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Electronic systems for managing consent do exist but are generally only able to record consent from the research subject directly. Consent for research is also challenging to integrate into many electronic patient record systems. The Born In Bradford study is a large, from birth cohort study in the North of England which requires consent to be recorded by the pregnant mother of a child who will be included in the study from birth. This creates a complex challenge for consent management that has previously been achieved through paper-based processes. As the study begins a new phase with the objective of inviting all new parents within the Bradford region to participate in the study the solution also needs to work with existing maternity systems. This paper considers the specific challenges of converting the often grey rules around consent of children into an electronic system that is transparent and supports the trust of both the family and the clinical and care teams recruiting research subjects into a large cohort study, and describes the user centred design and technical approach taken to resolve it.
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