Ethics guidance

Many ERC grants involve research ethics: compliance with legislation, disciplinary norms, duty of care, protection of and respect for research subjects, and so forth. A good management of these aspects adds value: excellence in ethics adds to the credibility and excellence of the science.

The responsibility for ‘ethics’ lies with the individuals carrying out the research. Meanwhile, the formal accountability lies with the signatory of the Grant Agreement, the Host Institution.

The Horizon Europe Framework Programme sets high expectations. 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).’

Horizon Europe puts in place an Ethics Appraisal Procedure which includes:

  1. the Ethics Review Procedure conducted before the start of the project, and
  2. Ethics Checks, Reviews and Audits conducted during the project. The aim is to ascertain that expected standards are met and that risks to research subjects and researchers are minimised. ERC closely follows the Horizon process, with minor adaptations to optimise it for the characteristics of ERC grants: bottom-up, freedom for the researcher, and long duration.

The majority of ERC grants will raise ethics issues that are known by researchers and commonly addressed in their daily work. In Horizon Europe, these are to be managed by the grant beneficiaries, and – unlike in Horizon 2020 – without involving contractual deliverables and without having to send documentation to the ERC. Instead, the beneficiaries are expected to “keep on file” all documentation (authorisations, certificates, consent declarations, etcetera) pertaining to the ethics compliance of the research. Beneficiaries may be requested to submit this documentation as a matter of maintaining trust and assurance.

A minority of grants will feature serious or complex ethics issues. As in Horizon 2020, these will be subject to an extensive assessment prior to grant signature: ethics deliverables may be included in the grant agreement as contractual obligations. In exceptional cases, adaptations to the scope, objectives or methodology may be required.

Finally – as in Horizon Europe 2020 – the ERC may request the beneficiaries to appoint an ethics advisor or ethics board. They will, on the one hand, help the researchers in achieving good ethics management, and, on the other hand, provide a degree of assurance to the ERC.

The Commission publishes extensive guidance on the various aspects of ethics in EU-funded research: please see the links provided in the right block of this page.

Ethics processes before grant-signature

The ERC carries out the ethics process with the assistance of independent and highly qualified ethics experts.

The ethics process starts with an examination of the proposal, with particular attention to the ethics table and ethics self-assessment. The Commission publishes a guide to the writing of this part of a proposal. A good self-assessment speeds up the ethics process, as it helps the ERC to determine whether ethics issues are well-addressed, and to establish confidence that the beneficiaries will manage them in a satisfactory and compliant manner.

The endpoint of the process is an “ethics clearance for grant signature”. An Ethics Summary Report is sent to the beneficiaries. It contains the general analysis of the issues, any observations to which the ERC wishes to draw particular attention, the requirement to appoint an advisor or a board, and – for complex or serious cases only – any contractual deliverables.

The details of the process are documented in Annex A of the ERC Rules for submission and evaluation under Horizon Europe (ERC-specific, please see link below). The process has multiple stages dealing with grants of increasing ethics complexity. This allows to clear grants with less complexity - the majority - and better self-assessments in the shortest time.

Ethics in the management of the grant

As a simple administrative measure, it is important to keep a good record of all documentation pertaining to the ethics of the grant. As signatory to the grant agreement, the Host Institution will be responsible for being able to transmit copies to the Commission or ERC on request. Obviously, this documentation should be consistent: for example, it should be demonstrable that information sheets and consent forms were obtained prior to the start of an experiment.

Given the long duration and inherent flexibility of ERC grants, it often happens that ethics issues arise as a result of the research taking new directions. For example, after three years of research, it becomes apparent that a newly developed device is sufficiently advanced for testing on humans – but this was not foreseen in the proposal. It is important to be aware of this kind of possibility, and to flag significant new issues to the ERC. This can be done by inclusion in a request for amendment of the technical description, or it can be done informally by contacting the ERC ethics team.

As a matter of substance: research ethics is not easy, especially not in high-excellence research at the frontiers of science. In a multi / trans-disciplinary context, problems can arise when the PI is not familiar with the ethics context, and the Host Institution may not be in a position to support the PI in these matters. Nevertheless, the legal obligations and the fundamental ethical principles need to be adhered to.

Besides the guidance published by the Commission, the ethics team of ERC is always willing to provide help and advice on managing the ethics aspects of a grant.