Informed Consent: A Monthly Review
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March 2025 :: Issue 75

In preparing this digest, we monitor a broad range of academic journals and utilize Google Scholar to search articles referencing  informed consent or assent. After careful consideration, a selection of these results appear in the digest. We also monitor other research, analysis, guidance and commentary beyond the academic literature globally, including calls for public consultation and symposia/conferences which address consent/assent in whole or in part. We recognize that some of the arguments presented in this edition may be controversial and may warrant closer scrutiny. We have elected to be generous in our inclusion with the goal of presentating of a wholistic landscape of informed consent literature as it is being published. 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: Center for Informed Consent Integrity – A Monthly Review_March 2025

EXPRESS: Beyond Opt-Out: How Presumed-Consent Language Shapes Persuasion
Research article
Romain Cadario, Jenny Zimmermann, Bram Van den Bergh
Journal of Marketing, 16 February 2025
Abstract
When using opt-out (vs. opt-in) policies, choice architects presume that people consent, rather than explicitly asking them to state their consent. While opt-out policies often increase compliance, they are also associated with managerial issues such as ethical considerations, legal regulations, limited public support, and increased no-show rates. This research demonstrates that choice architects can also establish presumed-consent through the language they use, holding the opt-in policy constant. Seven studies in various health domains indicate that presumed-consent language (e.g., “a vaccine was arranged for you”) rather than explicit-consent language (e.g., “you can choose to get a vaccine”) increases persuasion (i.e., behavioral intentions, actual behaviors). This effect occurs through perceived endorsement: Decision makers infer through the presumed-consent language that the desired health behavior (e.g., vaccination) is the recommended course of action. Furthermore, this research examines the proposed endorsement process under various conditions. When product tangibility is low (e.g., a flu shot), the effectiveness of presumed-consent language stems primarily from perceived endorsement rather than psychological ownership or perceived ease. In contrast, when product tangibility is high (e.g., a sunscreen lotion), the effect stems primarily from psychological ownership rather than perceived endorsement or perceived ease.

Informed Consent, Autonomy, False Beliefs, and Ignorance
James Stacey Taylor
Social Philosophy and Policy, 6 February 2025
Abstract
It is widely believed that health policy should take care to ensure that persons are informed about the expected risks as well as the anticipated advantages of medical procedures. This is often justified by a concern for the moral value of personal autonomy, as it is widely believed that to the extent that a person makes decisions on the basis of false beliefs or ignorance her autonomy with respect to them is compromised. This essay argues against this widespread claim. A person’s autonomy with respect to her decisions will not be compromised by either ignorance or false beliefs. However, it does not follow that there is no reason to provide persons with the opportunity to have access to the available information relevant to their decisions concerning their medical treatment. The epistemic requirements for a person to give her consent to her treatment are more stringent than those that must be met for her to be autonomous with respect to her consent. Consent, not autonomy, can be undermined by ignorance or false belief. It is a concern for consent, not a concern for autonomy, that justifies providing people with information about their prospective medical procedures.

Pragmatic Clinical Research, Informed Consent, and Clinical Equipoise
Lynn A. Jansen
Social Philosophy and Policy, 6 February 2025
Abstract
There is a growing movement within contemporary medical ethics to blur the boundaries between clinical medicine and clinical research. Some writers now argue that the research-practice distinction is outdated and the importance of distinguishing between research and medicine is no longer as pressing as it once was or seemed to be. Instead, we are now urged to view the health-care system as a dynamic “learning health-care system” in which research components are embedded within standard clinical care. This essay defends the ethical significance of the research-practice distinction while acknowledging the reality and usefulness of integrated health care. A key claim that this essay advances is that the principle of clinical equipoise, which has largely been rejected by research ethicists, can be reinterpreted and repurposed to help distinguish medical practices that call for more demanding forms of informed consent from those that do not.

Informed Consent: A Monthly Review
_________________

February 2025 :: Issue 74

In preparing this digest, we monitor a broad range of academic journals and utilize Google Scholar to search articles referencing  informed consent or assent. After careful consideration, a selection of these results appear in the digest. We also monitor other research, analysis, guidance and commentary beyond the academic literature globally, including calls for public consultation and symposia/conferences which address consent/assent in whole or in part. We recognize that some of the arguments presented in this edition may be controversial and may warrant closer scrutiny. We have elected to be generous in our inclusion with the goal of presentating of a wholistic landscape of informed consent literature as it is being published. 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: Center for Informed Consent Integrity – A Monthly Review_February 2025

Social Media, Informed Consent, and the Harm Principle
Charles Foster
Philosophies, 11 January 2025
Open Access
Abstract
This article examines whether social media users can validly consent to their own use of social media. It argues that, whether or not social media use is analogous to public health interventions, there is an obligation to provide users with information about risks and benefits, and absent that provision, there is no valid consent. Many or most users, in any event, do not have the capacity to consent, according to the criteria for capacity articulated in the ‘four abilities’ model: the ability to express a choice, the ability to understand the facts pertinent to the decision in question, the ability of a subject to believe that the information applies to them, and the ability to reason—in the sense of being able to consider and weigh (with reference to the patient’s own concerns, circumstances, and values) the main possible outcomes of the decision to opt for the intervention and the decision to opt not to undergo it. Even if an individual social media user is capacitous according to these criteria, many will fail to be judged capacitous if (as it is argued should be the case), a further criterion, identified by Jennifer Hawkins must be satisfied, namely that the individual can look after their own interests at least as well as most other people can. It follows from this consideration that not only can regulation of social media (in the form of a ban) be justified under Mill’s harm principle, but that non-regulation cannot be justified.

“Knowledge was clearly associated with education” epistemic positioning in the context of informed choice: a scoping review and secondary qualitative analysis
Research
Niamh Ireland-Blake, Fiona Cram, Kevin Dew, Sondra Bacharach, Jeanne Snelling, Peter Stone, Christina Buchanan, Sara Filoche
BMC Medical Ethics, 9 January 2025
Open Access
Abstract
Background
Being able to measure informed choice represents a mechanism for service evaluation to monitor whether informed choice is achieved in practice. Approaches to measuring informed choice to date have been based in the biomedical hegemony. Overlooked is the effect of epistemic positioning, that is, how people are positioned as credible knowers in relation to knowledge tested as being relevant for informed choice.
Aims
To identify and describe studies that have measured informed choice in the context of prenatal screening and to describe epistemic positioning of pregnant people in these studies.
Methods
Online databases to identify papers published from 2005 to 2021. The PRISMA-ScR checklist guided data collection, analysis and reporting. Secondary analysis that considered hermeneutics (e.g., knowledge that was tested, study design) and testimony (e.g., population descriptors) developed a priori.
Findings
Twenty-nine studies explored the measurement of informed choice. None reported that pregnant people were involved in the design of the study. Two studies reported pregnant people had some involvement in the design of the measurement. Knowledge tested for informed choice included technical aspects of screening, conditions screened and mathematical concepts. Twenty-seven studies attributed informed choice to population descriptors (e.g., race/ethnicity, age, education). Population descriptors were reified as characteristics of epistemic credibility for informed choice obtained. For example, when compared to a high school qualification, a tertiary qualification was a statistically significant characteristic of informed choice. When compared by race, white people were found to be significantly more likely to make an informed choice. Additional demographic descriptors such as age, language spoken, faith and previous pregnancies were used to further explain differences for informed choice obtained. Explanations about underlying assumptions of population descriptors were infrequent.
Conclusion
Using population descriptors in the biomedical hegemony as explanatory variables for informed choice can position (groups of) people as more, or less, epistemically credible. Such positioning could perpetuate epistemic injustices in practice leading to inequitable access to healthcare. To better uphold (pregnant) people as credible knowers population descriptors should instead be contextual (and contextualising) variables. For example, as indicators of social privilege. Further, making room for ways of knowing that go beyond the biomedical hegemony requires the development of epistemically just ‘measures’ through intentional, inclusive design.

Informed Consent: A Monthly Review
_________________

January 2025 :: Issue 73

In preparing this digest, we monitor a broad range of academic journals and utilize Google Scholar to search articles referencing  informed consent or assent. After careful consideration, a selection of these results appear in the digest. We also monitor other research, analysis, guidance and commentary beyond the academic literature globally, including calls for public consultation and symposia/conferences which address consent/assent in whole or in part. We recognize that some of the arguments presented in this edition may be controversial and may warrant closer scrutiny. We have elected to be generous in our inclusion with the goal of presentating of a wholistic landscape of informed consent literature as it is being published. 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: Center for Informed Consent Integrity – A Monthly Review_January 2025

Consent under Duress
Book
Tom Dougherty
Oxford Academic, 31 December 2024
Abstract
Consent can make actions morally permissible. But consent can lose its moral force when it is given under duress. Understanding how this happens requires answering the question of which types of duress undermine consent. Uncontroversially, severe coercion, like threats of violence, can prevent consent from creating moral permissions. But what about minor duress? Duress from natural causes? Duress from social norms? Duress that is merely apparent to the consent-giver with no objective basis in reality? To answer these questions, Consent under Duress defends an account that follows two key approaches. First, it adopts an expansive approach that broadens the class of misconduct that is constituted by acting on someone’s consent that is given under duress. Second, it adopts a scalar approach that allows that consent can be invalidated to varying degrees, which in turn can track the degrees of the severity of the duress to which the consent-giver is subject. The expansive and scalar approaches work in tandem. Once there is an expansion of the aforementioned class of misconduct, additional theoretical resources are needed to draw moral distinctions within this heterogeneous class. By providing these resources, the scalar approach supplements the expansive approach. Meanwhile, once it is recognized that consent can be partially invalidated by minor duress, it is necessary to expand the class of what constitutes misconduct that is constituted by acting on someone’s consent that is given under duress. By arguing independently for these mutually reinforcing approaches, Consent Under Duress offers a robust defense of their combination.