Table 3 Multi-stakeholder recommendations for the creation of a European guidance framework on eIC in clinical research

Overarching recommendations regarding the development of European guidance framework

1. Involve a multi-stakeholder taskforce to guide the creation of a European guidance framework, with a neutral stakeholder preferably taking the lead

2. Develop a European guidance framework with a high legal value, starting from recommendations or good research practices that may ultimately result in legislation

3. Aim to harmonize as much as possible and to report transparently about the elements for which and the reasons why harmonization cannot be achieved

Recommendations regarding the content of a European guidance framework

4. Address specific types of eIC (e.g., a combination of paper and electronic consent elements may be used)

5. Report and update the legal acceptance of eIC across EU Member States

6. Include an overview of the responsibilities of ECs and preferably the documents to be submitted to ECs

7. Emphasize that eIC applications are designed to support the interaction between the research participants and the research team

8. Emphasize the interactive and flexible character of eIC applications