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.
Center for Informed Consent Integrity 