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Naming it 'nano': Expert views on 'nano' terminology in informed consent forms of first-in-human nanomedicine trials
Journal
Nanomedicine
Volume
11
Number
8
Pages / Article-Number
933-940
Abstract
Obtaining valid informed consent (IC) can be challenging in first-in-human (FIH) trials in nanomedicine due to the complex interventions, the hype and hope concerning potential benefits, and fear of harms attributed to 'nano' particles.; We describe and analyze the opinions of expert stakeholders involved in translational nanomedicine regarding explicit use of 'nano' terminology in IC documents.; We draw on content analysis of 46 in-depth interviews with European and North American stakeholders.; We received a spectrum of responses (reluctance, ambivalence, absolute insistence) on explicit mention of 'nano' in IC forms with underlying reasons.; We conclude that consistent, clear and honest communication regarding the 'nano' dimension of investigational product is critical in IC forms of FIH trials.
