Rulings on jurisdiction and applying for ethics reviews

The first step in all clinical trials on medicinal product(s) is for the sponsor to apply for a ruling from TUKIJA on whether the ethical admissibility of the proposal is to be reviewed by TUKIJA or by one of the regional ethics committees.

Sponsors can apply for a ruling on jurisdiction as soon as it becomes likely that the trial in question will be run in Finland, even if the actual application is not yet complete. Depending on the ruling, the sponsor then applies for an ethics review to be carried out either by TUKIJA or by the relevant regional ethics committee.

All applications must be made using the form issued by the Finnish Ministry of Social Affairs and Health which is to contain all the information provided by the sponsor.

The ruling on jurisdiction is used by a working group appointed by TUKIJA for a fixed period of time. All applications will be reviewed within two weeks of receipt.

Application is requested to be submitted to TUKIJA via the electronic transaction service, “Asioi verkossa” in Finnish and “E-tjänster” in Swedish. You can access the service from the top bar of the front page.

Deadlines for submitting applications for rulings on jurisdiction:

2 Aug 2021, 16 Aug 2021, 20 Aug 2021, 13 Sept 2021, 27 Sept 2021, 11 Oct 2021, 25 Oct 2021, 8 Nov 2021, 22 Nov 2021 and 13 Dec 2021

 

Applying for ethics reviews on clinical drug trials from TUKIJA or a regional ethics committee

All applications must be made using the form issued by the Finnish Ministry of Social Affairs and Health according to the instructions provided. The documents listed on the form must be included in all applications.

All documents pertaining to trials must be submitted to TUKIJA no later than two weeks before the meeting at which the proposal involved is to be reviewed. Regional ethics committee have their own timetables for meetings and deadlines.

Opinions issued by TUKIJA and regional ethics committee are non-appealable. However, a request for a new opinion may be made if amendments and changes are made to the trial protocol after it has been rejected.

If a regional ethics committee issues an opinion rejecting the trial protocol and the applicant files it again for review without changing its content, the regional ethics committee must request an opinion from TUKIJA.