FOUNDATIONAL WORK FOR A NATIONAL RESEARCH PROGRAM IN ORGAN DONOR CARE

Abstract

This thesis is divided in three chapters: (i) introduction to organ donation, (ii) rationale, implementation and design of a pilot observational study currently underway and (iii) justification for use of a waived consent model for observational research studies on organ donor care. Organ donation is a complex event that remains a mystery to most health care providers. The first chapter reports knowledge gaps in clinical management of deceased organ donors across Canada and summarizes ongoing trials in organ donor care. The persistent deficit in transplantable organs along with the limited scientific evidence to guide the clinical management of the organ donor justify the need for a national research program in organ donor care. There are logistical and methodological challenges unique to the design and conduct of research on deceased donors. To identify potential stakeholders involved in the process of organ donation and to provide an accurate description of usual management of deceased donor and assess its variability, we developed and initiated a prospective observational study called DONATE. The second chapter of this thesis described the pilot phase of this study. It contains the following sections: i) objectives of the study ii) the screening process, iii) data collection, iv) clinical outcomes, v) methods of measurement, vi) analysis plan and vii) strategies used to minimize the biases inherent to observational studies. The normative goal of obtaining informed consent from participants may not be appropriate for an observational study in organ donor care. The third chapter summarizes the justification for use of a waived consent model for observational studies of organ donation medicine. In this chapter, I discuss regulatory, ethical and logistical issues relevant to use of a waived consent model in organ donation research.