Recent Submissions

  • Ethics and data protection in human biomarker studies.

    Casteleyn, Ludwine; Dumez, Birgit; Jamers, An; Van Damme, Karel (The Nofer Institute of Occupational Medicine, 2010)
    Human biomarker studies in environmental health are essential tools to study the relationship between health and environment. The development of relevant research potential and the setup of bio-monitoring surveys should ultimately lead to a better understanding and prevention of environmentally induced adverse health effects. In this volume we review ethics and data protection in environmental health studies using human biomarkers. The question is raised whether study participants are adequately and equally protected throughout Europe and whether at the same time progress in environmental health related studies is safeguarded. The collection of human samples and data is subject to regulations and rules of different kinds, from deontological codes to data protection laws, from the local to the international level. Within an EU context, the probably most important international references in this respect are the Data Protection Directive (95/46/EC), the Oviedo Convention, more in particular its Additional Protocol concerning biomedical research and Rec(2006)4 on research on biological material of human origin. A critical analysis of research experiences in various EU countries shows that difficulties, ambiguities or even inconsistencies exist in the way ethical and juridical challenges are framed and being dealt with within and across countries. The diverse implementations of EU regulations or international guidelines in domestic law may in particular hinder transnational research and bring about inequalities in the level of protection. Overall, in research on biological material of human origin emphasis is primarily on decisional autonomy and protection of the individual's rights whilst the collective need to protect health as a public asset is relatively less valued. This is particularly striking when personal data or samples collected for a specific research purpose could be of value in a new study. This secondary use often remains very complex or almost impossible, although there are strong and recognized arguments for facilitation of such further use in the context of environmental health research where public interest comes to the forefront and risks are minimal, on the condition that adequate collective protection and control against improper use of samples or data can be installed, and breach of confidentiality or any use of data which would be not in line with the subject's moral stakes can be excluded. An increasing demand exists for adapted communication strategies at all stages of a study, not only at the individual level, but also at the collective level, and including the time of translation of results in preventive actions and policy making. The vital role of communication is obvious. Each communicative act may affect trust in the study at hand and in science in general. Expertise in the field of social sciences is therefore demanded. Even though many improvements regarding the legal and ethical challenges in human studies have already been implemented in the EU in the last years, these issues are not well known among the actors involved and efforts should be devoted to better education and dissemination of information and enhanced transparency targeting researchers but also the general public, the media and the policymakers. Research ethics committees play a pivotal role in assessing to what extent decision making processes fit with both individual and societal interest. Respect for human dignity and equality of moral status of all individuals, social justice, solidarity and democratic participation may thereby be appealing reflections of European values and useful complements to the four conventional bioethical principles (autonomy, beneficence, non-maleficence, and justice) that are widely applied for evaluating policies, programs or activities that may entail risk to human health. To achieve more consistency in the research conditions nationally and internationally an ethics committee at the level of the ‘European research area' could be envisaged, mainly focusing on transnational research. Moreover, the analysis and evaluation of different cases in different situations would build-up an extensive knowledge and experience that may serve as an inspiring starting point for a well informed societal debate. This way, gradually, more consistency in the handling of study proposals and increased transparency in decision making might be reached, lifting the daily practices and the protection of both individual and community interest to a higher level of meeting up with ethical concerns in transnational research. Researchers have the duty to support the translation of research results in preventive actions at individual and at collective level whenever relevant. Participatory processes will facilitate the inclusion of arguments from the societal perspective and increase trust and mutual understanding between all parties involved, add to the legitimacy of the final outcome and the public support for the policy decision-making process, and implement democracy.
  • State of the art of genotype vs. phenotype studies.

    Nofer Institute of Occupational Medicine, 2008
  • Biomarkers of carcinogen exposure and early effects.

    The Nofer Institute of Occupational Medicine, 2006
    The purpose of this review is to summarise the current situation regarding the types and uses of biomarkers of exposure and effect for the main classes of food-derived genotoxic carcinogens, and to consider some aspects of the intercomparison between these biomarkers. The biomarkers of exposure and early effects of carcinogens that have been most extensively developed are those for genotoxic agents and for compounds that generate hydroxyl radicals and other reactive radical species, and it is on these that this review is mostly concentrated.
  • Epidemiological concepts of validation of biomarkers for the identification/quantification of environmental carcinogenic exposures.

    The Nofer Institute of Occupational Medicine, 2007
    The present report has been prepared by a group of European scientists in the context of the EU-funded Network of Exellence ECNIS whose goal is to provide effective biomarkers for the study of the relationships between environmental toxicants, dietary habits and cancer. The use of biomarkers in cancer epidemiology has a rather long history (the wording "molecular epidemiology" was originally proposed by Perera and Weinstein in 1982) and great successes have been achieved, like the investigation of the predictive ability of chromosome aberrations, the relationship between aromatic amines in tobacco, the NAT2 genotype and bladder cancer, or the mechanisms by which benzene induces leukaemia. However, many biomarkers are introduced into research without proper validation, and this hampers successful research, introducing bias or simply blurring existing associations. In addition, new and complex issues are emerging through the introduction of high-throughput technologies, like the expected large number of false positives, or the complex interplay between environmental exposures, intermediate markers, confounders and disease. Causality assessment has really become a challenge. For these reasons, we think it can be useful to summarize the main criteria for biomarker validation (Chapter 1); to offer some insights into new technical and statistical developments for the management and interpretation of biomarker data (Chapter 2); and to offer some examples of existing information (usually sparse) on biomarker validation (Chapter 3).
  • Dietary vitamins, polyphenols, selenium and probiotics: biomarkers of exposure and mechanism of anticarcinogenic action.

    The Nofer Institute of Occupational Medicine, 2007-04
    The major aim of this review was to summarize the state-of-the-art in use of biomarkers for some anticarcinogenic food components and to identify knowledge gaps, especially those of relevance for the partners of the NoE ECNIS and its contacts. Since this is a vast area, only certain selected topics, as outlined below, are considered in detail. The important links found between use of a substance as a biomarker and its mechanisms of action led to a further aim, that of reviewing the mechanisms of action of some of the most promising anticarcinogenic compounds.
  • State of validation of biomarkers of carcinogen exposure and early effects and their applicability to molecular epidemiology.

    The Nofer Institute of Occupational Medicine, 2007
    By providing objective measures of exposure to specific agents and early, biologically relevant effects, at the level of the individual, biomarkers can provide a way of investigating associations between exposure and disease. For their potential to be realised, it is essential that biomarkers undergo the critical process of validation. Biomarker validation encompasses two different levels: firstly, the analytical and operational methodology; and secondly the inherent ability of biomarkers to reflect the chemical nature, level and duration of an individual's exposure and/or the degree of disease risk. The current Report focuses on the second aspect, summarising the state of validation of the most important biomarkers of exposure to food-related carcinogens or their early effects and identifying the gaps in knowledge that remain.