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Dahl, Matthias
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Dahl, Matthias
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Dahl, Matthias
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Dahl, M.
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2004Journal Article [["dc.bibliographiccitation.firstpage","85"],["dc.bibliographiccitation.issue","1"],["dc.bibliographiccitation.journal","Journal of Medical Ethics"],["dc.bibliographiccitation.lastpage","87"],["dc.bibliographiccitation.volume","30"],["dc.contributor.author","Lenk, C."],["dc.contributor.author","Radenbach, K."],["dc.contributor.author","Dahl, Matthias"],["dc.contributor.author","Wiesemann, Claudia"],["dc.date.accessioned","2017-10-16T10:54:28Z"],["dc.date.available","2017-10-16T10:54:28Z"],["dc.date.issued","2004"],["dc.description.abstract","Objectives: Clinical trials in humans in Germany—as in many other countries—must be approved by localresearch ethics committees (RECs). The current study has been designed to document and evaluatedecisions of chairpersons of RECs in the problematic field of non-therapeutic research with minors. Theauthors’ purpose was to examine whether non-therapeutic research was acceptable for chairpersons atall, and whether there was certainty on how to decide in research trials involving more than minimal risk.Design: In a questionnaire, REC chairpersons had to evaluate five different scenarios with (in parts) nontherapeuticresearch. The scenarios described realistic potential research projects with minors, involvingincreasing levels of risk for the research participants. The chairpersons had to decide whether therespective projects should be approved.Methods: A total of 49 German REC chairpersons were sent questionnaires; 29 questionnaires werereturned. The main measurements were approval or rejection of research scenarios.Results: Chairpersons of German RECs generally tend to accept non-therapeutic research with minors ifthe apparent risk for the participating children is low. If the risk is clearly higher than ‘‘minimal’’, thechairpersons’ decisions differ widely.Conclusion: The fact that there seem to be different attitudes of chairpersons to non-therapeutic researchwith minors is problematic from an ethical point of view. It suggests a general uncertainty about thestandards of protection for minor research participants in Germany. Therefore, further ethical and legalregulation of non-therapeutic research with minors in Germany seems necessary."],["dc.format.mimetype","application/pdf"],["dc.identifier.doi","10.1136/jme.2003.005900"],["dc.identifier.fs","17497"],["dc.identifier.gro","3146746"],["dc.identifier.pmid","14872082"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?goescholar/4135"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/9420"],["dc.language.iso","en"],["dc.notes.intern","Migrated from goescholar"],["dc.notes.status","final"],["dc.relation.issn","0306-6800"],["dc.rights","Goescholar"],["dc.rights.access","openAccess"],["dc.rights.uri","https://goescholar.uni-goettingen.de/licenses"],["dc.subject","REC, research ethics committee"],["dc.subject.ddc","610"],["dc.title","Non-therapeutic research with minors: how do chairpersons of German research ethics committees decide?"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","no"],["dc.type.version","submitted_version"],["dspace.entity.type","Publication"]]Details DOI PMID PMC2001Journal Article [["dc.bibliographiccitation.firstpage","87"],["dc.bibliographiccitation.issue","1-2"],["dc.bibliographiccitation.journal","Ethik in der Medizin"],["dc.bibliographiccitation.lastpage","110"],["dc.bibliographiccitation.volume","13"],["dc.contributor.author","Dahl, Matthias"],["dc.contributor.author","Wiesemann, Claudia"],["dc.date.accessioned","2017-10-16T10:54:28Z"],["dc.date.available","2017-10-16T10:54:28Z"],["dc.date.issued","2001"],["dc.description.abstract","Medizinische Studien an Kindern und Jugendlichen erfordern eine gesonderte ethische Betrachtung. Als ein besonders sensibler Bereich erweist sich hierbei die rein fremdnützige Forschung. Die Haltung des Gesetzgebers in dieser Frage ist nicht eindeutig. Dies wirft vielfältige Probleme auf und ist in letzter Zeit vielfach kritisiert worden, da sie der Realität klinischer Studien nicht gerecht wird. Für eine gesetzliche und ethische Neuregelung sollte dazu auf die differenzierte internationale Diskussion zurückgegriffen werden. Diskutiert werden die historische Entwicklung der Forschung an Kindern und Jugendlichen aus ethischer Perspektive, der Begriff des minimalen Risikos, Bewertungskriterien für Risiko und Belästigung, Regelungen zur Einwilligung bzw. Zustimmung von Eltern sowie zur Beteiligung von Eltern und Kindern in der Planungsphase von Studien. Schließlich werden in sieben Punkten Mindeststandards für zukünftige ethische Richtlinien zur Forschung an Kindern und Jugendlichen entwickelt."],["dc.identifier.doi","10.1007/s004810100116"],["dc.identifier.gro","3146740"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/9414"],["dc.language.iso","de"],["dc.notes.status","final"],["dc.relation.issn","0935-7335"],["dc.title","Forschung an Minderjährigen im internationalen Vergleich: Bilanz und Zukunftsperspektiven"],["dc.type","journal_article"],["dc.type.internalPublication","unknown"],["dc.type.peerReviewed","no"],["dspace.entity.type","Publication"]]Details DOI