WP04 - Ethics and Ethical Issues

Objectives

  • Review ethical and legal issues regarding consent in cognitively impaired adults and how this must be addressed in the context of developing the project
  • Establish an Ethics Advisory Board (EAB) for the study
  • Demonstrate adherence to the ethical framework of FP7 and the relevant legislation in each participating country

Workpackage Description

This work package comprises the following tasks:

Task 1: Review of all local ethical approval documentation from all participating centres. There may also be a requirement for local ethics advice and coordination from a GCP perspective to ensure that the protocol adheres to local ethical considerations and to relevant EU legislation and FP7 regulations. The clinical trial protocol, patient information sheets and consent forms will be reviewed and all ethical concerns will be reported directly to the study coordinator and sponsor. We will seek ethics approval from an approved local ethics committee in each participating country prior to the commencement of the study. All ethics requirements from the Ethics review as detailed in Annex I will be incorporated and operationalized.

Task 2: Establish an Ethics Advisory Board (EAB) for the study.

Task 3: Adaptation of forms. Forms will be adapted for local participating centres listing items such as local investigator names and contact information. All forms will be translated into the relevant local language(s). Every attempt will be made to keep all information uniform across the participating centres.

Task 4: Participate in training on Ethical issues for clinical research staff (WP3). A web based assessment on ethical issues will be developed and used to test clinical research staff knowledge of ethical issues and must be taken to allow participation by research staff in the trial protocol. A training manual on ethical issues will be developed as part of this WP and then delivered at the training sessions for clinical staff. This will be completed prior to the enrolment of the first patient.

WP Leader

University College Cork (Prof. William Molloy)