PDF(Pubmed)
Abstract：
A shift from single to multi-site health studies enabled a range of research benefits including faster recruitment of larger and more diverse samples; increased statistical power, greater rigour, generalisability, and external reliability; and increased likelihood of impacting policy and clinical practice. However, ethical review of multi-site studies by Institutional Review Boards (IRBs) raises specific challenges compared with single site studies, with requirements to apply to multiple local IRBs increasing the burden on research, possibly endangering the integrity of the research process or inhibiting development of multi-site studies. The option of a single centralised IRB may offer a clearer, more consistent and efficient review process. This study presents a case report and commentary from 15 years engaging with IRBs in multiple sites in Ireland by the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA). It examines the ethics review process for IDS-TILDA through its first four waves. While the majority of 48 IRBs granted ethical approval within 13 weeks, six IRBs took 21-47 weeks to approve, leading to delays in data collection of up to 11 months. Despite additional review time, no changes were required to the study protocol. Therefore, a critical impact of the process was the delay in starting data collection within a small number of organisations, and reduced involvement in the study for one organisation. The ethical review process with multiple IRBs increased the degree of complexity of the process, with added bureaucracy and far greater communication required across 48 IRBs, substantially adding to the resource commitment for the review process. The relatively quick approval from the majority of IRBs was partially a result of the longitudinal study building relationships with organisations throughout multiple waves. That other health studies may not accrue this benefit supports calls for a single IRB system for multi-site health studies.
摘要：
从单站点健康研究转向多站点健康研究，实现了一系列研究益处，包括更快地招募更大和更多样化的样本；增加统计能力，更严格，概括性，和外部可靠性；以及影响政策和临床实践的可能性增加。然而,与单中心研究相比，机构审查委员会（IRB）对多中心研究的伦理审查提出了具体挑战，由于要求适用于多个本地IRB，增加了研究负担，可能危及研究过程的完整性或抑制多站点研究的发展。单一集中式IRB的选择可能会提供更清晰的，更加一致和有效的审查过程。本研究通过爱尔兰老龄化纵向研究的智力残疾补充（IDS-TILDA），提供了15年来与爱尔兰多个地点的IRB接触的案例报告和评论。它通过前四波考察了IDS-TILDA的道德审查过程。虽然48个IRB中的大多数在13周内获得了道德批准，六个IRB花了21-47周的时间批准，导致数据收集延迟长达11个月。尽管有额外的审查时间，本研究方案无需改变.因此,该过程的一个关键影响是在少数组织中开始数据收集的延迟，并减少对一个组织的研究参与。具有多个IRB的道德审查过程增加了过程的复杂性，由于增加了官僚作风，并且需要在48个IRB之间进行更大的沟通，大大增加了审查过程的资源承诺。大多数IRB的相对较快批准部分是纵向研究在多次浪潮中与组织建立关系的结果。其他健康研究可能不会产生这种好处，这支持了对多站点健康研究的单一IRB系统的呼吁。
