We include a spotlight section which highlights articles appearing in each edition which the editorial team has assessed to be strategically important and well aligned to our thematic focus areas of governance, ethics, policy and practice. The full citation/abstract for each spotlight item appears just below this summary.

In Exploring the Ethical and Moral Implications of Requiring Informed Consent to Determine Death by Neurologic Criteria Hibbs et al. discuss the role of consent in the declaration of brain death. While assessing and declaring brain death have been widely discussed, consent has been largely absent from this conversation to date.

In the article Explanation before Adoption: Supporting Informed Consent for Complex Machine Learning and IoT Health Platforms Eardley et al. write about explaining complex health technology platforms to non-technical audiences. A sufficiently comprehensive understanding of these systems is integral to gaining informed consent, and is becoming increasingly important with continuous technological integration in routine healthcare.

Jeyabalan et al. discuss consent for the use of drones in healthcare in their article To Obtain Informed Consent or Not to Obtain Informed Consent? Drones for Health Programs in the Grey Zone between Research and Public Health. In this article, the authors consider consent at both an individual and community level when using drones to map remote communities for health hazards, risks and safety concerns.

And finally, in Practical issues in pragmatic trials: the implementation of the Diuretic Comparison Project Ferguson et al. highlight the work of the US Department of Veterans Affairs Point of Care Clinical Trial Program. This study had a large patient population and worked to customize procedures to align with local clinical practice.

Exploring the Ethical and Moral Implications of Requiring Informed Consent to Determine Death by Neurologic Criteria
Matthew J. Hibbs, Morgan C. Arnold, Mark S. Beveridge
Journal of Pain and Symptom Management, May 2023; 65(5)
Abstract
Background
The American Academy of Pediatrics published guidelines in 1987 providing criteria for the declaration of brain death for children. Multiple societies, including neurology and critical care, renewed these guidelines in 2011 to further standardize the brain-death exam. Despite clear guidelines, laws regarding brain death vary among states, including whether consent is required to perform neurologic testing.
Objective
To examine the role of parental consent in brain-death testing from an ethicolegal perspective as well as its potential to create clinician distress.
Design/Method
Case report
Results
Patient is a 3-year-old, previously healthy male who suffered a tragic submersion injury requiring prolonged cardiopulmonary resuscitation. During the subsequent hospitalization, his clinical exam, head CT scan, and electroencephalogram demonstrated devastating, irreversible neurologic injury concerning for brain death. The family refused formal brain-death testing, instead requesting more time to allow for a miraculous recovery. The patient remains on life support after 5 weeks and is beginning to experience multiorgan dysfunction.
Discussion
Many physicians feel that brain-death testing should not require parental consent. Despite this, states vary in their requirements for parental consent for brain-death testing. When legally permissible, there are competing ethical principles governing a family’s request to delay or refuse brain-death testing.The principle of informed consent reflects the culture change from a paternalistic physician-patient relationship to a collaborative, family-centered approach. However, the argument remains that brain-death testing offers no therapeutic benefit and has the potential to cause harm via apnea testing, thereby requiring informed consent. This case presentation will illustrate the varied legal landscape surrounding pediatric brain-death testing, the ethical principles involved, and the moral injury that can result.

Explanation before Adoption: Supporting Informed Consent for Complex Machine Learning and IoT Health Platforms
Research Article
Rachel Eardley, Emma L. Tonkin, Ewan Soubutts, Amid Ayobi, Gregory J. L. Tourte, Rachael Gooberman-Hill, Ian Craddock, Aisling Ann O’Kane
Association for Computing Machinery: Human-Computer Interaction, 16 April 2023
Open Access
Abstract
Explaining health technology platforms to non-technical members of the public is an important part of the process of informed consent. Complex technology platforms that deal with safety-critical areas are particularly challenging, often operating within private domains (e.g. health services within the home) and used by individuals with various understandings of hardware, software, and algorithmic design. Through two studies, the first an interview and the second an observational study, we questioned how experts (e.g. those who designed, built, and installed a technology platform) supported provision of informed consent by participants. We identify a wide range of tools, techniques, and adaptations used by experts to explain the complex SPHERE sensor-based home health platform, provide implications for the design of tools to aid explanations, suggest opportunities for interactive explanations, present the range of information needed, and indicate future research possibilities in communicating technology platforms.

To Obtain Informed Consent or Not to Obtain Informed Consent? Drones for Health Programs in the Grey Zone between Research and Public Health
Vyshnave Jeyabalan, Lorie Donelle, Patrick Meier, Elysée Nouvet
Drones 2023, 2 April 2023; 7(4)
Abstract
Drones are increasingly being introduced to support healthcare delivery around the world. Most Drones for Health projects are currently in the pilot phase, where frontline staff are testing the feasibility of implementing drones into their healthcare system. Many of these projects are happening in remote localities where populations have been historically under-served within national healthcare systems. Currently, there exists limited drone-specific guidance on best practices for engaging individuals in decision-making about drone use in their communities. Towards supporting the development of such guidance, this paper focuses on the issue of obtaining community and individual consent for implementing Drones for Health projects. This paper is based on original qualitative research involving semi-structured interviews (N = 16) with program managers and implementation staff hired to work on health-related projects using drone technologies. In this paper, we introduce a scenario described by one participant to highlight the ethical and practical challenges associated with the implementation and use of drones for health-related purposes. We explore the ethical and practical complexities of obtaining informed consent from individuals who reside in communities where Drones for Health projects are implemented.

Practical issues in pragmatic trials: the implementation of the Diuretic Comparison Project
Research Article
Ryan E Ferguson, Sarah M Leatherman, Patricia Woods, Cynthia Hau, Robert Lew, William C Cushman, Mary T Brophy, Louis Fiore, Areef Ishani
Society for Clinical Trials, 29 March 2023
Abstract
Background/Aims
The US Department of Veterans Affairs Point of Care Clinical Trial Program conducts studies that utilize informatics infrastructure to integrate clinical trial protocols into routine care delivery. The Diuretic Comparison Project compared hydrochlorothiazide to chlorthalidone in reduction of major cardiovascular events in subjects with hypertension. Here we describe the cultural, technical, regulatory, and logistical challenges and solutions that enabled successful implementation of this large pragmatic comparative effectiveness Point of Care clinical trial.
Methods
Patients were recruited from 72 Veterans Affairs Healthcare Systems using centralized processes for subject identification, obtaining informed consent, data collection, safety monitoring, site communication, and endpoint identification with minimal perturbation of the local clinical care ecosystem. Patients continued to be managed exclusively by their clinical care providers without protocol specified study visits, treatment recommendations, or data collection extraneous to routine care. Centralized study processes were operationalized through the application layer of the electronic health record via a data coordinating center staffed by clinical nurses, data scientists, and statisticians without site-based research coordinators. Study data was collected from the Veterans Affairs electronic health record supplemented by Medicare and National Death Index data.
Results
The study exceeded its enrolled goal (13,523 subjects) and followed subjects for the 5-year study duration. The key determinant of program success was collaboration between researchers, regulators, clinicians, and administrative staff at the site level to customize study procedures to align with local clinical practice. This flexibility was enabled by designation of the study as minimal risk and determination that clinical care providers were not engaged in research by the Veterans Affairs Central Institutional Review Board. Cultural, regulatory, technical, and logistical problems were identified and solved through iterative collaboration between clinical and research entities. Paramount among these problems was customization of the Veterans Affairs electronic health record and data systems to accommodate study procedures.
Conclusions
Leveraging clinical care for large-scale clinical trials is feasible but requires a rethinking of traditional clinical trial design (and regulation) to better meet requirements of clinical care ecosystems. Study designs must accommodate site-specific practice variation to reduce the impact on clinical care. A tradeoff thus exists between designing trial processes tailored to expedite local study implementation versus those to produce a more refined response to the research question. The availability of a uniform and flexible electronic health record in the Department of Veterans Affairs played a major role in the success of the trial. Conducting Point of Care research in other healthcare systems without such research-friendly infrastructure presents a more formidable challenge.

Consent in Surrogacy – Free or Manufactured?
Ms. Soumya Verma
Indian Journal of Ethics, Logic and Philosophy, 21 April 2023
Abstract
Consent has an important role to play in the ethical domain, and the method by which consent is obtained should also be taken into consideration. It should not be taken by coercion, violence, or force. Surrogacy, a highly debatable topic in the domain of applied ethics whose legitimacy is significantly affected by consent, given by the surrogate mothers, which can change the different moral considerations and ethical claims. The contemporary debate on the issue of surrogacy seems to be between traditionalists and liberals, but this paper will take the debate further. In this paper, we shall try to problematize the liberal conception, which looks at the consent given by women in surrogacy limited to its face value, i.e., they limit consent to their saying “yes” because they have reproductive rights over their own bodies. This paper will further argue that consent in surrogacy should not be limited to its face value as taken by liberals, as it is not an ideal society, situations are different for different women, and there could be different social realities that constitute the factors behind that consent. Financial constraint, an important social reality, will be the focus of this paper, which leads a woman to give consent for surrogacy arrangements.

Consent as an act of commitment
Robert E. Goodin
European Journal of Philosophy, 16 April 2023
Abstract
Some say that consent is essentially just a state of mind. Others say it is essentially just a communication. Many say it is both. I say it is neither. Instead it is an act, or rather a pair of acts—an internal mental act in the first instance, an external performative act in the second. Each of those acts is an act of commitment, intrapersonally in the first case and interpersonally in the second. The content of the commitment is, familiarly enough, to give permission to someone else to do something that it would be wrong for them to do without your permission. The novelty lies in seeing consent as an act of commitment in those two dimensions and in seeing those as commitments that persist until and unless undone by an act of a similar sort.

Informed Consent: A Monthly Review
_________________

April 2023 :: Issue 52

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_April 2023

Trustworthiness as information: Satisfying the understanding condition of valid consent
Martin RK
Bioethics, 21 March 2023
Abstract
Within medical ethics, there is widespread agreement that morally valid consent includes an understanding condition. Disagreement centers on what is meant by that understanding condition. Tom Dougherty proposed that this understanding condition should be divided into the two mutually exclusive categories of descriptive information and contextual information. Further, Dougherty argues that each type of information is necessary to satisfy the understanding condition. In contrast, I argue that when the deontic aspect of valid consent is in view, each type of information can be sufficient to satisfy the understanding condition on its own. Moreover, by analyzing delegation, which is conceptually related to consent since both are morally transformative actions, I show that delegation often depends not on descriptive or contextual information but on trust. So, I argue that trustworthiness can also be a type of information that does the same work as descriptive and contextual information in satisfying the understanding condition for valid consent.

Editor’s note: The referenced article by Tom Do can be found here.

Consent and Trust in the Doctor Patient Relationship
Book Chapter
Philipp Bonhoeffer, Federico Festa, Lamia Ait Ali, Pierluigi Festa
The Patient as a Person, 21 March 2023 [Springer]
Abstract
Trust, defined as an assured reliance on the character, ability, strength, or truth of someone or something is an immensely precious subject matter in medicine. However, the historical doctor/patient relationship based on trust alone has shown important shortcomings. Consequently, the medical consent developed for the interest and legal protection of patients. This in turn led to a vulnerability of doctors who then needed to defend themselves whenever litigation occurred. As a result, the formal medical consent has rapidly shifted in its application as a protection to health professionals, far removed from its original purpose. Vigilance and trust need to be carefully balanced. After educating patients for years to be vigilant about wrong doings of doctors, patients have lost the clear benefit and comfort that trust brings in a good patient–doctor relationship. It is known that trust plays a major role in the healing process. Trust, therefore is a good thing and there is no reason why the positive effect of trust should be neglected in classical medicine.

Misconceptions about the Doctrine of Informed Consent in the Medical Profession
Kelvin Christie, Maurice A. Dean, Isiah Lyma
Research Developments in Medicine and Medical Science, 4 March 2023; pp 136-157
Abstract
This article focuses on common misunderstandings in healthcare regarding how physicians and medical researchers apply the doctrine of informed consent. The specific myth addressed has to do with the level of care expected of medical professionals when treating patients. This paper also explains how the legal history of informed consent has led to misconceptions about informed consent as applied to both medical researchers and medical physicians. There has long been a public misconception that medical researchers are subject to a lower standard of care than medical doctors in cases involving informed consent. We argue that this misconception is largely attributed to the fact that statutes, ethical regulations, guidelines, and legal precedents within the medical and research profession are governed by two separate bodies of laws and regulatory guidelines. Furthermore, informed consent in the medical setting has traditionally been enacted primarily from case law, while informed consent in the research setting has primarily been enacted from statutory law and regulations.

Informed Consent: A Monthly Review
_________________

March 2023 :: Issue 51

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_March 2023

Assent in applied behaviour analysis and positive behaviour support: ethical considerations and practical recommendations
Discussion papers
Cassi A. Breaux, Kristin Smith
International Journal of Developmental Disabilities, 1 February 2023; pp 111-121
Abstract
The term positive behaviour support (PBS) is used to describe the integration of the contemporary ideology of disability service provision with the clinical framework of applied behaviour analysis (ABA). Assent, the participation consent of those not legally able to consent, has gained recent popularity in the fields of ABA and PBS. The goal of assent-based ABA and PBS is a person-centered approach to assessment, intervention, and all other decision-making. In this model, the learner’s assent withdrawal for participation is honored, whether it be a vocal ‘no’ or a non-vocal expression of verbal behaviour. There is currently a limited subset of studies that mention or utilize assent with learners in ABA or PBS. The lack of published research can make assent-based practices seem to be a choice of the practitioner. The authors of this manuscript seek to further define assent, illuminate the necessity of assent-based practices, and offer assent-based procedures in ABA- and PBS-based intervention.