Comparing Attitudes Toward Different Consent Mediums: Semistructured Qualitative Study
Xengie Doan, Arianna Rossi, Marietjie Botes,  Annika Selzer
JMIR Human Factors, 30 April 2024
Abstract
Background
As consent for data sharing evolves with the digital age, plain-text consent is not the only format in which information can be presented. However, designing a good consent form is highly challenging. The addition of graphics, video, and other mediums to use can vary widely in effectiveness; and improper use can be detrimental to users.
Objective
This study aims to explore the expectations and experiences of adults toward consent given in infographic, video, text, newsletter, and comic forms in a health data sharing scenario to better understand the appropriateness of different mediums and identify elements of each medium that most affect engagement with the content.
Methods
We designed mock consent forms in infographic, video, text, newsletter, and comic versions. Semistructured interviews were conducted with adults who were interviewed about their expectations for consent and were then shown each consent medium and asked about engaging elements across mediums, preferences for consent mediums, and the value of document quality criteria. We transcribed and qualitatively co-coded to identify themes and perform analyses.
Results
We interviewed 24 users and identified different thematic archetypes based on participant goals, such as the Trust Seeker, who considered their own understanding and trust in organizations when making decisions. The infographic was ranked first for enhancing understanding, prioritizing information, and maintaining the proper audience fit for serious consent in health data sharing scenarios. In addition, specific elements such as structure, step-by-step organization, and readability were preferred engaging elements.
Conclusions
We identified archetypes to better understand user needs and elements that can be targeted to enhance user engagement with consent forms; this can help inform the design of more effective consent in the future. Overall, preferences for mediums are highly contextual, and more research should be done.

From opt-out to opt-in consent for secondary use of medical data and residual biomaterial: An evaluation using the RE-AIM framework
Research Article
Jennifer E. Lutomski, Peggy Manders
PLOS One, 28 March 2024
Open Access
Abstract
Background
Patient records, imaging, and residual biomaterial from clinical procedures are crucial resources for medical research. In the Netherlands, consent for secondary research has historically relied on opt-out consent. For ethical-legal experts who purport passive consent undermines patient autonomy, opt-in consent (wherein affirmative action is required) is seen as the preferred standard. To date, there is little empirical research exploring patient feasibility, organizational consequences, and the potential risks for research based on secondary data. Thus, we applied the RE-AIM framework to evaluate the impact of migrating from an opt-out to an opt-in consent process.
Methods
This evaluation was carried out in Radboud University Medical Center, a large tertiary hospital located in the southeast of the Netherlands. All non-acute, mentally competent patients ≥16 years of age registered between January 13, 2020 and June 30, 2023 were targeted (N = 101,437). In line with the RE-AIM framework, individual and organizational consequences were evaluated across five domains: reach, efficacy, adoption, implementation, and maintenance.
Results
101,437 eligible patients were approached of whom 66,214 (65.3%) consented, 8,059 (7.9%) refused consent and 27,164 (26.8%) had no response. Of the 74,273 patients with a response, 89.1% consented to secondary use. The migration to an opt-in consent system was modestly successful; yet notably, differential response patterns by key sociodemographic characteristics were observed. Adaptions to the process flow improved its effectiveness and resulted in a reasonable response over time. Implementation was most affected by budgetary restraints, thus impeding the iterative approach which could have further improved domain outcomes.
Conclusion
This evaluation provides an overview of logistical and pragmatic issues encountered when migrating from opt-out to opt-in consent. Response bias remains a major concern. Though not always directly transferable, these lessons can be broadly used to inform other health care organizations of the potential advantages and pitfalls of an opt-in consent system.

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.

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.

The Effects of Placement and Order on Consent to Data Linkage in a Web survey
Jonathan Burton, Mick P Couper, Annette Jäckle
Journal of Survey Statistics and Methodology, 24 February 2024
Abstract
We report on an experiment in a supplemental web survey as part of a longitudinal study in the United Kingdom where we ask survey respondents to consent to two forms of data linkage to health records and to consent to be mailed a serology kit. We varied the placement (early, early in context, or late in the survey) and order (linkage first or serology first) of the consent requests. We also examine reasons for consent or non-consent. We find that order of the requests does not make much difference, but making the requests early in the survey significantly increases consent rates over asking them after a series of content-related questions (by 3.4 percentage points) or later in the survey (by 7.2 percentage points). This is consistent with previous research showing that early requests for consent in a survey have a positive effect. The main reason chosen for not consenting related to the personal nature of the information requested.