Title: Empowering digital transformation: A Human Biomonitoring (HBM) Global Registry Framework

Abstract

Data generated by the rapidly evolving human biomonitoring (HBM) programmes are providing invaluable opportunities to support and advance regulatory risk assessment and management of chemicals in occupational and environmental health domains as well as supporting One Health policy needs. One Health is an umbrella concept that involves the evaluation and monitoring of the impact of environmental hazards on public health. However, heterogeneity across studies, in terms of design, terminology, biomarker nomenclature, and data formats, limits our capacity to compare and integrate data sets retrospectively (reuse). Registration of HBM studies is common for clinical trials; however, the study designs and resulting data collections cannot be traced easily. We are learning that it is not enough to deepen our knowledge of each individual scientific domain in ever increasing detail, we must also be able to bring these research topics together during public health and life sciences research! We argue that an HBM Global Registry Framework (HBM GRF) could be the solution to several of challenges hampering the (re)use of HBM (meta) data. The aim is to develop a global, host-independent HBM registry framework based on the use of harmonised open-access protocol templates from designing, undertaking of an HBM study, data generation and collection to information dissemination for decision-making. This framework should apply FAIR (Findable, Accessible, Interoperable and Reusable) principles as a core data management strategy to enable the (re)use of HBM (meta) data to its full potential through the data value chain. The HBM GRF would encompass internationally harmonised and agreed open access templates for HBM study protocols, structured web-based functionalities to deposit, find, and access harmonised protocols of HBM studies. Registration of HBM studies using the HBM GRF is anticipated to increase FAIRness of the resulting (meta)data. As a consequence, data wrangling activities to make data ready for analysis will be minimised. In addition, this framework would enable the HBM (inter)national community to trace new HBM studies already in the planning phase and their results once finalised. The HBM GRF could also serve as a platform enhancing communication between scientists, risk assessors, and risk managers/policy makers. Moreover, we believe that implementation of FAIR principles is a fundamental enabler for digital transformation within environmental health that support and acknowledge the shift from big data to smart data highlighting the importance of making full use of the potential of data, technology and digitalisation across the coming decade.