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      A human biomonitoring (HBM) Global Registry Framework: Further advancement of HBM research following the FAIR principles.

      1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 8 , 9 , 10 , 11 , 12 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 21 , 22 , 23 , 24 , 25 , 19 , 26 , 6
      International journal of hygiene and environmental health
      Elsevier BV
      Data governance, Data value chain, Harmonisation, Human biomonitoring, Registry, Regulatory risk assessment
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          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.

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          Author and article information

          Int J Hyg Environ Health
          International journal of hygiene and environmental health
          Elsevier BV
          September 2021
          : 238
          [1 ] National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands. Electronic address: maryam.zare.jeddi@rivm.nl.
          [2 ] Environmental Health Behaviour Lab, Instituto de Saúde Ambiental, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.
          [3 ] Quantitative Sustainability Assessment, Department of Technology, Management and Economics, Technical University of Denmark, Produktionstorvet 424, 2800, Kgs. Lyngby, Denmark.
          [4 ] Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Epalinges, Switzerland.
          [5 ] IOM - Institute of Occupational Medicine, Edinburgh, EH14 4AP, UK.
          [6 ] VITO - Flemish Institute for Technological Research, Health Unit, Mol, Belgium.
          [7 ] NOVA National School of Public Health, Public Health Research Centre, Universidade NOVA de Lisboa, 1600-560, Lisbon, Portugal; Comprehensive Health Research Center (CHRC), 1169-056, Lisbon, Portugal; H&TRC-Health & Technology Research Center, ESTeSL-Escola Superior de Tecnologia da Saúde, Instituto Politécnico de Lisboa, 1500-310, Lisboa, Portugal.
          [8 ] University of Granada, Center for Biomedical Research (CIBM), Granada, Spain; Consortium for Biomedical Research in Epidemiology & Public Health (CIBERESP), Madrid, Spain.
          [9 ] Federal Office of Public Health, Bern, Switzerland.
          [10 ] EEA - European Environment Agency, Kongens Nytorv 6, 1050, Copenhagen K, Denmark.
          [11 ] NORMAN Association, Rue Jacques Taffanel - Parc Technologique ALATA, 60550 Verneuil-en-Halatte, France.
          [12 ] SPF - Santé Publique France, Environmental and Occupational Health Division, France.
          [13 ] Environmental Health Science and Research Bureau, Health Canada, Ottawa, Ontario, Canada.
          [14 ] Japan Environment and Children's Study Programme Office, National Institute for Environmental Studies, Japan.
          [15 ] FIOH-Finnish Institute of Occupational Health, P.O. Box 40, FI-00032, Työterveyslaitos, Finland.
          [16 ] Université de Paris, Inserm Unit 1124, 45 rue des Saints Pères, 75006, Paris, France.
          [17 ] SECO - State Secretariat for Economic Affairs, Labour Directorate Section Chemicals and Work (ABCH), Switzerland.
          [18 ] Wageningen Food Safety Research (WFSR) - part of Wageningen University & Research, Wageningen, The Netherlands.
          [19 ] National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
          [20 ] HSE - Health and Safety Executive, Harpur Hill, Buxton, SK17 9JN, UK.
          [21 ] INSA - National Institute of Health Dr. Ricardo Jorge, Portugal; TOXOMICS - Centre for Toxicogenomics and Human Health, NOVA Medical School, Universidade NOVA de Lisboa, Portugal.
          [22 ] Wageningen University & Research, Biometris, Wageningen, the Netherlands.
          [23 ] Unit Environmental Hygiene and Human Biological Monitoring, Department of Health Protection, National Health Laboratory, Dudelange, Luxembourg; Centre Environment and Health, Department of Public Health and Primary Care, KU Leuven, Belgium.
          [24 ] University of Ulster, Coleraine, Northern Ireland, UK; Technical University of Denmark, Lyngby, Denmark.
          [25 ] Unit of Biostatistics, Epidemiology, and Public Health-University of Padua, Padua, Italy.
          [26 ] UBA - German Environment Agency, Berlin, Germany.

          Data governance,Data value chain,Harmonisation,Human biomonitoring,Registry,Regulatory risk assessment


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