Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research

(CETS no. 195)

Open for signature by the signatories to the Convention, in Strasbourg, on 25 January 2005.

Entry into force: 1 September 2007.

Summary of the treaty

This Protocol is intended to build on the principles embodied in the Convention (ETS No. 164), with a view to protecting human rights and dignity in the specific field of biomedical research. Its purpose is to define and safeguard fundamental rights in biomedical research, in particular of those participating in research.

The Protocol is to cover the full range of biomedical research activities involving interventions on human beings.

The fundamental principle for research involving human beings, as in the Convention itself, is the free, informed, express, specific, and documented consent of the person(s) participating. The Protocol addresses issues such as risks and benefits of research, consent, protection of persons not able to consent to research, scientific quality, independent examination of research by an ethics committee, confidentiality and the right to information, undue influence, safety and duty of care.