Council of Europe drafts Protocol on biomedical research 3/7/03. By the Public Health Genetics Unit New protocol on measures to protect people taking part in biomedical research projects.

The Steering Committee on Bioethics of the Council of Europe has published a draft Additional Protocol to its Convention on Human Rights and Biomedicine. The additional Protocol concerns the measures that should be taken to protect people taking part in biomedical research projects.

The Council of Europe is an intergovernmental organisation that aims to protect human rights and democratic stability in Europe. It has 45 member states, including all the members of the European Union. Member states are not obliged to ratify or adopt its Conventions, and indeed the UK has not so far ratified the Convention to which the new Protocol is to be added.

General provisions of the Protocol include a requirement that research on human subjects should only be carried out if there is "no alternative of comparable effectiveness" and should be approved by an ethics committee. If research does not have the potential to benefit the participant directly, it should entail no more than "acceptable risk and acceptable burden". Participation in research should not deprive people of necessary preventive, diagnostic or therapeutic treatment, and placebo should only be used in the control arm of a study if no existing treatment is available.

The nature and extent of information that researchers should provide to the ethics committee is set out fully in an appendix to the Protocol. Potential participants should also be provided with adequate and comprehensible information about the research, including its risks and benefits and their right to withdraw consent at any stage. They should also be told of any foreseen future use, including commercial use, of results or information arising from the research or of biological samples. Special provisions apply to protect people who are permanently or temporarily unable to give their consent, who are pregnant or breastfeeding, or who are prisoners.

The draft Protocol will now be considered by the Council of Europe's Committee of Ministers (the foreign affairs ministers of its member states) and its Parliamentary Assembly (whose members are appointed by the national parliaments). The text that is eventually adopted will be open for ratification by member states.

Article courtesy of the Public Health Genetics Unit .

Image credit: Barbara Bellingham