INTRODUCTION: The Challenge of Nanomedicine Human Subjects Research: Protecting Participants, Workers, Bystanders, and the Environment

The growing capacity to build materials at the nanoscale allows much needed problem-solving, but also raises questions about how to assess the effects and safety of the materials created. The promise and the challenge are especially acute in the domain of nanomedicine. Nanotherapeutics and in vivo nanodiagnostics (diagnostics used within the human body) have the potential to solve long-standing problems, including how to ferry drugs across the blood-brain barrier to treat brain tumors, how to find and destroy tiny micrometastases before cancer progresses, and how to transport corrective genes into human cells without the dangers of viral vectors. But none of these applications is possible without first testing the safety and efficacy of these interventions in human beings. Developing appropriate oversight for human subjects research in nanomedicine requires tackling two fundamental problems that have remained unsolved: (1) developing systematic criteria for the requirement of “extra” oversight above the baseline already required by the Common Rule and FDA regulations, and (2) designing oversight that addresses not only the protection of human subjects, but also protection of lab workers, clinicians, close contacts, and the environment.