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Ethics Review

Ethics Review is an important part of the process undertaken by the European Commission when evaluating research proposals submitted under the Seventh Framework Programme (FP7) . All applications that have been pre-selected for FP7 funding and that raise ethical issues must be submitted to an ethics review.

Reviewing research projects on ethical grounds at the EU level is a legal requirement under FP7, and is intended to ensure that all research activities carried out under the Framework Programme are conducted in accordance with fundamental ethical principles.

Ethics Review evaluates aspects of the design and methodology of the proposed research that raise ethical concerns. These may include intervention on humans, use of animals, data protection issues, use of children, and research proposed to take place in developing countries.

The work undertaken by the European Commission with regard to research ethics issues is not limited to Ethics Review. Complementary to this process, Commission Services administer a number of support activities (outlined below) that aim to facilitate the applicant's compliance with FP7 research ethics standards, to enhance the positive and constructive character of ethics reviews, and to maximise the positive impact of the research results.

Training

The Intensive Ethics Review training course helps diffuse information and awareness on the European Commission's Ethics Review procedure. The course targets the research community, Commission staff, National Contact Points (NCPs), related national authorities, and ethics reviewers themselves (e.g. they may need to learn how to adapt their experience of national reviews to the European level).

Ethics Review Help Desk

Provided to all FP7 project participants, this service allows people to obtain expert advice and guidance should ethical issues arise in the course of their research. The advice is offered in a confidential manner, free of charge, and only upon request by the FP7 participant through the Ethics Review Help Desk website .

Ethics Follow-up and Audit

The Ethics Follow-up and Audit (EFA) procedure was introduced for projects that require a particular follow-up on significant ethical issues during the implementation of the project. The EFA scheme was piloted in 2009 with real-time follow-up and audits conducted over the period 2010-2011 (covering approximately 10 % of the projects that had been processed through Ethics Review).

Ethics Review Guidance Notes

A number of Ethics Experts Working Groups were established to provide guidance notes to FP7 applicants and European Commission staff in areas such as research ethics in international cooperation, data protection, synthetic biology, intervention on humans, and (currently) improper use of research. The objective of these support documents is to promote a better understanding of the issues within the FP7 ethics framework. The documents are available via the CORDIS website on ethics .

Lessons learnt

The first ever self assessment of the Ethics Review process was recently conducted by the ethics reviewers themselves. The objective of the exercise was to examine the Ethics Review Reports produced by the Ethics Review Panels, focusing on the sections called 'Requirements'. The aim was to establish whether there was consistency between panels in their requirements for the resolution of similar ethical issues. This activity is part of a lessons learnt exercise that ran from 2008 to 2010.

Ethics Review Impact Assessment

In 2010, the Ethics Review Impact Assessment exercise was launched to examine the impact of this process on the participating scientists. Although all care was taken not to increase the workload that accompanies the design and implementation of a research project, it is evident that the process could be further streamlined and improved.

More information on the Ethics Review process under FP7 is available through the CORDIS website on ethics .

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