Paediatric systemic inflammatory response syndrome (SIRS) and the development of patient-specific therapy: ethical perspectives through experts' opinions

Background: Research for personalised therapies concerning the Systemic Inflammatory Response Syndrome (SIRS) in children involves the utilisation of OMICS technologies and Artificial Intelligence (AI).

Methods: To identify specific ethical challenges through the perspective of healthcare professionals, we conducted 10 semi-structured interviews. The development of interview questions for the interviews was preceded by a systematic review of the scientific literature. To address the complexities of paediatric emergency research, informed consent, and data processing, experts with expertise in paediatric intensive care, computer science, and medical law were sought. After the transcription and anonymisation, the analysis followed established guidelines for qualitative content and thematic analysis.

Results: Interviewees highlighted the intricacies of managing consent in personalised SIRS research due to the large amount and complexity of information necessary for autonomous decision-making. Thus, instruments aimed at enhancing the understanding of legal guardians and to empowering the child were appreciated and the need for specific guidelines and establishing standards was expressed. Medical risks were estimated to be low, but the challenges of securing anonymisation and data protection were expected. It was emphasised that risks and benefits cannot be anticipated at this stage. Social justice issues were identified because of possible biases within the research population. Our findings were analysed using current ethical and legal frameworks for research with a focus on the particularities of the patient group and the emergency background. In this particular context, experts advocated for an enabling approach pertaining to AI in combination with OMICS technologies.

Conclusion: As with every new technological development, ethical and legal challenges cannot be foreseen for SIRS-personalised treatment. Given this circumstance, experts emphasised the importance of extending the ethics-legal discourse beyond mere restrictions. The organisation of supervision should be reconsidered and not limited only to the precautionary principle, which per se was seen as impeding both the medical progress and clinical flexibility. It was noted that the establishment and monitoring of guidelines were emergent and should evolve through an interdisciplinary discourse. Therefore, it was recommended to enhance the qualifications of physicians in the field of computer science, impart ethics training to AI developers, and involve experts with expertise in medical law and data protection.