Register      Login
Australian Health Review Australian Health Review Society
Journal of the Australian Healthcare & Hospitals Association
RESEARCH ARTICLE

Red tape delays maternal morbidity study: problems and possible solutions

Joanne Frost https://orcid.org/0000-0002-5268-9458 A B * , Edward Weaver B C D and Leonie Callaway A B
+ Author Affiliations
- Author Affiliations

A Women’s and Newborn Services, Royal Brisbane and Women’s Hospital, Brisbane, Qld, Australia.

B The University of Queensland, School of Medicine, Brisbane, Qld, Australia.

C Department of Obstetrics and Gynaecology, Sunshine Coast University Hospital, Qld, Australia.

D Griffith University School of Medicine and Dentistry, Sunshine Coast, Qld, Australia.

* Correspondence to: j.frost@uq.edu.au

Australian Health Review 49, AH25018 https://doi.org/10.1071/AH25018
Submitted: 28 January 2025  Accepted: 9 July 2025  Published: 11 August 2025

© 2025 The Author(s) (or their employer(s)). Published by CSIRO Publishing on behalf of AHHA.

Abstract

Objective

This study aims to outline the bureaucratic process of obtaining ethical and governance approval to undertake a research project on severe acute maternal morbidity (SAMM), highlighting the effect this had on performing research in a timely way.

Methods

A retrospective, descriptive case study evaluation, from the researcher’s perspective, of the research ethics and governance process required, during 2022–2023, to conduct a retrospective audit of 20 years of one SAMM event (peripartum hysterectomy) in five public maternity care facilities (two Hospital and Health Services (HHSs)) within a single state of Australia. Outcome measures included: the number of documents/forms completed, emails sent, phone calls/meetings held, number of people involved in approval, the number of submissions/re-submissions required and the time to obtain ethics/governance approval (working days).

Results

Ten data custodian approvals from within the same organisation were required to obtain peripartum hysterectomy data from five statewide databases and from local records in two HHSs. Overall, it took 268 working days from submission of the first ethics application to obtaining approval for the final governance application.

Conclusions

Cumbersome research approval processes consume a lot of research time. Our study exemplifies the continuing overregulation of low- and negligible-risk research that continues to limit investigation and prevention of serious obstetric conditions.

Keywords: adverse events, health services administration, health services research, maternal health, pregnancy complications, research ethics, research support, women’s health.

References

Kildea S, Pollock WE, Barclay L. Making pregnancy safer in Australia: The importance of maternal death review. Aust N Z J Obstet Gynaecol 2008; 48: 130-136.
| Crossref | Google Scholar | PubMed |

Ozimek JA, Greene N, Geller A, et al. Routine Multidisciplinary Review of Severe Maternal Morbidity Is Associated with a Reduction in Preventable Cases of Severe Maternal Morbidity. Am J Perinatol 2022; 39: 307-311.
| Crossref | Google Scholar |

Lipkind H, Zuckerwise L, Turner E, et al. Severe maternal morbidity during delivery hospitalisation in a large international administrative database, 2008–2013: a retrospective cohort. BJOG 2019; 126: 1223-1230.
| Crossref | Google Scholar | PubMed |

Duke GJ, Maiden MJ, Huning EYS, et al. Severe acute maternal morbidity trends in Victoria, 2001–2017. Aust N Z J Obstet Gynaecol 2020; 60: 548-554.
| Crossref | Google Scholar | PubMed |

Debbink MP, Metz TD, Nelson RE, et al. Directly Measured Costs of Severe Maternal Morbidity Events during Delivery Admission Compared with Uncomplicated Deliveries. Am J Perinatol 2022; 39: 567-576.
| Crossref | Google Scholar |

New South Wales. Parliament. Legislative Council. Select Committee on Birth Trauma. Report no. 1. Birth trauma. May 2024. Sydney: Parliament of NSW, Legislative Council, Select Committee on Birth Trauma; 2024.

Vaughan G, Pollock W, Peek MJ, et al. Ethical issues: the multi-centre low-risk ethics/governance review process and AMOSS. Aust N Z J Obstet Gynaecol 2012; 52: 195-203.
| Crossref | Google Scholar |

Barnett AG, Campbell MJ, Shield C, et al. The high costs of getting ethical and site-specific approvals for multi-centre research. Res Integr Peer Rev 2016; 1: 16.
| Crossref | Google Scholar | PubMed |

Scott AM, Bryant EA, Byrne JA, et al. “No Country Bureaucratised its way to Excellence”: A Content Analysis of Comments on a Petition to Streamline Australian Research Ethics and Governance Processes. J Empir Res Hum Res Ethics 2022; 17: 102-113.
| Crossref | Google Scholar | PubMed |

10  White VM, Bibby H, Green M, et al. Inconsistencies and time delays in site-specific research approvals hinder collaborative clinical research in Australia. Intern Med J 2016; 46: 1023-1029.
| Crossref | Google Scholar |

11  NHMRC. Ethical Considerations in Quality Assurance and Evaluation Activities. In: National Health and Medical Research Council, editor. Canberra: Australian Government; 2014.

12  Duszynski KM, Pratt NL, Lynch JW, et al. Process trumps potential public good: better vaccine safety through linked cross-jurisdictional immunisation data in Australia. Aust N Z J Public Health 2019; 43: 496-503.
| Crossref | Google Scholar | PubMed |

13  Buck K, Nolte L, Kelly H, et al. Challenges in obtaining research ethics and governance approvals for an Australian national intersector, multisite audit study. Aust Health Rev 2020; 44: 799-805.
| Crossref | Google Scholar | PubMed |

14  Hollingworth S, Mckavanagh D, McPherson I, et al. Research governance authorisation: the next frontier. Aust Health Rev 2021; 45: 389-392.
| Crossref | Google Scholar |

15  Christie DRH, Gabriel GS, Dear K. Adverse effects of a multicentre system for ethics approval on the progress of a prospective multicentre trial of cancer treatment: how many patients die waiting? Intern Med J 2007; 37: 680-686.
| Crossref | Google Scholar | PubMed |

16  Maddern G. Ethical approval: unfit for purpose? ANZ J Surg 2021; 91: 2236.
| Crossref | Google Scholar |

17  Dudi-Venkata NN, Cox DRA, Marson N, et al. Variation in Human Research Ethics Committee and governance processes throughout Australia: a need for a uniform approach. ANZ J Surg 2021; 91: 2263-2268.
| Crossref | Google Scholar | PubMed |

18  Piasecki J, Dranseika V. Learning to Regulate Learning Healthcare Systems: CQ. Camb Q Healthc Ethics 2019; 28: 369-377.
| Crossref | Google Scholar |