Exploring solutions to the privacy paradox in the context of e‑assessment: informed consent revisited
Original Paper
Ekaterina Muravyeva, José Janssen, Marcus Specht, Bart Custers
Ethics and Information Technology, 24 April 2020
Open Access
Abstract
Personal data use is increasingly permeating our everyday life. Informed consent for personal data use is a central instrument for ensuring the protection of personal data. However, current informed consent practices often fail to actually inform data subjects about the use of personal data. This article presents the results of a requirements analysis for informed consent from both a legal and usability perspective, considering the application context of educational assessment. The requirements analysis is based on European Union (EU) law and a review of current practices. As the main outcome, the article presents a blueprint which will be the basis for the development of an informed consent template that supports data controllers in establishing an efective and efcient informed consent form. Because the blueprint, and subsequently, the template, distinguishes between legal and usability requirements, it also provides the basis for the mapping of legal requirements in other (non-European) contexts

The myth about consent forms
Advice
Russell Heathcote-Curtis
BDJ In Practice, 6 April 2020
Open Access
Excerpt
…The consent process is not about creating legal protection for the clinical team that will be providing treatment. It is a communication process that reflects the autonomy of the patient who will be receiving that treatment. Any consent form that you have asked the patient to sign, should be regarded as just one small part of the overall record of the communication that has taken place between patient and clinician in advance of treatment being provided. The larger part of the record needs to capture the essence of the information provided to the patient, the issues raised by any of the treatment options and the clinician’s response along with the patient’s final decision about their preferred choice from the options discussed…

Rethinking consent in mHealth: (A) moment to process [BOOK CHAPTER]
Iris Loosman
Aging between Participation and Simulation
Walter de Gruyter GmbH, 6 April 2020; Chapter 10
Abstract
The field of mobile health promises a transformation of the healthcare industry, by providing health-related information and services directly to individuals, through digital mobile devices. This presents society with new platforms for persuasive systems for healthy behavior change. Before such systems’ full potential can be utilized, however, the question of how to consent to their use needs to be addressed. In this paper, I argue that one-off all-encompassing consent moments at the start of use of persuasive mobile health services do not suffice, given the functions they present, and the context in which they are used. Persuasive mobile health services are not only data-intensive, they are also designed to influence the user’s behavior and health. Informed consent should be temporally distributed, in order to improve the quality of the user’s autonomous authorization, that this context requires.

Informed Consent and Ethical Research [BOOK CHAPTER]
Margit Sutrop, Kristi Lõuk
Handbook of Research Ethics and Scientific Integrity
Springer, 2 April 2020; pp 213-232
Abstract
Although today valid informed consent is considered key to ethical research, there is no agreement on what constitutes adequate informed consent. Problems ensue firstly from the circumstance that a principle adopted in one area of inquiry (biomedicine) cannot be extended literally to other areas of science. In addition, new areas of scholarly inquiry and changing research contexts contribute to the emergence of new forms of consent (open, broad, dynamic, meta-consent). A second difficulty derives from an overly narrow understanding of the concept of autonomy, resulting in an absolutizing of individual freedom and choices and relegating more collective values such as reciprocity, responsibility, and solidarity to the background.

In this chapter, we explain the origin of the concept of informed consent, what it consists of, and what forms it can take. We will then analyze what has caused shifts in the understanding of the informed consent principle: how much is due to advancements in science and technology and how much to changing ethical frameworks. Finally, we will show why it is important to develop a contextual approach by taking into account differences in research fields as well as types of research.

Informed Consent and Health: A Global Analysis [BOOK]
Edited by Thierry Vansweevelt and Nicola Glover-Thomas
Global Perspectives on Medical Law Series
Edward Elgar, 1 April 2020
Abstract
Informed consent is the legal instrument that purports to protect an individual’s autonomy and defends against medical arbitrariness. This illuminating book investigates our evolving understanding of informed consent from a range of comparative and international perspectives, demonstrating the diversity of its interpretations around the world. Chapters offer a nuanced analysis of the problems that impede the understanding and implementation of the concept of informed consent and explore the contemporary challenges that continue to hinder both the patient and the medical community.

Subsequent Consent and Blameworthiness
Jason Chen
HEC Forum, 28 March 2020
Abstract
Informed consent is normally understood as something that a patient gives prior to a medical intervention that can render it morally permissible. Whether or not it must be given prior to the intervention is debated. Some have argued that subsequent consent-that is, consent given after a medical intervention-can also render an otherwise impermissible act permissible. If so, then a patient may give her consent to an intervention that has already been performed and thereby justify a physician’s (paternalistic) act retroactively. The purpose of this paper is to argue that even if subsequent consent can render an otherwise impermissible act permissible, doctors are still blameworthy if they rely on it when prior consent could be given, because they would be banking on the justification of their interventions. Since doctors can only guess if patients will consent after the fact, they would be placing their patients at unreasonable risk of being disrespected as persons.

Informed Consent: A Monthly Review
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April 2020

This digest aggregates and distills key content around informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_April 2020

A Human-centric Perspective on Digital Consenting: The Case of GAFAM [CONFERENCE PAPER]
Human Soheil, Cech Florian
Human Centred Intelligent Systems, 17 June 2020 – 19 June 2020; Split, Croatia
Open Access
Abstract
According to different legal frameworks such as the European General Data Protection Regulation (GDPR), an end-user’s consent constitutes one of the well-known legal bases for personal data processing. However, research has indicated that the majority of end-users have difficulty in understanding what they are consenting to in the digital world. Moreover, it has been demonstrated that marginalized people are confronted with even more difficulties when dealing with their own digital privacy. In this research, we use an enactivist perspective from cognitive science to develop a basic human-centric framework for digital consenting. We argue that the action of consenting is a sociocognitive action and includes cognitive, collective, and contextual aspects. Based on the developed theoretical framework, we present our qualitative evaluation of the consent-obtaining mechanisms implemented and used by the five big tech companies, i.e. Google, Amazon, Facebook, Apple, and Microsoft (GAFAM). The evaluation shows that these companies have failed in their efforts to empower end-users by considering the human-centric aspects of the action of consenting. We use this approach to argue that their consent-obtaining mechanisms violate principles of fairness, accountability and transparency. We then suggest that our approach may raise doubts about the lawfulness of the obtained consent—particularly considering the basic requirements of lawful consent within the legal framework of the GDPR.

Informed Consent: A Monthly Review
___________________________

March 2020

This digest aggregates and distills key content around informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Fellow
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

Publisher
David R. Curry
President & CEO
GE2P2 Global Foundation
david.r.curry@ge2p2global.org

PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_March 2020

Unethical informed consent caused by overlooking poorly measured nocebo effects
J. Howick
Journal of Medical Ethics, 16 February 2020
Open Access
Abstract
Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to share intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which such risk information is shared. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside the principle of autonomy when obtaining (ethical) informed consent.