This conference presented the first systematic and comprehensive recommendations and analysis on protecting human participants in research on nanomedicine products, including drugs, devices, and gene therapy using nano-vectors. Nanomedicine research in human subjects is at the forefront of new challenges to research ethics and oversight posed by advanced technologies. This research raises significant questions about how to protect human subjects, especially in first-in-human (FIH) trials. But the challenges are even bigger — how to protect researchers, lab workers, the environment, and bystanders who may be exposed to nanomaterials in the course of research. This conference brought together the top experts in the country to address cutting-edge questions, including:
- Does some nanomedicine research pose unique risks? When are risk and uncertainty low enough to justify initiating nanomedicine research in humans?
- What are the special challenges in obtaining informed consent for nanomedicine research?
- How should occupational, bystander, and environmental risks be considered in deciding whether to authorize nanomedicine human subjects research?
- What innovations in the oversight of human subjects research are needed for nanomedicine research?
Read about the conference in an article in Nature
Continuing Legal Education (CLE)
6.75 hours of standard Continuing Legal Education (CLE) credit has been approved. Event code 157975.
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