Ethics and Governance Council

The ARISE consortium will be assisted and advised by an independent Ethics and Governance Council (EGC), which has been established in addition to the safety and oversight requirements of Good Clinical Practice. The role of the EGC is to provide independent external supervision and advice regarding the ethical and legal aspects concerning the clinical trial. The Council will monitor the procedures in place for the clinical trial to ensure the application of the highest ethical standards, thus safeguarding patients’ interests and rights. A further important role of the EGC is to mediate between the prejudices against new methods of treatment provided by for-profit organisations and the need for charitable tissue donation. This will form an important pillar in the project’s dissemination strategy.

The EGC will convene regularly as an independent forum and will also be invited to take part in the project’s annual SC meetings and will receive the project’s progress and ethics reports. Early in the project (Month 6), an initiation meeting of the Ethics and Governance Council will take place with its conclusions to be summarized in a report to the EC. The EGC will focus on ethics and regulatory issues including but not limited to aspects of homograft procurement and the inclusion/exclusion criteria of patients. Questions with ethical relevance concerning the research conducted in the project will also be communicated in a suitable and understandable way for the general public on the project website, helping to inform the public debate on tissue donation and new technologies, thus linking in with WP6 on Dissemination and Outreach.