SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
The consent is granted by the legal guardian(s) (in principle the parents). The consent must correspond to the minor's presumed will where such a will can be ascertained (informed assent).
Yes
Special provisions apply
Yes
Special provisions apply
Yes
With limitations
In Czech Republic, there is allowed to include patients to clinical trial without his/her prior consent. But there is required the consent of legal guardian (person authorized by the court). If the legal representative is not available, it is allowed to include patient to clinical trial without consent of legal guardian, but there is necessary to get consent (legal guardian or patient) as soon as it becomes possible. The CA and EC must have provided approval of the trial before and in the study protocol there must be described this situation – how to get the ICF in emergency situation.
No
The conduct of a clinical trial in pregnant or lactating women is prohibited
Section 52 (2) b) Act on Pharmaceuticals
The conduct of a clinical trial in vulnerable subjects is permissible only if expected to provide preventive or therapeutic benefits for these persons (pursuant to Section 52 Act on Pharmaceuticals).
