Naming it 'nano': Expert views on 'nano' terminology in informed consent forms of first-in-human nanomedicine trials

摘要

Background: 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. Aim: We describe and analyze the opinions of expert stakeholders involved in translational nanomedicine regarding explicit use of 'nano' terminology in IC documents. Methods: We draw on content analysis of 46 in-depth interviews with European and North American stakeholders. Results: We received a spectrum of responses (reluctance, ambivalence, absolute insistence) on explicit mention of 'nano' in IC forms with underlying reasons. Conclusion: We conclude that consistent, clear and honest communication regarding the 'nano' dimension of investigational product is critical in IC forms of FIH trials.