Universität zu Köln

Genske, Anna and Engel-Glatter, Sabrina (2016). Rethinking risk assessment for emerging technology first-in-human trials. Med. Health Care Philos., 19 (1). S. 125 - 140. DORDRECHT: SPRINGER. ISSN 1572-8633

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Abstract

Recent progress in synthetic biology (SynBio) has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials (FIH) will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including 'risk' minimization. These concerns are associated with any FIH trial, however, due to the novelty of the approach, they become more pronounced for medical applications of emerging technologies (emTech) like SynBio. To minimize potential harm for trial participants, scholars, guidelines, regulations and policy makers alike suggest using 'risk assessment' as evaluation tool for such trials. Conversely, in the context of emTech FIH trials, we believe it to be at least questionable to contextualize uncertainty of potential adverse events as 'risk' and apply traditional risk assessment methods. Hence, this issue needs to be discussed to enable alterations of the evaluation process before the translational phase of SynBio applications begins. In this paper, we will take the opportunity to start the debate and highlight how a misunderstanding of the concept of risk, and the possibilities and limitations of risk assessment, respectively, might impair decision-making by the relevant regulatory authorities and research ethics committees, and discuss possible solutions to tackle the issue.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Genske, Anna UNSPECIFIED UNSPECIFIED UNSPECIFIED Engel-Glatter, Sabrina UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-282686
DOI:	10.1007/s11019-015-9660-7
Journal or Publication Title:	Med. Health Care Philos.
Volume:	19
Number:	1
Page Range:	S. 125 - 140
Date:	2016
Publisher:	SPRINGER
Place of Publication:	DORDRECHT
ISSN:	1572-8633
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CLINICAL-TRIALS; GENE-THERAPY; SYNTHETIC BIOLOGY; ANIMAL-MODELS; ANALGESIC DRUGS; DECISION-MAKING; NANOMEDICINE; UNCERTAINTY; ETHICS; LIFE Multiple languages Ethics; History & Philosophy Of Science Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/28268