Ethical approval
Introduction
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.
Informed consent
Depending on what kind of research you are doing, you may be required to collect consent agreements from the research participants. This means that the participants—before they consent to participate—must be informed about the purpose of the research, as well as about any risks and benefits involved in their participation. The information that you plan to give to the participants should be attached to your ethical review application. The Ethical Review Act specifies when consent agreements are required.
The Swedish Ethical Review Authority offers a template (“Stödmall för forskningspersonsinformation”) on its website for writing the information that will be given to research participants. For your convenience, we have prepared an example paragraph (see below) that you can insert into the template (under the heading “Vad händer med mina uppgifter?”). The text should make it possible for you to share your data via FEGA Sweden.
Personuppgifter kan komma att lämnas vidare till forskare och andra behöriga för efterföljande forskning inom eller utanför landet. Varje utlämning av data kommer då att prövas individuellt för att säkerställa att forskningen sker i enlighet med det här projektets etikgodkännande och att personuppgifterna kan hanteras säkert. Personuppgifter som lämnas vidare kommer att vara pseudonymiserade, vilket innebär att de endast kan kopplas till en fysisk identifierbar person med hjälp av kompletterande uppgifter. Överföring av personuppgifter till tredje land, dvs. ett land utanför EU/EES, eller en internationell organisation får endast ske om EU-kommissionen beslutat att mottagande land kan säkerställa en adekvat dataskyddsnivå eller om mottagaren av uppgifterna i ett tredje land tecknar ett avtal om åtkomst av data enligt EU-kommissionens specifikationer som garanterar adekvat dataskyddsnivå.
Although we think that the text above would be appropriate to include in information to research participants, we cannot guarantee that the Swedish Ethical Review Authority will find it acceptable in an ethical review application.
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.
- Swedish Ethical Review Authority (in Swedish)
- Ethical review – by the Swedish National Data Service (SND)
- The Act concerning the Ethical Review of Research Involving Humans (2003:460) (in Swedish)
- CODEX rules and guidelines for research – by Uppsala University