Subject enrollment
What are the requirements for participation in a study? Potential subjects must receive sufficient information in advance to be able to make an informed decision about their participation in the respective study. The information provided must include, among other things, background information of the study, rights and responsibilities of the study subjects, anticipated procedures, data protection, intended use of the samples, rights of withdrawal, insurance coverage and risks and benefits of the study. The process of informed consent has to be documented. If the subject decides to participate in a study, both the principal investigator and the subject must approve the consent process. Furthermore, study-specific inclusion and exclusion criteria must be checked from the principal investigator prior study enrollment.
For vulnerable groups (e.g. minors), the are additional very detailled requirements and processes.
