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dc.contributor.authorBeran, RG
dc.contributor.authorBeran, ME
dc.date.accessioned2018-10-08T04:53:10Z
dc.date.available2018-10-08T04:53:10Z
dc.date.issued2006
dc.date.modified2007-08-07T04:40:42Z
dc.identifier.issn0723-1393
dc.identifier.urihttp://hdl.handle.net/10072/14085
dc.description.abstractIntroduction: Private clinics and clinicians have been involved in clinical drug trials for approximately two decades. This paper reviews the ethical consideration inherent in this process. Methods: Involvement of a single community based, private, Australian neurological clinic in the conduct of trials was audited. Changes in ethical considerations were analysed. Results: The clinic previously audited its clinical trial involvement, starting with pharmaceutical company orchestrated trials. These were vetted by hospital based ethics committees (ECs) which then refused to review private research. A private EC accommodating NH & MRC standards was formed to assess private research. Indemnity concerns forced return to institutional ECs with government guaranteed indemnification. Trials evolved to investigator initiated, company sponsored studies thence a company asking the clinic to devise, sponsor and manage a trial. The latter relegated trial co-ordination to the clinic which would control publication thereby creating new ethical standards. Discussion: Private practice trial involvement evolved from reluctant inclusion to a pivotal role in privately sponsored studies. Access to ECs is government endorsed and publication is independent for investigator-sponsored trials. There has been modification of standard operating procedures and enhanced ethical standards.
dc.description.peerreviewedYes
dc.description.publicationstatusYes
dc.languageEnglish
dc.language.isoeng
dc.publisherYozmot Heiliger Ltd
dc.publisher.placeIsrael
dc.publisher.urihttp://wafml.memberlodge.org/page-1150634
dc.relation.ispartofstudentpublicationN
dc.relation.ispartofpagefrom503
dc.relation.ispartofpageto512
dc.relation.ispartofissue3
dc.relation.ispartofjournalMedicine and Law: an international journal
dc.relation.ispartofvolume25
dc.rights.retentionY
dc.subject.fieldofresearchLaw
dc.subject.fieldofresearchcode1801
dc.titleEthics in clinical drug trial research in private practice
dc.typeJournal article
dc.type.descriptionC1 - Articles
dc.type.codeC - Journal Articles
dc.description.versionVersion of Record (VoR)
gro.facultyGriffith Health, School of Medicine
gro.description.notepublicAfter all reasonable attempts to contact the copyright owner, this work was published in good faith in interests of the digital preservation of academic scholarship. Please contact copyright@griffith.edu.au with any questions or concerns.
gro.rights.copyright© 2006 World Association for Medical Law. The attached file is reproduced here in accordance with the copyright policy of the publisher. Use hypertext link to access the journal's website.
gro.date.issued2006
gro.hasfulltextFull Text
gro.griffith.authorBeran, Roy G.


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