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

摘要

The growing capacity to build and manipulate materials at the nanoscale is both thrilling and challenging. Engineering at the level of atoms allows much needed problem-solving and innovation, 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 nano-diagnostics (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.