The Council of Europe Steering Committee on Bioethics has drawn up a
draft version of an additional protocol to the Convention on Human Rights and Biomedicine, agreed in 1997. The additional protocol deals with the ethical conduct of biomedical research involving human subjects, including such issues as the procedures to be followed by researchers seeking approval for a research project, the role of ethics committees, the need for informed consent by research subjects, participation by people unable to grant consent, confidentiality and the right of participants to information about the research, safety and supervision. An
explanatory report to the draft protocol has also been issued. Although the UK is not a signatory to the Convention on Human Rights and Biomedicine, the
NHS R&D Directorate is seeking the views of UK biomedical researchers and others, with a view to contributing to the development of the protocol. The consultation period ends on 31 December 2001.