The application should be submitted by the responsible research body, i.e. the state authority or the physical or legal entity under whose auspices the research is to be conducted. This body has the ultimate responsibility for the research and should therefore formally apply for ethical vetting. A university or a county council is always deemed to be the responsible research body when the research is carried out by one of its employees. By means of internal consultation, delegation, or by means of power of attorney, the responsible research body is to decide who is qualified to act as a representative.

The responsible research body is responsible for ensuring that research which is subject to the provisions of the law is not conducted without approval.

It is also the responsibility of the responsible research body to ensure that an application is complete. An application is complete when the application form has been filled in correctly and the fee has been paid.

The same application form (Word format) is used by all the regional boards.

An English translation of the application form with comments is available here (pdf)

IT IS NOT POSSIBLE TO USE THE ENGLISH VERSION OF THE APPLICATION. IT IS NOT PERMITTED TO FILL IN THE APPLICATION IN ENGLISH, ONLY SWEDISH.

What does it cost?

The fees vary from SEK 5,000 up to SEK 16,000 (changes in accordace with section 4, SEK 2,000). For more detailed information, refer to the application form.

Procedures

A written procedure is generally used by the boards.

At the meetings, any one of three decisions can be made: an application may be approved, approved subject to certain conditions or rejected.

In order for an application to be approved, the requirements of the ethical review act must be fulfilled.

If an application is approved and there is a change of circumstances to such a degree that the prerequisites for approval have changed, the responsible research body is to submit a new application for ethical vetting.

An approval ceases to be valid if the research has not commenced within two years of the final decision.

Time limits

The regional boards should normally make a decision within sixty (60) days of receiving a fully completed application.

As from 1 May 2004, special time limits apply to applications with respect to clinical trials of medicinal products for human use. Please refer to the statute concerning the ethical review of research involving humans (2003:615).