Background: Advocacy organisations (AOs) are increasingly involved in clinical research on various diseases, specifically as representatives of persons affected by the disease. As novel actors with unique and variegated features, their roles in clinical research are complex and understudied. Ethical justification, guidelines, and evidence on the impact of this trend have not yet been researched thoroughly. By using the case of neurodegenerative diseases, specifically the dementia syndrome, this thesis investigates the ethics of AOs’ involvement in clinical research.
Process & Methods: To explore this question, I develop an analysis framework that applies Emanuel et al.’s general requirements of ethical clinical research to dementia. The thesis draws from two main data sources. First, desk research of publicly available documentation allows understanding the breadth of the phenomenon. Second, semi-structured interviews with representatives of AOs allows going deeper into specific cases and the interactive dynamics of AOs’ involvement in clinical research.
Results: The thesis finds that AOs can assume a wide array of roles in clinical research. A five-part typology is proposed that systematises them: advocate, research community builder, investigator, member of a research consortium acting as a sponsor, and funder. I stress that these results are not mutually exclusive, and AOs may choose to fulfil multiple such roles in parallel. As each role raises specific challenges and potential contributions to the ethical conduct of research, it becomes particularly important to discern how AOs act as representatives of affected persons, mainly people with dementia and informal caregivers. A framework for scrutinising the legitimacy of AOs in this sense is proposed.
Conclusions: The study generates qualitative evidence on the implications for research ethics of AOs’ involvement in clinical research on dementia. As partners with potential to represent affected persons in clinical research, dementia AOs have a duty to ensure and continuously reinforce their legitimacy. As a determinant of AOs’ legitimacy in speaking ‘on behalf of’ the affected communities, the concept of throughput legitimacy is mobilised to ensure that persons with dementia and caregivers are meaningfully involved in clinical research.
