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所面临的挑战:PARITY 研究案例。

IF 2.1 3区 医学 Q2 PEDIATRICS
Frontiers in Pediatrics Pub Date : 2024-11-05 eCollection Date: 2024-01-01 DOI:10.3389/fped.2024.1460377
Eliana Lopez-Baron, Qalab Abbas, Paula Caporal, Asya Agulnik, Jonah E Attebery, Adrian Holloway, Niranjan Tex Kissoon, Celia Isabel Mulgado-Aguas, Kokou Amegan-Aho, Marianne Majdalani, Carmen Ocampo, Havugarurema Pascal, Erika Miller, Aimable Kanyamuhunga, Atnafu Mekonnen Tekleab, Tigist Bacha, Sebastian González-Dambrauskas, Adnan T Bhutta, Teresa B Kortz, Srinivas Murthy, Kenneth E Remy
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引用次数: 0

摘要

背景:在中低收入国家(LMIC)开展多中心研究的最大挑战之一是不同研究机构的监管流程存在差异。以前的研究报告称,不同中心的机构审查委员会(IRB)程序要求各不相同,缺乏标准化,这给多中心研究的审批、参与和发展造成了障碍:描述低收入国家儿科研究人员在一项国际多中心点流行病学观察研究(Global PARITY)的机构审查委员会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 道多选题的在线调查问卷,以了解 IRB 流程的特点、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 的特点:在 91 个申请 IRB 批准的研究机构中,有 46 个成功获得批准并完成了数据收集过程。46个参与中心(100%)和21个非参与中心(47%)完成了调查。参与中心和非参与中心在获得 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。非参与中心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独立研究委员会的支持。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.

Background: One of the greatest challenges to conducting multicenter research studies in low and middle-income countries (LMICs) is the heterogeneity in regulatory processes across sites. Previous studies have reported variations in requirements with a lack of standardization in the Institutional Review Board (IRB) processes between centers, imposing barriers for approval, participation, and development of multicenter research.

Objectives: To describe the regulatory process, variability and challenges faced by pediatric researchers in LMICs during the 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.

Results: Of the 91 sites that sought IRB approval, 46 were successful in obtaining approval and finishing the data collection process. The survey was completed by 46 (100%) participating centers and 21 (47%) non-participating centers. 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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来源期刊
Frontiers in Pediatrics
Frontiers in Pediatrics Medicine-Pediatrics, Perinatology and Child Health
CiteScore
3.60
自引率
7.70%
发文量
2132
审稿时长
14 weeks
期刊介绍: Frontiers in Pediatrics (Impact Factor 2.33) publishes rigorously peer-reviewed research broadly across the field, from basic to clinical research that meets ongoing challenges in pediatric patient care and child health. Field Chief Editors Arjan Te Pas at Leiden University and Michael L. Moritz at the Children''s Hospital of Pittsburgh are supported by an outstanding Editorial Board of international experts. This multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide. Frontiers in Pediatrics also features Research Topics, Frontiers special theme-focused issues managed by Guest Associate Editors, addressing important areas in pediatrics. In this fashion, Frontiers serves as an outlet to publish the broadest aspects of pediatrics in both basic and clinical research, including high-quality reviews, case reports, editorials and commentaries related to all aspects of pediatrics.
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