Research ethics implications in the development of personalised therapy for pediatric SIRS patients

Abstract

Abstract Background Pediatric Systemic Inflammatory Response Syndrome (SIRS) presents diagnostic and therapeutic challenge that can be addressed through personalised therapy. Related ethical challenges are understudied. Our report aims at identification and analysis of research ethics implications within the bigger ERA PerMed funded project of development of tailored immunotherapy for paediatric SIRS patients (TIPS) coordinated by Prof. Catharina Schütz from Technic University Dresden. Methods A sample of 10 experts with different backgrounds was studied through semi-structured interviews. Systematic literature review grounded the interview questionnaire. The transcripts were subjected to thematic analysis by two independent researchers. Results Five classical research ethics issues were identified: respect for autonomy; informed consent; risk-benefits ratio; data protection; social justice. All experts favoured the empowerment of children (N = 10) and obtainment of informed consent rather than assent was seen as a common goal (N = 5). The emergency context of SIRS research impeded the informed consent. Despite favourable risk-benefits ratio, no direct benefits resulted to study participants. Data anonymisation though necessary (N = 10), hinders proper dealing with incidental findings. Social justice issues apparently accompanied research design in personalised medicine (N = 2) but should not extend to access to personalised therapy. Conclusions The classical framework of research ethics is challenged by the new fields of medical research. Traditional concepts, such as informed consent in minors, are subject to rethinking. Current ethical and legal guidelines fall short of proper practical instructions in the specific case of SIRS pediatric patients. Thus, ethical aspects of new technology development should always be studied in parallel to the biometrics within personalised medicine projects so as to the development of guidelines is more evidence-based than precautionary driven. Key messages • Current ethical and legal guidelines fall short of proper practical instructions in the specific case of SIRS pediatric patients. • Ethical aspects of new technology development should always be studied within personalised medicine projects so as to the development of guidelines is more evidence-based than precautionary driven.