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

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.

Ethical aspects of human placental perfusion: interview of the mothers donating placenta.

Within the EU project "NewGeneris" human placental perfusion has been used for assessing in utero fetal exposure to food carcinogens. Within the work package of ethical aspects of the research, we were interested in the way mothers who donated placentas for perfusion perceived their participation in the study. Thematic interviews were conducted with 25 mothers who had donated the placenta for placental perfusion studies. The main themes covered during the interviews were recruitment for placental perfusion studies, informed consent, risks and benefits, handling and confidentiality of personal information and societal meaning of the placental perfusion studies. Data were analysed qualitatively using thematic content analysis. Mothers, when rightly informed about the purpose of the placental perfusion study were very interested in the study and supported the use of the placenta for such purpose. Overall, this study revealed several points of particular interest in placental perfusion studies. First, the recruiters' involvement with and commitment to the research project and its ethical conduct were of utmost importance for handling the informed consent procedure correctly. Second, the timing of the recruitment was important since it considerably affected the understanding of the given information, women in labour being obviously less receptive to such information. Third, the trust of participants depended on the multidisciplinary collaboration between the researchers and hospital personnel and this trust was enhanced by a thorough, objective and fair informed consent procedure.