Ethics Appraisal Process in Horizon Europe: Key Changes

Ethics Appraisal Process – the Context

The Horizon Europe introduced several important changes concerning the way the Ethics Appraisal Process is organised for EU-funded research projects. Beyond ensuring ongoing ethics compliance, these changes reflect both the evolution in terms of procedures as well as a reflection of the technological developments the European Commission consider the most important. This, in particular concerns the accent on the Artificial Intelligence.

Key changes concerning the Ethics Appraisal Process in Horizon Europe concern three areas:

• Research Integrity
• Ethics Self-Assessment
• Ethics Appraisal Process

European Code of Conduct For Research Integrity

The updated Ethics Self-Assessment in Horizon Europe makes now explicit reference to the European Code of Conduct for Research Integrity. In particular, the consortia submitting proposals must declare: “that the proposal complies with ethical principles (including the highest standards of research integrity as set out in the ALLEA European Code of Conduct for Research Integrity.”

Relevant guidelines to address this aspect at the proposal drafting stage and later if the project receives funding are also published as part of the SOPs4R project: Guideline for Promoting Research Integrity in Research Performing Organisations.

Updated Ethics Self-Assessment Table

In accordance with the Article 19.2(a) of the Regulation on Horizon Europe, the Ethics Self-Assessment is mandatory for all proposals with with one ‘yes’ in the Ethics issues Table. Now integrated in Part A, applicants have the opportunity to describe the ethical dimension of their proposal and the compliance with ethics principles. Depending on the call the applicants will have the possibility to submit additional information and/or supporting documents in separate annex to Part B.

Focus on the AI

One of the priorities of the European Commission, the Artificial Intelligence was added to the Ethics Self-Assessment table the consortia must complete before submission. In one of our previous articles, we discussed the Artificial Intelligence and Ethics in EU-funded Projects in great detail and provided useful links to relevant documentation there.

Dual use and Exclusive focus on civil applications

The ethics issues related to the potential dual use and exclusive focus on civil applications will no longer be part of the assessments performed by the ethics panels. From now on, the declaration by the applicant concerning dual use will be sufficient (no further checks in evaluation or grant management). The exclusive focus on civil applications aspects will be verified by scientific evaluators.

Ethics Appraisal Process

An important update concerning the Ethics Appraisal Process is reflected in the fact that while in H2020 ethics issues resulted in Conditional Clearance and Ethics Requirements, in Horizon Europe this does not have to be the case. On the other hand, the supervisory role of the Ethics Advisory Boards and individual advisors increased.

Relevant Resources

Reference documents this article is based upon can be accessed on the Horizon Europe Funding & Tender Opportunities and include:

• How-to complete your ethics self-assessment (‘How-to’)
• Horizon Europe Programme Guide
• Horizon Europe Model Grant Agreement (MGA) (Article 14 and Annex 5)
• HE Framework Programme Regulation 2021/695: Eligible actions and ethical principles (Article 18) and Ethics (Article 19)
• HE Specific Programme Decision 2021/764

Finally, the Ethics Review Helpdesk service is available for those applicants seeking more advice on ethics issues related to their projects.

Training for Ethics Experts

This article was inspired by the training provided to Ethics Experts organised virtually by the European Commission. Following the training, the EC services published relevant presentations and included a Youtube video. Link is provided below.