Designing and conducting clinical trials and research in palliative care and end of life: ethical and mental capacity, data integrity, and practical issues, Ludovica De Panfilis

This chapter discusses ethical, data, and practical issues involved in designing and conducting research in palliative care, including end of life. It highlights the principles considering ethical aspects in study design and conduct, including considerations on alternative models of informed consent and mental and ethical capacity. Contemporary approaches are discussed in relation to data management, study oversight and governance, and methodological challenges and their corresponding solutions to ensure best practice in research conduct. The chapter draws on the classical ethical principles of autonomy, beneficence, and justice and on how they may be applied in clinical and health research. Moreover, the key ethical concepts of vulnerability and relational autonomy will be considered to describe the multiple dimensions to be involved in conducting research in palliative care.