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DEMOCOPHES (LifePuls) – Demonstration of a study to Coordinate and Perform Human Biomonitoring on a European Scale

DEMOCOPHES aims to test the feasibility of a coherent approach to Human Biomonitoring (HBM) in Europe.

The purpose of this harmonised approach is to achieve comparable HBM data across Europe to support environment, health and chemicals policy needs. For this, DEMOCOPHES works in close collaboration with COPHES, a scientific consortium that elaborates the necessary methodologies, a functional framework and policy recommendations.

The DEMOCOPHES pilot study will look at biomarkers for mercury, cadmium, phthalates as well as environmental tobacco smoke in human hair and urine. The project will collect samples and data from 120 mother-child pairs in each participating country.
Operational framework for the implementation of the HBM pilot project.

The establishment of a National Management Unit (NMU) in each participating country will facilitate a good collaboration between field workers, scientists and policy makers as well as an adequate implementation of the different parts of the project.

The operational framework will be set up through the following process:

1. Preparation of the national study protocol based on the consensus protocol developed within COPHES (this protocol will be translated in official national languages):
− definition of the national study population and strategy for recruitment, taking into account national particularities,
− definition of national methods and related quality control aspects for sampling specimen including choice of collectors (criteria such as phthalates free), conditions of handling, preservation, sending, storing (including in existing biobanks), 
− redaction of the national questionnaire (translation, check of translation, cultural adaptations, specific questions, handbook in official languages),
− set up of the national laboratory program ensuring data comparability with data from other member states through tendering, evaluation and selection of laboratories, and corresponding quality control measures inside and/or outside the country,
− definition of the format of national databases for input and storage of results (of questionnaire data and results of specimen sample analysis,
− redaction of the statistical analysis plan and the guidelines for the identification of the country specific sources,
− compose a national communication plan for all stages of the project (from recruitment to dissemination of results at individual and collective level),
− redaction of the scenario for translation of HBM data and their appropriate interpretation into policy advice. 

2. Check of consistency between national study protocols:
− check consistency of the national protocols delivered in English with the consensus protocol of COPHES,
− finalisation of the national protocols based on the comments of COPHES (via help desk).

3. Preparation of the field work:
− submission of study proposal to national ethics committee,
− notification to privacy authority,
− organisation of adequate insurance,
− information and training of fieldworkers,
− sending of collectors to the persons in charge of sampling.

EXPECTED RESULTS

Fieldworkers will be trained and will dispose of the sample collectors as well as of national protocols in English and in national official languages explaining the way to implement the pilot project on the field. The authorisation of the national ethics committee will be obtained, the notification to privacy authority will be done and the adequate insurance will be contracted.

Leading institution
FPS Health, Food chain safety and environment, Brussels (Belgium)

Websites
: http://eu-hbm.info/democophes

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