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) |
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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: |
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Last Modified: | 04 Oct 2017 06:43 |
Deposited On: | 03 Oct 2017 14:30 |
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