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 as well as TUKIJA's decision. The application must be sent via mail to TUKIJA's address (at the bottom of the page).

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.

Applicants are also requested to submit their applications in electronic format (as word or rtf files) to TUKIJA's secretary by e-mail at tukija(a)valvira.fi. The electronic document is intended for TUKIJA's internal use only.

 

Deadlines for submitting applications for rulings on jurisdiction:

2 Oct 2017, 16 Oct 2017, 30 Oct 2017, 6 Nov 2017, 20 Nov 2017, 4 Dec 2017, 18 Dec 2017, 1 Jan 2018, 15 Jan 2018, 29 Jan 2018, 12 Feb 2018, 26 Feb 2018, 12 Mar 2018, 26 Mar 2018, 9 Apr 2018, 23 Apr 2018, 7 May 2018, 21 May 2018, 4 Jun 2018, and 18 Jun 2018.

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.