For all activities funded by the European Union, ethics is an integral part of research from beginning to end, and ethical compliance is seen as pivotal to achieve real research excellence. There is clear need to make a thorough ethical evaluation from the conceptual stage of the proposal not only to respect the legal framework but also to enhance the quality of the research. Ethical research conduct implies the application of fundamental ethical principles and legislation to scientific research in all possible domains of research. The process to assess and address the ethical dimension of activities funded under Horizon 2020 is called the Ethics Appraisal Procedure.
In addition to the scientific evaluation focusing on the scientific merit, the quality of the management and the potential impact, the Ethics Appraisal ensures that all research activities carried out under the Horizon 2020 Framework Programme are conducted in compliance with fundamental ethical principles.
Ethics Appraisal Procedure
The Ethics Appraisal Procedure concerns all activities funded in Horizon 2020 and includes the Ethics Review Procedure, conducted before the start of the project, as well as the Ethics Checks and Audits.
When preparing a proposal, it is required to conduct an Ethics Self-assessment starting with the completion of an Ethics Issues Table. You can read further practicalities in How to complete your ethics self-assessment guide.
Ethics Review Procedure
All proposals above threshold and considered for funding will undergo an Ethics Review carried out by independent ethics experts working in a panel. The Review starts with an Ethics Screening and if appropriate a further analysis called the Ethics Assessment is conducted. The Ethics Review can lead to ethics requirements that become contractual obligations.
The Ethics Review Procedure focusses on the compliance with ethical rules and standards, relevant European legislation, international conventions and declarations, national authorizations and ethics approvals, proportionality of the research methods and the applicants' awareness of the ethical aspects and social impact of their planned research.
- Ethics Screening
The first phase of the Ethics Review Procedure, the Ethics Screening, is carried out during the scientific evaluation or soon after. The ethics experts first perform an Ethics Pre-Screening taking into account the Self-assessment. The objective of the pre-screening is to list the (potential) ethical issues but not to assess them.
When there is at least one confirmed ethical issues, the proposal is subject to a complete Ethics Screening that will mainly assess the ethical aspects of its objectives, methodology and potential impact. The experts will notably identify all proposals that require (ethical) approval at the national level (e.g. with regards to data protection, the conduct of clinical trials and animal welfare). Because of the complexity or the nature of the ethical issues they at stake (e.g. severe intervention on humans) the ethics experts may also recommend an Ethics Assessment rather than formulating directly requirements. Proposals involving the use of Human Embryonic Stems Cells (hESCs) automatically proceed to the second step, the Ethics Assessment.
- Ethics Assessment
For a limited number of proposals (e.g. severe intervention on humans, lack of appropriate ethics framework in the country where the research will be performed, etc.) the Ethics Screening can be followed by an Ethics Assessment prior to the signature of the grant agreement.
The Ethics Assessment is an in-depth analysis of the ethical issues of the proposals, taking into account, when available the conclusions of the Ethics screening. As mentioned above, it is systematically performed on all proposals involving the use of Human Embryonic Stem Cells.
Ethics requirements and Ethics work package
There are two types of ethics requirements. Requirements that you need to comply with
- during grant preparation
- during the ongoing project
Ethics deliverables: All ethics requirements due after project start are automatically included in the grant agreement in the form of deliverables. These deliverables are known as 'ethics deliverables' and will be placed in an automatically generated work package called 'ethics requirements'.
Read more grant preparation related ethics information.
Ethics Checks and Audits
During the Ethics Screening or the Ethics Assessment, the experts identify the projects that need an Ethics Check, which are executed during the course of the research project. The procedure can also be initiated by the Commission services.
The objective of the procedure is to assist the beneficiaries to deal with the ethics issues raised by their research and if necessary to take preventive or/and corrective measures. The Ethics Check is conducted on the basis of the information provided by the concerned beneficiaries, who may be invited to a meeting in Brussels to discuss the issues at stake. On site visits can also be organised.
In case of substantial breach of ethical principles, research integrity or relevant legislation, the Commission can carry out an Ethics Audit following the provisions and procedures laid down in the grant agreement.
The Checks and Audits can result in an amendment of the grant agreement. In severe cases, it can lead, upon the decision of the Commission services to a reduction of the grant, its termination or any other appropriate measures, in accordance with the provisions of the grant agreement.
ETHICS APPRAISAL STEPS
|Ethics Self-assessment||Applicant||Application phase||Consideration of ethical issues of the proposal|
|Ethics experts||Evaluation phase||Review of application material|
(for proposals involving hESC or raising
serious ethical issues: severe intervention on humans)
Grant preparation phase
|Review of application material|
|Ethics Check/Audit||Ethics experts||Implementation phase||Review of project deliverables/interview with applicants|
The Ethics Appraisal Procedure is established by the Rules for submission of proposals, and the related evaluation, selection and award procedures.
More general information and an e-Library providing access to the most important pieces of European legislation, international conventions and declarations and codes of conduct relevant to research activities can be found on the Europa website.
For assistance please contact us at the Ethics Review Helpdesk (select subject 13. Ethics in the enquiry form).
Utilisation of Genetic Resources: EU Regulation on Access and Benefit Sharing (ABS) is in Force
The EU ABS Regulation, which transposes into EU law the compliance pillar of the Nagoya Protocol, entered into force on 12 October 2014 (the recently adopted Implementing Regulation document provides details on how the ABS Regulation is applied). The principal obligations defined in this Regulation apply since 12 October 2015. In particular, there are obligations of due diligence and monitoring compliance.
If you are utilising genetic resources (i.e. conduct research and development on the genetic and/or biological composition of genetic resources, including through the application of biotechnology), you should
- be aware of the obligations arising from the ABS Regulation
- ensure your project is compliant
Practical guidance for recipients of EU research funding will be made available on the Participant Portal as soon as possible. This will help you decide if you have obligations under the ABS Regulation and, if yes, how to comply.
More information about the Nagoya Protocol on Access and Benefit Sharing (ABS) or the ABS Clearing House.
IMPORTANT NOTE: In case of general and domain-specific guidance documents, although some of the documents refer to FP7 they remain valid for the Horizon 2020 programme.
Horizon 2020 Legislation
- Legal basis - Horizon 2020 Rules for Participation: Ethics Reviews (Article 14)
- Horizon 2020 - Regulation of Establishment: Ethical principles (Article 19)
- Model Grant Agreement: Ethics (Article 34)
- Statements by the Commission on human embryonic stem cell research
- Guide for proposal submission and evaluation
- Charter of Fundamental Rights of the European Union
- European Code of Conduct for Research Integrity
General guidance documents
- How to complete your ethics self-assessment
- Ethics in "Science with and for society"
- Ethics for Researchers
- European Textbook on Ethics in Research (2010)
- A comprehensive strategy on how to minimize research misconduct and the potential misuse of research in EU funded research
Domain-specific guidance notes
- Guidance Note for Researchers and Evaluators of Social Sciences and Humanities
- Guidance Note - Ethics and Food-Related Research
- Research on Human embryos/foetus
- Ethics for Clinical Trials on Medicinal Products Conducted with Paediatric Population
- Research on Animals
- Informed Consent
- Exploratory note - Guidance on research involving dual use items
- Exploratory note – Guidance on potential misuse of research results
- Exploratory note – Guidance on research focusing exclusively on civil applications