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1. Actions carried out under the Programme shall comply with ethical principles and relevant Union, national and international law, including the Charter and the European Convention for the Protection of Human Rights and Fundamental Freedoms and its Supplementary Protocols. Particular attention shall be paid to the principle of proportionality, to the right to privacy, the right to the protection of personal data, the right to the physical and mental integrity of a person, the right to non-discrimination and to the need to ensure protection of the environment and high levels of human health protection.

2. Legal entities participating in an action shall provide:

(a) an ethics self-assessment identifying and detailing all the foreseeable ethics issues related to the objective, implementation and likely impact of the activities to be funded, including a confirmation of compliance with paragraph 1 and a description of how it will be ensured;

(b) a confirmation that the activities will comply with the European Code of Conduct for Research Integrity published by All European Academies and that no activities excluded from funding will be conducted;

(c) for activities carried out outside the Union, a confirmation that the same activities would have been allowed in a Member State; and (d) for activities making use of human embryonic stem cells, as appropriate, details of licensing and control measures that shall be taken by the competent authorities of the Member States concerned as well as details of the ethics approvals that shall be obtained before the activities concerned start.

3. Proposals shall be systematically screened to identify actions which raise complex or serious ethics issues and submit them to an ethics assessment. The ethics assessment shall be carried out by the Commission unless it is delegated to the funding body. All actions involving the use of human embryonic stem cells or human embryos shall be subject to an ethics assessment. Ethics screenings and assessments shall be carried out with the support of ethics experts. The Commission and the funding bodies shall ensure the transparency of the ethics procedures without prejudice to the confidentiality of the content of those procedures.

4. Legal entities participating in an action shall obtain all approvals or other mandatory documents from the relevant national, local ethics committees or other bodies, such as data protection authorities, before the start of the relevant activities. Those documents shall be kept on file and provided to the Commission or the relevant funding body upon request.

5. If appropriate, ethics checks shall be carried out by the Commission or the relevant funding body. For serious or complex ethics issues, ethics checks shall be carried out by the Commission unless the Commission delegates this task to the funding body. Ethics checks shall be carried out with the support of ethics experts.

6. Actions which do not fulfil the ethics requirements referred to in paragraphs 1 to 4 and are therefore not ethically acceptable, shall be rejected or terminated once the ethical unacceptability has been established.