ECMultiCenterStudiesEthicalReview object

Ethical approval (favourable opinion) required from

Lead EC (authorised to issue a single opinion)

Submission of application required to

Lead EC + All concerned local ECs for site-specific assessment

Additional Information

There are 6 Regional Ethical Review Boards in Sweden who are authorized to issue a (single) vote in mono- and multi-centre trials (according to Chapter 5 (7) LVFS 2003:6).

The favourable single opinion shall be requested from the geographically relevant Regional Ethical Review Board depending where the responsible research body/ Principal Investigator is located. If a responsible research body is located in a country other than Sweden, or if its location is undetermined, the application is to be submitted to the board in whose catchment area most of the research is to be conducted.
The geographically defined catchment areas for the Regional ECs are listed in Annex 1 of 2003:615.

The EC’s review of the application includes an assessment for each trial site of the PI’s qualification and the suitability of the trial site (Chapter 4 (6) LVFS 2003:6).

Appeals against regional EC’s decisions can be submitted to the Central EC (pursuant to Section 36 2003:460).

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395