Dynamic Consent: A Possible Solution to Improve Patient Confidence and Trust in How Electronic Patient Records Are Used in Medical Research

Abstract

With one million people treated every 36 hours, routinely collected UK National Health Service (NHS) health data has huge potential for medical research. Advances in data acquisition from electronic patient records (EPRs) means such data are increasingly digital and can be anonymised for research purposes. NHS England’s care.data initiative recently sought to increase the amount and availability of such data. However, controversy and uncertainty following the care.data public awareness campaign led to a delay in rollout, indicating that the success of EPR data for medical research may be threatened by a loss of patient and public trust. The sharing of sensitive health care data can only be done through maintaining such trust in a constantly evolving ethicolegal and political landscape. We propose that a dynamic consent model, whereby patients can electronically control consent through time and receive information about the uses of their data, provides a transparent, flexible, and user-friendly means to maintain public trust. This could leverage the huge potential of the EPR for medical research and, ultimately, patient and societal benefit.

Data science for mental health: a UK perspective on a global challenge

“…Systems have been developed that protect privacy and, in future, innovations such as dynamic models of consent 49 …”

Big Data in medical research and EU data protection law: challenges to the consent or anonymise approach

“…36 As a response to this critique, it is emphasised that dynamic consent is not a replacement for existing consent models, but rather a tool that could better facilitate the process of obtaining any form of consent. 47,48 Adapting anonymisation mechanisms A conventional method to protect data and avoid consent or other legal requirements is anonymisation. Yet, there seems to be a broad consensus that it is impossible to guarantee anonymity, especially when health-related data are re-used in different contexts or genomic data are involved.…”

Unsolicited findings of next-generation sequencing for tumor analysis within a Dutch consortium: clinical daily practice reconsidered

“…Although the majority of experts state that the option to refuse genetic results should be addressed at the time of the informed consent, recently there are suggestions that patients should be able to reconsider their choices. 10 This means patients do not have to follow through on their earlier decisions. There is, in other words, a growing plea for facilitating the ongoing changing mind of participants during the study and after signing the informed consent form.…”

“…This so-called 'dynamic consent' provides additional functionality to allow ongoing engagement and maintenance of research participants' consent preferences. 10,11 Overall, the informed consent process and informed consent form should clarify the circumstances in which a patient may be re-contacted in the future. A topic for further debate is whether professionals should actively contact participants when new findings are found.…”