Variant | Condition of the patient at the time of provisional study enrolment | Action for possible legitimization of participation in the study | Result | Forms to be used |
---|---|---|---|---|
1 | Patient is able to give consent | Discuss study participation with patient | Patient decides according to own standards | • Patient information • Consent form |
2 | Patient is not able to give consent and has a legally authorized representative for health issues | Discuss study participation with legally authorized representative | legally authorized representative decides (according to the welfare and presumed will of the person being cared for) | • Information for the legal guardian and declaration of consent for the study participation of the person being cared for |
3 | Patient is not able to give consent and has no legally authorized representative for health issues | Ask relatives (or legally authorized representative with other responsibilities) about the presumed patient will | The presumed will justifies measures that are necessary as long as the incapacity to give consent exists or a legal guardian is appointed | • Information for the relatives and explanation of the presumed will of the patient |
4 | Patient will become able to give consent during the study | Discuss further study participation with patient | Patient decides according to own standards | • Patient information • Consent form |