All applicants submitting a proposal to the Seventh Framework Programme (FP7) must outline ethical issues that their research may potentially touch upon. This is done in the Ethical Issues Table that must be submitted along with their scientific proposal. In addition, the Ethics Annex must be included as part of the application. Here, the applicant explains how the ethical issues will be dealt with in detail, and how EU and national legislation will be taken into account.
Once submitted to the European Commission, the application is first evaluated by a panel of independent scientific experts. This panel identifies and briefly comments on the potential ethical aspects of the proposed research (based mainly on the submitted Ethics Issues Table). The experts do not necessarily enter into a discussion of the research ethics issues but are required to determine whether a proposal merits further (thorough) consideration of its ethical dimension.
Proposals selected for funding are then sent to independent Ethics Screening panels. Research proposals that involve intervention on human beings, research on human embryos and human embryonic stem cells, and experimentation with non-human primates are automatically submitted to an ethics review organised by the Ethics Review Sector of the European Commission's Directorate-General of Research (DG RTD).
Research proposals that raise research ethical issues that fall under the scope of EU Law (such as clinical trials, data protection, animal welfare, and human tissue collection and use) are approved, in principle, on the condition that copies of the required national approvals and/or positive opinions of the relevant competent authorities are submitted to the Commission prior to the commencement of the relevant part of the research. This falls under clauses 15 and 16 of the FP7 Grant Agreement .
For all other types of research (such as those relating to new and emerging technologies, social sciences, research involving children, and research in developing countries) that merit special attention on ethical grounds, the Ethics Review Sector (along with Commission Services for the funding of specific proposals) decide on the need for an ethics review on a case-by-case basis. Projects raising important ethical issues identified during the Ethics Screening process are submitted to an Ethics Review Panel.
Ethics Review commences once the Ethics Screening process is finalised, and is conducted by independent Ethics Review Panels. These panels are comprised of independent experts from a variety of disciplines such as law, sociology, psychology, philosophy and ethics, medicine, molecular biology, chemistry, physics, engineering, and veterinary sciences with a reasonable balance of scientific and non-scientific members. The panels reflect a balance with regard to geography and gender, and their composition also depends on the nature of the proposals under review.
The Ethics Review Panel discusses and analyses the ethical issues raised by a research proposal, and identifies the ethical requirements that need to be met by the applicant. The applications are reviewed on the basis of the following criteria:
The Ethics Review Panel produces an Ethics Review Report, which includes a list of research ethical issues identified by the panel that might be raised by the research proposal, and an account of the way the Commission Services will handle these issues.
The report also includes panel requirements that outline all actions that an applicant must take in order for the research to be conducted in accordance with the FP7 research ethics framework. The requirements become part of the applicant's contractual responsibilities with the European Union. In addition, the panel would offer, if necessary, a number of recommendations to the applicant. These recommendations are basically suggestions that can improve the ethical conduct of the research. They are neither obligatory in legal terms nor do they become part of the contract.
Finally, the Ethics Review Panel might also indicate if follow-up actions are necessary. These are added for applications that raise a number of ethical concerns where the ability of the applicant does not guarantee comprehensive and sound handling of the ethical issues unaided. The follow-up actions could lead to full ethics audits if the applicant has not fulfilled the contractual responsibilities or has failed to take into account the recommended ethics follow-up measures. In the decision to fund a project the results of the ethical review procedure will be considered. This may entail changes in the grant agreement and its annexes or (in extreme cases) termination of the preparation of the grant agreement.