Evaluation of a DIC Broad Consent Cohort

1 June 2025 ~ paigefitzsimmons ~ Leave a comment

Evaluation of a DIC Broad Consent Cohort

Observational Study

Marvin O Kampf, Hans-Ulrich Prokosch, Christian Gulden, Detlef Kraska, Thomas Ganslandt, Susanne A Seuchter

Studies in Health Technology and Informatics, 15 May 2025

Abstract

This single-center retrospective observational study accesses potential differences between adult patients who were admitted to the University Hospital Erlangen between March 2021 and December 2023 (hospital cohort) and adult patients who have given consent to use their documented data for research purposes (broad consent cohort). Demographic and clinical data (ICD-10 diagnoses) were extracted from the university hospitalt’s FHIR research data repository and analyzed in pseudonymized form. The two cohorts comprise 98,564 and 1,678 patients respectively and were compared concerning representativity of the BC cohort. The results suggest that the ongoing stepwise rollout of the consent obtainment process creates biases in clinical and demographic characteristics. For as long as these biases persist, we suggest researchers to prefer federated over centralized approaches to data analysis, where broad consent is not required and the analyses can be based on the total hospital cohort.

Ownership and Gatekeeping vs. Safeguarding and Consent: How Migrant Parents Navigate Child Data Management Complexities

1 June 2025 ~ paigefitzsimmons ~ Leave a comment

Ownership and Gatekeeping vs. Safeguarding and Consent: How Migrant Parents Navigate Child Data Management Complexities

Conference Proceedings

Rui Huan, Kopo M. Ramokapane, Awais Rashid

2025 IEEE Symposium on Security and Privacy, May 2025 [USA]; pp 2209-2227

Abstract

Parents pursuing opportunities abroad increasingly find themselves raising children in new cultural and legal environments. This responsibility extends to complying with unfamiliar regulations and safeguarding their children’s data which is often complex and a challenging task. In this study, we examine how migrant parents perceive, manage, and safeguard data related to their children. Through interviews with 17 migrant parents and guardians in the UK, we uncover nuanced and evolving perspectives on data ownership and management. Migrant parents express significant concerns about losing control over data shared locally and with extended families abroad, with fears of misuse that could harm their children or jeopardize their immigration status. We discuss their data management strategies and approaches to navigating changing concepts of data ownership and consent. Our findings underscore the need for culturally sensitive support to help migrant families safeguard their children’s data and highlight directions for future research into the complexities of cross-border data sharing and its implications.

Picturing informed consent: Exploring participatory visual methods to enhance meaningful consent conversations with young people

1 June 2025 ~ paigefitzsimmons ~ Leave a comment

Picturing informed consent: Exploring participatory visual methods to enhance meaningful consent conversations with young people

Research article

Jennifer A. Thompson, Emilia Gonzalez, Mónica Ruiz-Casares

Research Ethics, 20 May 2025

Open access

Abstract

Informed consent (IC) is a cornerstone of ethical research, ensuring participants are informed and provide voluntary agreement to participate. Yet IC remains complex, especially in research with young people, and practical examples for engaging youth meaningfully in IC processes are limited. Participatory visual methodologies engage youth as knowledge producers to think creatively, express diverse perspectives, and engage in dialog. This study explores how participatory visual methodologies can involve youth in IC by inviting them to create and discuss visual representations of its key concepts. Grounded in literature on research ethics with young people, we ask: How do young people in Cameroon represent some of the core concepts within IC visually, and what kinds of conversations emerge around these representations? To address these questions, we conducted workshops with 56 young people (10–16 years old) in Cameroon’s Southwest and Northwest Regions. Participants took photos to represent and discuss the benefits and risks of research, voluntary participation, and confidentiality as key elements of IC, and created visual representations of IC forms. Findings show that incorporating visual elements in IC prompted participants to critically engage with IC, facilitating a deeper contextualized and nuanced understanding and meaningful dialog about both the notion of consent and the study they are potentially consenting to. This study presents a case on adolescents and IC in an African context, emphasizing the importance of social and cultural factors in IC and contributing to literature that largely focuses on younger children in Western settings. Integrating participatory visual methods reframed IC as a collaborative, group-centered process rather than a researcher-driven, one-time event. These findings highlight the potential of participatory visual approaches to deepen youth engagement in research ethics, contributing to more equitable and locally relevant research practices.

Video-assisted education for informed consent in percutaneous nephrolithotomy: a prospective study on patient comprehension

1 June 2025 ~ paigefitzsimmons ~ Leave a comment

Video-assisted education for informed consent in percutaneous nephrolithotomy: a prospective study on patient comprehension

Research

Mucahit Gelmis, Yasar Pazir, Ufuk Caglar, Ahmet Halis, Caglar Dizdaroglu, Furkan Gunay, Sedat Cakmak, Faruk Ozgor

World Journal of Urology, 15 May 2025

Abstract

Purpose

The prevalence of urinary stone disease is increasing due to climate change, dietary habits, and obesity. Percutaneous nephrolithotomy (PCNL) remains the preferred treatment for large kidney stones. The informed consent process is essential for patient understanding; however, conventional verbal and written methods may be inadequate. This study aimed to evaluate the effectiveness of video-assisted education in improving informed consent for PCNL.

Methods

This randomized controlled study was conducted from January to July 2023. Eighty patients scheduled for PCNL were randomly assigned to either a written-consent-only group or a video-assisted consent group that received both written consent and a seven-minute 3D-animated video. Comprehension was assessed using a 17-question knowledge assessment questionnaire before and after the consent process. Improvements in knowledge and differences in comprehension were compared.

Results

The video-assisted consent group showed significantly greater comprehension improvement than the written-only group, benefiting patients across all education levels. Multivariate analysis confirmed the strong association between video education and knowledge gain, though older age was linked to lower improvement. Despite its effectiveness, two patients withdrew due to increased anxiety, underscoring the need to balance understanding with emotional reassurance.

Conclusion

Video-assisted informed consent significantly improves comprehension in PCNL patients, particularly in those with lower education levels. However, an increased awareness of surgical risks may contribute to preoperative anxiety. Future research should refine video content, assess long-term outcomes, and explore strategies to balance comprehension with emotional reassurance.

Uses of augmented reality in surgical consent and patient education – A systematic review

1 June 2025 ~ paigefitzsimmons ~ Leave a comment

Uses of augmented reality in surgical consent and patient education – A systematic review

Research Article

Thomas Evans, Adam Turna, Thomas D. Stringfellow, Gareth G. Jones

PLOS Digital Health, 28 April 2025

Open Access

Abstract

Augmented reality (AR) allows the real environment to be altered with superimposed graphics using a head-mounted-display (HMD), smartphone or tablet. AR in surgery is being explored as a potential disruptive technology and could be used to improve patient understanding of treatment and as an adjunct for surgery. The aim was to explore this use of AR and assess potential benefits for consent and patient education. A systematic review was conducted using PRISMA-SCR guidelines. 4 major bibliographic databases were searched using the terms: ‘(augmented reality OR mixed reality) AND surgery AND (consent OR patient education)’. Included papers evaluated an AR intervention on consenting patients for enhancing surgical consent or education about a procedure. Non-English language papers and studies which did evaluate an intervention were excluded. Three reviewers screened all abstracts and full text papers for inclusion. The review protocol was prospectively registered with PROSPERO (ID: CRD42020207360). 52 records were identified. Following removal of 13 duplicates, 21 were removed after abstract screening leaving 17 articles for full assessment. One article was a letter and 8 did not evaluate interventions, leaving 8 articles published between 2019 and 2023. 3 papers were randomised controlled trials comparing AR enhanced processes to standard consent, 2 cohort studies evaluated patient satisfaction with AR interventions and there was one randomised crossover trial of AR against traditional consent consultation. The Cochrane risk of bias tool was used most studies were deemed as high risk of bias. Patient satisfaction and understanding were improved using AR. However, advantages over other enhanced techniques are less clear. Using AR to enhance written literature was shown to require less mental effort from patients and was preferred to standard resources to understand complex surgery. The few randomised trials are limited by bias and lack of power calculation, highlighting the need for further research.

How Making Consent Procedures More Interactive can Improve Informed Consent: An Experimental Study and Replication

1 June 2025 ~ paigefitzsimmons ~ Leave a comment

How Making Consent Procedures More Interactive can Improve Informed Consent: An Experimental Study and Replication

Marije Aan Het Rot, Ineke Wessel

Journal of Empirical Research on Human Research Ethics, February-April 2025

Abstract

Prospective research participants do not always retain information provided during consent procedures. This may be relatively common in online research and is considered particularly problematic when the research carries risks. Clinical psychology studies using the trauma film paradigm, which aims to elicit an emotional response, provide an example. In the two studies presented here, 112-126 participants were informed they would be taking part in an online study using a variant of this paradigm. The information was provided across five digital pages using either a standard or an interactive format. In both studies, compared to the control condition, participants in the interactive condition showed more retention of information. However, this was only found for information about which they had been previously asked via the interactive format. Therefore, the impact of adding interactivity to digital study information was limited. True informed consent for an online study may require additional measures.

Empowering Voices: Implementing Ethical Practices for Young Children’s Assent in Digital Research

1 June 2025 ~ paigefitzsimmons ~ Leave a comment

Empowering Voices: Implementing Ethical Practices for Young Children’s Assent in Digital Research

Amanda M. Mirabella, Ilene R. Berson, Michael J. Berson

Education Sciences, 3 May 2025

Open Access

Abstract

This article examines how young children express informed assent in research settings that incorporate digital tools, participatory methods, and play-based approaches. Drawing on data from three studies involving kindergarten and first-grade children (ages 5 to 7) in the southeastern United States, this cross-case analysis explores how children navigated their participation using multimodal and relational strategies. Conceptual play theory, social semiotics, and participatory research frameworks guided the analysis, emphasizing assent as an evolving, co-constructed process rather than a singular verbal agreement. Through video recordings, field notes, and action-oriented transcripts, we investigated how children expressed comfort, curiosity, and agency across diverse contexts—including virtual reality storytelling, video-cued reflection, and interactive eBooks. Findings illustrate that assent was negotiated through gesture, movement, silence, humor, and peer interaction, often extending beyond adult-defined research routines. Children reinterpreted their roles, shaped the pace of sessions, and co-constructed meaning through play and dialogue. This retrospective synthesis of three previously conducted studies offers practical and ethical insights for researchers working with young children, including the importance of ongoing assent checkpoints, developmentally appropriate explanations, and flexible research environments. We argue that ethical research with children must prioritize multimodal communication, child-led pacing, and relational trust to support authentic and meaningful participation. By reframing assent as a dynamic and multimodal process, this research contributes to emerging conversations about ethical responsiveness, agency, and inclusive practices in early childhood research.

Consensus on Adolescent and Young Adult HIV Research Consent in Low- and Middle-Income Countries

1 June 2025 ~ paigefitzsimmons ~ Leave a comment

Consensus on Adolescent and Young Adult HIV Research Consent in Low- and Middle-Income Countries

Consensus Statement

Suzanne Day, Sonam J. Shah, Ujunwa F. Onyeama, Lauren Fidelak, Ucheoma Nwaozuru, Stuart Rennie, Abdulhammed Opeyemi Babatunde, Weiming Tang, Elzette Rousseau, Chisom Obiezu-Umeh, Kelechi Prince Chima, Nadia A. Sam-Agudu, Erin C. Wilson, Seema K. Shah, Susan Nkengasong, Titilola Gbaja-Biamila, Bill G. Kapogiannis, Linda-Gail Bekker, Juliet Iwelunmor, Oliver Ezechi, Joseph D. Tucker

JAMA Network Open, 29 April 2025; 8(4)

Open Access

Key Points

Question

What are practical strategies to improve informed consent processes for adolescents and young adults (AYAs; aged 10-24 years) in HIV research studies in low- and middle-income countries?

Findings

This consensus statement addresses critical questions about empowering AYAs, involving parents in the research process, and developing policies to increase AYA inclusion in research based on data from a comprehensive scoping review, a crowdsourcing open call, and a diverse global group of people.

Meaning

This consensus statement provides a framework to enhance inclusion of AYAs in HIV studies in low- and middle-income countries.

Abstract

Importance

Many adolescents and young adults (AYAs) in low- and middle-income countries (LMICs) are excluded from HIV research because of challenges with informed consent for study participation, which makes it difficult to understand and improve the lives of AYAs living with HIV and AIDS in a wide variety of settings.

Objective

To help increase the inclusion of AYAs in HIV research, we developed a consensus statement on practical strategies for improving AYA consent in HIV research in LMICs.

Evidence Review

The VOICE (HIV Youth Informed Consent & Ethics in Research) Working Group included AYAs, researchers, community organizers, advocates, research ethics committee members, parents of AYAs, and bioethicists who drafted initial statement items using data from a global open call and scoping review. An adapted Delphi process was then used to develop consensus statement items. The process involved 3 rounds of online Likert-scale questionnaires and a hybrid (online and in-person) consensus summit in Lagos, Nigeria, in 2022, with the total study period lasting from August 23, 2021, to February 10, 2023.

Findings

Thirty-five people participated in the final round of the Delphi process, including 14 individuals younger than 35 years (40.0%), 25 HIV researchers (71.4%), and 32 people who worked in an LMIC (91.4%). Twenty-five items reached a predefined threshold for consensus (≥80% agreement). Strong consensus emerged for formal mechanisms (eg, cocreation, crowdsourcing, or youth advisory boards) for AYA engagement in and education about research as well as for strategies to enhance parental and guardian involvement in HIV research when safe and appropriate. Capacity strengthening can allow AYAs to review research protocols, join ethical review committees, and advocate for regulatory change. Two items in the statement (alternatives to parental consent and raising awareness among research ethics committees about AYA-independent consent) required further refinement to reach the agreement threshold for inclusion.

Conclusions and Relevance

Greater engagement of both AYAs and parents may help to enhance consent processes and increase the inclusion of AYAs in LMIC HIV research studies. The resulting consensus statement provides practical strategies for implementing improved consent processes for AYA research participation at the organizational, community, and policy levels, which may help foster greater inclusion of AYAs in HIV research and address existing data gaps.

Conclusions [taken from the full statement]

In this consensus statement study of strategies to improve AYA consent processes for HIV research in LMICs, we identified a set of 25 practical approaches by which consent processes might be improved. Improving consent processes is the first (albeit not the only) step toward improving inclusion of AYAs in HIV research, which is essential to ensure the collection of data for informing treatment and prevention strategies that are effective and safe for AYAs. The strategies proposed in this consensus statement may be relevant to a wide range of other research topics beyond HIV, with potential to inform and improve research practices in other areas involving AYAs, such as mental health, sexual and reproductive health, and beyond. Further collaboration will be needed to assess the utility of this guidance in diverse LMIC settings.

The finalized consensus statement, including the preamble, glossary of terms, and open-access resources, are available in the eResults in the Supplement.

Ethical Considerations in Pediatric Surgery: Discussing Informed Consent, Parental Rights, and Decision-Making in Complex Cases

1 June 2025 ~ paigefitzsimmons ~ Leave a comment

Ethical Considerations in Pediatric Surgery: Discussing Informed Consent, Parental Rights, and Decision-Making in Complex Cases
Sahir Prasenjit Telang
Journal of New Century Innovations, 12 April 2025
Abstract
Ethical aspects in pediatric surgery represent a special area of medical practice where the interests of the child, parents, and medical professionals intersect. The purpose of this study is to analyze modern approaches to informed consent, parental rights, and decision-making in complex clinical situations. The study involved 450 pediatric surgeons and 320 parents from five multidisciplinary hospitals in Europe and Central Asia. The obtained data showed that only 37% of doctors involve children over 12 in the decision-making process, despite the recommendations of international organizations. In 64% of cases, doctors encountered disagreements from parents, and 17% of such situations required intervention from the ethics committee or judicial authorities. Significant cultural differences were also identified: in Central Asia, parental opinion dominance was noted in 83% of cases, compared to 51% in European clinics (p<0.01). The results highlight the need to develop unified protocols, improve the effectiveness of ethics committees, and implement medical ethics programs in the educational process. Strengthening the role of joint decision-making, taking into account the child’s opinion, can improve the ethical stability and quality of medical care in pediatric surgery.

Editor’s note: The Journal of New Century Innovations is published in Uzebekistan.