The EGE is supportive of a harmonisation of clinical trial evaluation first and foremost in the interests of patients accessing effective innovative medicines in a timely manner and also to enhance the European Union competitive performance in the clinical trial arena. However, it is our view that marginalising the role of research ethics evaluation achieves neither of those objective. In view of these comments, the EGE recommends the EU Institutions to
- Explicitly provide for research ethics committee evaluation of proposals in the interests of protecting the rights of research participants.
- Give consideration to how best to avoid any type of ethics shopping, which may weaken the legitimacy of the evaluation e.g. by rotating the reporting member state function
- Consider expanding the grounds upon which a MS can disagree with the Reporting MS in the interests of building consensus and respecting ethical subsidiarity
- Set realistic timelines which should serve to expedite the process while allowing a robust consideration of the issues.
