Understanding Data Practices, Consenting Processes, and Representation in Biobanks: A mixed-methods study with researchers, patients and data scientists
Personalised medicine aims to replace a one-size-fits-all approach with the ‘right treatment for the right person at the right time’. Achieving this requires broad participation of patients willing to share data and biological samples which are then analysed and utilised in the personalisation process. Previous work suggests that certain categories of participant are systematically under-represented in biobanks, resulting in biased data sets. It is possible therefore that “people like you” are not well represented in these biobanks; we are interested in how this affects the practice of personalized medicine, and whether different approaches to consent, sharing and use of data may help to reduce inequity.
Our ‘Perspectives on Consent’ project will inform a critical understanding the consenting processes and data processes at Imperial College Healthcare NHS Trust through a mixed methods case study of the consenting process of the Imperial Knowledge Bank in collaboration with Paul Elliott (IC), Paul Downey (IC) and Ben Glampson (ICHNT). To understand consent requires a clear overview of the context, the system and the processes by which people are approached. The study will focus on all facets of the creation of the biobank as they relate to personalising processes and participation,
including: informatics, data processing, analysis, de-identification, and application in research and clinical settings; the processes of obtaining consent for data collection and use; the mechanisms that produce inequality in representation; the meaning of consent for potential participants and researchers; patient understanding of biobanks, data security and privacy. Finally, the study will also attempt to reduce inequality in representation in the Imperial Knowledge Bank through the design and piloting of randomised controlled trials of modes of consent, for example comparing
electronic with face-to-face offer, and variations in the timing of the offer.
This study has approval from the NHS Health Research Authority, ID: 245816