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Maternal Informed Consent Form for clinical trials

This Informed Consent Form is a template which can be used in clinical drug trials or medical device trials conducted in Finland, involving pregnant woman as participants. In Finland by current law, pregnant women and nursing mothers may be research subjects only where it is not possible to obtain the same scientific results using other research subjects, and when the research is likely to be of direct benefit to the health of the woman or the unborn child, or the research is likely to be of benefit to the health of people related to the woman, or pregnant women or nursing mothers, or fetuses, newborn children or breastfed infants.

In cases where the child (fetus) has other (legal) parent which need to be considered when obtaining the ICF from the pregnant woman, it is advised to document the preliminary discussion of the participation, to seek the positive view and the acceptance of that other parent. This is to confirm, that the opinion of the other parent has been taken into account if that parent is not present at the time of the mother signing the consent.

Informed Consent Form template for pregnant woman (according to the study, editable passages written in red):

FPM-E-007-EN v1.0 17.03.2021

Trial Information Form template:

For pregnant women and nursing mothers there is not specific Trial Information template in English, but the Trial Information template (contents) addressed to adolescents 15-17 years of age can be used by modifying it case by case.