Month: December 2024

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Informed Consent: A Monthly Review
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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

Spotlight

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To start the new year, we have highlighted an article which broadens our thinking to informed consent at a population level. In the Public Health Ethics article Collective Consent to Xenotransplantation: A Critical Appraisal Bobier et al. discuss the need to go beyond surveying trends in public attitudes surrounding novel technologies which have the potential to impact the planet on a large scale and actively obtain collective consent for xenotransplantation procedures.

[Extract]
“…solid organ xenotransplantation… involves the transplantation of a genetically engineered porcine organ into a human recipient (Carrier et al., 2022; Fischer and Schnieke, 2022). There is concern, however, that a novel zoonotic disease could be trans­mitted from the source organ to the human recipient, then from the recipient to others. Theoretically, this could result in an epidemic or pandemic (Fishman, 2022; Thom et al., 2024).

Given the novelty of xeno­transplantation and the theoretical potential to cause significant harm, it has been the stated position of the World Health Organization (WHO) since 2008 that any xenotransplantation regulatory system must include ethical assessments that involve the public (WHO, 2008). Public engagement regarding novel medical technology promotes important (i) ethical, (ii) trans­parent and (iii) inclusive practices (Hurst and Cooper, 2024). However, some have gone further and argued that something more than the assessment of public viewpoints is needed. It has been argued that collective consent is required in addition to the due diligence of researchers and oversight organizations, such as the US Food and Drug Administration…

While the authors conclude that collective consent is not required in this case to proceed ethically, we have highlighted this article because it engages population level thinking, and is a useful example of a niche area in the informed consent landscape.

Collective Consent to Xenotransplantation: A Critical Appraisal
Christopher Bobier, Adam Omelianchuk, Daniel Rodger, Daniel J Hurst
Public Health Ethics, 12 December 2024
Abstract
Solid organ xenotransplantation may have the potential to help address the shortage of organs for transplantation. There is concern, however, that a novel zoonotic disease could be transmitted from the source organ to the human recipient, and then from the recipient to others. Theoretically, this could result in an epidemic or pandemic. Because of this potential risk, it has been argued that collective consent is required. Our goal is to critically evaluate the claim that collective consent is necessary for xenotransplantation to be ethically permissible. We argue that collective consent is not required and highlight the important roles of public engagement and due diligence in xenotransplant research moving forward.

Navigating the consent river: questions to consider before waiving consent requirements in pragmatic cluster randomised trials

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Navigating the consent river: questions to consider before waiving consent requirements in pragmatic cluster randomised trials
Cory E Goldstein, Monica Taljaard, Stephanie N Dixon, Charles Weijer
Journal of Medical Ethics, 18 December 2024
Open Access
Abstract
The robust design and conduct of pragmatic cluster randomised trials may be in tension with the ethical requirement to obtain written informed consent from prospective research participants. In our experience, researchers tend to focus on whether a waiver of consent is appropriate for their studies. However, pragmatic cluster randomised trials raise other important questions that have direct implications for determining when an alteration or waiver of consent is permissible. To assist those involved in the design, conduct and review of pragmatic cluster randomised trials, we outline four critical questions to consider: (1) What is the nature of the intervention being evaluated? (2) Is the choice to use cluster randomisation justified? (3) Can the risk of recruitment bias be addressed? and (4) Is an alteration or waiver of consent appropriately justified? We recommend that researchers and research ethics committees conduct a stepwise analysis of a planned cluster randomised trial using these questions. To illustrate the application of this stepwise analysis, we use three pragmatic cluster randomised trials in the haemodialysis setting as case studies.

Context is key: ethical considerations related to consent and study design in acute cardiac care research

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Context is key: ethical considerations related to consent and study design in acute cardiac care research
Journal Article
Neal W Dickert, Madeline Meer
European Heart Journal Acute Cardiovascular Care, 28 November 2024
Excerpt
    …There is also an important set of ethical issues that arise in cardiac critical care research. By their very nature, acute care studies involve ‘high stakes’ outcomes such as mortality, organ failure, and other major morbidities. Communicating about study enrolment with patients and family members in the context of life-or-death situations is difficult, and research itself is complex and unfamiliar. To make matters worse, decisions often must be made very quickly, because acute care must be delivered rapidly. These issues make consent processes difficult and, in some cases, impossible. Many patients with severe acute cardiac illness lack capacity to engage in decision-making, and surrogate decision makers are often unavailable and may struggle with having to make research enrolment decisions for someone else. The urgency of these situations only compounds baseline challenges related to deciphering patients’ preferences for participating in research.
In this piece, we focus on these ethical challenges and integrate them with practical considerations outlined above. We articulate paths forward for major types of acute cardiac care research, emphasising throughout the importance of attention to critical contextual factors…

On-site electronic consent in pediatrics using generic Informed Consent Service (gICS): Creating a specialized setup and collecting consent data

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On-site electronic consent in pediatrics using generic Informed Consent Service (gICS): Creating a specialized setup and collecting consent data
Research Article
Katharina Danhauser, Larissa Dorothea Lina Mantoan, Jule Marie Dittmer, Simon Leutner, Stephan Endres, Karla Strniscak, Jenny Pfropfreis, Martin Bialke, Dana Stahl, Bernadette Anna Frey, Selina Sophie Gläser, Laura Aurica Ritter, Felix Linhardt, Bärbel Maag, Georgia Donata Emily Miebach, Mirjam Schäfer, Christoph Klein, Ludwig Christian Hinske
PLOS Digital Health, 25 November 2024
Open Access
Abstract
Enrolling in a clinical trial or study requires informed consent. Furthermore, it is crucial to ensure proper consent when storing samples in biobanks for future research, as these samples may be used in studies beyond their initial purpose. For pediatric studies, consent must be obtained from both the child and their legal guardians, requiring the recording of multiple consents at once. Electronic consent has become more popular recently due to its ability to prevent errors and simplify the documentation of multiple consents. However, integrating consent capture into existing study software structures remains a challenge. This report evaluates the usability of the generic Informed Consent Service (gICS) of the University Medicine Greifswald (UMG) for obtaining electronic consent in pediatric studies. The setup was designed to integrate seamlessly with the current infrastructure and meet the specific needs of a multi-user, multi-study environment. The study was conducted in a pediatric research setting, where additional informed consent was obtained separately for the biobank. Over a period of 54 weeks, 1061 children and adolescents aged 3 to 17 years participated in the study. Out of these, 348 agreed also to participate in the biobank. The analysis included a total of 2066 consents and assents, with 945 paper-based and 1121 electronic consents. The study assessed the error susceptibility of electronic versus paper-based consents and found a significant reduction rate of errors of 94.7%. These findings provide valuable insights into the use of gICS in various studies and the practical implementation of electronic consent software in pediatric medicine.

“You knew what you were getting into”: Perspective differences in gauging informed consent

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“You knew what you were getting into”: Perspective differences in gauging informed consent
Rachel Schlund, Vanessa K. Bohns
Organizational Behavior and Human Decision Processes, January 2025
Abstract
We examine differences between perceived and experienced consent in organizational contexts—specifically, the aspect of consent that reflects how informed consenters feel. We theorize that people tasked with soliciting consent overestimate the extent to which consenters feel fully informed of what they are agreeing to and thus feel they have truly consented. We provide support for these predictions across six pre-registered studies (N = 2,993) and eight supplemental pre-registered studies (N = 4,406) that establish causal and mediation evidence, downstream organizational consequences, and real-world relevance. This research reveals that even when an agreement meets the legal criteria for consent, there may be misaligned perceptions of employees’ feelings of consent, with consequences for employees’ relationship with their organization. The current studies offer a significant step forward in understanding the markedly understudied role of consent in organizations.

Ethical Challenges in the Integration of Artificial Intelligence in Palliative Care

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Ethical Challenges in the Integration of Artificial Intelligence in Palliative Care
Abiodun Adegbesan, Adewunmi Akingbola, Olajide Ojo, Otumara Urowoli Jessica, Uthman Hassan Alao, Uchechukwu Shagaya, Olajumoke Adewole, Owolabi Abdullahi
Journal of Medicine, Surgery, and Public Health, December 2024
Abstract
The integration of artificial intelligence (AI) into palliative care offers the possibility of improved patient outcomes through enhanced decision-making, personalized care, and reduced healthcare provider burden. However, the use of AI in this sensitive area presents significant ethical challenges which require serious consideration to ensure that technology serves the best interests of patients without compromising their rights or well-being. This narrative review explores the key ethical issues associated with AI in palliative care, with a focus on low-resource settings where these challenges are often intensified. The review examines essential ethical principles such as autonomy, beneficence, non-maleficence, and justice, and identifies critical concerns including data privacy, informed consent, algorithmic bias, and the risk of depersonalizing care. It also highlights the unique difficulties faced in low-resource environments, where the lack of infrastructure and regulatory frameworks can exacerbate these ethical risks. To address these challenges, the review offers actionable recommendations, such as developing context-specific guidelines, promoting transparency and accountability through explainable AI (XAI), and conducting regular ethical audits. Interdisciplinary collaboration is emphasized to ensure that AI systems are ethically designed and implemented, respecting cultural contexts and upholding patient dignity. This study contributes to the ongoing discourse on ethical AI integration in healthcare, indicating the need for careful consideration of ethical principles to ensure that AI enhances rather than undermines the compassionate care at the heart of palliative care. These findings serve as a foundation for future research and policy development in this emerging field.

Ethical Considerations in Using AI for Mental Health Diagnosis and Treatment Planning: A Scoping Review

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Ethical Considerations in Using AI for Mental Health Diagnosis and Treatment Planning: A Scoping Review
Yewande Ojo
Proceedings of the International Conference on Artificial Intelligence and Robotics; Yaba Nigeria, 26-28 November 2024
Abstract
    Integrating Artificial Intelligence (AI) with mental healthcare presents a paradigm shift in diagnosis and treatment planning, offering potential efficiency, accuracy, and personalisation improvements. However, this technological advancement allows for the exploration of a complex array of ethical challenges that demand careful consideration. This research explores the vital ethical dimensions surrounding the adoption of AI in mental health contexts, emphasising the reason for a balanced approach that maximises benefits while mitigating risks.

Central to these considerations is the imperative of privacy and data protection. This type of mental health information requires comprehensive robust safeguards to prevent unauthorised access or misuse while allowing for responsible data utilisation to drive AI-powered advancements. The assurance of fairness and non-discrimination in AI systems is critical, as racial bias could exacerbate disparities in mental healthcare access and outcomes. Transparency and explainability emerge as crucial factors in fostering trust and accountability. AI systems must be capable of providing clear rationales for their diagnostic and proposed treatment planning, which aids clinicians and patients to make informed decisions. This transparency is intimately linked to the principles of autonomy and informed consent, requiring that individuals fully understand the role of AI in their treatment and have the agency to accept or decline its use.

The integration of AI also necessitates a reevaluation of professional ethics and responsibilities for mental health practitioners. As AI systems assume more significant roles in diagnosis and treatment planning, the boundaries of professional judgment and accountability must be delineated. Moreover, the broader societal implications, including potential changes in public perception of mental healthcare and shifts in the healthcare workforce, warrant careful consideration.

Regulatory and governance frameworks play a pivotal role in addressing these ethical challenges. Policymakers face the complex task of developing adaptive regulations that foster innovation while ensuring robust ethical safeguards. This requires a collaborative approach involving clinicians, researchers, ethicists, patients, and technology developers.

Qualitative Assessment of Proposed Visual Key Information Pages for Informed Consent

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Qualitative Assessment of Proposed Visual Key Information Pages for Informed Consent
Krista E. Cooksey, Eliana Goldstein, Clara Lee, Jessica Mozersky, Kimberly A. Kaphingst, Victor Catalan Gallegos, Mary C. Politi
Journal of Clinical and Translational Science, 21 November 2024
Open Access
Abstract
Introduction
The 2018 Common Rule revision intended to improve informed consent by recommending a concise key information (KI) section, yet provided little guidance about how to describe KI. We developed innovative, visual KI templates with attention to health literacy and visual design principles. We explored end users’ attitudes, beliefs, and institutional policies that could affect implementing visual KI pages.
Materials and Methods
From October 2023-April 2024, we conducted semi-structured interviews with principal investigators, research staff, institutional review board (IRB) personnel, including those in oversight/management, and community partners. 40 participants from 3 academic institutions (in the Midwest, Southeast, and Mountain West) viewed example KI pages and completed interviews. We coded written transcripts inductively and deductively based on the capability, opportunity, and motivation to change behavior (COM-B) framework. Data were analyzed using content analysis and organized thematically.
Results
Participants responded positively to the visual KI examples. They discussed potential benefits including improving information processing and understanding of study procedures, diversity in research, trust in research, and study workflow. They also described potential challenges to consider before widespread implementation: IRBs’ interpretations of federal guidelines, possible impact on the IRB submission processes, the effort/skill required to develop visuals, and difficulty succinctly communicating study risks. There was no consensus about when to use visual KI during consent, and some wondered if they were feasible for all study types.
Discussion
Visual KI offers a promising solution to long-standing informed consent challenges. Future work can explore resources and training to address challenges and promote widespread use.

Screenshot 2024-12-29 at 12.08.55
Editor’s note: This is an example of a visual KI sheet provided in the article.

Comparison Between Multimedia and Written Informed Consent for Lumbar Transforaminal Epidural Steroid Injection: A Randomized Controlled Pilot Trial

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Comparison Between Multimedia and Written Informed Consent for Lumbar Transforaminal Epidural Steroid Injection: A Randomized Controlled Pilot Trial
Sunmin Kim, Nam Woo Kim, Francis Nahm, Eun Joo Choi, Pyung Bok Lee
Pain Physician, November 2024; 27(8) pp 529-535
Abstract
Background
Informed consent is a crucial ethical and legal requirement in medical practice to ensure that patients understand the risks, benefits, and alternatives of medical procedures. Recent advances in multimedia technology have facilitated the exploration of multimedia consent, aiming to enhance patient understanding and satisfaction. Ascertaining that patients have full comprehension of the procedures before opting to undergo them is especially important now that instances of such procedures as lumbar transforaminal epidural steroid injections (TESIs) are increasing.
Objectives
To determine the effectiveness of multimedia consent forms for lumbar transforaminal steroid injections.
Study design
Randomized clinical trial.
Setting
Outpatient multidisciplinary pain medicine center of a tertiary hospital.
Methods
A randomized controlled trial was conducted with 30 patients who received lumbar TESIs for lumbar radiculopathy. Patients were randomly assigned to either the multimedia consent group (Group M) or the conventional paper consent group (Group C). This study evaluated patients’ comprehension of the procedure, their anxiety levels (using the State-Trait Anxiety Inventory short form), and the patients’ post-procedure satisfaction.
Results
Group M showed significantly greater understanding of the procedure and reported lower levels of anxiety than did Group C (P = 0.041; P = 0.03). However, there were no statistically significant differences in post-procedure satisfaction between the groups (P = 0.25). These findings suggest that multimedia consent can effectively improve patient comprehension and reduce anxiety without significantly affecting patient satisfaction.
Limitations
First, the limited sample size of 30 patients restricts the applicability of our findings to a wider population, suggesting a need for larger studies to better assess the effects of multimedia consent. Second, conducting the study in a single hospital might have introduced bias. Multicenter research may provide a more diverse and accurate evaluation of the efficacy of multimedia consent.
Conclusion
This pilot study contributes to the growing evidence supporting the use of multimedia consent to enhance patient understanding and reduce anxiety, marking a promising direction for improving informed consent practices for less invasive procedures, such as lumbar TESIs. Further research is required to fully explore the benefits and limitations of multimedia consent forms in various medical settings.