Council of Europe to set up standards to protect participants in biomedical research

July 1, 2004

Strasbourg, 30 Jun 2004

Strasbourg, 30.06.2004 – The Committee of Ministers of the Council of Europe has just adopted a new protocol improving protection for patients involved in research.

The protocol is the first international text aiming to harmonise ethical and legal standards in biomedical research and – when ratified by all 45 member countries of the Council of Europe – will ensure the same standards of protection throughout the whole continent.

The protocol sets standards concerning the level of risk that is acceptable for research participants, and details the information research participants should receive before giving their consent. It emphasises that no undue influence (including of a financial nature) should be put on individuals to encourage their participation in research and it also defines the duty of care owed to research participants.

The protocol outlines under which circumstances researchers can use placebo drugs, without depriving research subjects of much-needed medicine, and sets out ground rules for research in emergency situations – for instance on comatose patients who are incapable of giving consent. The optimum working practices when co-operating with countries which have not ratified the protocol, such as developing countries, are also covered.

The date of the opening for signature of the protocol will be decided in the near future.

The full text of the protocol is available at &Lang=en The explanatory memorandum is available at &Lang=en.

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NB: The Council of Europe will publish a book at the end of July:
"Ethical eye – Biomedical research"

To obtain the book, please write to

Press Contact
Council of Europe Spokesperson and Press Division
Tel. +33 3 88 41 25 60 - Fax. +33 3 88 41 39 11

Item source: htm

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