General conditions for application

The initial duration of the clinical studies will be 48 months.

Any IICS must clearly demonstrate the potential health, economic, and/or policy impacts, as well as the added value of transnational collaboration.

Proposals should follow the principles of Responsible Research and Innovation (RRI ). Consortia must show how they will engage with and address the relevant social, political, equity, environmental or cultural dimensions of the proposed research. The pre-proposal template and the ERA4Health RRI Guidelines further elaborate on how RRI dimensions can be approached (check the Guidelines for Applicants for more information).

IICS supported by ERA4Health must respect fundamental ethical principles. Applicants must fill an ethical grid and describe any potential ethical aspects of the work to be carried out, and how the clinical study will fulfil applicable requirements in institutional, national and European Union legislation (including the ethical standards and guidelines of Horizon 2020/Europe ).

The individual partners of the joint applications should be complementary in their expertise and the proposed work should pursue a high implementation potential to benefit of end-users/patients/citizens.

Furthermore, additional aspects need to be considered in the application:

• The design of the clinical study (sample collection, statistical power, interpretation, relevant models for hypothesis validation) must be well justified and should be part of the proposal.
• Strategies for recruitment, retention, assessment, and analysis must be included. The clinical study design and objectives should take into consideration the population that would be needed to reach the objective of the study.
• Gender equality as well as inclusiveness of the diversity of the population in the recruitment.
• Involvement of patient/patients' representatives and other relevant users in the co-creation and implementation of the tasks.

Please take in note that clinical studies conducted for direct commercial purposes are excluded from support by the ERA4Health programme.