Ethical aspects of facilitating the recruitment of people with dementia for clinical trials: A call for further debate.

Abstract

Under-representation of people with dementia in clinical research remains a significant obstacle to develop evidence-based practice guidelines and recommendation for dementia care and slows down the development of disease-modifying pharmacological interventions. This is partly due to the ethical challenges and complexities of recruiting people with dementia for clinical trials. The traditional approach adopted by research ethics committees and regulatory bodies has been to protect people with dementia as a vulnerable population from harms of participating in research. There are concerns that this approach is unduly rigid, precludes the conduct of necessary research, and has exclusionary, paternalistic and discriminatory ramifications. As such, there are increasing calls to shift to a new hybrid facilitative/protective approach. This paper identifies 4 strategies to operationalise the facilitative/protective approach in the context of dementia research. These are: (i) embedding dementia research in clinical care; (ii) increasing the recruitment of people at preclinical stages of dementia; (iii) streamlined proxy consent procedures; and (iv) advance research consent. I note that all 4 strategies hold the promise of facilitating the recruitment of people with dementia in clinical research. Nonetheless, they give rise to a diverse range of new ethical concerns and issues. This necessitates further scholarly work to explore possible ways to address the ethical concerns and issues arisen by the uptake of protective/facilitative approach. In particular, further research is necessary to clarify, to what extent, the said strategies ameliorate or increase the vulnerability of people with dementia.