Samir Nora, Amarasena Lahiru, Sealy Louise, Hodgins Michael, Gelaw Yalemzewod, Lingam Raghu, Zwi Karen
School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia.
Community Child Health, Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.
J Paediatr Child Health. 2022 Jan;58(1):16-23. doi: 10.1111/jpc.15747. Epub 2021 Sep 16.
Multi-site research studies are essential if we are to conduct national research across all Australian jurisdictions. There is widespread agreement among clinicians and researchers that obtaining essential approvals to conduct multi-site research studies in Australia can be complex, bureaucratic and time consuming. Although there is inherent value in the review process, resources and months of valuable research time are often expended long before the study has begun. Using our recent experience for a multi-site, longitudinal paediatric cohort study of children and adolescents who were detained in offshore immigration detention on Nauru, we describe the process of navigating the ethics and governance approval systems. We identify tips for researchers and clinicians conducting multi-site studies, including early consultation with ethics and governance committees, using their recommended templates, anticipating time delays, and commencing time consuming processes as early as permissible. Our recommendations at the systemic level include streamlined and integrated ethics and governance review processes for all Australian jurisdictions, with co-ordinated requests for further information, a standardised approach across all Research Governance Offices, a rapid system for addressing amendments and individualised study support and consultations. Above all, a nationally agreed framework whereby ethics and governance committees across jurisdictions communicate with each other, use the same electronic platform and present a unified process whilst protecting the welfare, rights, dignity and safety of research participants is required. The complexity of the current ethics and governance processes may inadvertently and unintentionally be a barrier to conducting ethical research.
如果我们要在澳大利亚所有司法管辖区开展全国性研究，多地点研究至关重要。临床医生和研究人员普遍认为，在澳大利亚获得开展多地点研究的必要批准可能复杂、官僚且耗时。尽管审查过程有其内在价值，但在研究开始之前，往往就已经耗费了资源和数月宝贵的研究时间。利用我们最近对瑙鲁境外移民拘留中心被拘留的儿童和青少年进行多地点纵向儿科队列研究的经验，我们描述了通过伦理和管理审批系统的过程。我们为开展多地点研究的研究人员和临床医生提供了一些建议，包括尽早与伦理和管理委员会协商、使用他们推荐的模板、预估时间延迟，并尽早开始耗时的流程。我们在系统层面的建议包括为澳大利亚所有司法管辖区简化和整合伦理和管理审查流程，协调进一步信息请求，所有研究管理办公室采用标准化方法，建立快速处理修正案的系统以及提供个性化的研究支持和咨询。最重要的是，需要一个全国商定的框架，使各司法管辖区的伦理和管理委员会能够相互沟通，使用相同的电子平台，并呈现统一的流程，同时保护研究参与者的福利、权利、尊严和安全。当前伦理和管理流程的复杂性可能会无意中成为开展符合伦理研究的障碍。
