背景:共同规则修订(CRR)要求为所有美国联邦资助的非豁免多站点人类参与者研究设立一个单一的机构审查委员会(IRB)。虽然CRR旨在提高研究效率,其在儿科研究中的成功仍不确定主要身体:有多种挑战威胁着单一IRB任务的所谓效率。虽然CRR很清楚道德审查是单一IRB的权限,对地方研究治理问题的责任界定较少。因此,信赖协议(RA)必须在单一IRB和参与机构之间进行谈判。这些谈判可以根据机构的当地情况而有很大的不同,而且往往是艰巨的,冗长,和负担。此外,在儿科研究中,同意等问题,代孕同意,和IRB风险确定增加了必须考虑的额外复杂性层。没有明确的系统来解决围绕这些关键的人类参与者保护问题的分歧。最后,针对儿科研究的机构资源的差异可能意味着只有少数儿科机构能够在单一IRB系统中发挥作用.为了成功实施CRR并实现其提高多站点研究效率的目标,需要克服这些挑战。我们建议,要使CRR和单个IRB有效,就必须采用经验性和协作性的方法来利用实施策略。
结论:CRR旨在提高美国多点人类参与者研究的效率。有多种挑战需要克服。经验性的协作方法是必要的。如果成功,单一IRB有可能开创一个有影响力和有效的多部位儿科研究的新时代。
BACKGROUND: The Common Rule Revision (CRR) mandates a single institutional review board (IRB) for all US federally funded nonexempt multisite human participant research. While the CRR aims to improve research efficiency, its success in pediatric research remains uncertain MAIN BODY: There are multiple challenges that threaten the purported efficiency of the single IRB mandate. While the CRR is clear that ethical review is the purview of the single IRB, responsibility for issues of local study governance are less well defined. Therefore, reliance agreements (RA) must be negotiated between single IRBs and participating institutions. These negotiations can vary significantly based upon the institution\'s local context and are often arduous, lengthy, and burdensome. Furthermore, in pediatric research, issues such as assent, surrogate consent, and IRB risk determination add additional layers of complexity that must be considered. No clear system exists for resolving disagreements surrounding these critical human participant protection issues. Finally, the variation in institutional resources directed towards pediatric research may mean that only a select few pediatric institutions will be able to function in the single IRB system. These challenges will need to be overcome to successfully implement the CRR and achieve its objective of improving multisite research efficiency. We suggest that an empiric and collaborative approach utilizing implementation strategies is necessary for the CRR and single IRBs to be effective.
CONCLUSIONS: The CRR seeks to improve the efficiency of multisite human participant research in the US. There are multiple challenges that will need to be overcome. An empiric collaborative approach is necessary. If successful, single IRBs have the potential to usher in a new era of impactful and efficient multisite pediatric research.