The process

Step 1: At submission the Ethics issues Table needs to be filled out. If there is one (1) YES in the table, an ethics self-assessment has to be carried out. Applicants need to describe the ethical dimension of their proposal and how they will comply with ethics principles. Self-assessment will become part of the Grant Agreement and may thus define obligations subject to control. 

Guidance on self-assessment for HORIZON EUROPE, DIGITAL EUROPE and EUROPEAN DEFENCE FUND.

Step 2a: The Commission may decide to perform a pre-screening. Pre-screening is a filtering step of all proposals based on the simplified ethics issue evaluation table, there are only 2 possible outcomes:

• Ethics clearance
• Flagged for screening

Step 2b: during the Ethics screening the key goal of (at least two) ethics evaluators  is to identify proposals that raise serious or complex ethics issues. There are again only 2 possible outcomes:

• No ethics issues : results in Ethics clearance
• Ethics issues : go to Step 3

 Step 3 : The evaluators answer the question if the issues are Serious and/or Complex. There are 3 possible outcomes :

• Ethics clearance
• Conditional ethics clearance: the beneficiaries need to appoint an external independent ethics advisor or board. Ethics Checks or Ethics Reviews (see further) can be required and technical reviews can check ethics issues.
• Ethics assessment : key goal is to identify additional measures that must be implemented during grant preparation or later during grant implementation, for ethics issues not satisfactorily addressed in the proposal

Step 4 : the results of screening and/or assessment will be implemented in the Grant Agreement in the form of requirements or deliverables and during the execution of the project there can be possible checks or reviews.

How to avoid unforeseen costs.

During preparation of the proposal seek advice from colleagues with ethics expertise, such as:

• specialised ethics and compliance departments
• relevant compliance managers
• hospital ethics committees
• ethics advisors in your organisation
• data protection officers.

For projects with a significant ethics dimension, consider involving/appointing an ethics advisor/advisory board and include the work in the budget. From the beginning of your project, an ethics advisor can help you deal with ethical issues and put in place the procedures to handle them appropriately. If your activities include several ethical concerns or involves several significant or complex ethical issues (such as the processing of special categories of personal data (formerly known as ‘sensitive data’), AI applications involving human-machine cooperation, participation of children from developing countries, non-human primates (NHPs), potential misuse or vulnerable populations), appoint an ethics advisor or an ethics advisory board (more details later in the text) comprising several experts from different backgrounds. The granting authority may also make this an ethics requirement during the selection procedure. For more information, see also Guidelines-on-serious-and-complex-cases.  

Ethics Check & Ethics Review

An Ethics Check is an internal check by the project officer or ethics officer who may be supported by ethics experts.

An Ethics Review is a more elaborate and in-depth procedure carried out by up to 5 external ethics experts (formerly known as Ethics Check in H2020)

The choice between Ethics Check and Ethics Review should reflect the size of the grant and the seriousness/complexity of the ethics issues.

External and independent advisors

External to the project and to the department(s) or group(s) conducting the research

Absence of professional, financial, family or other relationships or common interests that would result in a conflict of interest.

Disqualifying factors:

• involved in the preparation of the proposal/project
• stands to benefit should the project be positively evaluated
• has a close relationship with any person representing the beneficiary (but not anyone from the institution, in case of large organizations)
• Is a director, trustee or partner of beneficiary (hierarchical position or position of authority)
• is in a situation that compromises his impartiality vis-à-vis the project
• is involved in any substantial collaboration with the (sub-)group/department involved
• is in any other situation that could appear to cast doubt on their independence

• The appointment of external independent Ethics Advisor or an Ethics Advisory Board should be clearly justified in light of the number, severity and complexity of the ethics issues raised by the proposal and the capacity of the Applicant/Beneficiary to address the ethics issues appropriately.
• The choice between an Ethics Advisor and Board should reflect the size of the grant and the number, severity, and complexity of the ethics issues raised by the proposal.

Roles and Function in EU-funded Projects

Ethics-Advisors-and-Ethics-Advisory-Boards

• Voluntarily proposed by the applicant / beneficiary in their application
• Mandatory as a result of the Ethics Review.
• Appointed by the beneficiary/consortium
• External and independent from the beneficiary/consortium
• Responsibility to advise the beneficiary/consortium on identifying and addressing ethics issues
• Responsibility to report to the Commission/Agency/Funding Body
• Not responsible for ethics management and compliance

Ethics Mentor

Possibly the appointment of an Ethics Mentor is recommended (for cleared proposals) or required (for conditionally cleared proposals). Mentors should be:

• Not external / independent of the beneficiary. Can be a member of the same department or institution that advises, shares experience and knowledge on how to properly identify and address ethics issues.
• Not obliged to independently report to the Commission / Agency, although it is recommended to keep a report of the activities performed.

Interesting Links

Horizon Europe: key changes to the Ethics Appraisal Process (youtube.com)

Ethics-Advisors-and-Ethics-Advisory-Boards

Guidance on self-assessment

Guidelines-on-serious-and-complex-cases