Abstract
Population-level biomedical research has become crucial to the health system’s ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the ethical and practical credentials of these proposals and find them lacking. We suggest that the consent problem is not solved by adopting a technology driven approach grounded in a notion of ‘specific’ consent but by taking seriously the role of research governance in combination with broader conceptions of consent. In our view, these approaches misconstrue the rightful location of authority in the way in which population-level biomedical research activities are structured and organized. We conclude by showing how and why the authority for determining the nature and shape of choice making about participation ought not to lie with individual participants, but rather with the researchers and the research governance process, and that this necessarily leads to the endorsement of a fully articulated broad consent approach.
Highlights
Large scale or population-level biomedical research has become one of the most important requirements for the long-term capacity of a health system that aims to improve the health of the population
We focus on this ‘consent problem’, in light of the fact that the potential future benefits of this kind of research depend on its scale and efficiency in ways that run doi:10.1093/phe/phz015
We suggest that the ‘consent problem’ is not solved by adopting a technology-driven approach grounded in a notion of ‘specific’ consent, which is unachievable and likely to increase the workload of participants and researchers, but by taking seriously the role of research governance in combination with broader conceptions of consent
Summary
Large scale or population-level biomedical research (including big data, genomics and biobanking) has become one of the most important requirements for the long-term capacity of a health system that aims to improve the health of the population. Such studies are dependent for their scientific validity on consistent cohorts, maintained over the long term to ensure populations can be tracked over time so that meaningful comparisons and conclusions can be drawn from the data This need for stability implies a certain type of relationship with the participants, where the broad expectations are explained at the outset, with the understanding that participants will generally continue to allow use of data about them for the duration of the study. UK Biobank collects lifestyle and environmental information, medical history, physical measurements, and biological samples from participants over the life of their involvement in the study (UKBiobank, 2007) CHRIS study is a longitudinal population- based study that began in 2011 It investigates the genetic basis of common chronic conditions associated with human ageing. The Avon Longitudinal Study of Parents and Children (ALSPAC), or ‘Children of the 90’s is an ongoing longitudinal study of children of mothers who were pregnant in the early 1990’s in South West England, and ‘the overall objectives of the study are to understand the ways in which the physical and social environments interact over time with genetic inheritance to affect health, behavior and development in infancy, childhood and into adulthood’ (Golding & ALSPAC Study Team, 2004)
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