Naming it ‘nano’: Expert views on ‘nano’ terminology in informed consent forms of first-in-human nanomedicine trials-Reference-Cited by-同舟云学术

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

Published:2016-04 Issue:8 Volume:11 Page:933-940
ISSN:1743-5889
Container-title:Nanomedicine
language:en
Short-container-title:Nanomedicine

Author:

Satalkar Priya¹,Elger Bernice Simone¹,Shaw David¹

Affiliation:

1. Institute for Biomedical Ethics, University of Basel, Bernoullistrasse 28, 4056 Basel, Switzerland

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. 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.

Publisher

Future Medicine Ltd

Subject

Development,General Materials Science,Biomedical Engineering,Medicine (miscellaneous),Bioengineering

Link

https://www.futuremedicine.com/doi/pdf/10.2217/nnm-2015-0003

Reference30 articles.

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