INDIVUMED strictly respects patients’ confidentiality as well as international ethical and legal regulations. All patients sign a consent form in accordance with the US National Institutes of Health guidelines for “Protection of Human Subjects”. The consent includes permission of commercial use of tissue and body fluid samples collected in Indivumeds clinical network.
Confidentiality
Extremely tight precautions are in place to ensure patient confidentiality. Procedures follow German personal data protection laws and are in accordance with US regulations. A double-coded system assures that patient identifiers do not exist at Indivumed and its data base and that labeling of samples does not allow tracking of patients. Re-identification of patients can only be done by the collaborating hospitals. This approach has been approved by the competent authorities in Hamburg, University of Göttingen and Georgetown University/MedStar Health such as the ”Office for Data Protection” of the Federal State of Hamburg and local IRB-boards.
