Tessa I van Rijssel, Ghislaine J M W van Thiel, Johannes J M van Delden
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引用次数: 0
Abstract
Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to for example data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond its direct purposes, by shaping behaviors, experiences, social relations, and values. We examine four elements of the informed consent procedure that are affected by DCTs, while taking these soft impacts of technologies into account: (i) informing participants and testing understanding, (ii) freedoms in relation to responsibilities and burdens, (iii) trust in participant-researcher relations, and (iv) impacts on the concept of privacy. Our analysis reveals that a broad view is key for optimal conduct of DCTs. In addition, it provides insight into the ethical impacts of DCTs on informed consent. Technologies such as DCTs potentially have profound impacts which are not immediately addressed by the existing regulatory frameworks, but nonetheless important to recognize. These findings can guide future practices of DCTs to foster the important values of clinical research in this novel approach for conducting clinical trials.
期刊介绍：
Health Care Analysis is a journal that promotes dialogue and debate about conceptual and normative issues related to health and health care, including health systems, healthcare provision, health law, public policy and health, professional health practice, health services organization and decision-making, and health-related education at all levels of clinical medicine, public health and global health. Health Care Analysis seeks to support the conversation between philosophy and policy, in particular illustrating the importance of conceptual and normative analysis to health policy, practice and research. As such, papers accepted for publication are likely to analyse philosophical questions related to health, health care or health policy that focus on one or more of the following: aims or ends, theories, frameworks, concepts, principles, values or ideology. All styles of theoretical analysis are welcome providing that they illuminate conceptual or normative issues and encourage debate between those interested in health, philosophy and policy. Papers must be rigorous, but should strive for accessibility – with care being taken to ensure that their arguments and implications are plain to a broad academic and international audience. In addition to purely theoretical papers, papers grounded in empirical research or case-studies are very welcome so long as they explore the conceptual or normative implications of such work. Authors are encouraged, where possible, to have regard to the social contexts of the issues they are discussing, and all authors should ensure that they indicate the ‘real world’ implications of their work. Health Care Analysis publishes contributions from philosophers, lawyers, social scientists, healthcare educators, healthcare professionals and administrators, and other health-related academics and policy analysts.
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