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Table 4 Variants of information on participation in the study

From: Cytokine adsorption in patients with acute-on-chronic liver failure (CYTOHEP)—a single center, open-label, three-arm, randomized, controlled intervention trial

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