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.

Online unsupervised performance-based cognitive testing: a feasible and reliable approach to scalable cognitive phenotyping of Parkinson’s patients
Nasri Balit, Sophie Sun, Yilin Zhang, Madeleine Sharp
MedRxiv, 5 July 2024
Abstract
Introduction
A better understanding of the heterogeneity in the cognitive and mood symptoms of Parkinson’s disease will require research conducted in large samples of patients. Fully online and remote research assessments present interesting opportunities for scaling up research but the feasibility and reliability of remote and fully unsupervised performance-based cognitive testing in individuals with Parkinson’s disease is unknown. This study aims to establish the feasibility and reliability of this testing modality in Parkinson’s patients.
Methods
Sixty-seven Parkinson’s patients and 36 older adults completed two sessions of an at-home, online battery of five cognitive tasks and three self-report questionnaires. Feasibility was established by examining completion rates and data quality. Test-retest reliability was evaluated using the Intraclass Correlation Coefficient (ICC (2,1)).
Results
Overall completion rates and data quality were high with few participant exclusions across tasks. With regards to test-retest reliability, intraclass correlation coefficients were quite variable across measures extracted from a task as well as across tasks, but at least one standard measure from each task achieved moderate to good reliability levels. Self-report questionnaires achieved a higher test-retest reliability than cognitive tasks. Feasibility and reliability were similar between Parkinson’s patients and older adults.
Conclusion
These results demonstrate that remote and unsupervised testing is a feasible and reliable method of measuring cognition and mood in Parkinson’s patients that achieves levels of test-retest reliability that are comparable to those reported for standard in-person testing.

Designing Value-Centered Consent Interfaces: A Mixed-Methods Approach to Support Patient Values in Data-Sharing Decisions
David Leimstädtner, Peter Sörries, Claudia Müller-Birn
arXiv, 4 July 2024
Abstract
In the digital health domain, ethical data collection practices are crucial for ensuring the availability of quality datasets that drive medical advancement. Data donation, allowing patients to share their clinical data for secondary research use, presents a promising resource for such datasets. Yet, current consent interfaces mediating data-sharing decisions are found to favor data-collectors’ values by leveraging cognitive biases in data-subjects towards higher data-sharing rates. Seeking to establish patient-centered data collection practices in digital health, we investigate the design of consent interfaces that support end-users in making valuecongruent health data-sharing decisions. Focusing our research efforts on the situated context of health data donation at the psychosomatic unit of a German university hospital, we demonstrate how a human-centered design can ground technology within the perspective of a vulnerable group. We employed an exploratory sequential mixed-method approach consisting of five phases: (1) Participatory workshops explore patient values, informing the (2) design of a proposed Value-Centered Consent Interface. A (3) online experiment demonstrates our interface element’s effect, increasing value-congruence in data-sharing decisions. Our proposed consent interface design is then adapted to the research context through a (4) co-creation workshop with subject experts and (5) a user evaluation with patients. Our work contributes to recent discourse in CSCW concerning ethical implications of new data practices within their socio-technological context by exploring patient values on medical data sharing, introducing a novel consent interface leveraging reflection to support value-congruent decision-making, and providing a situated evaluation of the proposed consent interface with patients.

Consent Considerations for Generation and Sharing of Genomic Data
Review
Charles D. Warden
Preprints.org, 25 June 2024
Abstract
It is important to consider both requirements and limitations for the generation and sharing of genomic data. For example, human genomic sequence data should typically not be deposited publicly without the appropriate “explicit consent” to do so. This includes genetic identifying data that may exist within raw reads for bulk RNA Sequencing (RNA-Seq) data and genomic data from cell lines that are available to purchase. At the same time, data sharing is important for re-analysis and reproducibility/replication in the scientific community. A review of known rules and guidelines for genomic data sharing is provided. This includes specific rules for NIH-funded data for controlled access deposit of HeLa cell line data, including bulk RNASeq data. The ability to create “partial” Gene Expression Omnibus (GEO) public deposits with only processed data is described, with search criteria that can identify many “partial” GEO deposits for a variety of data types where reads were not made public for patient privacy concerns. However, it is the opinion of the author that this should be considered a short-term solution, and additional considerations and action should be carried out for genomic data generated in future experiments. Information about how to learn more about what is known for consent for cell line samples is also briefly provided, along with search results for genomic data from widely available cell lines that is deposited in controlled access databases. Finally, it should be made clear that this article presents some amount of opinion. Additionally, open feedback for this preprint is encouraged to further enhance knowledge and communication.

Informed Consent Practices Among Emergency Staff for Patients Undergoing Emergency Surgery in the Emergency Surgical Units of Two Tertiary Teaching Hospitals in Uganda: A Qualitative Study
Research Article
Olivia Kituuka, Ian Munabi, Moses Galukande, Adelline Twimukye, Erisa Mwaka
BMC Medical Ethics, 25 June 2024
Abstract
Background
Staff in low resourced emergency units of a low-income country face the challenge of obtaining informed consent for incapacitated patients or their next of kin in a time-constrained situation often in an overcrowded environment. Therefore, we aimed to establish the informed consent practices for emergency surgical care among healthcare professional at two emergency surgical units at two tertiary teaching hospitals in Uganda.
Methods
In October 2022 – February 2023we conducted key informant interviews in Uganda and purposively selected 16 staff in surgical emergency units at two tertiary teaching hospitals and directly observed the informed consent practices. Data was managed and analyzed inductively using NVivo version 12.
Results
Six themes emerged from key informant interviews including knowledge and perspectives no informed consent; processes, procedures, and practices regarding informed consent; communication strategies for informed consent; ethical considerations; benefits of informed consent during surgery; and challenges to emergency informed consent. Staff had adequate knowledge about informed consent but faced several challenges during the consent process due to lack of guiding institutional policies. Overall, the informed consent process was inadequate at both institutions with greeting of patients, disclosure of risks and assessment of understanding poorly done. Consent was conducted in a noisy environment at both institutions and there was no privacy in the public hospital.
Conclusion
Although knowledge about consent practices by emergency staff at both institutions was good, in practice there was inadequate disclosure of risks, inadequate knowledge about the surgical procedure, risks, and benefits. Emergency staff identified the need for procedure specific consent documents which capture the information that is given to the patient and guiding policies on consent for incapacitated patients who have no surrogates.