Persons not Able to Consent

Informed Consent of Persons Not Able to Consent

According to the Medical Research Act (488/1999) medical research cannot be conducted in human subjects without first obtaining the study subject’s informed consent in writing. Exceptions to this may be made where consent cannot be obtained due to the urgency of the matter and the patient’s state of health, and where the measure is expected to be of immediate benefit to the patient’s health.

People who have for example a mental health disorder or retardation may be research subjects only when it is not possible to obtain the same scientific results using other study subjects and when the risk of harming or distressing the study subject is only very slight. Also patient in intensive care may not able to give their consent themselves due to their condition.

In case the person does not have the capacity to give consent, as mentioned above, he/she may be entered into the trial as a research subject only when written consent for this has been given by his/her close relative or some other person closely connected with the subject or by his / her legal representative after having been provided essential study information. The consent must be in accordance with the study subject’s supposed will. Consent may be withdrawn on the same terms as generally for medical research. In addition, the study subjects shall be given, taking into account their capacity of understanding, information about the research as well as of its risks and benefits.