Why do FP7 health applications get classed as “unsatisfactory” during EU ethics reviews?
- Failure to show any significant appreciation of the potential ethical issues of the study
- Failure to detail the exact procedures to be given to children, adults and animals or other relevant topics
- Failure to provide appropriate documentation supporting the proposed research from the ethics and regulatory side
How do applications easily pass EU ethical review?
- Applicants show they fully understand all ethical issues in their application
- The applicants fully detail all interventional procedures and the ethical implications
- The applications relate national and EU guidelines to the project specifically, rather than simply quoting these or “copy and pasting” regulations
- The applicant, when necessary, is cautious and includes an independent ethics advisor, or an independent ethics advisory board, or in cases of major potential ethical challenges, a work package on ethics can be proposed.
- The applicant addresses informed consent, data protection and privacy issues in a comprehensive manner
- The applicant states clearly where what research will be carried out and what authorities will approve the studies.
