Protection of Clinical Trial Subjects

Adherence to the principles of good clinical practice (GCP), including human subject protection (HSP), is universally recognized as a critical requirement to the ethical conduct of research involving human subjects.

1) The Directive shall apply without prejudice to the national provisions on the protection of clinical trial subjects if they are more comprehensive than the provisions of this Directive and consistent with the procedures and time-scales specified therein. Member states shall, insofar as they have not already done so, adopt detailed rules to protect from abuse individuals who are incapable of giving their informed consent.

2) A clinical trial may be undertaken only if, in particular:

    • The foreseeable risks and inconveniences have been weighed against the anticipated benefit for the individual trial subject and other present and future patients. A clinical trial may be initiated only if the Ethics Committee and/or the competent authority comes to the conclusion that the anticipated therapeutic and public health benefits justify the risks and may be continued only if compliance with this requirement is permanently monitored;
    • The trial subject or, when the person is not able to give informed consent, his legal representative has had the opportunity, in a prior interview with the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the trial, and the conditions under which it is to be conducted and has also been informed of his right to withdraw from the trial at any time;
    • The rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him in accordance with Directive 95/46/EC are safeguarded;
    • The trial subject or, when the person is not able to give informed consent, his legal representative has given his written consent after being informed of the nature, significance, implications and risks of the clinical trial; if the individual is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases, as provided for in national legislation;
    • The subject may without any resulting detriment withdraw from the clinical trial at any time by revoking his informed consent;
    • Provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor.

3) The medical care given to, and medical decisions made on behalf of, subjects shall be the responsibility of an appropriately qualified doctor or, where appropriate, of a qualified dentist.

4) The subject shall be provided with a contact point where he may obtain further information.