An informed consent with participation in the clinical investigation (hereinafter referred to as the “Informed consent”) shall mean a voluntary and provable expression of the will of the person who is to become the trial subject, or, where applicable, his/her guardian or custodian, to be subjected to the clinical investigation, endorsed with the trial subject’s or his/her guardian’s or custodian’s signature.
The informed consent must be granted in writing prior to the commencement of the clinical investigation.
The trial subject must be adequately informed by the investigator about the conditions under which the clinical investigation is to be conducted, about the risks implied by participation in the clinical investigation as well as withdrawal from the clinical investigation, if applicable.
Such information must be provided in writing, in clear wording and in a language which the trial subject understands. It shall form part of the informed consent and shall contain:
Information about the clinical investigation, including the definition of its objective;
Expected duration of the clinical investigation and expected duration of trial subject’s participation in the clinical investigation;
Identification and description of the investigational medical device;
A list of medical procedures to be completed in the trial subject;
Information about potential benefit of the clinical investigation for the trial subject;
Information about foreseeable risks and potential discomfort associated with the participation in the clinical investigation;
Information about other possibilities of treatment or diagnostics;
Information about the processing of obtained personal data of the trial subject, including information about safeguarding their confidentiality;The rights and obligations of the trial subject.
Where possible, the opinion of a minor without full legal capacity on potential participation in the clinical investigation shall be established. If adequate with a view to the intellectual and volitional maturity of the minor corresponding to the minor’s age, the informed consent may be granted by the minor. The investigator shall inform the minor’s guardian about the established opinion or about the granting of the informed consent by the minor without unnecessary delay. The established opinion of the minor or the reason for which it was not possible to establish the opinion shall be recorded in the minor’s medical records.
Where, with a view to his/her condition of health, the trial subject is not able to grant the informed consent prior to the commencement of the clinical investigation, which should directly benefit the trial subject, the trial subject shall grant his/her written consent once he/she has been acquainted with the nature, significance, implications and risks of the clinical investigation. In such a case, the inclusion of the trial subject in the clinical investigation shall be conditioned by making a record about this fact in the patient’s medical records which shall be signed by the investigator and a witness.
Clinical Evaluation of Medical Devices Department
1. 7. 2015