The organisation

Ethical vetting will be the task of six regional boards. These are independent authorities, divided into two or more sections. At least one section in each locality is to vet cases within the field of medical science (medicine, pharmacology, odontology, the science of health care and clinical psychology), while one section is to vet matters concerning other research.

The sections are to make independent decisions on behalf of the regional board. Each section is to be headed by a chairman who is a judge or has been one. The sections are to have ten members with scientific qualifications and five to represent the general public. All members and their substitutes are to be appointed by the government. It is important that every application should be processed by members who have sufficient expert knowledge. The scientific members are therefore highly qualified. Within each section a scientific secretary is to be appointed from among the scientific members. Together with the chairman of the sections, the scientific secretaries are to be responsible for processing cases and dealing with them.

Each of the sections is expected to have 10-12 meetings annually.

The secretariats of the regional boards are situated at the Universities of Gothenburg, Linköping, Lund, Umeå and Uppsala as well as at the Karolinska Institut in Stockholm.

In principle each regional board will be responsible for its own geographically defined catchment area. A responsible research body located in a particular county should apply for ethical vetting to the regional board which has that county in its catchment area.

If a responsible research body is located in a country other than Sweden, or if its location is undetermined, the application is to be vetted by the board in whose catchment area most of the research is to be conducted.

When several responsible research bodies are cooperating on one and the same research project, only one of the responsible research bodies is to apply for ethical vetting. In such cases, the application should be submitted by the responsible research body which is primarily responsible for the project.

The transition

The law is applicable to research commencing after it came into force.

Decisions concerning ethical vetting that were made up to 31 December 2003 in the various ethics committees in various state institutions remain valid for research commencing after 1 January 2004.

Research that began prior to 1 January 2004 is not subject to the new law.