International context

A number of international argreements and conventions have impact on bioethics in medical research involving human subjects. These are to a variable degree legally binding for parties concerned.  

Important instruments include the Council of Europe's "Convention on Human Rights and Biomedicine (Oviedo)" and "Additional Protocol on Biomedical Research". The CoE has also published "Guide for Research Ethics Committee Members" and Directives of the European Union.

Some of these conventions are initiated by professional organisations such as the "Helsinki Declaration" formulated by and agreed upon by the World Medical Association (WMA) and the "International Ethical Guidelines for Biomedical Research Involving Human Subjects" of the Council for International Organizations of Medical Sciences (CIOMS).

Albeit different legal status of the documents above, they have jointly had great impact upon rules and regulation and legal provisons of different countries and upon recommendations and conventions of a number of professional scientific organisations worldwide. 

WMA - The Helsinki Declaration

UNESCO - Universal Declaration on Bioethics and Human Rights - International Declaration on Human Genetic Data - Universal Declaration on Human Genome and Human Rights

Council of Europe - Oviedo - Additional Protocol - Guide for Research Ethics Committee Members

CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects