Clarifying the proper normative scope of advance research directives
Hojjat Soofi1, University of Sydney Camperdown 1University of Sydney, Camperdown, NSW, Australia
Abstract
Reliance on advance research directives (ARDs) has been proposed as a possible solution to the under-representation of people with dementia in research. Similar to advanced care directives, ARDs afford individuals the opportunity to document their wishes and preferences regarding involvement in research through ARDs prior to the clinical onset of dementia. ARDs are being increasingly promoted as facilitators of appropriately including people with dementia in medical research by legal jurisdictions and research ethics guidelines. However, despite the growing interest in promoting ARDs as facilitators of appropriately including people with dementia in research, such directives are not commonly utilised in practice. One obstacle that may have limited the uptake of ARDs by dementia researchers is the lack of (sufficient) clarification about the proper scope of ARDs. In this presentation, I zoom in on one aspect of relying on ARDs that needs further clarificatory work: whether and the extent to which ARDs can be used to authorise non-therapeutic research or research with more than minimal risk of harm to participants (e.g., Phase I and Phase II investigational interventions or studies investigating medication washouts). I argue for the claim that, in certain situations, ARDs can be relied upon to meet the requirements of autonomous authorisation of research. I draw on what Steve Matthews conceptualises in the context of dementia as ‘moral self-orientation’ in laying out a number of desiderata for ethically defensible reliance on ARDs in dementia research. I end by addressing possible objections.
Biography
Dr Hojjat (Hoji) Soofi is a Lecturer in Bioethics at Sydney Health Ethics (School of Public Health, Faculty of Medicine and Health, University of Sydney). He is a pharmacist by training and an early career bioethics researcher.