Ethical issues: The multi-centre low-risk ethics/governance review process and AMOSS

Vaughan, G; Pollock, W; Peek, MJ; Knight, M; Ellwood, D; Homer, CS; Pulver, LJ; McLintock, C; Ho, M; Sullivan, EA

Ethical issues: The multi-centre low-risk ethics/governance review process and AMOSS

Vaughan, G

Pollock, W Peek, MJ Knight, M Ellwood, D Homer, CS

Pulver, LJ McLintock, C Ho, M Sullivan, EA

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Publication Type:: Journal Article
Citation:: Australian and New Zealand Journal of Obstetrics and Gynaecology, 2012, 52 (2), pp. 195 - 203
Issue Date:: 2012-04-01

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Field	Value	Language
dc.contributor.author	Vaughan, G https://orcid.org/0000-0002-0132-9946	en_US
dc.contributor.author	Pollock, W	en_US
dc.contributor.author	Peek, MJ	en_US
dc.contributor.author	Knight, M	en_US
dc.contributor.author	Ellwood, D	en_US
dc.contributor.author	Homer, CS https://orcid.org/0000-0002-7454-3011	en_US
dc.contributor.author	Pulver, LJ	en_US
dc.contributor.author	McLintock, C	en_US
dc.contributor.author	Ho, M	en_US
dc.contributor.author	Sullivan, EA https://orcid.org/0000-0002-8718-2753	en_US
dc.date.issued	2012-04-01	en_US
dc.identifier.citation	Australian and New Zealand Journal of Obstetrics and Gynaecology, 2012, 52 (2), pp. 195 - 203	en_US
dc.identifier.issn	0004-8666	en_US
dc.identifier.uri	http://hdl.handle.net/10453/18487
dc.description.abstract	Background: 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. © 2012 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology © 2012 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.	en_US
dc.relation.ispartof	Australian and New Zealand Journal of Obstetrics and Gynaecology	en_US
dc.relation.isbasedon	10.1111/j.1479-828X.2011.01390.x	en_US
dc.subject.classification	Obstetrics & Reproductive Medicine	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Health Care Surveys	en_US
dc.subject.mesh	Maternal Mortality	en_US
dc.subject.mesh	Risk	en_US
dc.subject.mesh	Prospective Studies	en_US
dc.subject.mesh	Pregnancy	en_US
dc.subject.mesh	Ethical Review	en_US
dc.subject.mesh	Ethics Committees, Research	en_US
dc.subject.mesh	Ethics, Research	en_US
dc.subject.mesh	Adult	en_US
dc.subject.mesh	Hospitals, Maternity	en_US
dc.subject.mesh	Medical Audit	en_US
dc.subject.mesh	Australia	en_US
dc.subject.mesh	New Zealand	en_US
dc.subject.mesh	Female	en_US
dc.subject.mesh	Multicenter Studies as Topic	en_US
dc.title	Ethical issues: The multi-centre low-risk ethics/governance review process and AMOSS	en_US
dc.type	Journal Article
utslib.citation.volume	2	en_US
utslib.citation.volume	52	en_US
utslib.for	111006 Midwifery	en_US
utslib.for	1114 Paediatrics and Reproductive Medicine	en_US
utslib.for	1117 Public Health and Health Services	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Arts and Social Sciences
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Public Health
pubs.organisational-group	/University of Technology Sydney/Strength - CHSP - Health Services and Practice
pubs.organisational-group	/University of Technology Sydney/Strength - WHO CC
utslib.copyright.status	closed_access
pubs.issue	2	en_US
pubs.publication-status	Published	en_US
pubs.volume	52	en_US

Abstract:

Background: 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. © 2012 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology © 2012 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

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http://hdl.handle.net/10453/18487