The Convention was signed by Norway in 1997, and was ratified on 13 October 2006. The Council of Europe has adopted several additional protocols to the Oviedo Convention. The most recent additional protocol deals specifically with issues related to genetic testing. This protocol was adopted in Strasbourg on 27 November 2008 and is now awaiting ratification in different countries. Additional protocols are also binding in Norway.
A total of 47 European countries have ratified the Convention and thereby undertaken to adhere to the provisions therein. Five other states outside Europe have also adopted the Convention.
The Convention covers the rights of research subjects and the duties of researchers. Medical and health research must be based on respect for the participants' dignity and human rights. Consideration for the participants' safety, privacy and welfare must take precedence over the interests of science and society.
Expected benefits for participants and society must be proportionate to potential drawbacks. Research on humans can only be conducted when there are no alternative methods that are equally effective.
The Convention also sets requirements for the quality of research, which must meet generally accepted criteria for scientific quality and be carried out by qualified personnel.
The Convention consists of 14 chapters and 38 articles. Some chapters are general and deal with the scope and purpose of the Convention. Chapter 2 focuses on consent, both ordinary informed consent and consent when the person does not have the capacity to consent. Chapter 3 deals with privacy and the right to information. Themes related to the human genome can be found in chapter 4. Research is specifically discussed in chapter 5. Chapter 6 of the Convention addresses issues related to organs and tissue taken from a donor for transplantation. Chapter 7 covers the prohibition of financial gain from the human body or parts thereof.
Several chapters of the Ministry of Health and Care Services' report NOU 2005: 1 God forskning – bedre helse (Good research - better health) refer to the Convention. The Oviedo Convention is also incorporated into the Act on medical and health research (Helseforskningsloven), which is concerned with research that involves humans, human biological material and personal health data.
This article has been translated from Norwegian by Carole Hognestad, Akasie språktjenester AS.