Ethical approval

FEGA Sweden requests relevant ethics documentation before a submission can move forward. This helps us understand what has been approved, what data are covered, and whether submission to a controlled-access repository has been described clearly enough.

This page gives practical guidance for submitters. It is not legal advice. The organisation or organisations responsible for the research (forskningshuvudman/forskningshuvudmän) are responsible for making sure that the project has the ethical approval it needs.

For the broader legal context, see Legal prerequisites for submission.

When ethical approval may be needed

Research in Sweden that involves sensitive personal data, human biological material, or other research involving humans often requires ethical approval before the research begins. Ethical approval is handled by the Swedish Ethical Review Authority.

Applications to the Swedish Ethical Review Authority are submitted in Swedish. If the project may later submit data to FEGA Sweden, it is useful to describe in the application how data may be made available through a repository with controlled access.

Example wording for participant information

The example text below can be used as a starting point when describing what may happen to personal data if data are submitted to a repository such as FEGA Sweden. It could, for example, be included under the section Vad händer med mina uppgifter? in the Swedish Ethical Review Authority’s template.

Dina personuppgifter kan komma att delas med forskare och andra behöriga mottagare för ytterligare forskning, utöver det aktuella projektet. Sådan forskning kan bedrivas både i Sverige och i andra länder. Varje begäran om att få ta del av uppgifter prövas innan uppgifter lämnas ut. Då kontrolleras bland annat att mottagaren har rättsligt stöd för sin användning, att eventuella krav på etikprövning är uppfyllda och att uppgifterna kan skyddas på ett lämpligt sätt.

Uppgifter som lämnas ut kommer att vara pseudonymiserade. Det betyder att de inte direkt kan kopplas till dig utan kompletterande uppgifter. Sådana kompletterande uppgifter lämnas inte ut tillsammans med forskningsdata.

Om personuppgifter överförs till ett land utanför EU/EES, eller till en internationell organisation, får det bara ske om det finns tillräckligt skydd för uppgifterna. Det kan till exempel vara att EU-kommissionen har beslutat att landet har en adekvat dataskyddsnivå, eller att mottagaren omfattas av ett avtal som innehåller EU-kommissionens standardvillkor för dataskydd.

Note

FEGA Sweden cannot guarantee that the Swedish Ethical Review Authority will find this wording acceptable in a specific ethical review application. Adapt the text to the project and check with the research principal, legal function, research support, or other relevant local contact.

Existing ethical approvals

If a project already has ethical approval, but data sharing through FEGA Sweden was not considered when the application was written, review the documentation before submitting data.

FEGA Sweden may identify cases where the documentation does not clearly describe data sharing through a controlled-access repository. The project and the relevant research principal(s) must then decide whether any action is needed, for example an amendment application or a new ethical review application.

Why FEGA Sweden asks for ethics documentation

FEGA Sweden requests the relevant ethics documentation in order to:

  • understand the research project and the data covered by the approval
  • assess whether the data are suitable for controlled-access archiving in FEGA Sweden
  • identify conditions, limitations, or documentation gaps that may need to be clarified before submission
  • help identify the relevant research principal(s) and, where the documentation is informative, the relevant data controller(s)

FEGA Sweden does not perform ethical review and does not decide whether the project has sufficient ethical approval. That responsibility remains with the research project and the relevant research principal(s).

Learn more about ethical review

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