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dc.contributor.authorVaughan, Geraldine
dc.contributor.authorPollock, Wendy
dc.contributor.authorPeek, Michael J
dc.contributor.authorKnight, Marian
dc.contributor.authorEllwood, David
dc.contributor.authorHomer, Caroline S
dc.contributor.authorPulver, Lisa Jackson
dc.contributor.authorMcLintock, Claire
dc.contributor.authorHo, Maria T
dc.contributor.authorSullivan, Elizabeth A
dc.date.accessioned2017-05-03T16:03:16Z
dc.date.available2017-05-03T16:03:16Z
dc.date.issued2012
dc.date.modified2013-10-11T02:17:42Z
dc.identifier.issn0004-8666
dc.identifier.doi10.1111/j.1479-828X.2011.01390.x
dc.identifier.urihttp://hdl.handle.net/10072/52988
dc.description.abstractBackground: The Australasian Maternity Outcomes Surveillance System (AMOSS) conducts surveillance and research of rare and serious conditions in pregnancy. This multi-centre population health study is considered low risk with minimal ethical impact. Objective: To describe the ethics/governance review pathway undertaken by AMOSS. Method: Prospective, descriptive study during 2009-2011 of the governance/ethical review processes required to gain approval for Australian and New Zealand (ANZ) maternity units with more than 50 births per year (n = 303) to participate in AMOSS. Results: Review processes ranged from a single application for 24 NZ sites, a single application for eligible hospitals in two Australian states, full Health Research Ethics Committee (HREC) applications for individual hospitals, through simple letters of support. As of September 2011, 46 full/expedited ethics applications, 131 site governance applications and 136 letters of support requests were made over 33 months, involving an estimated 3261 hours by AMOSS staff/investigators, and an associated resource burden by participating sites, to obtain approval to receive nonidentifiable data from 291 hospitals. Conclusion: The AMOSS research system provides an important resource to enhance knowledge of conditions that cause rare and serious maternal morbidity. Yet the highly variable ethical approval processes required to implement this study have been excessively repetitive and burdensome. This process jeopardises timely, efficient research project implementation, without corresponding benefits to research participants. The resource burden to establish research governance for AMOSS confirms the urgent need for the Harmonisation of Multi-centre Ethical Review (HoMER) to further streamline ethics/governance review processes for multi-centre research.
dc.description.peerreviewedYes
dc.description.publicationstatusYes
dc.format.extent508892 bytes
dc.format.mimetypeapplication/pdf
dc.languageEnglish
dc.language.isoeng
dc.publisherWiley-Blackwell Publishing Asia
dc.publisher.placeAustralia
dc.relation.ispartofstudentpublicationN
dc.relation.ispartofpagefrom195
dc.relation.ispartofpageto203
dc.relation.ispartofissue2
dc.relation.ispartofjournalAustralian and New Zealand Journal of Obstetrics and Gynaecology
dc.relation.ispartofvolume52
dc.rights.retentionY
dc.subject.fieldofresearchMedical and Health Sciences not elsewhere classified
dc.subject.fieldofresearchPaediatrics and Reproductive Medicine
dc.subject.fieldofresearchPublic Health and Health Services
dc.subject.fieldofresearchcode119999
dc.subject.fieldofresearchcode1114
dc.subject.fieldofresearchcode1117
dc.titleEthical issues: The multi-centre low-risk ethics/governance review process and AMOSS
dc.typeJournal article
dc.type.descriptionC1 - Articles
dc.type.codeC - Journal Articles
gro.rights.copyright© 2012 Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Published by Blackwell Publishing Ltd. This is the author-manuscript version of the paper. Reproduced in accordance with the copyright policy of the publisher. The definitive version is available at http://onlinelibrary.wiley.com/
gro.date.issued2012
gro.hasfulltextFull Text
gro.griffith.authorEllwood, David


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