SSStudyParticipantsInformedConsent object
Yes
Templates for Informed Consent and Clinical trial information leaflet are provided on the TUKIJA website in section: Publications.
Yes
Definition according to Regulation 2/2012: 'A document given to the trial subject which contains an explanation of the trial subject’s rights, the purpose and nature of the trial and procedures to be used therein and any associated risks and disadvantages, and which is signed by the giver and recipient of the consent (further information in the Medical Research Decree 986/1999, 313/2004). The document may be independent or comprise the trial subject information leaflet (or patient information leaflet) and consent form.'
Informed consent of the subjects is an elemental condition for carrying out medical research. Volunteer research subjects must also be allowed to withdraw their consent at any time without justifying their decision to anyone.
Participation in medical research can only be genuinely voluntary if the subjects understand the information that they have been given. In order to obtain informed consent, the researcher or the sponsor must produce written information for prospective subjects, describing the trial in sufficient detail and in plain language. The information must cover all of the issues that the subjects need to be aware of in order to give their informed consent to participating in the trial in question. Ideally, each of the procedures associated with the trial in question should also be explained both to the subject and to a representative of the same (where applicable).
Section 2 of Regulation 2/2012 (Definition)
Section 6 of Act No. 488/1999
Section 3 of Decree No. 986/1999