Consent-driven, semi-automated data collection during birth and newborn resuscitation: Insights from the NewbornTime study
Sara Brunner, Anders Johannessen, Jorge García-Torres, Ferhat Özgur Catak, Øyvind Meinich-Bache, Siren Rettedal, Kjersti Engan
medRxiv, 17 January 2025
Abstract
    Accurate observations at birth and during newborn resuscitation are fundamental for quality improvement initiatives and research. However, manual data collection methods often lack consistency and objectivity, are not scalable, and may raise privacy concerns. The NewbornTime project aims to develop an AI system that generates accurate timelines from birth and newborn resuscitation events by automated video recording and processing, providing a source of objective and consistent data. This work aims to describe the implementation of the data collection system that is necessary to support the project’s purpose.

Videos were recorded using thermal cameras in labor rooms and thermal and visual light cameras in resuscitation rooms. Consent from mothers were obtained before birth, and healthcare providers were given the option to delete videos by opting out. The video collection process was designed to minimize interference with ongoing treatment and not impose unnecessary burden on healthcare providers. Videos have been collected at Stavanger University Hospital since November 2021. By July 31st 2024, 645 thermal videos of birth and 186 visual light videos of resuscitation have been collected. Data collection and development and implementation of AI systems is still ongoing.

The utilization of automated data collection and AI video processing around birth may allow for consistent and enhanced documentation, quality improvement initiatives, and research opportunities on sequence, timing and duration of treatment activities during acute events, with less efforts needed for capturing data and improved privacy for participants.

Empowering Patients for Disease Diagnosis and Clinical Treatment: A Smart Contract-Enabled Informed Consent Strategy
Md Al Amin, Hemanth Tummala, Rushabh Shah, Indrajit Ray
arXiv, 13 December 2024
Open Access
Abstract
Digital healthcare systems have revolutionized medical services, facilitating provider collaboration, enhancing diagnosis, and optimizing and improving treatments. They deliver superior quality, faster, reliable, and cost-effective services. Researchers are addressing pressing health challenges by integrating information technology, computing resources, and digital health records. However, digitizing healthcare introduces significant risks to patient data privacy and security, with the potential for unauthorized access to protected health information. Although patients can authorize data access through consent, there is a pressing need for mechanisms to ensure such given consent is informed and executed properly and timely. Patients deserve transparency and accountability regarding the access to their data: who access it, when, and under what circumstances. Current healthcare systems, often centralized, leave much to be desired in managing these concerns, leading to numerous security incidents. To address these issues, we propose a system based on blockchain and smart contracts for managing informed consent for accessing health records by the treatment team members, incorporating safeguards to verify that consent processes are correctly executed. Blockchain’s inherent immutability ensures the integrity of consent. Smart contracts automatically execute agreements, enhancing accountability. They provide a robust framework for protecting patient privacy in the digital age. Experimental evaluations show that the proposed approach can be integrated easily with the existing healthcare systems without incurring financial and technological challenges.

Online cognitive assessments in elderly cohorts – the British 1946 birth cohort case study
Ziyuan Cai, Valentina Giunchiglia, Rebecca Street, Martina Del Giovane, Kirsty Lu, Maria Popham, Andrew Wong, Heidi Murray-Smith, Marcus Richards, Sebastian Crutch, Peter J. Hellyer, Jonathan M Schott, Adam Hampshire
medRxiv, 12 October 2024
This article is a preprint and has not been peer-reviewed. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.
Abstract
Introduction
Online assessments are scalable and cost-effective for detecting cognitive changes, especially in elderly cohorts with limited mobility and higher vulnerability to neurological conditions. However, determining the uptake, adherence, and usability of these assessments in older adults, who may have less experience with mobile devices is crucial.
Methods
1,776 members (aged 77) of the MRC National Survey of Health and Development (NSHD) [UK] were invited to complete 13 online cognitive tasks. Adherence was measured through task compliance, while uptake (consent, attempt, completion) was linked to health and sociodemographic factors. Usability was evaluated through qualitative feedback.
Results
This study’s consent (56.9%), attempt (80.5%), and completion (88.8%) rates are comparable to supervised NSHD sub-studies. Significant predictors of uptake included education, sex, handedness, cognitive scores, weight, smoking, alcohol consumption, and disease burden.
Discussion
With key recommendations followed, online cognitive assessments are feasible, with good adherence, and usability in older adults.

Patients’ Perceptions and Understanding of Pre-operative Informed Consent in a Tertiary Care Setting- Dar-es-salaam
Research Article
Steven Michael, Willbroad Kyejo, Allyzain Ismail, Eric Aghan, Columba Mbekenga, Athar Ali
BMC Medical Ethics, 11 October 2024
Abstract
Background
Informed consent, grounded in the ethical principle of autonomy, represents a patient’s agreement to undergo a procedure. Given its critical role in protecting human rights and autonomy, obtaining informed consent before any surgery or procedure is now a mandatory practice. However, many studies question whether informed consent is conducted genuinely, ensuring proper understanding of the information disclosed, or merely serves as a medico-legal formality. This has led to increased malpractice, misunderstanding, anxiety, and overall postoperative dissatisfaction.
Methods
This descriptive qualitative study was conducted at Aga Khan Hospital using individual in-depth interviews. Fourteen patients who had undergone elective surgery were recruited. Baseline data were presented in tables, and inductive thematic analysis was used to interpret the qualitative data.
Results
Seven themes emerged from the data: Consent as a legal formality, autonomy and decision-making, insufficient information, time constraints and lack of opportunities for questions, use of medical jargon, patients’ desired information, and overall satisfaction with care. Despite patients’ higher levels of education and the hospital’s patient-centered care approach, many felt the information provided was insufficient, superficial, and difficult to understand.
Conclusion
The study found a significant gap between the information patients desired and what was provided. Insufficient information, coupled with the use of medical jargon and time constraints, adversely affected the informed consent process. Enhancing clarity in communication and allowing adequate time for discussions could improve patient understanding and satisfaction.

Towards Personal Data Sharing Autonomy: A Task-driven Data Capsule Sharing System
Qiuyun Lyu, Yilong Zhou, Yizhi Ren, Zheng Wang, Yunchuan Guo
arXiv, August 2024
Abstract
Personal data custodian services enable data owners to share their data with data consumers in a convenient manner, anytime and anywhere. However, with data hosted in these services being beyond the control of the data owners, it raises significant concerns about privacy in personal data sharing. Many schemes have been proposed to realize fine-grained access control and privacy protection in data sharing. However, they fail to protect the rights of data owners to their data under the law, since their designs focus on the management of system administrators rather than enhancing the data owners’ privacy. In this paper, we introduce a novel task-driven personal data sharing system based on the data capsule paradigm realizing personal data sharing autonomy. It enables data owners in our system to fully control their data, and share it autonomously. Specifically, we present a tamper-resistant data capsule encapsulation method, where the data capsule is the minimal unit for independent and secure personal data storage and sharing. Additionally, to realize selective sharing and informed-consent based authorization, we propose a task-driven data sharing mechanism that is resistant to collusion and EDoS attacks. Furthermore, by updating parts of the data capsules, the permissions granted to data consumers can be immediately revoked. Finally, we conduct a security and performance analysis, proving that our scheme is correct, sound, and secure, as well as revealing more advantageous features in practicality, compared with the state-of-the-art schemes.

The research relationship: participant perspectives on consent in biobanking
Research Article
Rachel Thompson, Kate Lyle, Gabrielle Samuel, Jo Holliday, Fenella Starkey, Susan Wallace, Anneke Lucassen
BMC Medical Ethics, 26 August 2024
Abstract
Background
This paper examines the ethical challenges associated with the governance of large-scale biobanks. As the collection and interrogation of population-scale data is increasingly positioned as the route to new understandings of health and disease, these large-scale biobanks that rely on health research governance are becoming essential elements of research infrastructure. However, their longitudinal nature presents growing challenges for governance. Typically, health research governance uses a one-off consent model where participants agree to specific activities, but evolving technologies make it difficult to anticipate future research applications at the time of consent. Using a recent case study from UK Biobank, we demonstrate how trying to reconcile new research activities with old consent forms risks overlooking critical ethical issues —particularly how the proposed activity aligns with participants’ understanding and expectation of biobank research.
Methods
We report on our qualitative research with UK Biobank participants, conducting focus groups using individual and group exercises to explore their views on consent and research applications. We conducted thematic analysis of focus group transcripts applying both an inductive and deductive approach to coding, which was done using NVIVO qualitative data analysis software.
Results
Our findings show that participants locate responsibility for research decisions with the biobank, rather than seeking control through their consent. They perceive their consent not as a one-off agreement but as the ‘opening act’ for an enduring research relationship with the biobank.
Conclusions
Prioritising the ongoing research relationship and the practices that sustain it, rather than relying solely on consent procedures, can better support ethical research over time.

The First General Consent Implementation in Swiss Traditional Chinese Medicine Practices. A Prospective One-Year Study
Xiaying Wang, Xiaoying Lv, Bingjun Chen, Saroj Pradhan, Ralf Bauder, Yiming Li, Michael Furian
medRxiv, 20 August 2024
Abstract
Summary
Background
Traditional Chinese Medicine (TCM) encompasses a wide range of treatments focused on diagnosing and managing illnesses, with increasing adoption in Western countries. TCM is often applied in isolated practices, therefore, rigorous research and real-world data collection remain challenging. The implementation of the General Consent (GC) facilitates this research, therefore, the aim was to investigate the acceptance rate of the GC during the first year of its implementation in TCM practices.
Methods
This prospective cohort study was conducted from 1st January to 31st December 2023 in five TCM practices located in Bad Zurzach, Baden, Lenzburg, Wil, and Zug in Switzerland. GC, together with other registration forms, were sent to patients prior to their appointments, collected during their first visit, and recorded by clinic secretaries. Logistic regression analysis was performed to investigate demographic factors influencing GC acceptance, considering variables such as age, sex, and practice location.
Results
The study recorded 1,095 patients who sought TCM treatments in 2023, of which 73.6% returned a valid GC document. Overall, the GC acceptance rate was 611/1,095 (55.8%); of those returning the GC, the acceptance rate was 611/806 (75.8%). The median[IQR] age of patients was 52[37,64] years and female patients were twice as likely to seek TCM treatments compared to male patients. Logistic regression analysis, odds ratio (95%CI), revealed no difference in GC acceptance rate with older age: 1.015 (0.996 to 1.034), p=0.115; female sex: 1.847 (0.588 to 5.804), p=0.294 and age*female sex: 0.983 (0.962 to 1.004), p=0.119. Significant differences in GC acceptance rates were observed across the five TCM practices.
Conclusion
The GC implementation in TCM practices was feasible, and the GC was well accepted by patients, independent of sex and age. The observed practice-related differences in GC acceptance require further investigation. More TCM practices should implement the GC to enable practice-based TCM research.

Self-Sovereign Identity for Consented and Content-Based Access to Medical Records using Blockchain
Marie Tcholakian, Karolina Gorna, Maryline Laurent, Hella Kaffel Ben Ayed, Montassar Naghmouchi
arXiv, 31 July 2024
Abstract
Electronic Health Records (EHRs) and Medical Data are classified as personal data in every privacy law, meaning that any related service that includes processing such data must come with full security, confidentiality, privacy and accountability. Solutions for health data management, as in storing it, sharing and processing it, are emerging quickly and were significantly boosted by the Covid-19 pandemic that created a need to move things online. EHRs makes a crucial part of digital identity data, and the same digital identity trends — as in self sovereign identity powered by decentralized ledger technologies like Blockchain, are being researched or implemented in contexts managing digital interactions between health facilities, patients and health professionals. In this paper, we propose a blockchain-based solution enabling secure exchange of EHRs between different parties powered by a self-sovereign identity (SSI) wallet and decentralized identifiers. We also make use of a consortium IPFS network for off-chain storage and attribute-based encryption (ABE) to ensure data confidentiality and integrity. Through our solution, we grant users full control over their medical data, and enable them to securely share it in total confidentiality over secure communication channels between user wallets using encryption. We also use DIDs for better user privacy and limit any possible correlations or identification by using pairwise DIDs. Overall, combining this set of technologies guarantees secure exchange of EHRs, secure storage and management along with by-design features inherited from the technological stack.

LLM Doc: An Assessment of ChatGPT’s Ability to Consent Patients for IR Procedures
Research Article
Hayden Hofmann, Jenanan Vairavamurthy
CVIR Endovascular, 17 June 2024
Abstract
Purpose
The study aims to evaluate how current interventional radiologists view ChatGPT in the context of informed consent for interventional radiology (IR) procedures.
Methods
ChatGPT-4 was instructed to outline the risks, benefits, and alternatives for IR procedures. The outputs were reviewed by IR physicians to assess if outputs were 1) accurate, 2) comprehensive, 3) easy to understand, 4) written in a conversational tone, and 5) if they were comfortable providing the output to the patient. For each criterion, outputs were measured on a 5-point scale. Mean scores and percentage of physicians rating output as sufficient (4 or 5 on 5-point scale) were measured. A linear regression correlated mean rating with number of years in practice. Intraclass correlation coefficient(ICC) measured agreement among physicians.
Results
The mean rating of the ChatGPT responses was 4.29, 3.85, 4.15, 4.24, 3.82 for accuracy, comprehensiveness, readability, conversational tone, and physician comfort level, respectively. Percentage of physicians rating outputs as sufficient was 84%, 71%, 85%, 85%, and 67% for accuracy, comprehensiveness, readability, conversational tone, and physician comfort level, respectively. There was an inverse relationship between years in training and output score (coeff = -0.03413, p=0.0128); ICC measured 0.39 (p=0.003).
Conclusions
GPT-4 produced outputs that were accurate, understandable, and in a conversational tone. However, GPT-4 had a decreased capacity to produce a comprehensive output leading some physicians to be uncomfortable providing the output to patients. Practicing IRs should be aware of these limitations when counseling patients as ChatGPT-4 continues to develop into a clinically usable AI tool.

Emergency verbal consent for intrapartum research: a grounded theory study to explore its acceptability in a clinical trial of a novel device to treat postpartum haemorrhage
Bedwell C, Wendy Taylor, Caroline Cunningham, Andrew D Weeks, Dame Tina Lavender
Advance, 16 July 2024
Abstract
Objective
To understand the experiences of women, birth partners and health professionals of verbal followed by retrospective written consent in a prospective cohort study of a device to manage post-partum haemorrhage (PPH).
Design
Grounded Theory.
Setting
Tertiary facility in the North-West of England, UK.
Sample
We used purposive and theoretical sampling to recruit 51 participants; 12 women, 12 birth partners, 16 obstetricians and 11 midwives.
Methods
Semi-structured interviews were conducted, using a topic guide for focus, until data saturation was achieved. Data were analysed using framework analysis technique.
Results
Most women wanted sufficient information to make a decision at the time of the event, rather than in advance, and preferred not to be overwhelmed with detail. A key factor in making the decision to participate was a positive and trusting relationship with the attending obstetrician. Obtaining consent for research in emergencies was viewed by obstetricians as requiring a different approach and more challenging than consent for standard procedures in an emergency.
Conclusions
This is the first study to explore verbal followed by retrospective written consent processes with women, clinicians and observers. This was acceptable to all, however information needs to be appropriate, and consenters require adequate training.