Red tape delays maternal morbidity study: problems and possible solutions.

IF 1.4
Joanne Frost, Edward Weaver, Leonie Callaway
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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 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.

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。
本研究旨在概述在开展严重急性孕产妇发病率(SAMM)研究项目时获得伦理和治理批准的官僚程序,并强调这对及时开展研究的影响。方法从研究者的角度对研究伦理和治理过程进行回顾性、描述性案例研究评估,在2022-2023年期间,对澳大利亚一个州内五家公立妇产保健机构(两家医院和卫生服务机构)20年的一次SAMM事件(围产期子宫切除术)进行回顾性审计。结果衡量指标包括:完成的文件/表格数量、发送的电子邮件数量、电话/召开的会议数量、参与审批的人数、所需提交/重新提交的数量以及获得道德/管治批准的时间(工作日)。结果从5个州数据库和2个hhs的本地记录中获取围产期子宫切除术数据需要同一组织内的10个数据管理员的批准。从提交第一份伦理申请到获得最终治理申请的批准,总共花了268个工作日。结论繁琐的科研审批流程耗费了大量的科研时间。我们的研究例证了对低风险和可忽略的风险研究的持续过度监管,这继续限制了对严重产科疾病的调查和预防。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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