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’).

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
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
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.