Longitudinal study of informed consent in innovative therapy research: experience and provisional recommendations from a multicenter trial of intracerebral grafting.

ABSTRACT:

Background

There is an urgent need to assess and improve the consent process in clinical trials of innovative therapies for neurodegenerative disorders.

Methods

We performed a longitudinal study of the consent of Huntington's disease patients during the Multicenter Fetal Cell Intracerebral Grafting Trial in Huntington's Disease (MIG-HD) in France and Belgium. Patients and their proxies completed a consent questionnaire at inclusion, before signing the consent form and after one year of follow-up, before randomization and transplantation. The questionnaire explored understanding of the protocol, satisfaction with the information delivered, reasons for participating in the trial and expectations regarding the transplant. Forty-six Huntington's disease patients and 27 proxies c

SUBMITTER: Cleret de Langavant L 

PROVIDER: S-EPMC4444138 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature