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

Autor:	Peute LW; Centre for Human Factor Engineering of Health Information technology - Amsterdam UMC, University of Amsterdam, department of Medical Informatics, Amsterdam, The Netherlands., Lichtner V; Centre for Medication Safety and Service Quality, UCL School of Pharmacy, UK., Baysari MT; The University of Sydney, Faculty of Medicine and Health, Sydney, Australia., Hägglund M; Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden., Homco J; Department of Medical Informatics, University of Oklahoma - Tulsa School of Community Medicine, USA., Jansen-Kosterink S; Roessingh Research and Development, eHealth group, Enschede, The Netherlands., Jauregui I; Health Informatics Department, Hospital Italiano de Buenos Aires, Argentina., Kaipio J; Department of Computer Science, Aalto University, Finland., Kuziemsky CE; MacEwan University, Edmonton, AB, Canada., Lehnbom EC; Department of Pharmacy, Faculty of Health Sciences, UiT The Arctic University of Norway, Norway; Department of Health and Caring Sciences, Faculty of Health and Life Sciences, Linnaeus University, Sweden., Leite F; Hospital da Luz Learning Health, Portugal., Lesselroth B; Department of Medical Informatics, University of Oklahoma - Tulsa School of Community Medicine, USA., Luna D; Health Informatics Department, Hospital Italiano de Buenos Aires, Argentina., Otero C; Health Informatics Department, Hospital Italiano de Buenos Aires, Argentina., Pedersen R; Norwegian Centre for E-health Research, University Hospital of North Norway HF, Norway; Department of Clinical Medicine, Faculty of Health Sciences, UiT The Arctic University of Norway, Norway., Pelayo S; Univ. Lille, CHU Lille, ULR 2694 - METRICS: Évaluation des technologies de santé et des pratiques médicales, INSERM-CIC-IT 1403/Evalab, Lille, France., Santos R; Hospital da Luz Learning Health, Portugal., Silva NA; Hospital da Luz Learning Health, Portugal., Tyllinen M; Department of Computer Science, Aalto University, Finland., Van Velsen L; Roessingh Research and Development, eHealth group, Enschede, The Netherlands., Zheng WY; The University of Sydney, Faculty of Medicine and Health, Sydney, Australia., Jaspers M; Centre for Human Factor Engineering of Health Information technology - Amsterdam UMC, University of Amsterdam, department of Medical Informatics, Amsterdam, The Netherlands., Marcilly R; Univ. Lille, CHU Lille, ULR 2694 - METRICS: Évaluation des technologies de santé et des pratiques médicales, INSERM-CIC-IT 1403/Evalab, Lille, France.
Jazyk:	angličtina
Zdroj:	Yearbook of medical informatics [Yearb Med Inform] 2020 Aug; Vol. 29 (1), pp. 58-70. Date of Electronic Publication: 2020 Apr 17.
DOI:	10.1055/s-0040-1701979
Abstrakt:	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. Competing Interests: Disclosure The authors report no conflicts of interest in this work. (Georg Thieme Verlag KG Stuttgart.)
Databáze:	MEDLINE
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