Fee for ethical review

Payment of the fee is made using an invoice OCR number that you receive when you submit your application. Payment is made to bank giro 406–1107.

For a new application, the fee is SEK 5,000 or SEK 16,000. The fee for an amendment is SEK 2,000.

Payment of the fee is made using an invoice OCR number that you receive when you submit your application. Payment is made to bank giro 406–1107.

SEK 5,000 is payable for:

  • research in which only one entity responsible for the research is participating
  • research in which two or more entities responsible are participating, but the research participants have a direct connection with only one of these entities
  • research that concerns only processing of personal data; regardless of whether the research project is to be under the aegis of one or more entities responsible, the fee is only SEK 5,000 if personal data alone are to be used.

SEK 16,000 is payable for:

  • research related to clinical trials
  • research in which more than one entity responsible is participating, including projects where data are processed and/or analysed by one entity but research participants are included in the activities of two or more entities.

Initial application (grundansökan)

The Swedish Ethical Review Authority neither can nor may issue any advance ruling on the question of whether an ethical review is required. It falls on the entity responsible for the research to decide whether an initial application needs to be submitted. A new application for ethical review is known as an “initial” application (grundansökan).…

Amendment (ändringsansökan)

It is the entity responsible for research that must decide whether an amendment is “substantial”. The decisive factor is whether the change may affect the research participants’ safety or could otherwise affect the risk-benefit assessment made during the previous review of the initial application. Substantial amendments to an ongoing and previously approved study normally require…

What the Act says

Research may only be approved if it can be conducted with respect for human dignity. The purpose of the Ethical Review Act is to protect individuals and the respect for human dignity in research. Risks and knowledge gains are two factors that must be balanced against each other in the reviews. The Swedish Act (2003:460)…

Responsibility for research

The entity responsible for the research needs to make sure that no research subject to the Ethical Review Act is carried out without an approval. Entity responsible for research (Forskningshuvudman) The entity responsible for research is the natural or legal person in whose activities the research is carried out, such as a higher education institution,…