Ethical approval

When documentation becomes relevant

Initial submission request. You can create a request without ethics documentation.

Follow-up with the Helpdesk. We may ask for relevant documentation together with other information needed for the submission.

Before the submission can move forward. Relevant documentation may be needed and any open questions need to be clarified.

Ethics documentation helps FEGA Sweden understand what has been approved, what data are covered, and whether controlled-access sharing 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 roles in the submission process.

When ethical approval may be needed

Research in Sweden involving humans may require ethical approval before it begins. If a project may later submit data to FEGA Sweden, it is useful to describe controlled-access data sharing in the application. For guidance on when approval is required and how to apply, see information from the Swedish Ethical Review Authority.

Existing ethical approvals

If a project already has ethical approval but controlled-access data sharing was not considered, review the documentation as part of submission preparation. If anything is unclear, the project and relevant research principal(s) need to decide whether 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, the data covered, and the planned sharing
  • identify conditions, limitations, or documentation gaps that need to be clarified
  • help identify the relevant research principal(s) and, where 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).

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.

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.

Further guidance