Trust trumps comprehension, visceral factors trump all: A psychological cascade constraining informed consent to clinical trials: A qualitative study with stable patients
JournalArticle (Originalarbeit in einer wissenschaftlichen Zeitschrift)
 
ID 4602669
Author(s) Rost, Michael; Nast, Rebecca L.; Elger, Bernice S.; Shaw, David M.
Author(s) at UniBasel Rost, Michael
Nast, Rebecca
Elger, Bernice Simone
Shaw, David
Year 2020
Title Trust trumps comprehension, visceral factors trump all: A psychological cascade constraining informed consent to clinical trials: A qualitative study with stable patients
Journal Research Ethics
Volume 17
Number 1
Pages / Article-Number 87-102
Keywords research ethics, clinical trial, first-in-human trial, stable patients, informed consent, psychological factors
Abstract This paper addresses psychological factors that might interfere with informed consent on the part of stable patients as potential early phase clinical trial participants. 36 semi-structured interviews with patients who had either diabetes or gout were conducted. We investigated stable patients' attitudes towards participating in a fictitious first-in-human trial of a novel intervention. We focused on an in-depth analysis of those statements and explanations that indicated the existence of psychological factors impairing decision-making capacity. Three main themes emerged: insufficient comprehension of the inherent logic of clinical trials (actual comprehension), the recourse to trust over comprehension (prioritization of trust), and visceral factors that override deliberative process (visceral factors). Overall, our results indicate a limited psychological capacity on the part of stable patients to meet the requirements of informed consent as set by Declaration of Helsinki. A redesigned informed consent procedure should take account of these psychological realities.
Publisher Sage
ISSN/ISBN 1747-0161 ; 2047-6094
URL https://journals.sagepub.com/doi/pdf/10.1177/1747016120914335
edoc-URL https://edoc.unibas.ch/78294/
Full Text on edoc No
Digital Object Identifier DOI 10.1177/1747016120914335
 
   

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