Ethical approval


If you plan to do research in Sweden that involves processing of sensitive personal data, you must have an ethical approval from the Swedish Ethical Review Authority before you begin your research. An ethical approval may also be required under other circumstances that involve research on humans or on human biological material. You can enable others to reuse your data by specifying in the application how the data is going to be shared. The application that you send in to the Swedish Ethical Review Authority has to be in Swedish.

Renewing an ethical approval

If you already have an ethical approval but the application was written without having data sharing via FEGA Sweden in mind, you may want to apply for a renewal of the approval. Read more about renewal applications on the website of the Swedish Ethical Review Authority.

Why does FEGA Sweden ask to see projects’ ethical approval?

To find out who the data controller is

In order to comply with the GDPR, FEGA Sweden needs to know who the data controller is. The data controller is usually the university where the principal investigator is employed, but this is not always the case. The ethical approval may contain information that helps us figure out who the data controller is.

To determine whether the data is suitable for FEGA Sweden

FEGA Sweden only accepts data of certain types and which also require sharing under controlled access. Ethical approvals often contain descriptions of the data that help us assess the suitability of the data for FEGA Sweden.

To identify potential issues with existing documentation

When you apply for an ethical approval, you will be asked questions about the handling of data within the project. In order to clarify what will happen to the collected data, we recommend that each research project already in its ethical review application states that the data will be deposited in a repository that allows data to be shared under controlled access. If such information is not present in the project’s ethical approval, we will notify the research project about that. Then it will be up to the research project to decide whether measures need to be taken (for example, whether the project should apply for a renewal of the ethical approval to the Swedish Ethical Review Authority).


The entity responsible for the research (forskningshuvudman) needs to make sure that no research subject to the Ethical Review Act is carried out without an approval. FEGA Sweden takes no responsibility in this regard.

Learn more about ethical review

We have collected a few links where you can read more about ethical review in Sweden.