ETHNA SYSTEM
Ethics Governance System for RRI in Higher Education, Funding and Research Centres
Objectives
The Objective of ETHNA System is to implement and enforce an internal management and procedural system of the Responsible Research and Innovation (RRI) within 6 European Higher Education, Funding and Research Centres (HEFRC). It aims to generate a process of Ethical Governance of the RRI where Gender equality, Open Science, Citizens’ Engagement and Integrity Research (ethics) dimensions will be also necessarily addressed through a multi-stakeholder governance. It will be translated into a new formal organisational structure that will facilitate the compliance with all RRI dimensions in all scientific disciplines as well as assuring the innovations accomplished are made according to the needs of civil society demands.
And to move from theory to practice, an ethical infrastructure is developed: an ETHNA Office of the RRI that offers guidelines as well as a system to ethically manage the dimensions of the RRI through four tools (ethical code, ethics committee, ethical hotline and progress indicators to report). The ETHNA Office will be implemented in each HEFRC that will use the same protocol but adapted to its idiosyncrasy and specificity.
Outputs
- Implement and validate a new formal organizational structure within the management structure in 6 different HERCs of the consortium (Spain, Norway, Bulgaria, Estonia, Aus-tria and Portugal) and 3 types of contexts (Universities, Funding research organisations and Technological Parks)
- Develop a sustainability plan to to maximise the impact during 5 years after the end of the project
- Mutual learning among the consortium partners
Key project results/activities for RECs and ethics experts
To ensure compliance with RRI principles, the ETHNA project aimed to implement a formal organisational structure encompassing ethical governance principles, including gender equality, open science, citizen engagement, and research integrity, through multi-stakeholder collaboration.
ETHNA outlined several key elements of an “Ethical Governance System” which can be ensured by RECs. This entails an ethical code, which should clearly state the values that should guide the behavior of everyone involved in research and innovation, promote good practices, and provide indicators about the organisation's character and identity; an ethics committee, which should provide guidance on interpreting and applying an ethical code, handle reports submitted through an ethics hotline, and ensure employees and managers are informed about and involved in the ethics and compliance program; an ethics hotline, or confidential communication platform for expressing suggestions, alerts, and complaints regarding non-compliance with ethical codes, ensuring confidentiality and preventing reprisals, and providing advice and analysis on best practices and addressing areas for improvement; and progress indicators which monitor adherence to the ethical code.
The ETHNA project recommends RECs to develop a training plan for committee members and ensure new members receive basic training. Additionally, RECs should define the committee’s scope, composition, competencies, communication channels, and action protocol, as detailed in D4.3 “Blueprint for Institutional Change.” Overall, strong leadership support is paramount for sustainable institutional changes towards effective R&I governance. While implementation may start top-down, long-term impact relies on bottom-up engagement. Structural barriers must be addressed, and co-creation processes should be tailored to organisational realities.
Key project results/activities for RECs and ethics experts
c4c (conect4children) is a large European public private project that aims to facilitate the development of new drugs and other therapies for the entire paediatric population. It builds capacity for the implementation of multinational paediatric clinical trials whilst ensuring the needs of babies, children, young people and their families are met. An important part of the project is providing advice to bring clinical and innovative methodology expertise as well as the patient and parent perspective to paediatric drug development.
This is guaranteed by a network of experts that consists of various expert groups with EUREC leading the ethics expert group. Apart from giving advice on ethics in clinical trials the ethics expert group put a focus on the exchange between YPAGs (young persons advisory groups) and REC members.
Duration
January 2020 - June 2023
Website
Cordis Entry
Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or European Research Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.
