Ethics Appraisal Process: Main Reference Documents

Significance of the Ethics Appraisal Process

Ethical research conduct implies the application of fundamental ethical principles and legislation to scientific research in all possible domains of research. The Ethics Appraisal Process in Horizon Europe is conceived to assess and address the ethical dimension of funded projects.

Following the scientific evaluation of the proposals focusing on the scientific merit, the quality of the management, and the potential impact, the Ethics Appraisal Procedure ensures that all research activities are conducted in compliance with fundamental ethical principles. In addition, EU and national ethics legislation must also be respected by the researchers and host institutions or consortia.

This obligation is reflected in the article 34 of the Standard Grant Agreement which stipulates that the beneficiaries must comply with ethical principles and to provide all the relevant authorizations/approvals required by the implementation of the research activities planned in the project.

Legal References

Clinical Trials

Medical Studies

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

Human Genetic Materials and Bio Samples

  • Directive 2004/23/EC  of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells

Animal Experiments

  • Directive 2010/63/EU of the European Parliament and the council of 22 September 2010 on the protection of animals used for scientific purposes.

Data protection (GDPR)

  • Regulation (EU) 2016/679 with regards to the protection of natural persons concerning the processing of personal data and on the free movement of such data

Low-income countries and politically sensitive issues

Environment protection and safety

Dual use in the context of security/dissemination

Other Reference Documents

Ethics Appraisal Process References

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