Dynamic consent

Dynamic consent is an approach to informed consent that enables ongoing engagement and communication between individuals and the users and custodians of their data. It is designed to address the numerous issues raised by the use of digital technologies in research and clinical care, enabling the wide-scale use, linkage, analysis, and integration of diverse datasets, as well as the application of AI and big data analyses. These issues include how to obtain informed consent in a rapidly changing environment, growing expectations that people should understand how their data is being used, and increased legal and regulatory requirements for managing the secondary use of data in biobanks and other medical research infrastructures. The approach started to be implemented in 2007 by an Italian group who introduced the ways to have an ongoing process of interaction between researcher and participant, where "technology now allows the establishment of dynamic participant–researcher partnerships." The use of digital interfaces in this way was first described as 'Dynamic Consent' in the EnCoRe project (see below). Dynamic Consent, therefore, describes a personalised, digital interface that enables two-way communication between participants and researchers and is a practical example of how software can be developed to give research participants greater understanding and control over how their data is used. It also enables clinical trial managers, researchers and clinicians to know what type of consent is attached to the use of data they hold and to have an easy way to seek a new consent if the use of the data changes. It can support greater accountability and transparency, streamlining consent processes to enable compliance with regulatory requirements.