The Additional Protocol to the Convention on Human Rights and Biomedicine on Biomedical Research is intended to build on the principles embodied in the Oviedo Convention, 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. It is important to note that pharmaceutical research is not the only field of biomedical research to be addressed by the Protocol. New methods of treatment, diagnosis, and prevention may also require research on human beings. Research on embryos and foetuses in vivo, and pregnant women is to be covered by the Protocol.

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. It is foreseen that the Protocol will address 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, information to be submitted to the ethics committee, information for research participants, confidentiality and the right to information, dependent persons, undue influence, safety, duty of care, and research in states not Party to the Protocol.

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