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

Priya Satalkar*, Bernice Simone Elger, David Shaw

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

2 Citations (Web of Science)

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.
Original languageEnglish
Pages (from-to)933-940
JournalNanomedicine
Volume11
Issue number8
DOIs
Publication statusPublished - 2016

Keywords

  • ethics
  • exploratory qualitative research
  • first-in-human (FIH) trials
  • informed consent (IC)
  • nanomedicine
  • nanotechnology
  • research participant information sheets

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