SouthRock RECO-PART
(Re)thinking Information and Consent in Pediatric Oncology with a participatory approach
• To update and analyze, from a transdisciplinary perspective, the issues surrounding information and consent procedures related to the use of data and biological samples—whether or not they involve genomics—in pediatric oncology, in order to clarify the information processes that precede consent in research and clinical care.
• To conduct a participatory evaluation of existing information and decision-making tools, in collaboration with stakeholders (former patients, parents, and healthcare professionals).
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Project period
-
Main investigator
Sandrine de Montgolfier
SESSTIM member(s) of the project:
Sponsors:
The French National Cancer Institute (INCa)
Partners:
Pediacriex SouthRock
Research topics:
Research question:
Although information and consent are governed by clear ethical and legal requirements, their implementation is sometimes reduced to an administrative formality, without ensuring that the information provided is understood or that it supports a genuinely informed decision. These issues are particularly significant in paediatric oncology: minors have the right to receive information appropriate to their level of maturity and to express their views, while their legal representatives are responsible for providing consent. However, children remain insufficiently involved in this process. Furthermore, the development of genomic medicine, genetic testing and the reuse of biological samples, together with the growing interconnection between clinical care and research, has made information and consent procedures increasingly complex.
This project therefore aims to examine the practices, challenges and ethical issues associated with information and consent in paediatric oncology, taking into account recent scientific and regulatory developments. It adopts a participatory research approach involving former patients, families, healthcare professionals and researchers. Situated within the framework of the Paediatric Oncology Integrated Research Excellence Centres (PEDIACRIEXs), the project seeks to develop a better understanding of existing practices and contribute to the improvement of information and consent procedures by involving the people concerned in this process.
Method:
The project is organized around two complementary areas, each subdivided into several tasks:
1) identification and assessment of needs and issues;
2) participatory evaluation of existing tools and documents.
This project primarily employs qualitative methods, including participatory working groups and semi-structured interviews with clinicians, researchers, and representatives from nonprofit organizations and institutions. In addition, a quantitative survey of pediatric oncologists from the various Pédiacriex centers will also be conducted.
Research prospects:
1 Identify and analyze current issues related to informational materials, as experienced and expressed by the various stakeholders—organizations, researchers, and healthcare professionals—and identify the specific needs of each group.
2 Conduct a participatory evaluation of existing tools and documents with the people concerned (former patients and parents) to highlight the gaps between regulatory and ethical requirements and actual practices by professionals, as well as how these tools are received by their target audiences.
Results:
Ongoing project
Favorable opinion (No. 25-1261) from the ethics evaluation committee of Inserm
