The Horizon Europe Framework Programme sets high expectations in relation to scientific excellence of which ethical standards are an integral part. The Grant Agreement states:
‘The action must be carried out in line with the highest ethical standards and the applicable EU, international and national law on ethical principles.’
‘The beneficiaries must commit to and ensure the respect of basic EU values (such as respect for human dignity, freedom, democracy, equality, the rule of law and human rights, including the rights of minorities).’
PROPOSAL STAGE
At proposal stage, the applicant has to complete a project specific Ethics Self-Assessment, which consists of two steps:
Step 1: Complete Ethics Issue Table
Step 2: Explain details of how you address issues under Ethics Self-Assessment
Both steps are to be completed online in the administrative forms (section 4) in the EU Funding and Tender Opportunities. For preparing the ethics self-assessment, use the official guide “How to complete your ethics Self-Assessment” in its latest version.
We recommend keeping the Ethics Self-Assessment short while including the following, if relevant:
- list relevant local, national and international standards and regulations
- describe the aims, methods and implications of the project activity, the nature of the participation and any benefits, risks or discomfort that might ensue
- attach respective ethical approvals
- where applicable, describe the process to obtain outstanding ethical clearance
- refer to how the consortium aims to address ethical issues (eg. GDPR compliance task)
- involve an independent ethics advisor (or ethics advisory board) in case the ethics-self assessment raised ethical concerns
EVALUATION/GRANT PREPARATION STAGE
The Ethics Review of a research proposal happens after the scientific evaluation is completed. It is performed for all proposals above threshold. The Ethics Review consists of an Ethics (Pre)Screening and, if appropriate, Ethics Assessment. The results are compiled in the Ethics Summary Report that is sent to the beneficiaries. The endpoint of an Ethics Review is “ethics clearance for grant signature”. The Ethics Review can lead to Ethics Requirements (contractual obligations related to ethics included in the Grant Agreement, GA).
A requirement may be that the applicant appoints:
- Ethics Advisor / Ethics Advisory Board (advising of ethics issues)
We recommend including this role already in the proposal if the ethics-self assessment has identified critical ethical issues.
PROJECT/IMPLEMENTATION STAGE
For projects with severe and/or complex ethical issues:
- Ethics Checks (monitoring of ethics issues and how they are being addressed by EC/agency staff) – may be requested by EC
- Project Ethics Review (elaborate review during project implementation by a panel of up to 5 ethics experts) – may be requested by EC
- Audits (in-depth evaluation, also possible post-grant) may be requested by EC.
The aim is to ascertain that expected standards are met and that risks for research subjects and researchers are minimized or were adequately addressed.
All these activities shall ensure a project’s ethics compliance and include the work of external independent Ethics Advisors and Ethics Advisory Boards, and the Ethics Checks/Reviews/Audits.
We recommend to distinguish research ethics, ethical research and ethics requirements from research on ethics. Consider that an ELSI Work Package conducting research may not tackle the task of ethics monitoring and compliance.
Images[1]:
EU Grants. Horizon Europe Programme Guide. Version 4.0. 15 October 2023. P. 26
Acknowledgements:
N.A.
Resources
EU Grants. How to complete your ethics self-assessment. Version 2.0. 13 July 2021
This document aims to assist in the completion of the ethics self-assessment, which is a requirement in the proposal phase.
For ethics, especially section 12: Ethics and Integrity is recommended. This document further contains detailed guidance on the structure, budget, and political priorities of Horizon Europe, including how to prepare proposals.
ELSI Dialogues: ELSI Self-Assessment
This webinar provides an overview on ethical issues to consider for EU grants.
European Network of Research Ethics Committees (EUREC)
EUREC is a network that brings together already existing national Research Ethics Committees (RECs) associations, networks or comparable initiatives on the European level.
ALLEA Code of Conduct for Research Integrity. Revised Version 2023.
The European Code of Conduct for Research Integrity serves the European research community as a framework for self-regulation across all scientific and scholarly disciplines and for all research settings. The 2023 Revised Edition of the European Code of Conduct for Research Integrity has been updated to ensure that the European Code of Conduct remains fit for purpose and relevant to all disciplines, emerging areas of research, and new research practices.
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