在中低收入国家开展国际多中心临床研究的机构伦理审查程序和审批面临的挑战:PARITY 研究案例

Eliana Lopez Baron, Qalab Abbas, Paula Caporal, Asya Agulnik, Jonah E. Attebery, Adrian Holloway, Niranjan Kissoon, Celia Isabel Mulgado-Aguas, Kokou Amegan-Aho, Marianne Majdalani, Carmen Ocampo, Havugarurema Pascal, Erika Miller, Aimable Kanyamuhunga, Atnafu Mekonnen Tekleab, Tigist Bacha, Sebastian Gonzalez, Adnan T. Bhutta, Teresa B. Kortz, Srinivas Murthy, Kenneth E. Remy
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Remy","doi":"10.1101/2024.03.20.24304598","DOIUrl":null,"url":null,"abstract":"Objectives: To describe the regulatory process, variability and challenges faced by pediatric researchers in low- and middle-income countries (LMICs) during the institutional review board (IRB) process of an international multicenter observational point prevalence study (Global PARITY).\nDesign: A 16-question multiple-choice online survey was sent to site principal investigators (PIs) at PARITY study participating centers to explore characteristics of the IRB process, costs, and barriers to research approval. 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引用次数: 0

摘要

目的描述中低收入国家(LMICs)儿科研究人员在国际多中心点流行病学观察研究(Global PARITY)的机构审查委员会(IRB)程序中面临的监管程序、可变性和挑战:设计:我们向 PARITY 研究参与中心的主要研究人员(PI)发送了一份包含 16 道选择题的在线调查问卷,以了解机构审查委员会程序的特点、成本以及研究审批的障碍。对于表示有兴趣参与全球 PARITY 并已启动审批程序,但最终未参与数据收集的研究机构(非参与研究机构),则采用了更简短的调查来评估 IRB 的特征:全球 PARITY 研究的首席研究员:结果结果:91 个研究机构获得了当地 IRB 批准,46 个研究机构获得了 IRB 批准并完成了数据收集。46个参与中心(100%)和21个非参与中心(47%)完成了调查。尽管获得了研究牵头中心的批准,并被归类为低风险研究,但参与 PARITY 研究的医院中有 36 家(78%)需要自己的全面委员会审查。参与研究的医院和非参与研究的医院在获得 IRB 批准放弃同意书和要求对方案进行法律审查方面存在明显差异。非参与研究的研究机构认为研究面临的最大挑战是缺乏研究时间和机构支持:全球合作研究对于加深我们对各种资源水平医院的儿科危重症护理条件的了解至关重要,而确保这项研究符合伦理标准则需要国际注册评审委员会(IRB)的支持。在一些资源有限的国家,关键的障碍限制了研究活动。提高当地 IRB 审查的效率和可及性可以极大地影响资源有限的研究机构的参与和弱势人群的入组。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Challenges in Institutional Ethical Review Process and Approval for International Multicenter Clinical Studies in Lower and Middle-Income Countries: the case of PARITY Study
Objectives: To describe the regulatory process, variability and challenges faced by pediatric researchers in low- and middle-income countries (LMICs) during the institutional review board (IRB) process of an international multicenter observational point prevalence study (Global PARITY). Design: A 16-question multiple-choice online survey was sent to site principal investigators (PIs) at PARITY study participating centers to explore characteristics of the IRB process, costs, and barriers to research approval. A shorter survey was employed for sites that expressed interest in participating in Global PARITY and started the approval process, but ultimately did not participate in data collection (non-participating sites) to assess IRB characteristics. Subjects: PIs from the Global PARITY Study Interventions: None. Results: Ninety-one sites pursued local IRB approval and 46 sites obtained IRB approval and completed data collection. Forty-six (100 %) participating centers and 21 (47%) non-participant centers completed the survey. Despite receiving approval from the study's lead center and being categorized as a minimal risk study, 36 (78%) of the hospitals involved in PARITY study required their own full board review. There was a significant difference between participating and non-participating sites in IRB approval of a waiver consent and in the requirement for a legal review of the protocol. The greatest challenge to research identified by non-participating sites was a lack of research time and the lack of institutional support. Conclusions: Global collaborative research is crucial to increase our understanding of pediatric critical care conditions in hospitals of all resource-levels and IRBs are required to ensure that this research complies with ethical standards. Critical barriers restrict research activities in some resource limiting countries. Increasing the efficiency and accessibility of local IRB review could greatly impact participation of resource limited sites and enrollment of vulnerable populations.
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