The Oviedo Convention
The Oviedo Convention (Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine) was formulated in 1997 by the Council of Europe.
By: Lise Ekern, 2009, updates by Ingrid Torp 2022.
Read the complete Oviedo Convention at the Council of Europe's website
The Convention is the first convention in international law that has a particular focus on protecting the rights of individuals in connection with biomedical treatment and research. The Convention aims to ensure that scientific and medical advances are not at the expense of human rights.
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 was ratified in Norway on 1 July 2018.
In 2021 Andorra was the 36th country to sign the Convention. They have not yet ratified it [1]. 29 countries have ratified it so far, and thereby undertaken to adhere to its provisions.
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) [2] 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.
References
1. Chart of signatures and ratifications of Treaty 164, Full list (coe.int)
2. NOU (2005): Norges offentlige utredninger: God forskning – bedre helse. Lov om medisinsk og helsefaglig forskning, som involverer mennesker, humant biologisk materiale og helseopplysninger (helseforskningsloven)