Research proposals must respect fundamental ethical principles and comply with both FP7 and relevant national or regional ethics regulations in the Host Organisation's country. These include those in the Charter of Fundamental Rights of the European Union and the Ethical Guidelines for undertaking research in FP7. Applicants are also referred to the EU publication Ethics for Researchers.
Applicants, Fellows and Host Organisations are referred to the CODEX research ethics website as a useful knowledge base and educational resource, including instructive texts and extensive links to research bioethics topics and related issues.
All applications must include a completed Ethics Issues table and explain the ethical rules they expect to employ in their research project. If a proposal raises any ethical issues, you are expected to present a plan and expected timing for obtaining any required permissions or documentation.
Specific procedures apply to proposals using human embryonic stem cells (hESCs):
- Scientific evaluators must mention in their evaluation report whether the use of hESCs is justified and necessary for the success of the project
- If the project is recommended for funding, the Programme Office will immediately contact the REA Project Officer, who will forward the research proposal and the scientific reports for EC Ethics Review, and ask the FP7-PEOPLE Programme Committee for its opinion
- The research using hESCs may not start until the proposal has received the approval of the EC Ethics Review and the FP7-PEOPLE Programme Committee.
When writing your proposal, you should take the following special issues into account:
Informed consent: When describing issues relating to informed consent, you should illustrate an appropriate level of ethical sensitivity and consider issues of insurance, incidental findings and the consequences of leaving the study.
Data protection issues: Avoid the unnecessary collection and use of personal data. Identify the source of the data. Describe whether it is collected as part of the research or is reuse of previously collected data. Consider issues of informed consent for any data being used. Describe how the personal identity of the data is protected.
Use of animals: Where animals are used in research the application of the 3Rs (Replace, Reduce, Refine) must be addressed convincingly. Numbers of animals should be specified. Describe what will happen to the animals after the research experiments.
The EC webpage Getting through ethics review identifies the main ethical dilemmas that arise in research and indicates how each topic might be addressed to ensure compliance.