Ethics approval and consent to participate
ICH, prejudice
ADVERSE EVENTS
This study was approved by the ethics committee of the Leiden University Medical Center, also known as the METC Leiden Den Haag Delft. The protocol reference number is NL77876.058.21. The responsible investigator will ensure that this study is conducted in agreement with the Declaration of Helsinki (Brazil, October 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO). The protocol has been written, and the study will be conducted according to the ICH Harmonized Tripartite Guideline for Good Clinical Practice. Any proposed protocol modifications will be submitted to the ethics committee for approval. All patients will be informed about the aims of the study, the possible adverse events, the procedures and possible hazards to which they will be exposed. They will be informed about the strict confidentiality of their data, and that their medical records may be reviewed for trial purposes by authorized individuals other than their treating physician. Information will be given in both spoken and written form as given in the Patient Information text. It will be emphasized that the participation is completely voluntary, and the patient does not need to give any further explanation for not participating. The patient is allowed to refuse further participation in the protocol whenever he wants. This will not prejudice the patient’s subsequent care. Documented informed consent must be obtained for all patients included in the study before they are registered in the study.