Georg Philip Krog
Journal of Data Protection & Privacy, Spring 2021; 4(2)
Abstract
This paper analyses the ISO/IEC 29184:2020 standard and compares its requirements for notice and consent with those specified by the General Data Protection Regulation (GDPR). More specifically, it considers the extent to which the ISO/IEC 29184 standard can be applied to demonstrate compliance with the requirements of the GDPR and to identify the additional requirements in areas where it is not sufficient. The paper concludes with remarks on the potential role of ISO/IEC 29184 as a certification mechanism under the GDPR for consent and notice.

Informed Consent of Minors with a Special Focus on the Czech Legal Regulation
Tomáš Doležal
The Lawyer Quarterly, January 2021; 11(1) pp 126-140
Open Access
Abstract
This article is focused on the examination of the law concerning medical treatment of minors, that is, persons under the age of 18. The first part of this article brings a short overview of the international documents regulating the rights of the child and specifically children’s rights within the area of health care provision. This article analyzes the issue of the maturity and competence of children and discusses whether persons under the age of 18 may be regarded as being capable of consenting to medical treatment. Furthermore this article brings a short comparative overview of the laws concerning medical treatment of minors in different countries and tries to extract the common features of the regulations in the different countries. Finally, the last and longest part of this article analyzes the issue of the capacity of minors to consent to medical treatment in the territory of the Czech Republic from the historical perspective and brings a structured overview of this issue under the current Czech laws.

The Concept of “Person” in the Italian Legislation on Informed Consent and Advance Healthcare Directives
Matteo Cresti
International Journal for the Semiotics of Law, 10 February 2021
Open Access
Abstract
The aim of the paper is that of investigating the concept of “person” in the context of Italian law on informed consent and advance healthcare directives (law n. 219/2017). The following paper will first consider the importance of the concept of “person” within bioethics; secondly it will exhibit how there are different levels of bioethics, and that on the discussion level of laws and regulations, concepts worthy of metaphysical and value references cannot be used, because they must be shared by everyone in a pluralistic society. I’ll then move on to discuss the law on informed consent and advance healthcare directives; first I’ll discuss the references to the Italian Constitution, showing that the implied concept of “person” is closely linked to the concepts of “equality” and “autonomy”, and finally I’ll discuss the particular case of minors and the protection that the law provides them.

[Expert consensus on informed consent for vaccination(Part One)]
Zhonghua Yu Fang Yi Xue Za Zhi
Chinese Preventive Medicine Association, 1 February 2021; 55(2) pp 135-166
Abstract
The Vaccine Administration Law of the People’s Republic of China and other relevant laws require that vaccine recipients or their guardians be educated about vaccines and how they work, and described in general the methods and contents of such vaccination education. With the new law and “Standard Operational Procedures for Immunization” as foundation documents, and in consultation with experts at home and abroad, the Chinese Preventive Medicine Association developed a consensus statement about informed consent for vaccination. This consensus statement is written for disease control and prevention health care personnel in vaccination services and describes the educational content of informed consent, a theoretical framework for immunization and immunization knowledge, the informed consent processes, principles of planning for vaccination, and an informed consent form. Part One of the consensus includes the general principles of vaccination and provides specific information on hepatitis B vaccine, Bacillus Calmette-Guérin vaccine, poliomyelitis vaccine, diphtheria, tetanus and pertussisvaccine, measles-containing vaccine, Japanese encephalitis vaccine, meningococcal vaccine, and hepatitis A vaccine.

Editor’s note: This is a Chinese language publication

The importance of consent in case reports
Ross J Thomson, C Fielder Camm
European Heart Journal – Case Reports, 4 January 2021
Open Access
Excerpt
…The Committee on Publication Ethics and the International Committee of Medical Journal Editors have issued guidelines on the publication of case reports. These state that, with limited exceptions, consent from the patient should be obtained prior to publication of a case report. When obtaining informed consent authors must advise their patients not only that their case will be placed in the public domain but that despite every effort at anonymisation there exists a possibility that they may be identified, and that their consent is irrevocable after (but not before) publication. As part of the consent process, the patient should have the opportunity to read the manuscript and view any images accompanying it…

The patient’s right to informed consent in the US Legal System. Genesis, development, foundations and brief questioning comparison with the Spanish model
Noelia Martinez-Doallo
Derecho y Salud, 2020; 30(2) pp 57-83
Abstract
A legal analysis on the informed consent of the patient primarily requires considering the common law, regardless of solutions provided by the malpractice statutes and a promising constitutional protection route, despite the ascertainment of some preventable shortcomings. This paper aims to offer a comprehensive review on the genesis, advancement and basis of the U.S. legal protection of the informed consent in the healthcare extent, to afterwards carry out a brief comparative study with the Spanish regulation.