{"title":"繁文缛节延误了孕产妇发病率研究:问题和可能的解决办法。","authors":"Joanne Frost, Edward Weaver, Leonie Callaway","doi":"10.1071/AH25018","DOIUrl":null,"url":null,"abstract":"<p><p>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 20years 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.</p>","PeriodicalId":93891,"journal":{"name":"Australian health review : a publication of the Australian Hospital Association","volume":" ","pages":""},"PeriodicalIF":1.4000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Red tape delays maternal morbidity study: problems and possible solutions.\",\"authors\":\"Joanne Frost, Edward Weaver, Leonie Callaway\",\"doi\":\"10.1071/AH25018\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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 20years 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.</p>\",\"PeriodicalId\":93891,\"journal\":{\"name\":\"Australian health review : a publication of the Australian Hospital Association\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2025-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Australian health review : a publication of the Australian Hospital Association\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1071/AH25018\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Australian health review : a publication of the Australian Hospital Association","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1071/AH25018","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Red tape delays maternal morbidity study: problems and possible solutions.
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 20years 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.