Landi Annalisa, D'Ambrosio Federica, Faggion Silvia, Rocchi Francesca, Paganin Carla, Lain Maria Grazia, Ceci Adriana, Giannuzzi Viviana
Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, 70124 Bari, Italy.
Fondazione Penta ETS, 35127 Padova, Italy.
Healthcare (Basel). 2024 Dec 6;12(23):2473. doi: 10.3390/healthcare12232473.
EPIICAL (Early treated Perinatally HIV-Infected individuals: Improving Children's Actual Life) is a consortium of European and non-European research-driven organizations inter-connected with the aim of establishing a clinical and experimental platform for the early identification of novel therapeutic strategies for the pediatric Human Immunodeficiency Virus (HIV). Within the EPIICAL project, several pediatric clinical studies were conducted, requiring the collection and transfer of biological samples and associated data across boundaries within and outside Europe. To ensure compliance with the applicable rules on pediatric data and sample transfer and to support the efforts of academic partners, which may not always have the necessary expertise and resources in place for designing, managing and conducting multi-national studies, the consortium established a dedicated expert Working Group. This group has guided the consortium since the start of the project through the complexities of the ethical and regulatory aspects of international clinical studies. The group provided support in the design and preparation of the prospective and retrospective multi-center and multi-national pediatric studies with a focus on the clinical study protocols, informed consent and assent forms. In particular, well-structured informed consent and assent templates were developed, and data sharing and material transfer agreements were set up to regulate the transfer of samples among partners and sites. We considered that such support and the implementation of ad hoc agreements could provide effective practical solutions for addressing ethical and regulatory hurdles related to sharing data and transferring samples in international pediatric clinical research.
EPIICAL（围产期早期接受治疗的艾滋病毒感染个体：改善儿童实际生活）是一个由欧洲和非欧洲研究驱动型组织组成的联盟，这些组织相互关联，旨在建立一个临床和实验平台，用于早期识别针对儿童人类免疫缺陷病毒（HIV）的新型治疗策略。在EPIICAL项目中，开展了多项儿科临床研究，这需要在欧洲内外跨越边界收集和转移生物样本及相关数据。为确保遵守关于儿科数据和样本转移的适用规则，并支持学术合作伙伴的工作，这些合作伙伴在设计、管理和开展跨国研究方面可能并不总是具备必要的专业知识和资源，该联盟成立了一个专门的专家工作组。自项目启动以来，该小组一直指导联盟应对国际临床研究在伦理和监管方面的复杂问题。该小组在设计和筹备前瞻性和回顾性多中心、跨国儿科研究方面提供支持，重点关注临床研究方案、知情同意书和同意书。特别是，制定了结构完善的知情同意书和同意书模板，并建立了数据共享和材料转移协议，以规范合作伙伴和研究地点之间的样本转移。我们认为，这种支持以及临时协议的实施可以为解决国际儿科临床研究中与数据共享和样本转移相关的伦理和监管障碍提供有效的实际解决方案。
