RT Journal Article
T1 A human biomonitoring (HBM) Global Registry Framework: Further advancement of HBM research following the FAIR principles.
A1 Zare Jeddi, Maryam
A1 Virgolino, Ana
A1 Fantke, Peter
A1 Hopf, Nancy B
A1 Galea, Karen S
A1 Remy, Sylvie
A1 Viegas, Susana
A1 Mustieles, Vicente
A1 Fernandez, Mariana F
A1 von Goetz, Natalie
A1 Vicente, Joana Lobo
A1 Slobodnik, Jaroslav
A1 Rambaud, Loïc
A1 Denys, Sébastien
A1 St-Amand, Annie
A1 Nakayama, Shoji F
A1 Santonen, Tiina
A1 Barouki, Robert
A1 Pasanen-Kase, Robert
A1 Mol, Hans G J
A1 Vermeire, Theo
A1 Jones, Kate
A1 Silva, Maria João
A1 Louro, Henriqueta
A1 van der Voet, Hilko
A1 Duca, Radu-Corneliu
A1 Verhagen, Hans
A1 Canova, Cristina
A1 van Klaveren, Jacob
A1 Kolossa-Gehring, Marike
A1 Bessems, Jos
K1 Data governance
K1 Data value chain
K1 Harmonisation
K1 Human biomonitoring
K1 Registry
K1 Regulatory risk assessment
AB 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.
YR 2021
FD 2021-09-25
LK https://hdl.handle.net/10668/26947
UL https://hdl.handle.net/10668/26947
LA en
DS RISalud
RD Apr 10, 2025