Titre :

Challenges and Best Practices in Ethical Review of Human and Organizational Factors Studies in Health Technology: a Synthesis of Testimonies.

Auteur(s) :

Peute, Linda W. [Auteur]
University of Amsterdam [Amsterdam] = Universiteit van Amsterdam [UvA]
Lichtner, Valentina [Auteur]
Baysari, Melissa T. [Auteur]
The University of Sydney
Hägglund, Maria [Auteur]
Harvard Medical School [Boston] [HMS]
Homco, Juell [Auteur]
University of Oklahoma [OU]
Jansen-Kosterink, Stephanie [Auteur]
Jauregui, Ignacio [Auteur]
Kaipio, Johanna [Auteur]
Aalto University
Kuziemsky, Craig E. [Auteur]
Lehnbom, Elin Christina [Auteur]
The Arctic University of Norway [Tromsø, Norway] [UiT]
Leite, Francisca [Auteur]
Lesselroth, Blake [Auteur]
University of Oklahoma [OU]
Luna, Daniel [Auteur]
Otero, Carlos [Auteur]
Pedersen, Rune [Auteur]
Norwegian Centre for E-health Research
Pelayo, Sylvie [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Silva, Nuno-André [Auteur]
Tyllinen, Mari [Auteur]
Aalto University School of Science and Technology [Aalto, Finland]
Van Velsen, Lex [Auteur]
Zheng, Wu Yi [Auteur]
The University of Sydney
Jaspers, Monique [Auteur]

Marcilly, Romaric [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Titre de la revue :

IMIA Yearbook of Medical Informatics

Nom court de la revue :

Yearb Med Inform

Date de publication :

2020-04-18

ISSN :

2364-0502

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Objective: Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may ...
Lire la suite >Objective: Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may not fit standard regulations and IRB practices. Gaining IRB approval may pose difficulties for HOF researchers. This paper aims to provide a first overview of HOF study challenges to get IRB review by exploring differences and best practices across different countries. Methods: HOF researchers were contacted by email to provide a testimony about their experience with IRB review and approval. Testimonies were thematically analyzed and synthesized to identify and discuss shared themes. Results: Researchers from seven European countries, Argentina, Canada, Australia, and the United States answered the call. Four themes emerged that indicate shared challenges in legislation, IRB inefficiencies and inconsistencies, general regulation and costs, and lack of HOF study knowledge by IRB members. We propose a model for IRB review of HOF studies based on best practices. Conclusion: International criteria are needed that define low and high-risk HOF studies, to allow identification of studies that can undergo an expedited (or exempted) process from those that need full IRB review. Enhancing IRB processes in such a way would be beneficial to the conduct of HOF studies. Greater knowledge and promotion of HOF methods and evidence-based HOF study designs may support the evolving discipline. Based on these insights, training and guidance to IRB members may be developed to support them in ensuring that appropriate ethical issues for HOF studies are considered.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
CHU Lille

Collections :

• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Date de dépôt :

2023-11-15T08:59:44Z
2023-12-06T13:12:33Z