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

• Regulation No 536/2014 of the European Parliament
• Commission Directive 2005/28/EC of 8 April 2005

Medical Studies

• Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subject

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

• EU Fundamental Rights
• UN Rights of Child
• UNESCO Universal Declaration

Environment protection and safety

• Directive 2000/54/EC On the protection of workers from risks related to exposure to biological agents at work.
• Directive 2001/18/EC On the deliberate release into the environment of genetically modified organisms.
• Directive 2009/41/EC || 98/81/EC On the contained use of genetically modified micro-organisms.
• Regulation EC No 1946/2003 On transboundary movements of genetically modified organisms.
• Directive 2008/56/EC Marine environmental policy
• Council Directive 92/43/EEC On conservation of natural habitats and wild fauna and flora.
• Council Regulation EC No 338/97 On the protection of species of wild fauna and flora.

Dual use in the context of security/dissemination

• Council Regulation (EC) No 428/2009

Other Reference Documents

• ERC Guide “Ethics Self-Assessment step by step” (for applicants)
• Guide “How to complete your ethics self-assessment” (for applicants) Manual
• Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo Convention)
• Convention on Biological Diversity (CBD) CBD Index
• Nagoya Protocol (for benefit sharing)Protocols
• Guidance on Information Requirements and Chemical Safety Assessment (under REACH, including guidance for nanomaterials)
• TRUST’s “Global Code of Conduct for Research in Resource-Poor Settings”
• European Commission “Ethics guidelines for trustworthy AI“
• Guidance Note “Ethics in Social Science and Humanities”
• Guidance Note on “Ethics and Data Protection”
• Guidance note “Research with an exclusive focus on civil applications”
• Guidance note “Research involving dual-use items”
• Guidance note “Potential misuse of research”
• Guidance note “Research on refugees, asylum seekers & migrants”