Project Description

 

Tissue Engineering

Ethical issue spotting and governance in a clinical trial of innovative tissue engineered products

Brief

consentris advisors set up and managed the clinical trial’s Ethics and Governance Board, produced regular reports and provided guidance and analysis on the basis of the trial’s Serious Adverse Incident reporting.

  • Analysis

  • Advice

Deliverables

This clinical trial involved an innovative tissue engineered product. consentris advisors played a crucial role in setting up the trial’s Ethics and Governance Council, organised and ran the meetings of the Council and provided guidance on the production of a comprehensive ethics governance structure for the undertaking.

  • Ethics issue spotting

  • Governance structure

  • External EGC management

Report on ethics issues
Draft governance document
Updated consent documentation
Advice and support in meetings with sponsor