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.