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Principle 3
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No medical research may be carried out without the informed, free, express and specific consent of the person undergoing it. Such consent may be freely withdrawn at any phase of the research and the person undergoing the research should be informed, before being included in it, of his right to withdraw his consent.
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The person who is to undergo medical research should be given information on the purpose of the research and the methodology of the experimentation. He should also be informed of the foreseeable risks and inconveniences to him of the proposed research. This information should be sufficiently clear and suitably adapted to enable consent to be given or refused in full knowledge of the relevant facts.
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The provisions of this principle should apply also to a legal representative and to a legally incapacitated person having the capacity of understanding, in the situations described in Principles 4 and 5.
Principle 4
A legally incapacitated person may only undergo medical research where authorised by Principle 5 and if his legal representative, or an authority or an individual authorised or designated under his national law, consents. If the legally incapacitated person is capable of understanding, his consent is also required and no research may be undertaken if he does not give his consent.
Principle 5
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A legally incapacitated person may not undergo medical research unless it is expected to produce a direct and significant benefit to his health.
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However, by way of exception, national law may authorise research involving a legally incapacitated person which is not of direct benefit to his health when that person offers no objection, provided that the research is to the benefit of persons in the same category and that the same scientific results cannot be obtained by research on persons who do not belong to this category.
Principle 7
Persons deprived of liberty may not undergo medical research unless it is expected to produce a direct and significant benefit to their health.
Principle 8
In an emergency situation, notwithstanding Principle 3, where a patient is unable to give a prior consent, medical research can be carried out only when the following conditions are fulfilled:
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the research must have been planned to be carried out in the emergency in question;
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the systematic research plan must have been approved by an ethics committee;
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the research must be intended for the direct health benefit of the patient.
Principle 13
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Potential subjects of medical research should not be offered any inducement which compromises free consent. Persons undergoing medical research should not gain any financial benefit. However, expenses and any financial loss may be refunded and in appropriate cases a modest allowance may be given for any inconvenience inherent in the medical research.
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If the person undergoing research is legally incapacitated, his legal representatives should not receive any form of remuneration whatever, except for the refund of their expenses.
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