Elsevier

Environmental Research

Volume 141, August 2015, Pages 3-14
Environmental Research

A pilot study on the feasibility of European harmonized human biomonitoring: Strategies towards a common approach, challenges and opportunities

https://doi.org/10.1016/j.envres.2014.10.028Get rights and content

Highlights

  • A common European Human Biomonitoring (HBM) survey protocol was developed through a bottom-up approach.

  • A joint process for prioritization was established to select a limited set of biomarkers, some covered by experience and others for emerging substances.

  • The protocol was tested in a pilot study, resulting in HBM results comparable on a European scale which sustained environmental health policy.

  • Ethics and privacy regulations were not an obstacle for transnational harmonization.

Abstract

In 2004 the European Commission and Member States initiated activities towards a harmonized approach for Human Biomonitoring surveys throughout Europe. The main objective was to sustain environmental health policy by building a coherent and sustainable framework and by increasing the comparability of data across countries. A pilot study to test common guidelines for setting up surveys was considered a key step in this process. Through a bottom-up approach that included all stakeholders, a joint study protocol was elaborated.

From September 2011 till February 2012, 17 European countries collected data from 1844 mother–child pairs in the frame of DEMOnstration of a study to COordinate and Perform Human Biomonitoring on a European Scale (DEMOCOPHES).1 Mercury in hair and urinary cadmium and cotinine were selected as biomarkers of exposure covered by sufficient analytical experience. Phthalate metabolites and Bisphenol A in urine were added to take into account increasing public and political awareness for emerging types of contaminants and to test less advanced markers/markers covered by less analytical experience. Extensive efforts towards chemo-analytical comparability were included.

The pilot study showed that common approaches can be found in a context of considerable differences with respect to experience and expertize, socio-cultural background, economic situation and national priorities. It also evidenced that comparable Human Biomonitoring results can be obtained in such context. A European network was built, exchanging information, expertize and experiences, and providing training on all aspects of a survey. A key challenge was finding the right balance between a rigid structure allowing maximal comparability and a flexible approach increasing feasibility and capacity building. Next steps in European harmonization in Human Biomonitoring surveys include the establishment of a joint process for prioritization of substances to cover and biomarkers to develop, linking biomonitoring surveys with health examination surveys and with research, and coping with the diverse implementations of EU regulations and international guidelines with respect to ethics and privacy.

Introduction

Estimates of the impact of environmental exposures on health are limited and contradictory. Part of the uncertainty lies in the high level of misclassification of exposures that hampers environmental health risk assessment (Weuve and Yonasky, 2012; Willett, 2002; Blair et al., 2009). Scientists, policy-makers and the general public have long focused mainly on external exposure assessments for regulation and control. In analogy with practices in occupational health and as technologies evolved, focus has now increasingly turned to pollution in the body, seized by the notion of body burden: the presence of chemicals in the body. Such body burdens can be assessed through Human Biomonitoring (HBM), which integrates information on exposure to potentially toxic chemical elements and substances from all sources (soil, water, air, food, packaging and consumer products) as well as bioavailability, toxicokinetics and metabolism (Angerer et al., 2007). HBM and other biomarker studies have shown their use in research, in surveys and in advocacy efforts. Whilst research projects are typically hypothesis driven and geared at the collection of data to link health outcomes causally to exposures, the objective of surveys typically is to support and evaluate public health policy by producing information on the prevalence of exposure to environmental toxicants based on periodic monitoring (European Commission, 2004; ECETOC, 2005; National Research Council of the National Academies, 2006).

HBM is a powerful tool in the democratization of knowledge of exposure. Personal exposure information in particular might have a strong impact on societal perception of environmental pollution. Human biomarkers data make pollution ‘personal’ and can raise awareness, support preventive actions at individual and collective level, and contribute to policy making (Stokstad, 2004). The full exploitation of the potential benefits of HBM surveys in environmental health requires accurate knowledge transfer and integration. Findings of HBM efforts however, often fail to find their way into policy and practice, resulting in a limited impact on public health policies and programs. Often single teams have proprietary control of their data and specimens; the inner workings of protocols and analyzes are invisible to outsiders and raw data do not become available (Khoury et al., 2013). HBM surveys increasingly obtain a legal embedding at national or regional level, permitting repeated cycles of measurement (Viso et al., 2009). In 2004, the European Commission started discussions on a harmonized approach throughout Europe (European Commission, 2003; European Commission, 2004; Casteleyn et al., 2007) so to improve comparability. A European pilot study was proposed to “test the hypothesis that human biomonitoring in the field of environment and health can be performed in a coherent and harmonized approach throughout Europe by means of commonly developed protocols, strategies and scientific tools ensuring reliable and comparable data, whilst also leading to a more effective use of resources”. In an interdisciplinary context, epidemiologists, chemists, toxicologists, geneticists, exposure scientists, medical professionals, social scientists and environmental health experts and policy makers, working in the fields of environmental health, public health, research and policy evaluation and support, worked closely together to develop the framework. A stakeholders group set up by the European Commission (European Commission, 2003)2 was involved in this process. Study population, exposures and outcomes, as well as parameters to be estimated, were partly defined during a broad negotiation process from 2004 until 2010. Finally a consortium of scientists from 27 European countries completed the decisions during the final negotiation process from September 2010 until March 2011 and developed a common European HBM study protocol, despite dissimilarities in approaches, technical jargon, understanding of concepts and national priorities. An extensive exchange system was set up to take into account national particularities, existing experience, expertize and infrastructure. Organizations from 17 countries, all member of the consortium, implemented the pilot study DEMOCOPHES.3 This article reports on the opportunities and the challenges for a European harmonization of HBM surveys in environmental health. It addresses the set-up of a pilot feasibility study and related discussions on data sharing, prioritization, linking with health examination, research and policy. Finally, it also discusses ethics and privacy issues as the transboundary nature of the study in a legal framework with diverse transpositions of EU regulations or of international guidelines into national laws was thought to be an additional obstacle for harmonization of methodologies and comparability of results.

Section snippets

A common study protocol

The common European study protocol was built in line with STrengthening the Reporting of OBservational studies in Epidemiology: Molecular Epidemiology (STROBE ME) guidelines (Gallo et al., 2011) developed to facilitate reporting of biomarker-based studies. Specific additions from STROBE ME to the STROBE guidelines relate to the collection, handling and storage of biological samples; laboratory methods, validity and reliability of biomarkers; specificities of study design; and ethical

Reference values

One of the aims of setting up HBM surveys is to gain knowledge of the background exposure of the population under study and establish reference values. These are required by policymakers and researchers to support their work. Together with information on health based guidance values, which are totally different in scope and use, such reference values are deemed essential for interpretation and communication of results and for translation into preventive policies. Although definitions may differ

Ethics and privacy: an obstacle?

The donation of tissues or fluids by healthy volunteers implies sensitive ethical and privacy questions. To ensure the protection of the rights and dignity of study participants a complex legal and ethical framework exists in Europe. One of the most important international references to define and safeguard fundamental human rights in the field of biomedical research, in particular of those participating in research, is the Oviedo Convention30

Conclusion

Overall the pilot study allowed (i) the development of a common study protocol, that was translated, with minor adaptations to national situations, in 17 European countries and (ii) the generation of comparable HBM data. Through a process of extensive communication and a tailor made QC system, a balance was found between flexibility and capacity building on the one hand and a rigid structure with strict criteria on the other hand. Although a limited number of biomarkers were measured and the

Financial support

COPHES (COnsortium to Perform Human Biomonitoring on a European Scale) was funded by the Seventh EU Framework Programme 2007–2011 under grant agreement no [244237].

DEMOCOPHES (DEMOnstration of a study to COordinate and Perform Human Biomonitoring on a European Scale) was co-funded (50%:50%) by the European Commission LIFE+ Programme (LIFE09/ENV/BE/000410) and the partners.

For information on both projects as well as on the national co-funding institutions: see http://www.eu-hbm.info/.

Acknowledgements

Many people contributed to the success of this project. We would in particular like to thank the mothers and children that participated in the study, the people involved in the fieldwork and laboratory work, and all our partners in COPHES and DEMOCOPHES.

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