Informed Consent: A Monthly Review
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August 2022

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 2022

Privacy Behaviour: A Model for Online Informed Consent
Original Paper
Gary Burkhardt, Frederic Boy, Daniele Doneddu, Nick Hajli
Journal of Business Ethics, 14 July 2022
Open Access
Abstract
An online world exists in which businesses have become burdened with managerial and legal duties regarding the seeking of informed consent and the protection of privacy and personal data, while growing public cynicism regarding personal data collection threatens the healthy development of marketing and e-commerce. This research seeks to address such cynicism by assisting organisations to devise ethical consent management processes that consider an individual’s attitudes, their subjective norms and their perceived sense of control during the elicitation of consent. It does so by developing an original conceptual model for online informed consent, argued through logical reasoning, and supported by an illustrative example, which brings together the autonomous authorisation (AA) model of informed consent and the theory of planned behaviour (TPB). Accordingly, it constructs a model for online informed consent, rooted in the ethic of autonomy, which employs behavioural theory to facilitate a mode of consent elicitation that prioritises users’ interests and supports ethical information management and marketing practices. The model also introduces a novel concept, the informed attitude, which must be present for informed consent to be valid. It also reveals that, under certain tolerated conditions, it is possible for informed consent to be provided unwillingly and to remain valid: this has significant ethical, information management and marketing implications.

Malpractice Claims and Ethical Issues in Prison Health Care Related to Consent and Confidentiality
Review
Oana-Maria Isailă, Sorin Hostiuc
Healthcare, 12 July 2022
Open Access
Abstract
Respecting the consent and confidentiality of a patient is an underlying element in establishing the patient’s trust in the physician and, implicitly, obtaining the patient’s compliance. In particular, cases of inmate patients require increased attention in order to fulfill this goal against a background of institutional interferences, which, in certain situations, may endanger the autonomy of the physician and their respect for the inmate’s dignity. The purpose of this article is to depict the characteristics of consent and confidentiality in a prison environment, in special cases, such as hunger strikes, violent acts, HIV testing, COVID-19 measures, and drug use, bringing into focus the physician and the inmate in the context of the particular situation where the target is disciplining someone in order for them to conform to social and juridical norms. Respecting the dignity of the inmate patient requires an adequate approach of informed consent and confidentiality, depending on each case, considering the potential unspoken aspects of the inmate’s account, which can be key elements in obtaining their compliance and avoiding malpractice claims.

Ethics Considerations Regarding Donors’ and Patients’ Consent
Book Chapter
Jeremy Sugarman
Brain Organoids in Research and Therapy, 10 July 2022; pp 121-130 [Springer]
Abstract
Informed consent is a crucial factor in determining whether particular uses of brain organoids for research and clinical translation are ethically acceptable. In the context of basic research, the consent of donors whose tissues are used to derive brain organoids is of primary concern, whereas in clinical translation the consent of both allogeneic donors and patients may be relevant. In this chapter, I examine key ethics considerations related to informed consent for brain organoid research and clinical translation. In order to do so, I first describe both a standard conceptual approach to informed consent that aims at meeting the ethical goal of respecting the autonomy of persons and some of the other ethically relevant functions of informed consent. This conceptual work provides a foundation for mapping ethics considerations related to informed consent in regard to the decision-making capacity and voluntariness of those being asked to consent, disclosure requirements associated with brain organoids in general and for particular proposed uses that involve morally significant aspects, threats to understanding that must be overcome, and considerations for authorization. Finally, I offer some suggestions for grappling with such informed consent challenges related to brain organoids.

The Scope of Consent
Joseph Millum
The Philosophical Quarterly, 2 July 2022
Extract
Suppose you come to my house and I invite you in. ‘I’m just heading out’, I say, ‘but make yourself at home’. I have consented to you remaining in my house, but what else? In your home, you put your feet up on the coffee table, so may you now do that in mine? If I complain that you’ve left crumbs from eating biscuits in my bed, can you defend yourself on the grounds that I told you to make yourself at home? These questions concern the scope of my consent. How we should ascertain the scope of someone’s consent is the topic of Tom Dougherty’s book. The book is divided into three main parts, each corresponding to a view about what fixes the scope of consent: the mental account, the successful communication account, and the evidential account, which Dougherty favours…

Informed Consent: A Monthly Review
_________________

July 2022

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_July 2022

Animal-informed consent: sled dog tours as asymmetric agential events
David A. Fennell
Tourism Management, December 2022; 93
Abstract
Standing in the way of a stronger voice for animals used in tourism is Cartesian and contractarian thinking on the part of operators and ontologically and epistemically constructed barriers by theorists. This paper pushes the animal ethics agenda forward by developing a novel, first-of-its-kind animal-informed consent framework in tourism under the assumption that sled dogs do, in fact, consent or deny consent through their emotions, preferences, behaviours, and physical state. The Five Domains model of animal welfare focused on the subjective experiences of animals is used to build the framework. The discussion culminates with a discussion on asymmetric agency, which speaks to the lack of balance between human and animal agents working in the same events.

Mapping consent practices for outpatient psychiatric use of ketamine
David S. Mathai, Scott M. Lee, Victoria Mora, Kelley C. O’Donnell, Albert Garcia-Romeu, Eric A. Storch
Journal of Affective Disorders, 1 September 2022; 312, pp 113-121
Abstract
Background
Given increasing community-based and off-label use of ketamine for psychiatric indications, we examined current informed consent processes from a convenience sample of outpatient ketamine clinics to identify areas of congruence with current evidence and opportunities for growth.
Methods
Using a rubric developed from existing practice guidelines, we conducted an exploratory analysis of informed consent documents (IC-Docs) from 23 American clinics offering ketamine as a psychiatric treatment. Domains assessed included clinical content, procedures, and syntax.
Results
Participating clinics (23/288) varied widely in their constitution, training, and services provided. We found that IC-Docs addressed a majority of consent elements, though did so variably on an item-level. Areas for improvement included communication around long-term adverse effects, treatment alternatives, medical/psychiatric evaluation prior to treatment, medical/psychological support during treatment, adjunctive psychological interventions, and subjective/dissociative-type effects. All forms were limited by poor readability.
Limitations
Our study was limited by convenience sampling along with possible underestimation of verbal consent processes.
Conclusions
As ketamine continues to emerge as a psychiatric intervention, both patients and providers will benefit from a deliberate consent process informed by scientific, ethical, and pragmatic factors toward the goal of shared decision-making regarding treatment.

Comparing shared decision making using a paper and digital consent process. A multi-site, single centre study in a trauma and orthopaedic department
Rory Dyke, Edward St-John, Hemina Shah, Joseph Walker, Dafydd Loughran, Raymond Anakwe, Dinesh Nathwani
The Surgeon, 11 June 2022
Abstract
Introduction
The importance of shared decision making (SDM) for informed consent has been emphasised in the updated regulatory guidelines. Errors of completion, legibility and omission have been associated with paper-based consent forms. We introduced a digital consent process and compared it against a paper-based process for quality and patient reported involvement in shared decision making.
Methods
223 patients were included in this multi-site, single centre study. Patient consent documentation was by either a paper consent form or the Concentric digital consent platform. Consent forms were assessed for errors of legibility, completion and accuracy of content. Core risks for 20 orthopaedic operations were pre-defined by a Delphi round of experts and forms analysed for omission of these risks. SDM was determined via the ‘collaboRATE Top Score’, a validated measure for gold-standard SDM.
Results
72% (n = 78/109) of paper consent forms contained ≥1 error compared to 0% (n = 0/114) of digital forms (P < 0.0001). Core risks were unintentionally omitted in 63% (n = 68/109) of paper-forms compared to less than 2% (n = 2/114) of digital consent forms (P < 0.0001). 72% (n = 82/114) of patients giving consent digitally reported gold-standard SDM compared to 28% (n = 31/109) with paper consent (P < 0.001).
Conclusion
Implementation of a digital consent process has been shown to reduce both error rate and the omission of core risks on consent forms whilst increasing the quality of SDM. This novel finding suggests that using digital consent can improve both the quality of informed consent and the patient experience of SDM.

Informed Consent: A Monthly Review
_________________

June 2022

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_June 2022