Author(s):
Zare Jeddi, Maryam ; Virgolino, Ana ; Fantke, Peter ; Hopf, Nancy B. ; Galea, Karen S. ; Remy, Sylvie ; Viegas, Susana ; Mustieles, Vicente ; Fernandez, Mariana F. ; von Goetz, Natalie ; Vicente, Joana Lobo ; Slobodnik, Jaroslav ; Rambaud, Loïc ; Denys, Sébastien ; St-Amand, Annie ; Nakayama, Shoji F. ; Santonen, Tiina ; Barouki, Robert ; Pasanen-Kase, Robert ; Mol, Hans G.J. ; Vermeire, Theo ; Jones, Kate ; Silva, Maria João ; Louro, Henriqueta ; van der Voet, Hilko ; Duca, Radu Corneliu ; Verhagen, Hans ; Canova, Cristina ; van Klaveren, Jacob ; Kolossa-Gehring, Marike ; Bessems, Jos
Date: 2021
Persistent ID: http://hdl.handle.net/10362/125760
Origin: Repositório Institucional da UNL
Subject(s): Data governance; Data value chain; Harmonisation; Human biomonitoring; Registry; Regulatory risk assessment; Public Health, Environmental and Occupational Health; SDG 3 - Good Health and Well-being
Description
Funding Information: Stephanie Bopp (European Commission, DG Joint Research Centre) is acknowledged to provide valuable information regarding the IPCHEM Platform. The VITO HBM data management team is acknowledged for providing specific input. The HBM expert working group of the European Chapter of the International Society for Exposure Science (ISES Europe) is acknowledged for their great support. Publisher Copyright: © 2021
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. 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 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 to the use and possible reuse of the resulting HBM (meta)data. 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. Moreover, we believe that implementation of FAIR principles is a fundamental enabler for digital transformation within environmental health. 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. It is also considered that harmonisation of existing data sets could be performed retrospectively. 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. The planned European Partnership for the Assessment of Risk from Chemicals (PARC) work along these lines, based on the experience obtained in previous joint European initiatives. Therefore, PARC could very well bring a first demonstration of first essential functionalities within the development of the HBM GRF.
