Sharing Data and Transferring Samples Within Pediatric Clinical Studies: How to Overcome Challenges and Make Them a Science Opportunity.

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.