title: Beyond human subjects: risk, ethics, and clinical development of nanomedicines.
abstract: Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine translation arena.
authors.affiliation: Biomedical Ethics Unit/Social Studies of Medicine, McGill University, Montreal, Quebec.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Kimmelman
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D004781:Environmental Exposure / Q000517:prevention & control; D028744:Ethics Committees, Research; D018014:Gene Transfer Techniques / Q000009:adverse effects; D033161:Government Regulation; D006801:Humans; D050997:Nanomedicine / Q000941:ethics*; D049329:Nanostructures / Q000009:adverse effects; D011634:Public Health; D012308:Risk Management; D012941:Social Responsibility; D057170:Translational Research, Biomedical / Q000941:ethics* / Q000458:organization & administration; D014481:United States