1. A Joint Contribution from the International Medical Informatics Association's Human Factors Engineering and the European Federation for Medicatl Informatics’ Human and Organizational Factors of Medical Informatics Working Groups
- Author
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Peute, LW, Lichtner, V, Baysari, MT, Hägglund, M, Homco, J, Jansen-Kosterink, S, Jauregui, I, Kaipio, J, Kuziemsky, CE, Lehnbom, EC, Leite, F, Lesselroth, B, Luna, D, Otero, C, Pedersen, R, Pelayo, S, Santos, R, Silva, N-A, Tyllinen, M, Van Velsen, L, Zheng, WY, Jaspers, M, Marcilly, R, APH - Aging & Later Life, APH - Methodology, Medical Informatics, APH - Societal Participation & Health, APH - Health Behaviors & Chronic Diseases, Aalto University, University of Tromsø (UiT), Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 (CIC Lille), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), and CHU Lille
- Subjects
Organizational Factors ,Internationality ,Ethical review human factors organizational factors ergonomics social sciences ,VDP::Medical disciplines: 700::Basic medical, dental and veterinary science disciplines: 710::Pharmacology: 728 ,Human Factors ,Biomedical Technology ,Social Sciences ,Public Policy ,Other Medical Sciences not elsewhere specified ,ergonomics ,[SCCO.PSYC]Cognitive science/Psychology ,Övrig annan medicin och hälsovetenskap ,Humans ,Ethical review ,VDP::Medisinske Fag: 700::Basale medisinske, odontologiske og veterinærmedisinske fag: 710::Farmakologi: 728 ,Working Group Contributions ,Special Section: Ethics in Health Informatics ,Ethics Committees, Research - Abstract
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.
- Published
- 2020