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

Satalkar, Priya and Elger, Bernice Simone and Shaw, David. (2016) Naming it 'nano': Expert views on 'nano' terminology in informed consent forms of first-in-human nanomedicine trials. Nanomedicine, 11 (8). pp. 933-940.

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Official URL: http://edoc.unibas.ch/44848/

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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.
Faculties and Departments:08 Cross-disciplinary Subjects > Ethik > Institut für Bio- und Medizinethik > Bio- und Medizinethik (Elger)
03 Faculty of Medicine > Departement Public Health > Ethik in der Medizin > Bio- und Medizinethik (Elger)
UniBasel Contributors:Satalkar, Priya and Elger, Bernice Simone and Shaw, David
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Future Medicine
ISSN:1743-5889
e-ISSN:1748-6963
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:04 Oct 2017 06:43
Deposited On:03 Oct 2017 14:30

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