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

ABSTRACT:

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 is the involvement of a proxy in the recruitment process. In Italy, the system of proxy is determined by the courts. In this study we evaluate the timing for appointment of a legal proxy in Italy and identify predictive variables of appointment.

Methodology/principal findings

Subjects were recruited among the outpatients seeking medical advice for cognitive complaints at the Centre for Research and Treatment of Cognitive Dysfunctions, University of Milan, "Luigi Sacco" Hospital. The Centre was participating to the AdCare Study, a no-profit randomised clinical trial coordinated by the Italia

SUBMITTER: Gainotti S 

PROVIDER: S-EPMC2886844 | biostudies-literature | 2010 Jun

REPOSITORIES: biostudies-literature