Abstract
BackgroundData-intensive research in medicine and healthcare such as health-related big data research (HBDR) implies that data from clinical routine, research and patient-reported data, but also non-medical social or demographic data, are aggregated and linked in order to optimize biomedical research. In this context, notions of patient participation and involvement are frequently invoked to legitimize this kind of research and improve its governance. The aim of this debate paper is to critically examine the specific use and ethical role of participatory concepts in the context of HBDR and data-intensive research in medicine and healthcare.DiscussionWe introduce basic conceptual distinctions for the understanding of participation by looking at relevant fields of application in politics, bioethics and medical research. Against this backdrop, we identify three paradigmatic participatory roles that patients/subjects are assigned within the field of HBDR: participants as providers of biomaterials and data, participants as administrators of their own research participation and participants as (co-)principal investigators. We further illustrate these roles by exemplary data-intensive research-initiatives. Our analysis of these initiatives and their respective participatory promises reveals specific ethical and practical shortcomings and challenges. Central problems affecting, amongst others, ethical and methodological research standards, as well as public trust in research, result from the negligence of essential political-ethical dimensions of genuine participation.ConclusionsBased on the conceptual distinctions introduced, we formulate basic criteria for justified appeals to participatory approaches in HBDR and data-intensive research in medicine and healthcare in order to overcome these shortcomings. As we suggest, this is not only a matter of conceptual clarity, but a crucial requirement for maintaining ethical standards and trust in HBDR and related medical research.
Highlights
Data-intensive research in medicine and healthcare such as health-related big data research (HBDR) implies that data from clinical routine, research and patient-reported data, and non-medical social or demographic data, are aggregated and linked in order to optimize biomedical research
In 2013, the so-called ‘care.data’ scheme was introduced in the UK. It aimed at collecting the medical information of all patients treated within the National Health Service (NHS) in a central database that was open to researchers and others, unless patients explicitly opted out
This implies that data from clinical routine, research and patient-reported data, and non-medical, even unstructured, social or demographic data, are aggregated and linked in order to optimize biomedical research
Summary
We introduce basic conceptual distinctions for the understanding of participation by looking at relevant fields of application in politics, bioethics and medical research. Against this backdrop, we identify three paradigmatic participatory roles that patients/subjects are assigned within the field of HBDR: participants as providers of biomaterials and data, participants as administrators of their own research participation and participants as (co-)principal investigators. We identify three paradigmatic participatory roles that patients/subjects are assigned within the field of HBDR: participants as providers of biomaterials and data, participants as administrators of their own research participation and participants as (co-)principal investigators We further illustrate these roles by exemplary data-intensive researchinitiatives. Amongst others, ethical and methodological research standards, as well as public trust in research, result from the negligence of essential political-ethical dimensions of genuine participation
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