The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation and the Tuskegee syphilis study. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws. Invigorated by the U.S…
Legal, regulatory, and ethical perspectives on balancing social benefit and human autonomy in research using human biospecimens. Advances in medicine often depend on the effective collection, storage, research use, and sharing of human biological specimens and associated data. But what about the sources of such specimens? When a blood specimen is drawn from a vein in your arm, is that specimen …