Now showing 1 - 6 of 6
  • 2012Journal Article
    [["dc.bibliographiccitation.firstpage","342"],["dc.bibliographiccitation.issue","6"],["dc.bibliographiccitation.journal","Journal of Medical Ethics"],["dc.bibliographiccitation.lastpage","346"],["dc.bibliographiccitation.volume","38"],["dc.contributor.author","Lenk, Christian"],["dc.contributor.author","Beier, Katharina"],["dc.date.accessioned","2018-11-07T09:09:56Z"],["dc.date.available","2018-11-07T09:09:56Z"],["dc.date.issued","2012"],["dc.description.abstract","The human body and its parts are widely perceived as matters beyond commercial usage. This belief is codified in several national and European documents. This so-called 'no-property rule' is held to be the default position across the countries of the European Union. However, a closer look at the most pertinent national and European documents, and also current practices in the field, reveals a gradual model of commercialisation of human tissue. In particular, we will argue that the ban on commercialisation of body material is not as strict as it may appear at first sight, leaving room for the commercial practice of tissue procurement and transfer. We argue for more transparent information for patients and tissue donors, an intensified ethical debate on commercialisation practices, and a critical review of current normative principles."],["dc.description.sponsorship","European Union"],["dc.identifier.doi","10.1136/jme.2010.038760"],["dc.identifier.isi","000304447500004"],["dc.identifier.pmid","21697294"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/9097"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/26386"],["dc.notes.intern","Merged from goescholar"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.publisher","B M J Publishing Group"],["dc.relation.issn","0306-6800"],["dc.rights","Goescholar"],["dc.rights.uri","https://goescholar.uni-goettingen.de/licenses"],["dc.title","Is the commercialisation of human tissue and body material forbidden in the countries of the European Union?"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.status","published"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]
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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"]]
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  • 2014Review
    [["dc.bibliographiccitation.firstpage","537"],["dc.bibliographiccitation.journal","Therapeutics and Clinical Risk Management"],["dc.bibliographiccitation.lastpage","546"],["dc.bibliographiccitation.volume","10"],["dc.contributor.author","Lenk, Christian"],["dc.contributor.author","Duttge, Gunnar"],["dc.date.accessioned","2018-11-07T09:46:02Z"],["dc.date.available","2018-11-07T09:46:02Z"],["dc.date.issued","2014"],["dc.description.abstract","For more than 20 years the off-label use of drugs has been an essential part of the ethical and legal considerations regarding the international regulation of drug licensing. Despite a number of regulatory initiatives in the European Union, there seems to remain a largely unsatisfactory situation following a number of critical descriptions and statements from actors in the field. The present article gives an overview of the ethical and legal framework and developments in European countries and identifies existing problems and possible pathways for solutions in this important regulatory area. In addition to the presentation of the ethical and legal foundations, some attention is given to criticisms from medical practitioners to the current handling of off-label drug use. The review also focuses on the situation confronted by patients and physicians when off-label prescriptions are necessary. Through legal descriptions from a number of countries, possible solutions for future discussion of European health care policy are selected and explained."],["dc.identifier.doi","10.2147/TCRM.S40232"],["dc.identifier.isi","000338788000001"],["dc.identifier.pmid","25050064"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/11881"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/34773"],["dc.notes.intern","Merged from goescholar"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.publisher","Dove Medical Press Ltd"],["dc.relation.issn","1178-203X"],["dc.rights","CC BY-NC 3.0"],["dc.rights.uri","https://creativecommons.org/licenses/by-nc/3.0"],["dc.title","Ethical and legal framework and regulation for off-label use: European perspective"],["dc.type","review"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.status","published"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]
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  • 2018Journal Article
    [["dc.bibliographiccitation.firstpage","e0198249"],["dc.bibliographiccitation.issue","6"],["dc.bibliographiccitation.journal","PLoS One"],["dc.bibliographiccitation.volume","13"],["dc.contributor.author","Flatau, Laura"],["dc.contributor.author","Reitt, Markus"],["dc.contributor.author","Duttge, Gunnar"],["dc.contributor.author","Lenk, Christian"],["dc.contributor.author","Zoll, Barbara"],["dc.contributor.author","Poser, Wolfgang"],["dc.contributor.author","Weber, Alexandra"],["dc.contributor.author","Heilbronner, Urs"],["dc.contributor.author","Rietschel, Marcella"],["dc.contributor.author","Strohmaier, Jana"],["dc.contributor.author","Kesberg, Rebekka"],["dc.contributor.author","Nagel, Jonas"],["dc.contributor.author","Schulze, Thomas G."],["dc.contributor.editor","DeAngelis, Margaret M."],["dc.date.accessioned","2020-12-10T18:42:07Z"],["dc.date.available","2020-12-10T18:42:07Z"],["dc.date.issued","2018"],["dc.identifier.doi","10.1371/journal.pone.0198249"],["dc.identifier.eissn","1932-6203"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/15687"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/77816"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-354"],["dc.notes.intern","Merged from goescholar"],["dc.rights","CC BY 4.0"],["dc.rights.uri","https://creativecommons.org/licenses/by/4.0/"],["dc.title","Genomic information and a person’s right not to know: A closer look at variations in hypothetical informational preferences in a German sample"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]
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  • 2011Journal Article
    [["dc.bibliographiccitation.firstpage","357"],["dc.bibliographiccitation.issue","3"],["dc.bibliographiccitation.journal","Ethical Theory and Moral Practice"],["dc.bibliographiccitation.lastpage","359"],["dc.bibliographiccitation.volume","14"],["dc.contributor.author","Lenk, Christian"],["dc.date.accessioned","2019-07-09T11:53:21Z"],["dc.date.available","2019-07-09T11:53:21Z"],["dc.date.issued","2011"],["dc.identifier.doi","10.1007/s10677-011-9267-x"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/7355"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/60407"],["dc.language.iso","en"],["dc.notes.intern","Merged from goescholar"],["dc.publisher","Springer"],["dc.publisher.place","Dordrecht"],["dc.rights","Goescholar"],["dc.rights.uri","https://goescholar.uni-goettingen.de/licenses"],["dc.subject.ddc","610"],["dc.title","Jan-Christoph Heilinger: Anthropologie und Ethik des Enhancements"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]
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  • 2009Journal Article
    [["dc.bibliographiccitation.firstpage","1473"],["dc.bibliographiccitation.issue","12"],["dc.bibliographiccitation.journal","European Journal of Pediatrics"],["dc.bibliographiccitation.lastpage","1478"],["dc.bibliographiccitation.volume","168"],["dc.contributor.author","Lenk, Christian"],["dc.contributor.author","Koch, Philipp"],["dc.contributor.author","Zappel, Hildegard"],["dc.contributor.author","Wiesemann, Claudia"],["dc.date.accessioned","2017-10-16T10:54:26Z"],["dc.date.available","2017-10-16T10:54:26Z"],["dc.date.issued","2009"],["dc.description.abstract","ff-label drug use in paediatrics is associated with an increased risk of adverse drug reactions. Any risk-benefit analysis has to be based on value judgments that should include parents' views. However, nothing is known so far about the parents' perspective on this critical issue. Therefore, a quantitative survey with parents of healthy and chronically ill children was carried out (n = 94). Knowledge about the practise of off-label use is generally poor in both groups. Surprisingly, this is also true for the parents of children with chronic disease. Nine percent of the parents of chronically ill children and 20% of the parents of healthy children would refuse treatment with an off-label drug. Parents who have poor knowledge about the practise of off-label use tend to refuse to volunteer their child for study participation. Therefore, the information of parents on the off-label use of drugs is important to meet ethical standards and to increase the parents' acceptance of medical studies with children."],["dc.identifier.doi","10.1007/s00431-009-0956-6"],["dc.identifier.gro","3146729"],["dc.identifier.pmid","19277709"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?goescholar/3759"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/9402"],["dc.language.iso","en"],["dc.notes.intern","Merged from goescholar"],["dc.notes.status","public"],["dc.relation.issn","0340-6199"],["dc.rights","Goescholar"],["dc.rights.uri","https://goescholar.uni-goettingen.de/licenses"],["dc.title","Off-label, off-limits? Parental awareness and attitudes towards off-label use in paediatrics"],["dc.type","journal_article"],["dc.type.internalPublication","unknown"],["dc.type.peerReviewed","no"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]
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