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Eurecnet - National Information: Sweden

National Information: Sweden

Short description of RECs system:

According to the Swedish ethical review act, issued 5 June, 2003 (SFS no 2003:460), research ethics review is mandatory in research involving interventions using methods intended to physically or mentally influence the person participating in the research. It is also mandatory in cases where there is an obvious risk that the subject of the research may be affected physically or mentally, even if unintentionally. The act also involves research on biological material taken from living or dead identifiable persons as well as sensitive personal data obtained from registers or questionnaires/interviews.

In other kinds of research with humans, a researcher could optionally apply at/for the REC for an ethics review and advice. In this case, the decision would not be legally binding.

The regional research ethics boards are independent bodies responsible to the ministry of education. All of the six large universities in Sweden have a regional research ethics board, which, in regions comprising larger universities, may involve one to four different units for medical research review and always one separate unit for review of non-medical research with humans. The regional committees have their own administration and economy although they are located close to or within the university building. They may get administrative help from the university but the internal work of the ethics boards is entirely independent from the university and they have their own internal organization.

There is also the Central ethical review board. Besides making decisions on controversial issues delivered by a REC, the central board is an appeal body for researchers who want to complain about a decision made by a regional board. The central board also has the responsibility to supervise the researchers' adherence to the research ethics law. However, this is only the case when supervision is not already the task of the medical project agency (in cases of clinical trials) or the Swedish board of health and welfare (if the study concerns patients in the health care system).

The Swedish research council is authorized by the education ministry to give provisions for the procedures of the research vetting including changes in the application forms. The research council is responsible for education of the research ethics board members. For these purposes the council has instituted an advisory group including scientific secretaries and/or judges from each of the central and regional research boards in Sweden.

Both the regional and the central research review boards have a common web site – www.epn.se – where relevant information including related links to laws and other regulations can be found in Swedish and in English. Changes in guidelines or regulations are published there as well as interesting and potentially policymaking decisions from the central review board (in Swedish only).

Networking between RECs:

There are five types of networking/educational activities between RECs (involving also the Central ethics board):

1. The chairmen (all judges) meet 1-2 times yearly to discuss mainly juridical problems.

2. Yearly the chairs and the scientific secretaries (for the 17 different units of the six regional committees an in addition to the central) all RECs meet at a two-days seminar including updating lectures and case discussions.

3. Once or two times yearly the Swedish Research Council arranges a one day seminar for all members of the RECs involving more than 530 persons.

4. The research council together with the Central ethics board arranges 2-3times per year meetings with appointed representatives for each of the six REC (2 per REC) to discuss issues related to the detailed regulations of the law such as the application form and guidance for applicants and to discuss common issues with other authorities such as the Data inspection board and the Medical product agency.

RECs arrange yearly local educational activities for their own members including invited lecturers and case discussions.

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