Sweden - Provisions and Guidelines

Provisions Part 3. Ethical examination

Section 1 To ensure that a clinical medicinal product trial is ethically justifiable, the responsible investigator shall apply for authorization of the trial from a regional ethics committee. A copy of the application to the ethics committee shall be attached to the application for authorization to conduct the trial which is submitted to the Medical Products Agency. The trial shall not be commenced before it has been approved by the ethics committee.

In the case of trials involving radioactive medicinal products, the ethics committee shall have access to an assessment by the local radiation protection committee.

In the case of trials with veterinary medicinal products, the stipulations of the Protection of Animals Act (1988:534) and the Protection of Animals Ordinance (1988:539) shall be complied with.

Section 2 If the decision of the ethics committee is not attached to the application to the Medical Products Agency, the responsible investigator shall submit a copy of the ethics committee's decision to the Medical Products Agency immediately when it becomes available.

The ethics committees have an advisory function to the Medical Products Agency and have the task of examining the design of the trial before it is started. The examination shall in particular relate to the scientific feasibility of the project, the ethical problems which are thrown up, how the information to patients is formulated and how consent from the patients to take part in the trial is obtained. On the other hand, the committees do not have the task of monitoring the conduct of the trial thereafter.

A regional ethics committee may delegate the work of examining a trial to a local ethics committee.

An application form for human medicinal products which is common to all the ethics committees in Sweden has been drawn up.

Applications may be examined in parallel by the ethics committee and the Medical Products Agency. If the opinion of the committee is not available when the application for authorization for a trial is submitted to the Medical Products Agency, the Board may nevertheless complete its handling of the application and grant authorization which is subject to the condition that the trial must not start until it has been approved by the ethics committee.