Using human samples in proteomics-based drug development: bioethical aspects.

Human samples and related medical data are expected to play an elevated role in application-based biomedical proteomics research. Against this framework, some facts should be kept in mind by academic and industrial researchers: international framework conditions on the use of human samples for research purposes are heterogeneous. For example, the value added by the use of human samples for product development is significant and the patient's personal and property rights may be affected. The body of national laws is growing and these laws are binding; guidelines published by international organizations should be respected. The most important aspect regards the informed consent of the patient, which is addressed in detail.