How Ethical Review works in FP7

Date: 10/10/2007

Despite the recommendation from the Commission that, in FP7, every proposal should address ethical issues at the very submission (and not in a later stage like in FP6), a large number of proposals in the first and second Health calls did not include them. It is important to note that this is an eligibility criteria and that a proposal can be disregarded without further warning because the ethical issues are not included. If the scientific evaluators are concerned about the ethical aspects of a proposal, it may be submitted to an Ethical Review Panel.
We strongly advice to include an Ethical Review in all proposals, even if it obviously raises no ethical problem.

In order to help you in that difficult matter, besides your always-available-SMEs go Health-expert and your National Contact Point, some important information are available online. You should go through the well explained ethical checklist at: http://cordis.europa.eu/fp7/ethics_en.html and include it in your proposal.

If your project includes ethically sensitive activities, two main questions should be answered in the Ethical Review:
• Are these activities necessary to achieve the scientific objectives set forth in the proposal? Is there no alternative?
• What will be the benefit/burden balance of the research project? i.e. the impact of this research not only regarding scientific advance but also in terms of Human dignity as well as social and cultural impact?

Ethical issues in FP7: The Importance of “getting it right the first time”

Despite frequent announcements by the European Commission that proposals submitted in FP7 need to thoroughly address ethical issues, a large number of proposals from the first Health call were found deficient in this respect. It is therefore important to bear in mind that the adequate coverage of ethical issues in a FP7 proposal constitutes an eligibility criterion - a proposal may be disregarded without further warning, solely because of insufficient treatment of ethical issues.

All proposals received by the Commission must describe the ethical, safety and socioeconomic issues raised by the research proposed and how they will be addressed so as to conform to national, European and international regulations.

The major changes from FP6 to FP7 in the context of ethical issues are:

• The Ethics Review will be carried out on the proposal submitted
• No additional information will be requested from the Consortium at a later stage
• The Consortium is asked to submit drafts of Information Sheets and Consent Forms
• The Consortium does not need to submit copies of legislation

Following a call for proposals, all applications submitted to the Commission are evaluated on their scientific merit. During this evaluation, the panel of scientists also makes a preliminary check of the ethical issues raised by a project and identifies any projects requiring special attention. This applies when projects raise sensitive ethical issues or when applicants fail to address ethical issues appropriately.

Following the evaluation, those proposals retained by the Commission with a view to funding, but identified by the experts as raising ethical issues, will be submitted to an Ethics Review panel. Ethics Review is automatic for proposals which include a research intervention on human beings, the use of human embryonic stem cells (hESC), or the use of non human primates.

The European Commission provides guidance on addressing ethical issues for prospective applicants at the following website: http://cordis. europa.eu/fp7/ethics_en.html, including a document on “ethics for researchers” at ftp://ftp.cordis.europa.eu/pub/fp7/docs/ethics-for-researchers.pdf

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