Reflections on dynamic consent in biomedical research: the story so far

Harriet J A Teare,Jane Kaye,Megan Prictor

doi:10.1038/s41431-020-00771-z

Harriet J A Teare, Jane Kaye + Show 1 more

Open Access

https://doi.org/10.1038/s41431-020-00771-z

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Abstract

Dynamic consent (DC) was originally developed in response to challenges to the informed consent process presented by participants agreeing to ‘future research’ in biobanking. In the past 12 years, it has been trialled in a number of different projects, and examined as a new approach for consent and to support patient engagement over time. There have been significant societal shifts during this time, namely in our reliance on digital tools and the use of social media, as well as a greater appreciation of the integral role of patients in biomedical research. This paper reflects on the development of DC to understand its importance in an age where digital health is becoming the norm and patients require greater oversight and control of how their data may be used in a range of settings. As well as looking back, it looks forwards to consider how DC could be further utilised to enhance the patient experience and address some of the inequalities caused by the digital divide in society.

Highlights

Digital health on the whole has been slow to progress compared with the digitalisation of other sectors
Alongside the establishment of NHSX [2], the UK Government unit tasked with driving digital health strategy and policy, this marked a decisive moment to promote the use of digital tools to support healthcare, and by extension, biomedical research in the UK
dynamic consent (DC) goes beyond an informed consent tool for biomedical research and could help individuals and groups navigate their entire online presence, with data from a variety of different areas being shared for a range of activities

Summary

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Digital health on the whole has been slow to progress compared with the digitalisation of other sectors. In response to the implications of these changes, the DC approach to consent was developed to allow participants to review and update their consent decisions over time and to be informed of the many research uses of their data and samples. This discussion has provided further opportunity to understand the expectations that individuals have for data use, and the extent to which privacy and security will need to be supported within research contexts It raises interesting questions surrounding the role of patients as consumers, in light of the explosion of health apps and other self-monitoring tools that are relevant to patient care and which provide new sources of information available to patients to shape their understanding of health. Ensuring there are mechanisms to support these groups, to mitigate the digital divide, is crucial

Conclusion

Findings

Compliance with ethical standards