For research funded by the European Union, ethics is an integral part of research from beginning to end and ethical compliance is pivotal to achieve real research excellence. There is clear need to make a thorough ethical evaluation from the conceptual stage of the proposal to enhance the quality of the research. Ethical research conduct implies the application of fundamental ethical principles to scientific research in all possible domains of research. The process to assess and address the ethical dimension of proposals and projects funded under FP7 is called the Ethics Review.
- to ensure that all research activities carried out under the 7th Framework Programme are conducted in compliance with fundamental ethical principles
Ethics Review Procedures
All research proposals submitted to the European Commission are evaluated both on their scientific merit and on its ethical and social impact. When preparing a proposal, it is required to include an Ethics Annex with a completed Ethical Issues Table.
During the scientific evaluation of the proposals the experts identify the proposals that may require further assessment due to the importance of the ethical issues raised by the proposal or the degree of adequacy of the way the ethical issues are addressed in the proposal.
The proposals retained by the experts with a view to funding, but identified as raising ethical issues, will undergo Ethics Review Procedures, which can contain up to three phases.
STEP 1. Ethics Screening
The first phase of the Ethics Review Procedures, the Ethics Screening, is meant to 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) and identifies the proposals that require a full Ethics Review due to complexity or the nature of the ethical issues they raise (e.g. severe intervention on humans, use of non-human primates in research and research on human embryos and human embryonic stem cells).
STEP 2. Ethics Review
After the Ethics Screening process the European Commission may decide to submit proposals to a full Ethics Review. As mentioned above, this is notably mandatory when the research involves intervention on humans, the use of non-human primates, human embryos or human embryonic stem cells. After an individual assessment of the proposals, the experts meet as a panel to discuss the proposal and produce an Ethics Review Report.
The Ethics Review Panel assesses the compliance with ethical rules and standards, relevant European legislation and relevant 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.
STEP 3. Ethics Follow-up and Audit
During the Ethics Screening or the Ethics Review, the experts identify the projects that need a follow-up or audit.
The follow-up and audit procedures are executed during the course of the research project and are meant "to assist the beneficiaries to deal with the ethical issues that are raised by their work and if necessary take preventive and/or corrective measures."
The procedure can also be initiated by the Commission services.
This procedure is established by the
Rules for submission of proposals, and the related evaluation, selection and award procedures (Annex A).
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 Helpdesk.
Graphical presentation of Ethics Review in the evaluation and the selection procedure:
General guidance documents
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
- Informed Consent
- Ethics in ICT
- Research on Animals
- Research Involving Developing Countries
- Dual Use