Informed Consent: A Monthly Review
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December 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_December 2021

Applying utilitarianism to the presumed consent system for organ donation to consider the moral pros and cons
Jelena Morris, Janet Holt
British Journal of Nursing, 1 November 2021; 30(19)
Abstract
In May 2020, England adopted an opt-out approach for organ donation, also referred to as the deemed consent system, with the aim of alleviating the demand for organs in the UK. This system dictates that those who have not opted out will have their organs donated following their death, with the exception of those meeting certain criteria. This article applies the philosophical theory of utilitarianism to the deemed consent system for organ donation, focusing particularly on topics such as that of informed consent and family refusal. Utilitarianism is a consequentialist theory that attempts to determine whether an action is morally right or wrong based on whether or not it maximises the preferences of the greatest number of people, with each person’s satisfaction being considered as equal to another’s.

Respondent understanding of data linkage consent
Joseph Sakshaug, Alexandra Schmucker, Frauke Kreuter, Mick P Couper, Leonie Holtmann
JournalSurvey Methods: Insights from the Field, 1 October 2021
Abstract
Across survey organizations around the world, there is increasing pressure to augment survey data with administrative data. In many settings, obtaining informed consent from respondents is required before administrative data can be linked. A key question is whether respondents understand the linkage consent request and if consent is correlated with respondent understanding. In the present study, we investigate these issues in separate telephone and Web surveys, where respondents were presented with follow-up knowledge questions to assess their understanding of the linkage consent request. Overall, we find that understanding of the linkage request is relatively high among respondents who consent to linkage and rather poor among those who do not consent, with some variation in the understanding of specific aspects of the linkage request, including data protection. Additional correlates of understanding were also identified, including demographic characteristics, privacy attitudes, and the framing and placement of the linkage consent questions. Practical implications of these results are provided along with suggestions for future research.

Informed Consent: A Monthly Review
___________________________

November 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_November 2021

Editor’s Note: CICI Webinar Series
On October 20th 2021 the GE2P2 Global Foundation’s Center for Informed Consent Integrity continued a series of webinars focused on integrity in informed consent. Foundation President David Curry, who has led the Foundation’s Center for Vaccine Ethics and Policy since 2008, opened the session with a discussion on the intersection of limited supply of WHO/SRA [Stringent Regulatory Authority] reviewed vaccines, licensing and use of “questionable” vaccines outside WHO/SRA review, growing vaccine hesitancy/refusal as a global challenges, growing use of mandates of various types but specifically involving young persons and a return to FTF education, and limited options for young people who find themselves with few options to exercise. After the initial presentation participants on the call shared local perspectives.

Following a successful first year, we are pausing the CICI webinar series to evaluate future directions.  Please watch for updates.

Ethical Benefits and Drawbacks of Digitally Informed Consent [BOOK CHAPTER]
Wendy Charles, Ruth Magtanong
Applied Ethics in a Digital World, 2022 [IGI Global]
Abstract
As organizations steadily adopt remote and virtual capabilities, informed consent processes are increasingly managed by digital technologies. These digital methods are generating novel opportunities to collect individuals’ permissions for use of private information but are blurring traditional boundaries of consent communication and documentation. Therefore, the rapid growth of digital technologies used for informed consent as well as the sheer volume of data resulting from electronic data capture are generating complex questions about individual engagement and data practices. This chapter presents emerging risks, benefits, and ethical principles about digital informed consent methods and technologies. For the areas where digital informed consent creates ethical uncertainties, ethical guidelines and user-design recommendations are provided.

Informed Consent: A Monthly Review
___________________________

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
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
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?
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.