Technological Adjuncts to Streamline Patient Recruitment, Informed Consent, and Data Management Processes in Clinical Research: Observational Study
Jodie Koh, Stacey Caron, Amber N Watters, Mahesh Vaidyanathan, David Melnick, Alyssa Santi, Kenneth Hudson, Catherine Arguelles, Priyanka Mathur, Mozziyar Etemadi
JMIR Formative Research, 29 January 2025
Abstract
Background
Patient recruitment and data management are laborious, resource-intensive aspects of clinical research that often dictate whether the successful completion of studies is possible. Technological advances present opportunities for streamlining these processes, thus improving completion rates for clinical research studies.
Objective
This paper aims to demonstrate how technological adjuncts can enhance clinical research processes via automation and digital integration.
Methods
Using one clinical research study as an example, we highlighted the use of technological adjuncts to automate and streamline research processes across various digital platforms, including a centralized database of electronic medical records (enterprise data warehouse [EDW]); a clinical research data management tool (REDCap [Research Electronic Data Capture]); and a locally managed, Health Insurance Portability and Accountability Act–compliant server. Eligible participants were identified through automated queries in the EDW, after which they received personalized email invitations with digital consent forms. After digital consent, patient data were transferred to a single Health Insurance Portability and Accountability Act–compliant server where each participant was assigned a unique QR code to facilitate data collection and integration. After the research study visit, data obtained were associated with existing electronic medical record data for each participant via a QR code system that collated participant consent, imaging data, and associated clinical data according to a unique examination ID.
Results
Over a 19-month period, automated EDW queries identified 20,988 eligible patients, and 10,582 patients received personalized email invitations. In total, 1000 (9.45%) patients signed consents to participate in the study. Of the consented patients, 549 unique patients completed 779 study visits; some patients consented to the study at more than 1 time period during their pregnancy.
Conclusions
Technological adjuncts in clinical research decrease human labor while increasing participant reach and minimizing disruptions to clinic operations. Automating portions of the clinical research process benefits clinical research efforts by expanding and optimizing participant reach while reducing the limitations of labor and time in completing research studies.

Examining Trust and Consent Models for Patient-Generated Health Data-sharing and Incentives
Brian Thoms, Nathan Botts, Evren Eryilmaz
Proceedings of the 58th Hawaii International Conference on System Sciences, 7 January 2025
Abstract
This research explores mitigating factors that influence personal health information sharing as it relates to the adoption of personal health information systems (PHIS). We examine the willingness of online users to share specific types of health data, their general concerns about sharing their health data, and what incentives might exist to motivate health data-sharing in the future. Findings across 336 survey respondents identify an overall sense of concern towards online data-sharing and privacy policies, and yet a willingness to share information, including personal health data, and the potential for health incentives to affect their willingness to share various types of health data. The implications of this research will play an important role as organizations and individuals increasingly adopt personal health information systems. This research also addresses the need for established guidelines and frameworks that address patient privacy as more data is captured and stored within cloud computing environments.

Data altruism and the ‘consent’ question: A study into the ‘consent’ models used under the GDPR and how the data altruism mechanism can act as a potential solution for the research community in the reuse of health data
Maria Christofidou, Theodoros N Arvanitis, Dipak Kalra, Nathan Lea, Mahsa Shabani, Pascal Coorevits
Frontiers in Medicine: Regulatory Science, 26 December 2024
Abstract
The General Data Protection Regulation (‘GDPR’) legal basis for obtaining consent for the processing of personal data for research purposes, where those purposes cannot be fully specified in advance, is provided for in Articles 6, 7 and Recital 33. However, GDPR’s requirements for obtaining consent, as to the secondary use and sharing of data in research, have been argued to have generated confusion, whilst the conflicts between the Regulation itself, its practical application and research ethics are well-documented. The requirements for ‘informed consent’, as defined within the GDPR, have not been well defined in the context of genome research or clinical trials, which has in turn led to the implementation and interpretation of the lawful basis to span into different idiosyncratic models. This naturally has fed into the uncertainty of how the legal basis can be applied in practice and calls for an investigation into the requirements for consent to be “informed” in the context of health research. This work aims to provide a scoping review and analysis of relevant publications with ultimate purpose to examine whether the concept of ‘data altruism’, as stipulated within Article 2(10) of the Data Governance Act (‘DGA’), addresses the gaps left behind by the application of the legal basis of ‘consent’, under the GDPR (Art. 6(1) and 7), in so far as the secondary uses of data for research are concerned. In this light the article, by exploring available solutions found in relevant literature and used in practice in national and European projects, examines how ‘data altruism’ can add any value and work as a cohesive solution that the research community can use. The article, through its research, intends to answer the following questions: 1. What gaps has the GDPR left when it comes to the interpretation and practical application of ‘consent’ towards the secondary use of health data; 2. Can the DGA, through the mechanism of ‘data altruism’, address these issues and provide a solution.

Smart contract empowered dynamic consent: decentralized storage and access control for healthcare applications
Aparna Singh, Geetanjali Rathee
Peer-to-Peer Networking and Applications, 10 December 2024
Abstract
The ability to share Electronic Health Records (EHRs) with the right people plays a crucial role in providing on-time diagnosis. The outsourcing of private health data on the cloud, with negligible control in the hands of the data owners, poses a significant challenge for e-healthcare applications. Obtaining the owner’s consent is not just essential for data sharing but also to protect the privacy of the data being shared. With the help of Blockchain and Interplanetary File System (IPFS), this research paper proposes a purpose-based framework for obtaining dynamic consent before sharing data among healthcare providers, academicians, etc. The study develops a blockchain system on the Ethereum network to store encrypted EHRs on IPFS. This architecture allows for secure and privacy-enhanced data sharing. The proposed model demonstrates effectiveness in enhancing data security, privacy, scalability, ownership, and integrity of medical records. The cost analysis shows a negligible contract deployment cost of 0.00174363 ETH, equivalent to $2.78. The framework presents a viable solution for securing EHRs and obtaining dynamic consent, ensuring improved healthcare data management. The use of blockchain and IPFS offers a promising avenue for enhancing data security and privacy in e-healthcare applications.

Patient and practice characteristics related to patient’s consent for health data exchange
J J Keuper, K Hek, LHD van Tuyl, R S Batenburg, R A Verheij
European Journal of Public Health, 28 October 2024
Abstract
Background
Sharing patient health data electronically between healthcare providers can prevent medical errors and improve patient safety. In the Netherlands, exchange of health information is facilitated on a national level and is only allowed with patient consent. Consequently, it is important to know which factors are related to this patient consent.
Methods
Routine electronic health records data from up to 10% of Dutch general practices (sourced from the Nivel Primary Care Database) were utilized, covering the period from 2016 to 2020. We examined whether patient consent for health data exchange varied depending on patient and practice characteristics, which are expected to have a relationship with granting consent for health data exchange. Therefore, multilevel analysis was performed.
Results
The percentage of patients granting consent ranged between 40%-50% in the period 2016 to 2019, while this was 97% in 2020, due to the governmental corona opt-in regulation. Significant disparities were observed across several of the included patient and practice characteristics in relation to patient consent for all the years examined. In most years, patient consent provision varied by gender, age, socioeconomic position, location, and healthcare use. Practice characteristics showed notable differences in patient consent across information systems, patient volumes, and practice types over all years examined.
Conclusions
We observed significant variations in patient consent for health data exchange, both among the included patient (need) and practice characteristics. These differences may stem from unequal exposure to opportunities to grant consent, differences in risk of inadequate communication between healthcare providers, levels of health literacy, and practice resources. These factors should be taken into account by policymakers when further implementing and upscaling the national health data exchange system.

Parental Confirmation of a Child’s Consent to Data Processing
Paulina Klisowska
Adam Mickiewicz University Law Journal, 2024; pp 49–59
Open Access
Abstract
This article attempts to define the conditions for consenting to the processing of children’s personal data under the GDPR. The article focuses on analysing the data protection law, regarding to the most important problem, that at present, consent to data processing involves at most a few clicks or nudges, making it difficult to speak of any real control of data controllers over whether consent to the processing of a child’s personal data has been lawfully given or confirmed by an authorized person. It’s not hard to see that the young age of users, along with limited awareness of data protection and the risks associated with its use, makes this topic extremely relevant and worth addressing.

Editor’s note: Adam Mickiewicz University is based in Poznań, Poland.

Data professionals’ attitudes on data privacy, sharing, and consent in healthcare and research
Research Article
Katya Kaplow,Max Downey, Darren Stewart, Allan B. Massie, Jennifer D. Motter, Lauren Taylor, John Massarelli, Taylor Matalon, Carolyn Sidoti, Macey L. Levan, Brendan Parent
Digital Health, 22 October 2024
Open Access
Abstract
Objective
Individuals who work on health data systems and services are uniquely positioned to understand the risks of health data collection and use. We designed and conducted a survey assessing the perceptions of those who work with health data around health data consent, sharing, and privacy practices in healthcare and clinical research.
Methods
A 43-item online survey was distributed via a market research firm to individuals (18+) who work with health data in the United States from March to April 2023. Descriptive statistics were calculated for all variables. Associations with demographic variables were assessed using Pearson’s X2 tests and ordinal logistic regression.
Results
Most of our respondents (61.7%) reported that they would trust people to use their health data across various sectors, but more respondents trusted those working in academic medical research (86.5%) and healthcare offices (89.9%) compared to those working in industry (68.2%). Despite this reported trust, a strong majority believed that individuals should have complete control over their health data (97.3%), specific consent should be obtained for each use of their health data (92.0%), and that there should be higher standards of consent and privacy for health records data than other types of data (93.7%).
Conclusions
Based on our findings, we might infer that people who work with health data generally trust institutions across sectors to protect their health data. However, many would prefer to have complete control over who has access to their health data and how it is used. These insights should be explored further through qualitative studies.

Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives
Research article
Brian J. McInnis, Ramona Pindus, Daniah Kareem, Camille Nebeker
Journal of Empirical Research on Human Research Ethics, 14 October 2024
Abstract
The research team, prospective participants, and written materials all influence the success of the informed consent process. As digital health research becomes more prevalent, new challenges for successful informed consent are introduced. This exploratory research utilized a human centered design process in which 19 people were enrolled to participate in one of four online focus-groups. Participants discussed their experiences with informed consent, preferences for receiving study information and ideas about alternative consent approaches. Data were analyzed using qualitative methods. Six major themes and sixteen sub-themes were identified that included study information that prospective participants would like to receive, preferences for accessing information and a desire to connect with research team members. Specific to digital health, participants expressed a need to understand how the technologies worked and how the volume of granular personal information would be collected, stored, and shared.

Trust and Inclusion in Digital Health: The Need to Transform Consent
Brief Communication
Celia Brightwell, Stefanie Brückner, Orit Halpern, Stephen Gilbert
Digital Society, October 2024
Open Access
Abstract
As health systems increasingly adopt digital solutions, such as remote monitoring and telemedicine, the use of health apps is becoming increasingly widespread. Meanwhile, data protection regulations and digital transformation initiatives are making the individual responsible for protecting their health data. In this brief communication, we focus on how the consent interface in a health app can impact trust and inclusion in digital health for privacy-sensitive people. As the consent interface determines how an individual’s health data can be used in medical research, it represents a critical point between the citizen’s right to informational self-determination and the potential public benefit of advances in medical science. We find that app developers’ interests in controlling access to health data may influence the design of the consent interface and undermine an individual’s ability to understand what they are consenting to. We describe how a standardized consent interface applied to health apps could foster a trusting relationship between individuals and the digital transformation of healthcare.

Rethinking Informed Consent in the Big Data Age
Book
Adam J. Andreotta
Routledge, 23 December 2024
Abstract
    In the “big data age”, providing informed consent online has never been more challenging. Countless companies collect and share our personal data through devices, apps, and websites, fuelling a growing data economy and the emergence of surveillance capitalism. Few of us have the time to read the associated privacy policies and terms and conditions, and thus are often unaware of how our personal data are being used. This is a problem, as in the last few years, large tech companies have abused our personal data. As privacy self-management, through the mechanism of providing online consent, has become increasingly difficult, some have argued that surveillance capitalism, and the data economy more broadly, need to be overthrown.

This book presents a different perspective. It departs from the concept of revolutionary change to focus on pragmatic, incremental solutions tailored to everyday contexts. It scrutinizes how consent is currently sought and provided online and offers suggestions about how online consent practices can be improved upon. These include: the possibility of subjecting consent-gathering practices to ethics committees for review; the creation of visual-based consent agreements and privacy policies, to help with transparency and engagement; the development of software to protect privacy; and the idea of automated consent functionalities that allow users to bypass the task of reading vast amounts of online consent agreements. The author suggests that these “small-scale” changes to online consent-obtaining procedures, could, if successfully implemented, provide us with a way of self-managing our privacy in a way that avoids a revolutionary dismantling of the data economy. In the process, readers are encouraged to rethink the very purpose of providing inform consent online.

Rethinking Informed Consent in the Big Data Age will appeal to researchers in normative ethics, applied ethics, philosophy of law, and the philosophy of AI. It will also be of interest to business scholars, communication researchers, students, and those in industry.