Better governance, better access: practising responsible data sharing in the METADAC governance infrastructure

摘要: Genomic and biosocial research data about individuals is rapidly proliferating, bringing the potential for novel opportunities integration use. The scale, pace novelty of these applications raise a number urgent sociotechnical, ethical legal questions, including optimal methods storage, management access. Although open science movement advocates unfettered access to data, many UK’s longitudinal cohort studies operate systems managed access, in which governed by agreements between stewards datasets researchers wishing make use them. Amongst other things, aim respect reasonable expectations participants who provided samples, as expressed consent process. Arguably, responsible governance sample are foundational process an important source trustworthiness eyes those contribute genomic research. This paper presents ethnographic case study exploring principles infrastructure Managing Ethico-social, Technical Administrative issues Data ACcess (METADAC), operationalised through committee known METADAC Access Committee. governs phenotype, genotype ‘omic’ samples from five UK studies. Using example METADAC, we argue that three key structural features practising sharing: independence transparency; interdisciplinarity; participant-centric decision-making. We observe international community proactively working towards optimising integrating/linking with routine generated health social care services administrative improve analysis, interpretation utility data. new complex assemblages will require range expertise across domains disciplines, participants. Human-mediated decision-making bodies be central ensuring achievable, reasoned decisions data; model described this provides how could realised.