Global Perspectives™: Obtaining Ethical Approvals Across Europe for Outcomes Research
Over the past 12 months at Global Perspectives, we have obtained a lot of knowledge and experience regarding ethical approvals for market research studies in Europe.
Many of our healthcare clients obtain US IRB approval for their Patient Outcomes and other market research projects. However, they are less certain on what approval is needed around Europe.
Each country in Europe has different rules and regulations regarding when ethical and regulatory approval is needed. From our experience, we can summarise the following:
- In general, ethical approval in Europe is not needed if it is a market research study and recruitment will not be taking place at clinical sites
- However, ethical approval may be desired if the research will be subsequently published in a scientific journal
- Obtaining FEKI approval in Germany is a good option as this is fairly quick and straight forward and recognised in many countries across Europe
- Other countries such as France may simply require the project to be registered with the relevant regulatory body