‘Incapacitated subject’ means a subject who is, for reasons other than the age of legal competence to give informed consent, incapable of giving informed consent according to the law of the Member State concerned;

With a view to respecting those rights, while safeguarding the robustness and reliability of data from clinical trials used for scientific purposes and the safety of subjects participating in clinical trials, it is appropriate to provide that, without prejudice to Directive 95/46/EC, the withdrawal of informed consent should not affect the results of activities already carried out, such as the storage and use of data obtained on the basis of informed consent before withdrawal.

3. Member States may allow supplementary pension schemes not to retain the vested rights of an outgoing worker but to pay, with the worker's informed consent, including as regards applicable charges, a capital sum equivalent to the value of the vested pension rights to the outgoing worker, as long as the value of the vested pension rights does not exceed a threshold established by the Member State concerned.

5. Informed consent: prior to the trial, participants must be given clear information about their rights (including the right to withdraw); conditions, duration, nature, objectives, implications, risks and inconveniences of the trial; possible treatment alternatives; and the possible damage compensation system.

ensure that the informed consent of the data subject complies with the requirements set out in Article 2(e) of this Delegated Decision, in particular informed consent given freely, unambiguously and explicitly by the subject or his/her legal representative after being informed of the purpose, nature, significance and implications of the use of his/her personal and health data, if personal health data is exchanged under this Delegated Decision, and being informed of his/her rights under the applicable data protection rules.

have put strategies in place to ensure that care is patient-centred, that patients' rights (such as the right to informed consent; the right to information concerning their own health; the right to access to their medical records; the right to privacy; the right to complain and the right to obtain compensation, the right to be empowered and to participate (for example, through customer relations management strategies, patient education strategies and active engagement strategies for patients and families throughout the healthcare institution)) are respected.