Informed Consent: A Monthly Review
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October 2021

This digest aggregates and distills key content addressing 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_October 2021

Editor’s Note:
On September 15th 2021 the GE2P2 Global Foundation’s Center for Informed Consent Integrity continued a series of webinars focused on integrity in informed consent. Dr. Eline M. Bunnik of Erasmus University shared perspectives from her May 2021 paper Mainstreaming informed consent for genomic sequencing: A call for action. During her presentation Dr. Bunnik also provided detail on the consortium and the help desk capability that was formed during this research. Her presentation was followed by an open discussion involving all call participants.

Informed consent challenges and strategies: A qualitative study of the orthodontists’ perspective

Informed consent challenges and strategies: A qualitative study of the orthodontists’ perspective
N Conduru Fernandes Moreira, L Keenan, G Cummings, C Flores-Mir
Orthodontics & Craniofacial Research, 18 September 2021
Abstract
Objective
To identify the barriers and strategies perceived by orthodontists when obtaining consent from their adult patients concerning patients’ comprehension or recollection of treatment information.
Settings and sample population
The sample comprised 12 orthodontists working in 8 different cities in Alberta, Canada.
Methods
An exploratory investigation using qualitative inquiry was conducted. Participants were recruited through a combination of purposive, maximum variation and snowball sampling. Data were collected through audio-recorded, semi-structured interviews until saturation was reached. Then, data were analysed using thematic analysis. Quality and credibility were achieved by employing member checks, memo writing and analyst triangulation strategies.
Results
Two major themes were identified, with subthemes: (1) Challenges that may interfere with patients’ comprehension and recollection of treatment information (i. patients’ internal barriers, ii. patients’ external barriers and iii. financial barriers); and (2) strategies to optimize information delivery and communication (i. tailoring the content to be delivered, ii. communication fashion, iii. communication timing and iv. being accommodative).
Conclusion
The participants reported barriers that may be overlooked in the daily routine of orthodontic practices. Information is provided that may guide orthodontists to overcome or minimize these challenges, increase patient comprehension and improve the quality of informed consent processes.

Raising Awareness of Data Sharing Consent Through Knowledge Graph Visualisation

Raising Awareness of Data Sharing Consent Through Knowledge Graph Visualisation
Research Article
Christof Bless, Lukas Dötlinger, Michael Kaltschmid, Markus Reiter, Anelia Kurteva, Antonio J. Roa-Valverde, Anna Fensel
IOS Press, 2021; 53 pp 44 – 57
Open Access
Abstract
Knowledge graphs facilitate systematic large-scale data analysis by providing both human and machine-readable structures, which can be shared across different domains and platforms. Nowadays, knowledge graphs can be used to standardise the collection and sharing of user information in many different sectors such as transport, insurance, smart cities and internet of things. Regulations such as the GDPR make sure that users are not taken advantage of when they share data. From a legal standpoint it is necessary to have the user’s consent to collect information. This consent is only valid if the user is aware about the information collected at all times. To increase this awareness, we present a knowledge graph visualisation approach, which informs users about the activities linked to their data sharing agreements, especially after they have already given their consent. To visualise the graph, we introduce a user-centred application which showcases sensor data collection and distribution to different data processors. Finally, we present the results of a user study conducted to find out whether this visualisation leads to more legal awareness and trust. We show that with our visualisation tool data sharing consent rates increase from 48% to 81.5%.

Informed Consent: A Monthly Review
___________________________

September 2021

This digest aggregates and distills key content addressing 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_September 2021

Does the General Medical Council’s 2020 guidance on consent advance on its 2008 guidance?

Does the General Medical Council’s 2020 guidance on consent advance on its 2008 guidance?
Clinical Ethicsz
Abeezar I Sarela
Journal of Medical Ethics, 23 August 2021
Abstract
The General Medical Council renewed its guidance on consent in 2020. In this essay, I argue that the 2020 guidance does not advance on the earlier, 2008 guidance in regard to treatments that doctors are obliged to offer to patients. In both, doctors are instructed to not provide treatments that are not in the overall benefit, or clinical interests, of the patient; although, patients are absolutely entitled to decline treatment. As such, consent has two aspects, and different standards apply to each aspect. To explore this paradigm, I propose the reconceptualisation of consent as a person’s freedom to achieve treatment, using Amartya Sen’s approach. Sen explains that freedom has two aspects: process and opportunity. Accordingly, a patient’s freedom to achieve treatment would comprise a process for the identification of proper treatment, followed by an opportunity for the patient to accept or decline this treatment. As per Sen, the opportunity aspect is to be assessed by the standard of public reason, whereas the standard for the process aspect is variable and contingent on the task at hand. I then use this reconceptualised view of consent to analyse case law. I show that senior judges have conceived the patient’s opportunity to be encompassed in information, which is to be decided by public reason. On the other hand, the process aspect relies on the private reason of medical professionals. Given the nature of professionalism, this reliance is inescapable, and it is maintained in the case law that is cited in both guidances.

Consent is an organizational behavior issue

Consent is an organizational behavior issue
Vanessa K.Bohns, RachelSchlund
Research in Organizational Behavior, 18 August 2021
Abstract
Consent is central to many organizational interactions and obligations. Employees consent to various terms of employment, both formal (contractual obligations) and informal (extra-role responsibilities, interpersonal requests). Yet consent has traditionally been considered a legal matter, unrelated to organizational behavior. In this article, we make a case for why, and how, organizational behavior scholars should undertake the study of consent. We first review scholarship on the legal understanding of consent. We argue that the traditional legal understanding is an incomplete way to think about consent in organizations, and we call for a more nuanced understanding that incorporates psychological and philosophical insights about consent—particularly consent in employer-employee relationships. We then connect this understanding of consent to traditional organizational behavior topics (autonomy, fairness, and trust) and examine these connections within three organizational domains (employee surveillance, excessive work demands, and sexual harassment). We conclude with future directions for research on consent in organizations.

ICME: an informed consent management engine for conformance in smart building environments [CONFERENCE PAPER]

ICME: an informed consent management engine for conformance in smart building environments [CONFERENCE PAPER]
Chehara Pathmabandu, John Grundy, Mohan Baruwal Chhetri, Zubair Baig
ESEC/FSE 2021: Proceedings of the 29th ACM Joint Meeting on European Software Engineering Conference and Symposium on the Foundations of Software Engineering, August 2021; pp 1545–1549
Open Access
Abstract
Smart buildings can reveal highly sensitive insights about their inhabitants and expose them to new privacy threats and vulnerabilities. Yet, convenience overrides privacy concerns and most people remain ignorant about this issue. We propose a novel Informed Consent Management Engine (ICME) that aims to: (a) increase users’ awareness about privacy issues and data collection practices in their smart building environments, (b) provide fine-grained visibility into privacy conformance and infringement by these devices, (c) recommend and visualise corrective user actions through “digital nudging”, and (d) support the monitoring and management of personal data disclosure in a shared space. We present a reference architecture for ICME that can be used by software engineers to implement diverse end-user consent management solutions for smart buildings. We also provide a proof-of-concept prototype to demonstrate how the ICME approach works in a shared smart workplace. Demo: <a>https://youtu.be/5y6CdyWAdgY</a>

Communication and Libertarianism [BOOK]

Communication and Libertarianism [BOOK]
Pavel Slutskiy
Springer, 3 August 2021
Editor’s note: In Communication and libertarianism, which covers a range of themes, the four chapters below were relevant to consent.

Communicating Consent
Abstract
The libertarian non-aggression principle rests on two concepts: the concept of property rights, which defines the borders of individual autonomy, and the concept of consent, which defines unwarranted intrusion. Both concepts depend on communication—borders of property need to be publicly manifested on the one hand, and consent needs to be expressed in order to exist in the reality of human action on the other. Unless consent is manifested, it remains hypothetical, and hypothetical consent is never valid. Even if an action based on hypothetical consent coincides with the preferences of the consent-giver, it happens to be so only by coincidence. Counting on such hypothetical consent is risky, and the actor who takes the risk bears full responsibility for potential mistakes which may lead to uninvited interference. Hypothetical consent needs to be separated from tacit and implied consent, both of which can be valid. Internal “mental” aspects of consent may be important felicity conditions for consent, but they are not enough for a successful performance of the act of consenting. It is “external” or expressive aspects of consenting which are crucial for making the preferences of the consent-giver identifiable to another agent, thus changing the status of his actions. Only communicated consent is capable of performing the “magic” of making actions permissible, and only communicated consent can be used by actors to defend against potential accusations in rights violation.

Communication Ethics: Consent as the Foundation of Non-aggression
Abstract
One of the major challenges for political philosophy is the postulated impossibility of building a sound theory without a solid foundation in ethics. Ethical questions of what is good and what is bad arise within the context of social interactions—in relation to actions unto other people. But judgements on what is good and what is bad are necessarily subjective. This, however, does not mean that this subjective judgement is not true. Man’s opinion about what is a bad action unto him is a correct evaluation of the action in question. For an acting agent, the opinion of the action’s recipient is thus the source of the correct ethical assessment of the action. This assessment can only become known to the acting agent by the means of communication. Communicating a subjective value judgement on what is good and what is bad gives the other agent knowledge about the ethical value of the intended action. Acting unto another man against his consent thus implies wrongdoing.

Manipulation of Consent
Abstract
This chapter examines several criticisms of non-fraudulent commercial speech. According to critics, even if business propaganda does not constitute fraud by intentionally misleading consumers, it still may be illegitimate for other reasons. Advertising is accused of coercion through manipulative persuasion, exaggeration and puffery. Other charges include accusations of promoting products and services that are harmful for consumers who therefore later regret purchasing them, and this regret invalidates the consent given at the moment of making the purchase. These accusations are examined from the property rights perspective as well from the communication perspective.

The Role of Property Rights in the Ethics of Consent
Abstract
Consent is what allows us to tell others whether their actions unto us are acceptable from our point of view. Proceeding with an action without our consent, or after consent has been refused, would constitute a moral wrongdoing. However, consent is only required for giving moral evaluation to actions that are directed towards other actors and affect them. An action can be considered as intended towards another person if it interferes with this person’s “zones of control”—borders of physical objects with which one creates a particular relationship. This relationship is ownership—it assumes that any hindrance to the use of the object without the consent of the owner is a wrongdoing. Ownership comes from the direct control of bodies, and original appropriation of external objects and voluntary transfers forms the foundation of property rights—violation against property is a violation against the owner. A legal system based on the idea that property rights violations constitute an offence recognises the validity of the non-aggression principle. The non-aggression principle prohibits the initiation of force, which is understood as an action of border crossing without the owner’s consent. The concept of consent and the concept of borders are ontologically based on communication, which means that communication is the basis of the non-aggression principle.

Informed Consent: A Monthly Review
___________________________

August 2021

This digest aggregates and distills key content addressing 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_August 2021

Editor’s Note:

Informed Consent in the Council for International Organizations of Medical Sciences (CIOMS) guidance on Clinical research in resource-limited settings, held on July 21st 2021, was the latest webinar in the Center’s continuing series. David Curry opened the call with a high-level overview of the guidance. Paige Fitzsimmons followed with a brief summary of how informed consent is treated in the guidance. Getnet Yimer then provided observations and reflections on this guidance and associated challenges with implementation from a field research and ethics review board perspective. Dónal O’Mathúna closed the discussion by examining how community engagement is treated in the new guidance.

Just Because the Data Is There, It Doesn’t Mean It’s Yours to Take

Just Because the Data Is There, It Doesn’t Mean It’s Yours to Take
Kate McCandless
Emerging Library & Information Perspectives, 2 July 2021; 4(1)
Abstract
In research conducted using Twitter data, informed consent has taken the back seat. This literature review examines the perspectives of users, researchers and research ethics boards to provide nuance and context to the issue. Users are generally unaware that their data can be taken for research purposes and that they have agreed to be studied within the platform’s terms of service. This is concerning for both researchers and users alike, as it continues to blur the line of public and private information. Users want to be informed when they are being studied. When informed consent is not obtained, researchers are not respecting the data and the humans who created it. If researchers were required to obtain informed consent when engaging with Twitter data, the resulting research would be more ethical and protect everyone involved: the researcher, the user, and the university.