Evaluation of a group-based online informed consent conversation (eConsent) in participants from a low-risk vaccination clinical trial
Research
Ngoc H. Tan, Melvin Lafeber, Roos S. G. Sablerolles, Isabelle Veerman Roders, Anna van de Hoef, Karenin van Grafhorst, Leo G. Visser, Douwe F. Postma, Abraham Goorhuis, Wim J. R. Rietdijk, P. Hugo M. van der Kuy
Trials, 7 August 2024
Open Access
Abstract
Background
Electronic informed consent (eConsent) usage has expanded in recent years in Europe, especially during the pandemic. Slow recruitment rate and limitations in participant outreach are the challenges often faced in clinical research. Given the benefits of eConsent and group counselling reported in the literature, group eConsent was implemented in recruitment for the SWITCH-ON study. We aim to explore the experience of participants who attended group eConsent for the SWITCH-ON study and evaluate its potential for future use.
Methods
SWITCH-ON study aims to analyse the immunogenicity of a healthy population following bivalent COVID-19 booster vaccination. Four hundred thirty-four healthcare workers aged 18–65 were successfully recruited and sent a questionnaire about their experience with group eConsent. Out of 399 completed questionnaires (response rate 92%), 39 participants did not join group eConsent. The remaining 360 responses were included in the final analysis. Quantitative and qualitative data were reported using descriptive statistical analysis and thematic analysis respectively.
Results
Participants found that group eConsent was an efficient method that it allowed them to hear each other’s questions and concerns and created a sense of togetherness. However, limited privacy, barriers to asking questions in a group, and peer pressure can limit the use of group eConsent. One hundred sixty-five (46%) participants thought that group eConsent was suitable to recruit participants with diseases or conditions, while 87 (24%) reported limitations with this method. The remaining participants suggested that applicability of group eConsent depended on the diseases or conditions of the study population, and one-to-one conversation should always be available. Participants who had experienced both one-to-one and group eConsent shared different preferred consent formats for future studies.
Conclusion
Group eConsent was positively evaluated by the participants of a low-risk vaccination study. Participants advised using webinars to provide general information about the study, followed by an individual session for each participant, would retain the benefits of group eConsent and minimise the limitations it posed. This proposed setting addresses privacy questions and makes group eConsent easier to implement.
IRB Consent Guidelines: Potential Barriers to Diversity in Research
IRB Consent Guidelines: Potential Barriers to Diversity in Research
Research Article
Evan Decker, Tana Chongsuwat
Health Promotion Practice, 2 August 2024
Abstract
Despite initiatives aimed at improving study participation and inclusion among ethnic and racially minoritized and marginalized populations, participation remains low. While necessary to ensure ethical practice in human participant research, certain Institutional Review Board (IRB) guidelines may introduce additional barriers in research involving these populations. This work outlines guidelines pertaining to consent translation for non-English speaking populations and offers discussion on a greater emphasis for more inclusive methods for marginalized communities. The University of Wisconsin’s IRB approved alternative oral consent processes after the community partner determined that standard translation processes would be inefficient. Researchers used translated consent materials for four different ethnic groups (Hmong, Karen, Karenni, and Burmese). We provided recorded consents in each respective language to participants before study participation and obtained verbal consent prior to study participation at the study location. We experienced time and resource constraints in both access to translators and the consent-translation process itself. Furthermore, many participants were unable to read in their native language making standard written consent processes both difficult and impractical. Oral discussion and verbal consent processes were efficient. Adjustments to consent-related guidelines may prevent and eliminate time and resource-related barriers in consent processes. In eliminating such barriers, subsequent improved efficiency in both study design and study promotion areas can work to better promote diversity in research among populations that emphasize oral language and in instances where literacy rates in written non-English language may be lower.
Meaningful and Informed Consent and Satisfactory Education for Physicians Using AI in Radiology
Meaningful and Informed Consent and Satisfactory Education for Physicians Using AI in Radiology
Katerina Kapotas Tapas
Journal of Health Care Compliance, 2024
Abstract
The article explores the use of artificial intelligence (AI) in radiology and the challenges it poses in terms of transparency and understanding. It emphasizes the importance of human oversight and control over AI systems, as well as the principles of prudence, human autonomy, and responsibility. The article also highlights the need for informed consent and adequate education and training for physicians using AI. While AI has the potential to improve diagnostic accuracy and patient outcomes in radiology, ethical considerations must be carefully addressed. The text includes a list of sources and covers various topics related to Medicare Advantage, improper payments, compliance audits, online trackers, HIPAA compliance, challenges in healthcare operations, business formation, and compliance program fundamentals. It provides factual information and insights without expressing personal judgments or opinions.
Safeguarding Data Privacy and Informed Consent: Ethical Imperatives in AI-Driven Mental Healthcare
Safeguarding Data Privacy and Informed Consent: Ethical Imperatives in AI-Driven Mental Healthcare
Souvik Dhar, Utsa Sarkar
Intersections of Law and Computational Intelligence in Health Governance, 2024 [IGI Global]
Abstract
This chapter explores the ethical challenges surrounding data privacy and informed consent in artificial intelligence (AI)-driven mental healthcare in India. The integration of AI technologies in mental health services offers potential for enhanced patient outcomes, but also raises significant ethical issues. Emphasizing patient autonomy and the protection of personal information, the chapter examines the complexities of informed consent and data privacy. It highlights the importance of transparent communication and robust regulatory frameworks to safeguard patient rights. By analysing key principles and the Digital Personal Data Protection Act 2023, the chapter provides insights into balancing technological advancements with ethical imperatives. It advocates for comprehensive ethical guidelines and collaborative efforts among stakeholders to foster a responsible and patient-centred AI-driven mental healthcare system. The chapter emphasizes the need for education on AI’s impact, potential biases, and the significance of maintaining trust and accountability in patient care.
Privacy, Data Protection and Data-driven Technologies
Privacy, Data Protection and Data-driven Technologies
Book
Martin Ebers, Karin Sein
Routledge, 2025
Description
This book brings together contributions from leading scholars in law and technology, analysing the privacy issues raised by new data-driven technologies. Highlighting the challenges that technology poses to existing European Union (EU) data protection laws, the book assesses whether current legal frameworks are fit for purpose, while maintaining a balance between supporting innovation and the protection of individual’s privacy. Data privacy issues range from targeted advertising and facial recognition, systems based on artificial intelligence (AI) and blockchain, and machine-to-machine (M2M) communication, to technologies that enable the detection of emotions and personal care robots. The book will be of interest to scholars, policymakers and practitioners working in the fields of law and technology, EU law and data protection
[Chapters Relating to Consent]
Part II: Consent, Data Protection and New Technologies
Chapter 2: Dark Patterns and the Scraping Consumer Consent: Comparative Remarks on More Effective Legal Compliance, Giorgia Guerra
Chapter 3: The Consent Service in Estonia: Enhancement of State-held Data Sharing vs Privacy Risks, Karin Sein
Chapter 4: Consent to Data Processing in Biobanking: Regulatory Challenges of Data Processing in Biobanking, Using the Estonian Example, Kärt Pormeister
Retrospective Radiology Research: Do We Need Informed Patient Consent?
Retrospective Radiology Research: Do We Need Informed Patient Consent?
Original Research
Yfke Ongena, Thomas C. Kwee, Derya Yakar, Marieke Haan
Journal of Bioethical Inquiry, 19 August 2024
Open Access
Abstract
While knowledge of the population’s view on the need for informed consent for retrospective radiology research may provide valuable insight into how an optimal balance can be achieved between patient rights versus an expedited advancement of radiology science, this is a topic that has been ignored in the literature so far. To investigate the view of the general population, survey data were collected from 2407 people representative of the Dutch population. The results indicate that for non-commercial institutions, especially hospitals (97.4 per cent), respondents agree with the retrospective use of imaging data, although they generally indicate that their explicit consent is required. However, most respondents (63.5 per cent) would never allow commercial firms to retrospectively use their imaging data. When including only respondents who completed the minimally required reading time of 12.3 s to understand the description about retrospective radiology research given in the survey (n = 770), almost all (98.9 per cent) mentioned to have no objections for their imaging data to be used by hospitals for retrospective research, with 57.9 per cent indicating their consent to be required and 41.0 per cent indicating that explicit patient consent to be unnecessary. We conclude that the general population permits retrospective radiology research by hospitals, and a substantial proportion indicates explicit patient consent to be unnecessary when understanding what retrospective radiology research entails. However, the general population’s support for the unrestricted retrospective use of imaging data for research purposes without patient consent decreases for universities not linked to hospitals, other non-commercial institutions, government agencies, and particularly commercial firms.
Statistical Analysis of Abilities to Give Consent to Health Data Processing
Statistical Analysis of Abilities to Give Consent to Health Data Processing
Antonella Massari, Biagio Solarino, Paola Perchinunno, Angela Maria D’Uggento, Marcello Benevento, Viviana D’Addosio, Vittoria Claudia De Nicolò, Samuela L’Abbate
Applied Mathematics, August 2024
Abstract
The recent pandemic crisis has highlighted the importance of the availability and management of health data to respond quickly and effectively to health emergencies, while respecting the fundamental rights of every individual. In this context, it is essential to find a balance between the protection of privacy and the safeguarding of public health, using tools that guarantee transparency and consent to the processing of data by the population. This work, starting from a pilot investigation conducted in the Polyclinic of Bari as part of the Horizon Europe Seeds project entitled “Multidisciplinary analysis of technological tracing models of contagion: the protection of rights in the management of health data”, has the objective of promoting greater patient awareness regarding the processing of their health data and the protection of privacy. The methodology used the PHICAT (Personal Health Information Competence Assessment Tool) as a tool and, through the administration of a questionnaire, the aim was to evaluate the patients’ ability to express their consent to the release and processing of health data. The results that emerged were analyzed in relation to the 4 domains in which the process is divided which allows evaluating the patients’ ability to express a conscious choice and, also, in relation to the socio-demographic and clinical characteristics of the patients themselves. This study can contribute to understanding patients’ ability to give their consent and improve information regarding the management of health data by increasing confidence in granting the use of their data for research and clinical management.
Dynamic governance: A new era for consent for stem cell research
Dynamic governance: A new era for consent for stem cell research
Perspective
Rosario Isasi, Heidi B. Bentzen, Morris Fabbri, Antonie Fuhr, Joel C. Glover, Nancy Mah, Deborah Mascalzoni, Sabine Mueller, Stefanie Seltmann, Andreas Kurtz
Stem Cell Reports, 15 August 2024
Open Access
Summary
Governance infrastructures streamline scientific and ethical provenance verification of human pluripotent stem cell (SC) lines. Yet, scientific developments (e.g., SC-derived embryo models, organoids) challenge research governance approaches to stored biospecimens, questioning the validity of informed consent (IC) models. Likewise, e-health platforms are driving major transformations in data processing, prompting a reappraisal of IC. Given these developments, participatory research platforms are identified as effective tools to promote longitudinal engagement, interactive decision-making, and dynamic governance. Learning from European initiatives piloting dynamic IC for biobanking and SC research, this Perspective explores the benefits and challenges of implementing dynamic IC and governance for SC.
Consent to Data Processing in Biobanking: Regulatory Challenges of Data Processing in Biobanking, Using the Estonian Example
Consent to Data Processing in Biobanking: Regulatory Challenges of Data Processing in Biobanking, Using the Estonian Example
Book Chapter
Kärt Pormeister
Privacy, Data Protection and Data-driven Technologies, 2024 [Taylor&Francis]
Abstract
Under European Union (EU) data protection law, consent can generally only be relied upon as a legal basis for processing personal data if the consent has been given for one or more specified purposes. The fact is that in the world of scientific research, this is not always possible or feasible, is recognized in the recitals of the General Data Protection Regulation. Unfortunately, the European Data Protection Board has rendered this recognition in the recitals effectively moot by maintaining that even in research, a broader consent to data processing could only go as far as to cover multiple pre-defined projects, but not undefined future projects. This ‘one-size-fits-all’ stance on consent to data processing is a problem for biobanks, the existence and data processing purposes of which cannot be confined to pre-defined research projects. In the first part of this chapter, the author explores the evolution of consent to data processing for research purposes in EU data protection law and the interpretations given to it by a number of data protection institutions, and contrasts these to other emerging regulatory regimes within the EU concerning the (secondary) research use of personal data. In the second half of the chapter, the author exemplifies the previously explored theoretical problems using the Estonian Biobank as a practical example.
Genomic sequencing in newborn screening: balancing consent with the right of the asymptomatic at-risk child to be found
Genomic sequencing in newborn screening: balancing consent with the right of the asymptomatic at-risk child to be found
Bartha Maria Knoppers, Ana Eliza Bonilha, Anne-Marie Laberge, Arzoo Ahmed, Ainsley J. Newson
European Journal of Human Genetics, 12 August 2024
Open Access
Abstract
In this paper, we explore key aspects of the complex ethical and legal landscape surrounding consent in the context of incorporating genomic sequencing into existing newborn bloodspot screening programs. In particular, we consider the potential impact of genomic sequencing on the health rights of the child in relation to existing consent practices in newborn screening. We begin with an introduction to newborn screening programs and their population health goals. We then discuss public health ethics as a rationale underpinning newborn screening before turning to consent. We go on to describe seven current research projects on genomic sequencing in newborn screening and then introduce the ‘right of the asymptomatic at-risk child to be found’ as a useful concept to draw on when considering consent to newborn screening. We draw on this novel right to argue for the adoption of “appropriate consent” when it comes to certain uses of genomics in newborn screening. We contend that, for ‘virtual panels’ at least, appropriate consent proportionately balances the ongoing universality of newborn screening for important health conditions with an acknowledgement of the complex outcomes that bringing a complicated diagnostic technology into the screening domain will generate.
Editor’s Note: After assessing the observations and arguments made in this paper, we are reaching out to the corresponding author for clarification.
Center for Informed Consent Integrity 