Monitoring Mental Health: Legal and Ethical Considerations of Using Artificial Intelligence in Psychiatric Wards
Barry Solaiman, Abeer Malik, Suhaila Ghuloum
American Journal Of Law & Medicine, 12 February 2024
Abstract
Artificial intelligence (AI) is being tested and deployed in major hospitals to monitor patients, leading to improved health outcomes, lower costs, and time savings. This uptake is in its infancy, with new applications being considered. In this Article, the challenges of deploying AI in mental health wards are examined by reference to AI surveillance systems, suicide prediction and hospital administration. The examination highlights risks surrounding patient privacy, informed consent, and data considerations. Overall, these risks indicate that AI should only be used in a psychiatric ward after careful deliberation, caution, and ongoing reappraisal.
Month: April 2024
From opt-out to opt-in consent for secondary use of medical data and residual biomaterial: An evaluation using the RE-AIM framework
From opt-out to opt-in consent for secondary use of medical data and residual biomaterial: An evaluation using the RE-AIM framework
Research Article
Jennifer E. Lutomski, Peggy Manders
PLOS One, 28 March 2024
Open Access
Abstract
Background
Patient records, imaging, and residual biomaterial from clinical procedures are crucial resources for medical research. In the Netherlands, consent for secondary research has historically relied on opt-out consent. For ethical-legal experts who purport passive consent undermines patient autonomy, opt-in consent (wherein affirmative action is required) is seen as the preferred standard. To date, there is little empirical research exploring patient feasibility, organizational consequences, and the potential risks for research based on secondary data. Thus, we applied the RE-AIM framework to evaluate the impact of migrating from an opt-out to an opt-in consent process.
Methods
This evaluation was carried out in Radboud University Medical Center, a large tertiary hospital located in the southeast of the Netherlands. All non-acute, mentally competent patients ≥16 years of age registered between January 13, 2020 and June 30, 2023 were targeted (N = 101,437). In line with the RE-AIM framework, individual and organizational consequences were evaluated across five domains: reach, efficacy, adoption, implementation, and maintenance.
Results
101,437 eligible patients were approached of whom 66,214 (65.3%) consented, 8,059 (7.9%) refused consent and 27,164 (26.8%) had no response. Of the 74,273 patients with a response, 89.1% consented to secondary use. The migration to an opt-in consent system was modestly successful; yet notably, differential response patterns by key sociodemographic characteristics were observed. Adaptions to the process flow improved its effectiveness and resulted in a reasonable response over time. Implementation was most affected by budgetary restraints, thus impeding the iterative approach which could have further improved domain outcomes.
Conclusion
This evaluation provides an overview of logistical and pragmatic issues encountered when migrating from opt-out to opt-in consent. Response bias remains a major concern. Though not always directly transferable, these lessons can be broadly used to inform other health care organizations of the potential advantages and pitfalls of an opt-in consent system.
GDPR Requirements for Biobanking Activities Across Europe
GDPR Requirements for Biobanking Activities Across Europe
Book
Valentina Colcelli, Roberto Cippitani, Christoph Brochhausen-Delius, Rainer Arnold
Springer, 2023
About this book
The book deals with the effective operation of the rules related to biomedical research and pays attention to the activities of the national legislatures of the 27 Member States in the field of scientific research. This multilevel system has an impact on biobanking activity. The book answers questions realized by operators on the main biobanks around the EU in the field of GDPR. The authors and editors used the questions born from brainstorming among members of the Association European, Middle East & Africa for Biopreservation and Biobanking (ESBB) to offer to the operators in biobanking activity and researchers quickly answer to their daily questions, but with authors highest quality. Further the book provides a comprehensive review of the rapidly expanding field of biobanking. It provides researchers and scholars working on biobanking and bio-sharing and more in general in the university hospitals and clinical trial consortiums, and companies, biomedical researchers, but also jurists and the professionals (in particular judges, lawyers, officers) an instrument rigorous but easy to use of the GDPR in the case of biobanking activities. The book identifies a methodological path to tackle the legal or ethical problem on a specific scientific-technological to verify existing solutions and give ideas for future applications. The importance of the legal solution influences the implementation of the development of the biobanking activity service itself.
Improving Patient Information and Enhanced Consent in Urology: The Impact of Simulation and Multimedia Tools. A Systematic Literature Review from the European Association of Urology Patient Office
Improving Patient Information and Enhanced Consent in Urology: The Impact of Simulation and Multimedia Tools. A Systematic Literature Review from the European Association of Urology Patient Office
Review – Education
Carlotta Nedbal, Patrick Juliebø-Jones, Eamonn Rogers, James N’Dow, Maria Ribal, Jens Rassweiler, Evangelos Liatsikos, Hein Van Poppel, Bhaskar
European Urology, 25 April 2024
Abstract
Background and objective
Discussions surrounding urological diagnoses and planned procedures can be challenging, and patients might experience difficulty in understanding the medical language, even when shown radiological imaging or drawings. With the introduction of virtual reality and simulation, informed consent could be enhanced by audiovisual content and interactive platforms. Our aim was to assess the role of enhanced consent in the field of urology.
Methods
A systematic review of the literature was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, using informed consent, simulation, and virtual reality in urology as the search terms. All original articles were screened.
Key findings and limitations
Thirteen original studies were included in the review. The overall quality of these studies was deemed good according to the Newcastle-Ottawa Scale. The studies analysed the application of different modalities for enhanced consent: 3D printed or digital models, audio visual multimedia contents, virtual simulation of procedures and interactive navigable apps. Published studies agreed upon a significantly improved effect on patient understanding of the diagnosis, including basic anatomical details, and surgery-related issues such as the aim, steps and the risks connected to the planned intervention. Patient satisfaction was unanimously reported as improved as a result of enhanced consent.
Conclusions and clinical implications
Simulation and multimedia tools are extremely valuable for improving patients’ understanding of and satisfaction with urological procedures. Widespread application of enhanced consent would represent a milestone for patient-urologist communication.
Patient summary
Several multimedia tools can be used to improve patients’ understanding of urological conditions and procedures, such as simulation and models. Use of these tools for preoperative discussion enhances knowledge and patient satisfaction, resulting in more realistic patient expectations and better informed consent.
Enhancing comprehension of online informed consent: the impact of interactive elements and presentation formats
Enhancing comprehension of online informed consent: the impact of interactive elements and presentation formats
Research Article
Bree Holtz, Katharine Mitchell, Robyn Adams, Caitlin Grier, Jason Wright
Ethics & Behavior, 29 March 2024
Abstract
Informed consent, a cornerstone of research ethics, ensures participant protection and informed participation, particularly in online settings. Despite its significance, engagement with online consent forms remains low, underscoring the need for improved presentation strategies. This study investigates the impact of interactive elements and diverse presentation formats on the comprehension and engagement of online informed consent documents among a broad demographic beyond the commonly studied student populations. Employing a between-subjects experimental design, we explored six versions of online consent forms varying in interactivity, readability, and visual formatting to identify optimal strategies for enhancing participant comprehension and engagement. Our findings reveal that interactive formats significantly improve comprehension and perceived readability, highlighting the pivotal role of design in facilitating informed consent. The study also examines the influence of individual differences, such as self-efficacy and trust in science, on the effectiveness of consent forms, providing insights into the nuanced dynamics between participant characteristics and consent form engagement. These results advocate for integrating interactive elements and thoughtful design in consent forms to foster a more informed and engaged participant base. Implications for research ethics, best practices in consent form development, and future research directions are also discussed, emphasizing the need for ongoing innovation in the consent process to adapt to the evolving landscape of online research. This study contributes to the body of knowledge on research ethics by offering evidence-based recommendations for enhancing the informed consent process, ultimately promoting participant-centered research practices.
Closing the gaps: consent and preoperative assessment for children and young people
Closing the gaps: consent and preoperative assessment for children and young people
Editorial
Hugo Wellesley, Simon P. Courtman
British Journal of Anaesthesia, 15 April 2024
Summary
The changing ethical and legal landscape in the UK means that anaesthetists should routinely be discussing the risk of death during the consent process. To do this effectively means expanding anaesthetic preassessment services for children and young people, something that has been recognised as a priority, but which still needs investment and an appreciation of its value at the trust level.
Consent and assent in paediatric practice: it’s the conversation that matters
Consent and assent in paediatric practice: it’s the conversation that matters
Viewpoint
Hugh T Davies, Jenny Preston
Archives of Disease in Childhood, 4 April 2024
Excerpt
In paediatric medical research, across jurisdictions, parental consent and the assent of their child will usually come from a shared conversation between the researcher and family. This is how a study is introduced, information delivered, uncertainties addressed and understanding confirmed. Evidence indicates the crucial importance of the dialogue1 yet it currently goes unguided, undocumented, and often unchecked as review and research design continue to focus on the Participant Information Sheets (PIS).2 We propose that it’s time to move our focus on to this conversation to help families make their decision and in this viewpoint we suggest how this can be realised working within the constraints that researchers face. We address consent to research, but would contend that this idea has equal applicability in clinical practice…
From vulnerable subjects to research partners: a critical policy analysis of biomedical research ethics guidelines and regulations
From vulnerable subjects to research partners: a critical policy analysis of biomedical research ethics guidelines and regulations
Research Article
Maria Cristina Murano
Research Ethics, 29 March 2024
Open Access
Abstract
Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s, international regulatory frameworks defined the paediatric population as vulnerable due to unaddressed public health needs. More recently, ethical recommendations have promoted the active engagement of minors as research partners. In this paper, I adopt a post-structuralist approach to policy analysis to examine deep-seated assumptions and presuppositions underlying the changes in the problematisation of children as biomedical research participants over time. While biomedical research ethics focuses on the autonomy and vulnerability of minors, ethical guidelines are situated in specific sociocultural contexts, shaped, among other things, by contingent public health needs and changing conceptions of the value of research and science for society. In the process, I demonstrate the challenge of moving away from an approach that in taking adults as the model overshadows the complexity of children’s lived experiences as well as their personal, cultural, and social lives. The lack of acknowledgement of this complexity makes children vulnerable to epistemic injustice, which is particularly crucial to address in public involvement initiatives.
Navigating Theoretical, Methodological, and Ethical Interdependences in Researching Children
Navigating Theoretical, Methodological, and Ethical Interdependences in Researching Children
Book Chapter
Chikezie E. Uzuegbunam
Children and Young People’s Digital Lifeworlds, 27 March 2024; pp 55–75
Abstract
This chapter discusses the theoretical, methodological, and ethical approaches to conducting research with children in specific, local contexts. It is a journey from negotiating theories and methodological decision-making to data collection, while highlighting the various processes and challenges involved in negotiating access to the actual participants used in both the focus groups and the surveys conducted. There is a conscious and deliberate decision to foreground the entire research on a child-centred approach, from theory, methodology, and ethics to analyses, making all of these components interdependent. Due to contextual differences and the nascent nature of digital media and youth research in Nigeria, conducting research with children and young people in such contexts can present unique ethical and methodological challenges. Such dilemmas dealt with include adult–child power relationships, gendered and group dynamics, problems of language and cognition, techno-shame, shy and assertive participants, the challenges of conducting fieldwork in school settings, and absentee participants.
Reconciling Children’s Best Interests and Right to be Heard
Reconciling Children’s Best Interests and Right to be Heard
Hege Stein Helland
The International Journal of Children’s Rights, 6 March 2024
Abstract
This article explores the tension between the child’s best interests principle and children’s participation and examines the inherent challenges and different approaches to reconcile the dilemma in law and practice: how can children’s best interests be reconciled with their right to be heard? By exploring different systems’ institutional approaches and empirical ability to implement and honour children’s right to participation in national contexts, this article reviews the literature and suggests a framework for understanding participation through a lens of a global typology of child protection systems. Drawing on the conceptual and empirical reviews and elements from the deliberative ideal for decision-making, the article concludes by drawing up a sketch for a best interest model for meaningful, respectful and successful participation with global applicability. The model aims to enhance children’s citizenship and legitimacy of decision-making in child protection.