title: Naming it 'nano': Expert views on 'nano' terminology in informed consent forms of first-in-human nanomedicine trials.
abstract: 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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  We conclude that consistent, clear and honest communication regarding the 'nano' dimension of investigational product is critical in IC forms of FIH trials.
authors.affiliation: Institute for Biomedical Ethics, University of Basel, Bernoullistrasse 28, 4056 Basel, Switzerland.
authors.forename: Priya
authors.initials: P
authors.lastname: Satalkar
authors.affiliation: Institute for Biomedical Ethics, University of Basel, Bernoullistrasse 28, 4056 Basel, Switzerland.
authors.forename: Bernice Simone
authors.initials: BS
authors.lastname: Elger
authors.affiliation: Institute for Biomedical Ethics, University of Basel, Bernoullistrasse 28, 4056 Basel, Switzerland.
authors.forename: David
authors.initials: D
authors.lastname: Shaw
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D032962:Consent Forms / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D016743:Mental Competency / Q000331:legislation & jurisprudence; D050997:Nanomedicine / Q000941:ethics* / Q000331:legislation & jurisprudence*; D009626:Terminology as Topic
keywords: ethics; exploratory qualitative research; first-in-human (FIH) trials; informed consent (IC); nanomedicine; nanotechnology; research participant information sheets