Project Summary Sepsis is the leading cause of child mortality worldwide, with most of these deaths occurring in low and middle- income countries (LMICs). Novel digital technologies, including the use of mobile health tools (mHealth), machine learning and artificial intelligence (ML/AI), wearables devices, and clinical decision support tools, hold great promise for improving the care for children with sepsis in LMICs by overcoming human resource and infrastructural barriers. However, digital health research among critically ill children in LMICs presents novel ethical issues including concerns regarding understandability, data security, privacy, bias, and informed consent. Additionally, ethical frameworks and policies regarding the use of these technologies (which are often not cleared for medical use) are nearly non-existent in LMICs due to a lack of regulatory oversight and governance specific for digital health research. Critically ill children in LMICs are a special population who require careful consideration given their vulnerability, reliance on caregivers for decision-making, and high variability in caregiver awareness and exposure to digital technologies. Successful development of these novel technologies to improve patient health relies on understanding the attitudes of key stakeholders, and barriers and facilitators to ethical implementation, to ensure the use of best practices for facilitating trust and participation in research using these technologies, while respecting patient/caregiver autonomy. This project integrates new bioethical aims, research, and capacity building into an ongoing parent R33 study, which has an objective to develop a novel wearable-linked mHealth tool deploying machine learning predictive models for pediatric sepsis decision support in Bangladesh. This proposed research will examine and elucidate the ethical concerns of caregivers of children with sepsis, as well as stakeholders in bioethical research decision-making (clinicians, researchers, ethical review board members, administrators), related to research using digital health technologies for clinical care among children with sepsis in LMICs. Knowledge gained from this study will aid in developing an evidence base upon which to build policies, tools and approaches to aid in the development and implementation of use of digital technologies for research in Bangladesh and other similar LMIC settings. With guidance from a leading pediatric bioethics expert consultant, this collaborative research between the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) and Rhode Island Hospital / Brown University, will help augment icddr,b’s reputation in research ethics in South Asia, and build a hub of bioethical research expertise on digital tools for studies conducted in LMICs.