The Act concerning the Ethical Review of Research Involving Humans
The Act concerning the Ethical Review of Research Involving Humans (2003:460) came into force on 1 January 2004. The purpose of the Act is to protect the individual person and ensure respect for human dignity in research. The Act includes provisions with a requirement for ethical review of research involving living or deceased persons or biological material from humans.
An ethical review shall be based on:
- respect for human dignity
- human rights and fundamental freedoms
- interest in the development of new knowledge through research
- the well-being of humans shall be given priority ahead of the needs of society and science
Research may only be approved if the risks it may entail to the health, safety and personal integrity of study participants are outweighed by the scientific value. On the other hand, research cannot be approved if the expected results can be reached in another way that presents fewer risks to the health, safety and personal integrity of study participants. Handling of sensitive personal data and personal data on breaches of the law may only be approved if it is needed to carry out the research. Finally, research may only be approved if it is to be conducted by, or under the supervision of, a researcher who possesses the necessary scientific competence.
The Act also includes provisions on information to study participants, requiring information on the overall plan for the research, the purpose of the research, the methods that will be used, the consequences and risks that the research may entail, the identity of the research principal, and the facts that participation is voluntary and that participants can end their participation at any time. Special rules apply for study participants who are younger than 18 years.
The Act concerning the Ethical Review of Research Involving Humans does not cover activities carried out within health and medical care in order to develop and safeguard care quality systematically and continuously. Such activities do not constitute research in the meaning of the Act.