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.
When you prepare the information for the participants, it might be a good to think of the following:
- Express clearly that the participant’s personal data may be used in other research projects. Try to define the data reuse conditions by specifying a research purpose rather than by stating with whom the data can be shared. In particular, do not limit the data access to only researchers, since researchers sometimes need help from non-researchers (e.g. technical staff) with the data.
- Consider which countries the data can be shared with. Can it be shared only within EU/EES? Or perhaps only within Sweden?
- Personal data must normally be pseudonymised before it is shared. Don’t forget to inform the participants about that. Data that is pseudonymised can only be used to identify individuals in combination with other data.
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.
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