Research on ethics in two large Human Biomonitoring projects ECNIS and NewGeneris: a bottom up approach.

2.50
Hdl Handle:
http://hdl.handle.net/10146/76460
Title:
Research on ethics in two large Human Biomonitoring projects ECNIS and NewGeneris: a bottom up approach.
Authors:
Dumez, Birgit; Van Damme, Karel; Casteleyn, Ludwine
Abstract:
Assessment of ethical aspects and authorization by ethics committees have become a major constraint for health research including human subjects. Ethical reference values often are extrapolated from clinical settings, where emphasis lies on decisional autonomy and protection of individual's privacy. The question rises if this set of values used in clinical research can be considered as relevant references for HBM research, which is at the basis of public health surveillance. Current and future research activities using human biomarkers are facing new challenges and expectancies on sensitive socio-ethical issues. Reflection is needed on the necessity to balance individual rights against public interest. In addition, many HBM research programs require international collaboration. Domestic legislation is not always easily applicable in international projects. Also, there seem to be considerable inconsistencies in ethical assessments of similar research activities between different countries and even within one country. All this is causing delay and putting the researcher in situations in which it is unclear how to act in accordance with necessary legal requirements. Therefore, analysis of ethical practices and their consequences for HBM research is needed.This analysis will be performed by a bottom-up approach, based on a methodology for comparative analysis of determinants in ethical reasoning, allowing taking into account different social, cultural, political and historical traditions, in view of safeguarding common EU values. Based on information collected in real life complexity, paradigm cases and virtual case scenarios will be developed and discussed with relevant stakeholders to openly discuss possible obstacles and to identify options for improvement in regulation. The material collected will allow developing an ethical framework which may constitute the basis for a more harmonized and consistent socio-ethical and legal approach. This will not only increase the possibilities for comparison between data generated but may also allow for more equality in the protection of the rights of European citizens and establish trustful relationships between science and society, based on firmly rooted ethical values within the EU legislative framework.These considerations outline part of the research on legal, socio-ethical and communication aspects of HBM within the scope of ECNIS (NoE) and NewGeneris (IP).
Citation:
Environ. Health 2008, 7 Suppl 1:S7
Journal:
Environmental health : a global access science source
Issue Date:
2008
URI:
http://hdl.handle.net/10146/76460
DOI:
10.1186/1476-069X-7-S1-S7
PubMed ID:
18541073
Additional Links:
http://www.ehjournal.net/content/7/S1/S7/?mkt=; http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=18541073
Type:
Article
Language:
en
ISSN:
1476-069X
Sponsors:
This work was partly supported by ECNIS NoE (Environmental Cancer Risk, Nutrition and Individual Susceptibility) (Contract No 513943), and NewGeneris IP (Newborns and Genotoxic exposure risks) http://www.newgeneris.org (Contract No 016320-2), operating within the European Union 6th Framework Program, Priority 5: "Food Quality and Safety". Partners ECNIS Partners are Lisbeth E. Knudsen, University of Copenhagen; Micheline Kirsh-Volders, Free university of Brussels, Kinga Polanska, Nofer Institute and Paolo Vineis, Michaela Ghisleni, the Institute for Scientific Interchange Foundation/Oxford University.
Appears in Collections:
Articles

Full metadata record

DC FieldValue Language
dc.contributor.authorDumez, Birgit-
dc.contributor.authorVan Damme, Karel-
dc.contributor.authorCasteleyn, Ludwine-
dc.date.accessioned2009-08-06T08:13:22Z-
dc.date.available2009-08-06T08:13:22Z-
dc.date.issued2008-
dc.identifier.citationEnviron. Health 2008, 7 Suppl 1:S7en
dc.identifier.issn1476-069X-
dc.identifier.pmid18541073-
dc.identifier.doi10.1186/1476-069X-7-S1-S7-
dc.identifier.urihttp://hdl.handle.net/10146/76460-
dc.description.abstractAssessment of ethical aspects and authorization by ethics committees have become a major constraint for health research including human subjects. Ethical reference values often are extrapolated from clinical settings, where emphasis lies on decisional autonomy and protection of individual's privacy. The question rises if this set of values used in clinical research can be considered as relevant references for HBM research, which is at the basis of public health surveillance. Current and future research activities using human biomarkers are facing new challenges and expectancies on sensitive socio-ethical issues. Reflection is needed on the necessity to balance individual rights against public interest. In addition, many HBM research programs require international collaboration. Domestic legislation is not always easily applicable in international projects. Also, there seem to be considerable inconsistencies in ethical assessments of similar research activities between different countries and even within one country. All this is causing delay and putting the researcher in situations in which it is unclear how to act in accordance with necessary legal requirements. Therefore, analysis of ethical practices and their consequences for HBM research is needed.This analysis will be performed by a bottom-up approach, based on a methodology for comparative analysis of determinants in ethical reasoning, allowing taking into account different social, cultural, political and historical traditions, in view of safeguarding common EU values. Based on information collected in real life complexity, paradigm cases and virtual case scenarios will be developed and discussed with relevant stakeholders to openly discuss possible obstacles and to identify options for improvement in regulation. The material collected will allow developing an ethical framework which may constitute the basis for a more harmonized and consistent socio-ethical and legal approach. This will not only increase the possibilities for comparison between data generated but may also allow for more equality in the protection of the rights of European citizens and establish trustful relationships between science and society, based on firmly rooted ethical values within the EU legislative framework.These considerations outline part of the research on legal, socio-ethical and communication aspects of HBM within the scope of ECNIS (NoE) and NewGeneris (IP).en
dc.description.sponsorshipThis work was partly supported by ECNIS NoE (Environmental Cancer Risk, Nutrition and Individual Susceptibility) (Contract No 513943), and NewGeneris IP (Newborns and Genotoxic exposure risks) http://www.newgeneris.org (Contract No 016320-2), operating within the European Union 6th Framework Program, Priority 5: "Food Quality and Safety". Partners ECNIS Partners are Lisbeth E. Knudsen, University of Copenhagen; Micheline Kirsh-Volders, Free university of Brussels, Kinga Polanska, Nofer Institute and Paolo Vineis, Michaela Ghisleni, the Institute for Scientific Interchange Foundation/Oxford University.en
dc.language.isoenen
dc.relation.urlhttp://www.ehjournal.net/content/7/S1/S7/?mkt=en
dc.relation.urlhttp://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=18541073en
dc.subjectEnvironmental Monitoringen
dc.subjectEthics Committeesen
dc.subjectHuman Experimentationen
dc.subject.meshCommunication-
dc.subject.meshDecision Making-
dc.subject.meshEnvironmental Monitoring-
dc.subject.meshEthics Committees, Research-
dc.subject.meshEthics, Research-
dc.subject.meshHuman Experimentation-
dc.subject.meshHumans-
dc.titleResearch on ethics in two large Human Biomonitoring projects ECNIS and NewGeneris: a bottom up approach.en
dc.typeArticleen
dc.identifier.journalEnvironmental health : a global access science sourceen

Related articles on PubMed

All Items in ECNIS-NIOM are protected by copyright, with all rights reserved, unless otherwise indicated.