How are the interests of incapacitated research participants protected through legislation? An Italian study on legal agency for dementia patients

S Gainotti, S Fusari Imperatori, S Spila-Alegiani… - PloS one, 2010 - journals.plos.org
Background Patients with dementia may have limited capacity to give informed consent to
participate in clinical research. One possible way to safeguard the patients' interests in …

Research involving subjects with Alzheimer's disease in Italy: the possible role of family members

C Porteri, C Petrini - BMC medical ethics, 2015 - Springer
Background Alzheimer's disease is a very common, progressive and still incurable disease.
Future possibilities for its cure lie in the promotion of research that will increase our …

Advance directives in dementia research: the opinions and arguments of clinical researchers− an empirical study

K Jongsma, S van de Vathorst - Research ethics, 2015 - journals.sagepub.com
In order to discover an effective treatment for dementia it is necessary to include dementia
patients in clinical research trials. Dementia patients face an increased risk to lose the …

Integrating advance research directives into the European legal framework

R Andorno, E Gennet, K Jongsma, B Elger - european Journal of health …, 2016 - brill.com
The possibility of using advance directives to prospectively consent to research participation
in the event of dementia remains largely unexplored in Europe. Moreover, the legal status of …

Advance research directives: avoiding double standards

B Heinrichs - BMC medical ethics, 2021 - Springer
Background Advance research directives (ARD) have been suggested as a means by which
to facilitate research with incapacitated subjects, in particular in the context of dementia …

How legislation on decisional capacity can negatively affect the feasibility of clinical trials in patients with dementia

F Galeotti, N Vanacore, S Gainotti, F Izzicupo… - Drugs & aging, 2012 - Springer
Antipsychotic drugs are widely used to treat behavioural and psychological disturbances
associated with Alzheimer's disease (AD), although only modest evidence from randomized …

Opinions regarding who should consent to research on behalf of an older adult suffering from dementia

G Bravo, M Pâquet, MF Dubois - Dementia, 2003 - journals.sagepub.com
In many jurisdictions, consent to research on a decisionally incompetent adult can be
provided only by the legal guardian. Yet, few cognitively impaired older adults are legally …

Beyond competence: advance directives in dementia research

KR Jongsma, S van de Vathorst - Monash Bioethics Review, 2015 - Springer
Dementia is highly prevalent and incurable. The participation of dementia patients in clinical
research is indispensable if we want to find an effective treatment for dementia. However …

Comfort with proxy consent to research involving decisionally impaired older adults: do type of proxy and risk-benefit profile matter?

MF Dubois, G Bravo, J Graham, S Wildeman… - International …, 2011 - cambridge.org
Background: Dementia research often requires the participation of people with dementia.
Obtaining informed consent is problematic when potential participants lack the capacity to …

Participation in dementia research: rates and correlates of capacity to give informed consent

J Warner, R McCarney, M Griffin, K Hill… - Journal of medical …, 2008 - jme.bmj.com
Background: Many people participating in dementia research may lack capacity to give
informed consent and the relationship between cognitive function and capacity remains …