Translating to the Community (T2C): a protocol paper describing the development of Canada’s first social epigenetic FASD biobank

摘要

Translating to the Community (T2C) is a social biorepository designed to advance new diagnostic tools and realign community–clinical processes, with the aim to mitigate the short- and long-term impacts of fetal alcohol spectrum disorder (FASD) as well as prenatal alcohol exposure and its co-morbidities and behaviors. In this paper, we describe the evolution of this repository as a new translational partnership to advance a precision-medicine approach to FASD. Key to its evolution was a partnership between academic researchers, Indigenous communities, families, and a regional diagnostic clinic. We further describe the rationale for social biobanking, the type of banking, ethical engagement of families, communities, and clinics, their roles in repository design, governance, translation, and research activities, types of data collected from families, and how the study data are managed, reported, and accessed. The repository design includes biological samples, social-contextual health-survey data, and clinical data (which are linkable to administrative data) from community and clinical cohorts of diagnosed children, children prenatally exposed but not diagnosed, children suspected to have had a prenatal exposure, and related siblings, biological parents, and unrelated children and their parents. From these cohorts and families, potential studies drawing on this data will shed light on various risk factors, social and biological pathways, and service utilization issues, with the aim to implement primary and secondary prevention and intervention strategies.