Attitude towards consent-free research use of personal medical data in the general German population
Research Article
Gesine Richter, Nourane Trigui, Amke Caliebe, Michael Krawczak
Heliyon, 30 March 2024; 10(6)
Open Access
Abstract
Background
The design of appropriate consent procedures for the secondary use of personal health data is a key concern of current medical research. In Germany, the concept of ‘data donation’ has recently come into focus, defined as a legal entitlement to the research use of personal medical data without prior consent, combined with an easy-to-exercise right of the data subjects to opt-out.
Methods
Standardized online interviews of 3,013 individuals, representative of the German online population, were conducted in
August 2022 to determine their attitude towards data donation for medical research.
Results
A majority of participants supported a consent-free data donation regulation, both for publicly funded (85.1%) and for private medical research (66.4%). Major predictors of a positive attitude towards data donation included (i) sufficient appreciation of the respective kind of research (i.e. public or private), (ii) a reciprocity attitude that patients who benefit from research have a duty to support research, and (iii) sufficient trust in data protection and data control.
Conclusion
People’s attitude towards data donation to medical research is generally positive in Germany and depends upon factors that can be curbed by legislation and internal rules of procedure. Worthy of note, designing data donation in the form of an opt-out regulation does not necessarily mean that the paradigm of informedness has to be abandoned. Rather the process of information provision must be shifted towards the creation of basic knowledge in the general population about the risks and benefits of data-intensive medical research (‘health data literacy’).
Month: April 2024
Beware: Processing of Personal Data—Informed Consent Through Risk Communication
Beware: Processing of Personal Data—Informed Consent Through Risk Communication
Lukas Seiling, Rita Gsenger, Filmona Mulugeta, Marte Henningsen, Lena Mischau, Marie Schirmbeck
IEEE, 14 March 2024
Open Access
Abstract
Background
The General Data Protection Regulation (GDPR) has been applicable since May 2018 and aims to further harmonize data protection law in the European Union. Processing personal data based on individuals’ consent is lawful under the GDPR only if such consent meets certain requirements and is “informed,” in particular. However, complex privacy notice design and individual cognitive limitations challenge data subjects’ ability to make elaborate consent decisions. Risk-based communication may address these issues.
Literature review
Most research focuses on isolated aspects of risk in processing personal data, such as the actors involved, specific events leading to risk formation, or distinctive (context-dependent) consequences. We propose a model combining these approaches as the basis for context-independent risk communication.
Research questions
1.What are relevant information categories for risk communication in the processing of personal data online? 2. Which potentially adverse consequences can arise from specific events in the processing of personal data online? 3. How can consequences in the processing of personal data be avoided or mitigated?
Research methodology
The GDPR was examined through a systematic qualitative content analysis. The results inform the analysis of 32 interviews with privacy, data protection, and information security experts from academia, Non-Governmental Organizations, the public, and the private sector.
Results
Risk-relevant information categories, specific consequences, and relations between them are identified, along with strategies for risk mitigation. The study concludes with a specified framework for perceived risk in processing personal data.
Conclusion
The results provide controllers, regulatory bodies, data subjects, and experts in the field of professional communication with information on risk formation in personal data processing. Based on our analysis, we propose information categories for risk communication, which expand the current regulatory information requirements.
Consent as a compositional act – a framework that provides clarity for the retention and use of data
Consent as a compositional act – a framework that provides clarity for the retention and use of data
Research
Minerva C. Rivas Velarde, Christian Lovis, Marcello Ienca, Caroline. Samer, Samia Hurst
Philosophy, Ethics, and Humanities in Medicine, 6 March 2024
Open Access
Abstract
Background
Informed consent is one of the key principles of conducting research involving humans. When research participants give consent, they perform an act in which they utter, write or otherwise provide an authorisation to somebody to do something. This paper proposes a new understanding of the informed consent as a compositional act. This conceptualisation departs from a modular conceptualisation of informed consent procedures.
Methods
This paper is a conceptual analysis that explores what consent is and what it does or does not do. It presents a framework that explores the basic elements of consent and breaks it down into its component parts. It analyses the consent act by first identifying its basic elements, namely: a) data subjects or legal representative that provides the authorisation of consent; b) a specific thing that is being consented to; and c) specific agent(s) to whom the consent is given.
Results
This paper presents a framework that explores the basic elements of consent and breaks it down into its component parts. It goes beyond only providing choices to potential research participants; it explains the rationale of those choices or consenting acts that are taking place when speaking or writing an authorisation to do something to somebody.
Conclusions
We argue that by clearly differentiating the goals, the procedures of implementation, and what is being done or undone when one consent, one can better face the challenges of contemporary data-intensive biomedical research, particularly regarding the retention and use of data. Conceptualising consent as a compositional act enhances more efficient communication and accountability and, therefore, could enable more trustworthy acts of consent in biomedical science.
Ethical considerations in healthcare IT: A review of data privacy and patient consent issues
Ethical considerations in healthcare IT: A review of data privacy and patient consent issues
Review Article
Adekunle Oyeyemi Adeniyi, Jeremiah Olawumi Arowoogun, Chioma Anthonia Okolo, Rawlings Chidi, Oloruntoba Babawarun
World Journal of Advanced Research and Reviews, 22 February 2024; 21(02) pp 1660–1668
Abstract
This paper delves into the ethical considerations in healthcare Information Technology (IT), focusing on data privacy and patient consent issues. It explores the intersection of technological advancements in healthcare IT and the ethical imperatives guiding their application, specifically examining challenges in ensuring data privacy and obtaining informed consent amidst the complexities introduced by digital health technologies. Through a review of existing ethical theories, regulatory frameworks, and the implications of artificial intelligence (AI) and big data, the paper highlights technological solutions and policy recommendations to address these ethical challenges. It emphasizes the importance of balancing innovation with ethical considerations to protect patient rights and maintain trust in the healthcare system. The paper advocates for ongoing research and stakeholder engagement to evolve ethical standards aligned with technological advancements in healthcare IT.
Data Privacy and E-Consent in the Public Sector
Data Privacy and E-Consent in the Public Sector
Book Chapter
Abhay Bhatia, Anil Kumar, Pankhuri Bhatia
The Ethical Frontier of AI and Data Analysis, 2024 [IGI Global]
Abstract
In the era of the internet, all face administrative and legal responsibilities obtaining informed consent and safeguarding personal information, with the public growing mistrust to data collection. Moral consent management takes place in account of person’s views, subjective norms, and sense of control. When obtaining consent, this chapter aims to combat this cynicism. It accomplishes this by creating a novel conceptual model of online informed consent that combines the TPB with the autonomous authorisation model of informed consent. It is argued logically and is bolstered. As a result, it develops a model for online informed consent that is based on the ethic of autonomy and makes use of theory based on behaviour to enable a method of eliciting agreement that can put interest of users first and then promotes moral the information management and the marketing techniques. This approach also presents an innovative idea, the informed attitude for the validity of informed consent. It also indicates that informed permission may be given against.
Optimizing the consent process for emergent laparoscopic cholecystectomy using an interactive digital education platform: a randomized control trial
Optimizing the consent process for emergent laparoscopic cholecystectomy using an interactive digital education platform: a randomized control trial
Anood Alqaydi, Erin Williams, Sulaiman Nanji, Boris Zevin
Surgical Endoscopy, 18 March 2024
Abstract
Background
Informed consent is essential for any surgery. The use of digital education platforms (DEPs) can enhance patient understanding of the consent discussion and is a method to standardize the consent process in elective, ambulatory settings. The use of DEP as an adjunct to standard verbal consent (SVC) has not been studied in an acute care setting.
Methods
We conducted a prospective randomized control trial with patients presenting to the emergency department of a tertiary care hospital with acute biliary pathology requiring a laparoscopic cholecystectomy (LC) between August 2021 and April 2023. Participants were randomized 1:1 to receive either a DEP module with SVC or SVC alone. Baseline procedure-specific knowledge and self-reported understanding of risks and benefits of LC were collected using a questionnaire. Primary outcome was immediate post-intervention knowledge assessed using a 21-question multiple choice questionnaire. Secondary outcomes were delayed procedure-specific knowledge and participants’ satisfaction with the consent discussion.
Results
We recruited 79 participants and randomized them 1:1 into the intervention group (DEP + SVC, n = 40) and the control group (SVC, n = 39). Baseline demographics and baseline procedure-specific knowledge were similar between groups. The immediate post-intervention knowledge was significantly higher for participants in the intervention versus the control group with a Cohen’s d effect size of 0.68 (85.2(10.6)% vs. 78.2(9.9)%; p = 0.004). Similarly, self-reported understanding of risks and benefits of LC was significantly greater for participants in the intervention versus the control group with a Cohen’s effect size of 0.76 (68.5(16.4)% vs. 55.1(18.8)%; p = 0.001). For participants who completed the delayed post-intervention assessment (n = 29), there continued to be significantly higher retention of acquired knowledge in the intervention group with a Cohen’s effect size of 0.61 (86.5(8.5)% vs. 79.8 (13.1)%; p = 0.024). There was no difference in participants’ self-reported satisfaction with the consent discussion between groups (69.5(6.7)% vs. 67.2(7.7)%; p = 0.149).
Conclusion
The addition of digital education platform to standard verbal consent significantly improves patient’s early and delayed understanding of risks and benefits of LC in an acute care setting.
Assessing the impact of mixed reality-assisted informed consent: A study protocol
Assessing the impact of mixed reality-assisted informed consent: A study protocol
Gianluca Scalia, Stefano Maria Priola, Sruthi Ranganathan, Tejas Venkataram, Valeria Orestano, Salvatore Marrone, Bipin Chaurasia, Rosario Maugeri, Domenico Gerardo Iacopino, Lidia Strigari, Maurizio Salvati, Giuseppe Emmanuele Umana
Surgical Neurology International, March 2024
Abstract
Background Informed consent is a crucial aspect of modern medicine, but it can be challenging due to the complexity of the information involved. Mixed reality (MR) has emerged as a promising technology to improve communication. However, there is a lack of comprehensive research on the impact of MR on medical informed consent. The proposed research protocol provides a solid foundation for conducting future investigations and developing MR-based protocols that can enhance patients’ understanding and engagement in the decision-making process.
Methods
This study will employ a randomized controlled trial design. Two arms will be defined: MR-assisted informed consent (MRaIC) as the experimental arm and conventional informed consent (CIC) as the control arm consent, with 52 patients in each group. The protocol includes the use of questionnaires to analyze the anxiety levels and the awareness of the procedure that the patient is going to perform to study the impact of MRaIC versus CIC before medical procedures.
Results
The study will evaluate the impact of MR on patients’ information comprehension, engagement during the process of obtaining informed consent, emotional reactions, and consent decisions. Ethical concerns will be addressed.
Conclusion
This study protocol provides a comprehensive approach to investigate the impact of MR on medical informed consent. The findings may contribute to a better understanding of the effects of MR on information comprehension, engagement during the process of obtaining informed consent, psychological experience, consent decisions, and ethical considerations. The integration of MR technology has the potential to enhance surgical communication practices and improve the informed consent process.
Trust-Building: Why Virtual Formats Threaten the Moral Ends of Surgical Informed Consent
Trust-Building: Why Virtual Formats Threaten the Moral Ends of Surgical Informed Consent
John H. Lee, Katherine E. Neff, Christian J. Vercler
Annals of Surgery, Surgical Perspectives, 26 February 2024
Abstract
The COVID-19 pandemic forced a wide range of medical practices to virtual formats, including the preoperative informed consent practice. However, virtual informed consent persists despite the pandemic largely considered resolved. The continued use of virtual formats relies on a problematic “information-transfer” model of informed consent. We suggest that a “trust-building” model of consent as a better conceptualization of what is occurring during the consent process. Highlighting how virtual formats might fail to fulfill this fuller understanding of consent on both interpersonal and systemic levels, we offer up an ethical structure for physicians to navigate this novel virtual space.
Gillick competence: an inadequate guide to the ethics of involving adolescents in decision-making
Gillick competence: an inadequate guide to the ethics of involving adolescents in decision-making
Clinical ethics
Avraham Bart, Georgina Antonia Hall, Lynn Gillam
Journal of Medical Ethics, 20 February 2024
Abstract
Developmentally, adolescence sits in transition between childhood and adulthood. Involving adolescents in their medical decision-making prompts important and complex ethical questions. Originating in the UK, the concept of Gillick competence is a dominant framework for navigating adolescent medical decision-making from legal, ethical and clinical perspectives and is commonly treated as comprehensive. In this paper, we argue that its utility is far more limited, and hence over-reliance on Gillick risks undermining rather than promoting ethically appropriate adolescent involvement. We demonstrate that Gillick only provides guidance in the limited range of cases where legal decisional authority needs to be clarified. The range of cases where use of Gillick actually promotes adolescent involvement is narrower still, because several features must be present for Gillick to be enacted. Each of these features can, and do, act as barriers to adolescent involvement. Within these limited situations, we argue that Gillick is not specific or strong enough and is reliant on ethically contestable principles. Moreover, in most situations in adolescent healthcare, Gillick is silent on the ethical questions around involving adolescents. This is because it focuses on decisional authority—having the final say in decision-making—which is one small subset of the many ways adolescents could be involved in decision-making. The implication of our analysis is that use of Gillick competence tends to limit or undermine adolescent involvement opportunities. We propose that those working with adolescents should be judicious in seeking Gillick’s guidance, instead drawing on and developing alternative frameworks that provide a comprehensive model for adolescent involvement.
Evaluating the Decisional Capacity for Informed Consent of Transition age Children to Adolescents in Human Subject Research
Evaluating the Decisional Capacity for Informed Consent of Transition age Children to Adolescents in Human Subject Research
Research Article
Kamran Salayev, Ulviyya Aslanova, Kerim Munir
Journal of Empirical Research on Human Research Ethics, 10 December 2023
Abstract
This study aimed to evaluate children’s capacity for informed consent. We translated into Azerbaijani language and adapted the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC). We enrolled four healthy groups: children aged 11, 12, and 13 years and adults. We provided the participants with information about the simulated research proposal and a related informed consent form. Subsequently, they were administered the UBACC. The mean total UBACC scores were 11.9 (11-year-olds), 12.7 (12-year-olds), 14.0 (13-year-olds), and 16.0 (adults). The gradual increase in the mean UBACC scores with age suggests the continuous maturation of the capacity to comprehend the informed consent process. There was no specific cutoff age to decide whether the children were competent enough to provide informed consent.
Center for Informed Consent Integrity 