Ethics Advisory Board in Horizon Europe: Functions and Role

Ethics Advisory Board in EU-funded Projects

There are various approaches to ethical issues. While some of these issues invite simple solutions, other demand complex, multilayered solutions. Regardless of the favored approach, the actions of the Ethics Advisory Board (EAB) and its Ethics Advisors (EA) must be carried out with the best interests of the general public and civil society in perspective. In any EU-funded project, the function of the EA/EAB is to ascertain that no EU rule is violated while also ensuring that the research conducted abroad is up to the accepted EU standards. Overall, where any EC-financed project is deemed to have societal ramifications, the issue of ethics arises, and it is in these instances that the EAs/EABs are invited to make the relevant assessments.

Ethics Advisory Board: External Supervisor Ethics Issues

According to the guidance document on the Roles and Functions of Ethics Advisors/Ethics Advisory Boards in EC-funded Projects, the EAB/EA refers to: “a group of ethics experts or an individual ethics expert who provide advice on ethics in any EC-funded project.” Ethics refer to: “questions of legal and regulatory compliance that constitute a part of the governance process.” In Horizon Europe, ethics is deemed a transversal issue and Ethics Advisory Board a key oversight mechanism to ensure understanding o the Ethics Appraisal Procedure, proper implementation of the Ethics Requirements, addressing specific issues such as Privacy and Data Protection Impact Assessments or Artificial Intelligence  and ensuring ethics compliance in general.

Among others, some of the benefits that attend the consideration of ethics in projects include the promotion of research integrity, increase in the likelihood of social impact, increase of the quality of research, aiding public acceptance of the products of the research. Depending on the circumstance, consultation with ethics advisors or the creation of an Ethics Advisory Board for a project can either be voluntary or mandated.

The Role of the Ethics Advisory Board

The EAB performs several roles and functions. The board assumes an oversight function in projects, and helps in efforts to preempt problems and propose possible solutions. The EAB functions as resource points for guidance on ethical issues that arise in projects, and also works in close connection with any partner saddled with ethics-related responsibilities.

The EA/EAB makes sure that projects conform with the relevant EU standards, particularly those involving research outside the EU. Also, where the EAB is involved in a technical deliverable, it is recommended that ethics experts be integrated as project partners to incorporate their expertise in the daily research. In all, the EA/EAB must be on the look out to ensure that the Commission and the general public are not negatively impacted by any aspect of a funded project. Also, any ethics advice given by the EA/EAB must have a foundation in EU/National Laws and must not conflict with them.

How to form your Ethics Advisory Board (and how not to)

The delivery of impeccable ethics advice in projects is often conditional on the proper constitution of an EAB. Some of the important factors to consider in constituting the membership of your EAB include:

• Expertise: the competencies of the membership of the EAB must not be in doubt. Members should have demonstrable expertise in the relevant ethical issues peculiar to the project at hand.
• Independence: The EAB must be independent of external influences. The board should be able to make judgements, even when they conflict with the project goals.
• Understanding real life application of projects: Not only should members have expertise in ethics and ethical issues, they must also have the relevant practical knowledge, particularly how the projects are managed in real life and how the research activities are usually organised. A good ethics advisory board member should not negatively impact the project life cycle.
• Transparency: The board must be open and clear about all of their activities and decisions.

Additionally, some pitfalls you want to avoid in constituting your EAB include:

• Engaging bias and not expertise.
• Failing to conduct due diligence in examining the competencies of prospective members of the board.
• Failure to be proactive. For example, delay in considering the issue of security clearances, failing to discuss confidentiality and failing to execute necessary confidentiality documents, etc.
• Compromising the independence of the board.

Privanova’s management of Ethics Advisory Board across different projects

We are leaders in ethics. Leveraging our extensive network of ethicists, we often assist in the constitution of EABs for EU projects we are involved in. Our expert ethicists are drawn from several areas such as Law, Data Privacy/Security, Research Ethics, law enforcement, animal welfare, research with children among others. We have experience working with the EU Commission as ethics evaluators, meaning we have a profound understanding of the Ethics Requirements for EC-funded projects.

Privanova leads the ethics compliance in several ongoing EU-funded projects. In most of them, we are responsible for ensuring full ethics compliance during the project life-cycle.

CC-DRIVER: Ethics Advisory Board for cyber-crime project

In the CC-DRIVER project for instance, we championed the establishment and management of the Ethics Advisory Board. The sensitive context this project addresses requires careful consideration of ethics issues and continuous monitoring of ethics compliance. For this reason, Privanova assists the project coordinator with whom we organise regular quarterly meetings of the Ethics Advisory Board. In terms of membership we provided the project with a number of experts who deal with cybercrime issues on a daily basis, besides their background in privacy, data protection and research ethics. We also assisted in addressing the Ethics Requirements raised at the proposal’s evaluation phase.

AI4HealthSec: Ethics Advisory Board in the context of healthcare ICT infrastructure protection

We also performed similar roles in the AI4HEALTHSEC project. Privanova was responsible for the constitution of the EAB and liaised between the board and the consortium. The ethicists we provided to the consortium ensure the quality oversight and continuous monitoring of the project activities. Finally, they validate relevant deliverables and are involved in the project risk management component when it comes to identification and mitigation of privacy and data protection related risks.

MARVEL: Ethics Advisory Board for project addressing smart cities

Managing the Ethics Advisory Board for the MARVEL project required finding experts with specific expertise capable of understanding the complex privacy, data protection and other relevant issues concerning this project. In addition, it was absolutely necessary they were capable of interpreting for themselves the Ethics Requirements the project received following a successful scientific evaluation. Starting from the MARVEL Kick Off meeting, together with the project coordinator, Privanova highlighted the importance of ethics compliance and timely fulfillment of all ethics requirements. At a later stage, we formed the project’s Ethics Advisory Board and organised its first meetings and deliverable reviews.

DigiCare4You: Ethics Advisory Board for a large-scale medical study

Privanova leads legal and ethics compliance work package for DigiCare4You – an interdisciplinary project delivering digital tools for early screening, prevention and management of type 2 diabetes and hypertension. Within the project, more than 10 000 families will be targeted in two middle-income and two high-income countries. Due to the sensitive nature of the personal data processed within the scope of the project as well as the number of targeted human participants (including children) Privanova implemented the Ethics Advisory Board from the proposal drafting phase. For this project, the Ethics Advisory Board will consist of several independent ethicists with relevant expertise: personal data processing in the context of medicine. The EAB will ensure continuous compliance of communication, dissemination and exploitation activities, support the coordinator by providing ad-hoc advice and contribute to Ethics & Compliance Report.