1. Final Report Summary - ESBIO (Development of a coherent approach to human biomonitoring in Europe)
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Abstract: The project was outlined as coordinated action which aimed to enable networking and coordination of those institutes playing an active role in European biomonitoring research with a focus on the integration of environmental monitoring and health data and those institutes transposing research results into policy programmes. Accordingly, very close and intensive networking and coordination of the involved parties was crucial in order to achieve the overall objectives:
(1) development of a coordinated approach for biomonitoring based on existing expertise and experiences available in Member States surveillance programmes and results from research;
(2) elaborate how biomonitoring results can be integrated most efficiently with environmental monitoring and registered health data;
(3) develop strategies to communicate biomonitoring results to stakeholders (populations affected, regulators, politicians) including the establishment of websites publicly available and with links to national and international activities resulting in full transparency for all stakeholders;
(4) elaborate scenarios for the use of biomonitoring results for policy making.
In order to accompany a European human biomonitoring pilot project a communication strategy has to follow four main principles:
- There should be no double work between the involved actors.
- There should be a close coordination with other EU activities in the field of E&H
- The red thread and the core statements have to match in all communication activities.
- The campaign should be flexible and adaptable according to different needs.
In order to meet these principles BIPRO has developed a modular concept which provides a tool to establish an effective and efficient communication. Starting point are the five modules target groups, aims, content to be communicated, actors to realise and tools to be used, which are elaborated in terms of their use for a HBM project supporting communication. To establish a communication strategy the individual modules are linked appropriately in a way to follow the causal chain to whom, why, what, how, who? The concept provides a common ground for communication activities within one project even if they differ greatly from each other e.g. due to different needs and expectations. The concept is ready to be used in a future HBM pilot project by the responsible communication unit.
The concept is ready for use and has to be applied according to the framework in which an HBM pilot project will be performed. With the concept it can be ensured that all concerned actors as well as the general public are involved and will be kept informed on the project performance. As HBM and the link between environment and health is a topic of increasing public awareness it is seen as essential to ensure a maximum of transparency. Actors to realise the communication and therefore to use the concept should be experts for communication on an international level together with experts in the field of HBM. A close cooperation with the institutions performing the project has to be guaranteed. Investments involved depend on several factors like the level of involvement of the Commission or the tools to be used (e.g. brochures, videos, etc.). In main costs will incur within the cost category personnel costs.
In order to perform a socio economic optimisation for a future EU HBM pilot project first of all tasks necessary for a HBM pilot project have been identified. Subsequently an Excel tool has been developed in which different parameters are variable to be filled in by the user and which calculates with the inserted figures the total necessary budget for several different study approaches. In order to achieve the optimal approach several contradictions had to overcome, this means to maximise the number of participating Member States, the biomarkers to be measured, the number of samples, the synergies effects and to maximise the scientific progress while keeping costs as low as possible. In addition a coordination concept has been elaborated proposing different work levels, i.e. performance of the pilot study should be done in each country by a national team; the harmonisation, support and evaluation of the study and its results should be done on EU level by multinational teams. In order to take into account the different levels of existing experiences a research-component should be established. The results have been discussed with all Member States and can be used for a future HBM pilot project.
The results offer an excellent basis for the establishment of an EU wider HMB network performing a harmonised pilot project. The results are usable for a unit setting up an EU network on HBM in Europe. To use the results a high rate of coordination and communication skills is necessary. A team of HBM experts, laboratories, national authorities as well as coordination and communication experts should be formed to use the full range of results. Investments involved only incur in case the HBM pilot project will be realised using the results obtained.
Part of the work concentrated on ethical issues related to present and future biomonitoring programs in EU countries by describing rules and practices in a number of countries and by organising a workshop. Special supplementary issue of the web based journal Environmental Health reporting from the workshop on ethical issues and communication within biomonitoring in Copenhagen March 2007 will be issued and a number of reports are available on the ESBIO web site and in open literature. The recommendations are:
- A protocol must be developed at an early stage describing rationale, justification of study, calculation of minimum number of study persons needed for sufficient power of study, recruitment of study persons, informed consent and information of ethics committees before initiation of studies.
- Biobanking issues needs to be solved prior to study initiation to ensure legal uses of data and samples.
- Incentives for participation must be considered to avoid economic pressure for participants and special concerns have to be made regarding children.
- Information to study persons about study results must be described and ensure respect of the right not to know.
- Harmonised approaches to steps of recruitment, information, consent, data protection, biobanking, dissemination and data / sample transfer between countries and institutions should be considered e.g. in future directives / guidelines for human environmental biomonitoring in Europe (and worldwide).
One other result is an online inventory of European human research and non-research biomonitoring actions, either ongoing or having been carried out in the last ten years. The online structure and the procedure for self registration of activities provide the optimum strategy for maintaining the available information both accurate and up-to-date. Additional functionalities such as user-defined searches of the activities and the message-board are also favoured by the web environment, and move the inventory closer to the concept developed for a platform for exchange of expertise and experience between human biomonitoring (HBM) stakeholders. The inventory holds potential for impacting all research, industry or policy sectors in any way related to HBM, in that it provides information on what is being done in the field, who is carrying out the actions, what methodologies are being applied and which laboratories have analytical experience in the area. Developments planned for the platform, such as discussion forums and webpages dedicated to specific issues within HBM, including the organisation of events, will expand this potential further through greater user involvement and a larger target public, ensuring the platform self-fulfils its potential, as a larger amount of information is registered and its usefulness consequently increases.
The opportunity for the dissemination of human biomonitoring activities conducted by private or public entities or institutes around Europe is of interest to parties wishing to establish a partnership or exchange information on procedures and practices. This already includes the publicising of specialised analytical services offered by laboratories and intends to include in the future the widespread dissemination of periodic events such as conferences or workshops among a targeted audience with a stated interest in the field. Free and practically unrestricted usage is suggested to be complemented by the charging of e.g. commercial laboratories with an 'advertising' fee for the dissemination of biomonitoring analyses conducted, as a means of funding the upkeep of the online inventory.
Subject Descriptors: Biophysics; Biotechnology; Environmental medicine
Subject Index Codes: Life Sciences; Medicine, Health; Biotechnology