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
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.
Piloting a tool for informed consent comprehension in a cardiovascular clinical trial in South Africa: An IMPI-2 pilot trial substudy (ICC Study)
Piloting a tool for informed consent comprehension in a cardiovascular clinical trial in South Africa: An IMPI-2 pilot trial substudy (ICC Study)
G C Isiguzo, M A Familusi, K Sliwa, L Thabane, M Ntsekhe, B M Mayosi, J de Vries
South African Medical Journal, 12 April 2023
Abstract
Background
Informed consent is a key requirement in research. However, the comprehension of information presented is rarely evaluated prior to or during the research. Ensuring that participants understand the key issues in trials is important, not just for ethical reasons, but also because it can help set patient expectations. We evaluated the feasibility of using the University of California Brief Assessment of Capacity to Consent (UBACC) questionnaire to guide informed consent comprehension in the pilot study for the second Investigation of the Management of Pericarditis in Africa (IMPI-2) trial. IMPI-2 is a randomised controlled trial (RCT) on the use of alteplase-facilitated pericardial drainage, compared with routine care among patients with large pericardial effusion. We used an abbreviated version of the UBACC to evaluate participant comprehension of key elements of the consent documentation and to guide discussions.
Method
Comprehension was assessed using a 10-item UBACC at baseline, 6 weeks, 3 months and 6 months follow-up to reiterate the information about the trial. Each response was scored from 0 to 3 and the sum at each visit was recorded to represent comprehension. A UBACC score ≥25 was considered adequate comprehension. Bivariate logistic regression was performed to evaluate comprehension over time. A multivariate analysis was conducted to identify predictors of UBACC score.
Results
The Informed Consent Comprehension (ICC) Study included 71 participants with a median age of 42 years; 45% were females and 49% had at least a secondary level of education. Level of comprehension improved with time; the odds of passing the evaluation at baseline compared with 6 months was higher (odds ratio (OR) 1.39, 95% confidence interval (CI) 1.17 – 1.65, p<0.001). Not using interpreters and having a secondary level of education were associated with higher comprehension. Despite knowing that they were participating in research, many participants still did not accept that the trial drug may have no effect.
Conclusion
It is feasible to use the UBACC questionnaire for informed consent comprehension evaluation in RCTs. Repeated learning during follow-up improves comprehension over time, while a low level of education and use of interpreters reduces comprehension.
“Ethics Ready”? Governing Research Through Informed Consent Procedures
“Ethics Ready”? Governing Research Through Informed Consent Procedures
Florence Caeymaex, Carole Wenger, Felicien de Heusch, Jean-Michel Lafleur
International Journal of Qualitative Methods, 11 April 2023
Open Access
Abstract
Social Scientists using ethnographic methods are increasingly confronted with ethical clearance procedures imposed by universities, national authorities, professional organizations and funders. In this article, we focus on informed consent procedures in particular and discuss how they govern fieldwork interactions. To do so, we first show how ethical clearance procedures in Europe have been influenced by biomedical science, creating a risk of “governing the social science research in the name of ethics” (Haggerty, 2004) through “anticipatory regulatory regimes” (Murphy and Dingwall, 2007). We subsequently discuss the implementation of ethical procedures negotiated with an ethical review panel in the framework of an EU-funded project in migration studies. In doing so, we show how Research Ethics Committees (RECs) can incentivize researchers to comply with ethical guidelines and procedures in order to be considered as “ethics ready” by the funder. Providing examples of different ethnographic situations, we argue that —while informed consent procedures might reinforce participants’ vulnerabilities— they can also activate their desire to assert power. The article concludes with three recommendations that call for a redefinition of the relationships between institutions, researchers and participants through a co-construction of research ethics.
Privacy for IoT: Informed consent management in Smart Buildings
Privacy for IoT: Informed consent management in Smart Buildings
Chehara Pathmabandu, John Grundy, Mohan Baruwal Chhetri, Zubair Baig
Future Generation Computer Systems, August 2023; 145 pp 367-383
Abstract
Smart Buildings (SBs) employ the latest IoT technologies to automate building operations and services with the objective of increasing operational efficiency, maximising occupant comfort, and minimising environmental impact. However, these smart devices – mostly cloud-based – can capture and share a variety of sensitive and private data about the occupants, exposing them to various privacy threats. Given the non-intrusive nature of these devices, individuals typically have little or no awareness of the data being collected about them. Even if they do and claim to care about their privacy, they fail to take the necessary steps to safeguard it due to the convenience offered by the IoT devices. This discrepancy between user attitude and actual behaviour is known as the ‘privacy paradox’. To address this tension between data privacy, consent and convenience, this paper proposes a novel solution for informed consent management in shared smart spaces. Our proposed Informed Consent Management Engine (ICME) (a) increases user awareness about the data being collected by the IoT devices in the SB environment, (b) provides fine-grained visibility into privacy conformance and compliance by these devices, and (c) enables informed and confident privacy decision-making, through digital nudging. This study provides a reference architecture for ICME that can be used to implement diverse end-user consent management solutions for smart buildings. A proof-of-concept prototype is also implemented to demonstrate how ICME works in a shared smart workplace. Our proposed solution is validated by conducting expert interviews with 15 highly experienced industry professionals and academic researchers to understand the strengths, limitations, and potential improvements of the proposed system.
Assent and vulnerability in patients who lack capacity
Assent and vulnerability in patients who lack capacity
Commentary
Christopher A Riddle
Journal of Medical Ethics, 17 April 2023
Excerpt
Smajdor’s Reification and Assent in Research Involving Those Who lack Capacity claims, among other things, that ‘adults who cannot give informed consent may nevertheless have the ability to assent and dissent, and that these capacities are morally important in the context of research’. More pointedly, she suggests we can rely upon Gillick competence, or that ‘it is worth thinking about why the same trajectory [as children] has not been evident in the context of [adults with impairments of capacity to give informed consent (AWIC)]’. I argue that her likening assent in AWIC to assent in children is problematic for at least two related reasons. First, direct comparisons between AWIC and children run the risk of perpetuating or reinforcing infantilising stereotypes against people with disabilities. Second, I argue that people with disabilities are vulnerable in ways that most children are not, and thus, are dissimilar in a morally relevant manner…
Editor’s note: The article which is referenced in this commentary was featured in the February edition of this digest.
Autonomy of Individuals with Alcohol-Related Disorders: Informed Consent and Empowerment
Autonomy of Individuals with Alcohol-Related Disorders: Informed Consent and Empowerment
João Paulo Barbosa Azevedo
Journal of Addiction & Addictive Disorders, 12 April 2023
Abstract
Informed consent is a central concern in the care practice of individuals with alcohol- related disorders, with research and clinical practice indicating that they often refuse or abandon treatment early. In the relational care encounter it is important not only to recognize the patient as the subject of will and decision-making power, but also to pay attention to the experiences of vulnerability and the importance of promoting autonomy. These issues are particularly relevant when individuals with alcohol-use disorders come to treatment suffering from coercion or disturbed by anxiety and/or depression. A study on informed consent ethical practice was conducted on a sample of 85 professionals from the Addictive Behaviours and Dependencies network of the Regional Health Administration of the North, Portugal. A questionnaire was used to survey ethical attitudes. The results suggest the importance of reinforcing the practice of informed consent of individuals with alcohol-related disorders suffering from coercion, anxiety or depression as a place of a psychological empowerment process.
Informed consent with people judged incapable of legally consenting
Informed consent with people judged incapable of legally consenting
Amy Bittick, Ryan Holliman
Advances in Mental Health and Intellectual Disabilities, 6 April 2023
Abstract
Purpose
The purpose of this study is to consider informed consent with those who may be legally judged incapable of consent. Frequently individuals with traumatic brain injuries and intellectual disabilities may fall into this category. This paper seeks to consider aspects of guardianship, moral and legal implications and best practices for mental health professionals.
Design/methodology/approach
This practice piece reviews literature regarding informed consent, as well as pertinent issues in the professional literature regarding types of guardianship as well as the occurrence of “Lucid intervals.” Furthermore, literature from moral philosophy and current legal research was examined to fully provide readers with a grasp of the legal and ethical landscape of this issue.
Findings
The paper finds that treating consent as a one-time binary event is lacking in both practicality and nuance. Moral philosophy and issues regarding paternalism are raised, as well as practice approaches to assessment of capability and how to engage in therapy in meaningful ways.
Originality/value
This paper provides insight into providing dignity-affirming therapy with a population that is often not considered in the literature of mental health ethics. When it is considered, the suggestions are so vague as to be of limited use. This manuscript provides nuance and practical applications to be a therapist that promotes dignity in those who might have varying levels of capacity to consent.
The Role of Different Aspects of Communication Behavior in the Assessment of Capacity to Consent
The Role of Different Aspects of Communication Behavior in the Assessment of Capacity to Consent
Luise Badenhoop, Stefanie Baisch, Susanne Penger, Julia Haberstroh
Journal of Gerontopsychology and Geriatric Psychiatry, 5 April 2023
Open Access
Abstract
Any medical treatment that interferes with physical integrity requires the informed consent of a patient capable of such consent. For people with dementia, the capacity to consent is questioned even in the early course of the disease. Particularly diagnostic instruments like the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) often deny people with dementia the capacity to consent because of high confounding of the results with patients’ verbal abilities. To date, it remains unclear whether not only verbal but also nonverbal communication is associated with assessments of capacity to consent. The current study investigates associations between patients’ verbal and nonverbal communication behaviors as assessed by the measure for Communication Behavior in People with Dementia in Ambulant Settings (CODEMamb) and capacity to consent as assessed by the MacCAT-T. We expected the strongest positive associations for verbal communication behaviors compared to nonverbal communication behaviors. Data of N = 43 patients with dementia (n = 8 capable of consent) were collected at two different German psychiatric clinics. The results show small to moderate correlations between the overall scores of CODEMamb and MacCAT-T. As expected, correlations were strongest for the verbal CODEMamb subscale. The results support current findings on the dependency of the MacCAT-T on verbal communication. Based on the findings, the discussion addresses how people with dementia can be enabled to make self-determined medical treatment decisions.
Informed Consent, Assent, and Confidentiality
Informed Consent, Assent, and Confidentiality
Book Chapter
Eron Linver
Caring for the Hospitalized Child, May 2023 [American Academy of Pediatrics]
Excerpt
Informed consent is defined as the voluntary agreement of an individual or their authorized representative who has the legal authority to give such agreement. This consent must be exercised within the context of free choice, without any application of inducement or coercion. To give informed consent, an individual must have sufficient knowledge and understanding to be able to make a knowledgeable decision. Health care providers may have a different level of education and understanding than patients and their guardians. This knowledge gap can add complexity and potential misunderstandings to conversations surrounding informed consent…
Center for Informed Consent Integrity 