Rethinking informed consent in the time of COVID-19: An exploratory survey

Sutter, Evelien De; Lalova-Spinks, Teodora; Borry, Pascal; Valcke, Peggy; Kindt, Els; Negrouk, Anastassia; Verhenneman, Griet; Derèze, Jean-Jacques; Storme, Ruth; Huys, Isabelle

doi:10.3389/fmed.2022.995688

Cited by 8 publications

(9 citation statements)

References 25 publications

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“…The results of the larger study as regards data protection and (electronic) informed consent were published elsewhere ( 5 , 16 ). The results as regards stakeholders’ views on data altruism are described in this article, as they provide an illustration of early reflections on the new mechanism and they constitute a suitable basis for further analysis on the legal implications of data altruism.…”

Section: Methodsmentioning

confidence: 99%

The application of data altruism in clinical research through empirical and legal analysis lenses

2023

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BackgroundThe legal framework for clinical research in the EU is complex and the lack of harmonization of the relevant legal and ethical rules remains one of the main challenges for stakeholders in the field. The recently adopted Data Governance Act (DGA) and the proposal for a European Health Data Space (EHDS) promise to solve the existing challenges with respect to access to and (re)use of personal data for research, but also risk to further complexify the field. The DGA introduced a novel mechanism – data altruism. Data altruism is understood as the voluntary sharing of personal and non-personal data, based on the consent of data subjects or the permission of natural and legal persons, without seeking a reward and for objectives of general interest. This study aimed to gain insights into the opinion of clinical research stakeholders on data altruism, and to critically discuss key issues pertaining to the application of data altruism from a legal point of view.MethodsSemi-structured interviews with (1) data protection officers (DPOs) and legal experts working with commercial and academic sponsors of clinical trials, (2) investigators, and (3) members of research ethics committees. Data underwent framework analysis. The legal discussion was comprised of legal doctrinal research with focus on the DGA, EHDS proposal, and the interplay with the EU General Data Protection Regulation (GDPR).ResultsFourteen experts took part in the interviews, more than half of which were DPOs/legal experts. Interviewees were based in seven EU Member states and the United Kingdom. The majority of participants were critical towards the data altruism mechanism and pointed out challenges and risks associated with its application.ConclusionAlthough data altruism holds the potential to facilitate data sharing, its application in clinical research at the moment is still riddled with uncertainties. The interplay of the DGA rules with the provisions of the GDPR and the EHDS proposal are insufficiently clear and further efforts from the legislator are required to build a working, patient-centered, and research fostering data altruism system.

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Section: Methodsmentioning

confidence: 99%

The application of data altruism in clinical research through empirical and legal analysis lenses

2023

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“…While the advantages of electronic informed consent are clear, its application in clinical trial research so far has been scattered. 3 , 20 , 21 Available literature reporting the use of electronic informed consent in clinical trials is sparse. 18 , 22 , 23 Despite some case examples of eConsent in practice (see Table 1 ), widespread implementation of personalized, interactive platforms going beyond the use of electronic signatures and static electronic documents is lagging.…”

Section: Current Status and Potentialmentioning

confidence: 99%

“…Among stakeholders active in European Union Member States, such as investigators and data protection officers/legal experts, there is currently a perceived low degree of regulatory acceptance and the heterogeneity in guidelines among regulatory authorities further clouds the application potential of electronic informed consent. 21 …”

Section: Challenges To Implementationmentioning

confidence: 99%

Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?

De Sutter,

Barbier,

Borry

et al. 2024

DIGITAL HEALTH

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Changes in the clinical trials landscape have been driven by advancements in digital technology. The use of electronic informed consent to inform research participants and to obtain their consent electronically has the potential to improve participant–researcher interactions over time, facilitate clinical trial participation, and increase efficiency in clinical trial conduct. A personalized electronic informed consent platform that enables long-term interactions with the research team could function as a tool to empower participant engagement in clinical trials. However, significant challenges persist impeding successful and widespread implementation. This Perspective provides insights into the opportunities and challenges for the implementation of electronic informed consent in clinical trials. It sets out key recommendations to promote the implementation of this innovative approach to the informed consent process, including the creation of uniform electronic informed consent platforms at regional and national level.

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“…The global research community has highlighted the substantial impact of the COVID-19 pandemic on biomedical and research ethics, 1 2 underscoring the necessity for government-led policy changes and national coordination. 3 4 5 However, there is limited research examining the government’s specific measures in the realm of clinical research ethics. Several studies have explored the Korean government’s response and strategies for COVID-19, but research focusing on research ethics is scarce.…”

Section: Introductionmentioning

confidence: 99%

“… 9 COVID-19 pandemic brought substantial challenges in the informed consent process, including uncertainties about new treatments and comorbidities, isolation from family for shared decision making, and limited patient-doctor interactions, while enabling novel mode of communication and electronic informed consent if provided with constant transparent access to information. 5 10 11 12 Ethical questions has been raised for exceptional allowances during a pandemic such as delayed consent or consent by a proxy, waiver of informed consent for studies using electronic medical charts or surveys under public health emergencies. 13 14 15 16 Despite growing scholarly reflections on pandemic responses for research ethics at the level of institutions and academic communities, government responses for research ethics have been left as lacuna in the literature.…”

Section: Introductionmentioning

confidence: 99%

Government Initiatives for Research Ethics During COVID-19 Pandemic in Korea

Park,

Kim

2024

J Korean Med Sci

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Background Despite the growing necessity for government-led policy changes on clinical research ethics during pandemic, the scope of previous literature is limited to Korean government’s pandemic response strategies or reflections of research ethics at the level of institutions and academic societies. This paper examines the proactive policy changes and responses by the South Korean government in addressing the challenges and issues of research ethics against the backdrop of the urgency of rapid development and emergency supply of medical products during the coronavirus disease 2019 (COVID-19) pandemic. Methods We conducted searches of various government documents, using predetermined keywords related to research ethics and integrity during the COVID-19 pandemic. Only documents issued by governments or public institutions were included. A total of 24 documents were selected for analysis. They were divided into two phases: the first phase for urgent response (January 2020–February 2021) and the second phase (March 2021–February 2023) for long-term preparedness. Results The Korean government recommended several measures of research governance to accelerate the ethical review of COVID-related research to be shortened less than one week: the joint operation of Institutional Review Boards (IRBs), exempted or expedited review by a special review committee, guidelines for urgent reviews, and designation of the Korean Academy of Medical Sciences as the supervising agency for the Clinical Trial Safety Support Institution as well as the Central IRB. It allowed temporary non-face-to-face methods for informed consent process (telephone explanations and a photo of the original signed consent) and clinical trials (telephone counselling and prescription, proxy prescription, and drug delivery and supply to clinical trial participants, and online ethics training). Conclusion As a result of South Korea’s commitment to ethical principles in their pandemic response, the medical system did not experience collapses due to the pandemic, and pandemic research was conducted with careful ethical considerations. The pandemic ethics immunization during the Middle East respiratory syndrome epidemic in 2015 laid the foundation for prompt government initiatives that ensured both pandemic research ethics and pandemic response ethics.

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Rethinking informed consent in the time of COVID-19: An exploratory survey

Cited by 8 publications

References 25 publications

The application of data altruism in clinical research through empirical and legal analysis lenses

The application of data altruism in clinical research through empirical and legal analysis lenses

Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?

Government Initiatives for Research Ethics During COVID-19 Pandemic in Korea

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