Perspectives on Consent: Understanding Representation in Biobanks
Research type
Research Study
Full title
Understanding Data Practices, Consenting Processes, and Representation in Biobanks: A mixed-methods study with researchers, patients and data scientists
IRAS ID
245816
Contact name
Helen Ward
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
‘Perspectives on Consent’ 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 Health Bank in collaboration with Paul Elliott (IC), Paul Downey(IC) and Ben Glampson(ICHNT). 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 Health Bank through the design and piloting of randomised controlled trials of modes of consent.
We propose a three part, mixed methods research programme: 1) Analysis of patient data to understand the baseline characteristics of the population who will be asked to participate in the biobank, including the demographics, disease characteristics, and patient pathways of those who do and do not participate; 2) An ethnographic study of the consenting process for the bioresource; 3) Develop and pilot methodologies for randomised controlled trials to better understand which modes of recruitment engender more inclusive participation. The proposed variations for the RCTs will come from the literature on increasing participation and response in behavioural economics, sociology, and medical humanities, as well as from knowledge learned about current inequalities and concerns from parts one and two of the of the research program (VanEpps et al 2016). The pilots will inform the design of larger trials with appropriate consideration of study arms, power calculations, randomisation methods, and ethical considerations.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
18/SC/0595
Date of REC Opinion
5 Nov 2018
REC opinion
Further Information Favourable Opinion