SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
a) the intended purpose of the investigational medical device is prevention against a serious disease, determination of diagnosis or improvement of a serious medical condition of such trial subjects; and
b) the clinical investigation would not provide satisfactory results in trial subjects older than 18 years of age. (Section 14(3) of Act No 268/2014 Coll. on Medical Devices)
Specific requirements regarding Informed Consent are covered by Section 18(6) of this Act.
Section 14(3) & 18(6) of Act No 268/2014 Coll. on Medical Devices
Yes
Special provisions apply
For inclusion of Partially legally incapacitated trial subjects:
a) the intended purpose of the investigational medical device is prevention against a serious disease, determination of diagnosis or improvement of a serious medical condition of persons with the same disease or medical handicap;
b) the clinical investigation, if conducted in subjects with another diagnosis or subjects with full legal capacity would not render satisfactory results; and
c) the conduct of the clinical investigation poses only a slight risk for the person with the given medical condition. (Section 14(5) of Act No 268/2014 Coll. on Medical Devices)
Specific requirements regarding Informed Consent are covered by Section 18(7) of this Act.
Section 14(5) & 18(7) of Act No 268/2014 Coll. on Medical Devices
Yes
With limitations
If, with a view to his/her state of health, the trial subject is unable to grant informed consent prior to the commencement of the clinical investigation, which aims at the trial subject’s direct benefit, he/she shall provide his/her written consent at the time he/she is informed about the nature, significance, impacts and risks of the clinical investigation. In such a case, the inclusion of the trial subject in the clinical investigation shall be conditioned by the execution of a record of this fact in the medical records kept about the patient, which shall be signed by the investigator and a witness. (Section 18(8) of Act No 268/2014 Coll. on Medical Devices)
Yes
Special provisions apply
a) the intended purpose of the investigational medical device is prevention against a serious disease,
non-official translation
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determination of diagnosis or improvement of a serious medical condition of pregnant or lactating women or unborn children;
b) the conduct of the clinical investigation poses only a slight risk for the unborn child or infant; and c) there is a justified presumption that satisfactory results of the clinical investigation may be achieved only in case a pregnant or lactating woman participates therein.
Section 14(4) of Act No 268/2014 Coll. on Medical Devices