Ethical Considerations in Human Subjects Research

Clinical research ethics continues to evolve. This evolution is due in large part to increasing amounts of data that must be managed appropriately. Existing regulations in the United States continue to provide not only the legal framework but because they are based historically on ethical principles they also provide an ethical framework against which emerging issues in clinical research are cast. These emerging issues include big data, biobanks, clinical and research tissue, and informed consent related to tissue-based research.