2.10. Ethical and Legal Aspects
• The study will be performed according to the Decla-
ration of Helsinki.
• Ethical approval has been obtained from the local
ethical board.
• Participation of patients is entirely voluntary. Patients
are free to withdraw their consent at any time without
any disadvantages for their medical treatment or
nursing care. Patients will give written, informed
consent after comprehensive oral and written infor-
mation. Furthermore, patients will be informed that
already collected data will be used in pseudomized
form if they do not explicitly state otherwise.
• Data will be pseudomized by using a numerical ID.
The master file with patient names and ID number will be kept on local servers of the clinic and will be
locked via a password that will only be known by the
project leader and her substitutes.