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

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

Peute, Linda W. (författare): Centre for Human Factor Engineering of Health Information technology - Amsterdam UMC, University of Amsterdam, department of Medical Informatics, Amsterdam, The Netherlands

Lichtner, Valentina (författare): Centre for Medication Safety and Service Quality, UCL School of Pharmacy, UK

Baysari, Melissa T. (författare): The University of Sydney, Faculty of Medicine and Health, Sydney, Australia

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Hägglund, Maria, Lektor, 1975- (författare): Karolinska Institutet,Uppsala universitet,Klinisk psykologi i hälso- och sjukvård,Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA,Harvard Medical School, USA;Uppsala University, Sweden

Homco, Juell (författare): Department of Medical Informatics, University of Oklahoma - Tulsa School of Community Medicine, USA

Jansen-Kosterink, Stephanie (författare): Roessingh Research and Development, eHealth group, Enschede, The Netherlands

Jauregui, Ignacio (författare): Health Informatics Department, Hospital Italiano de Buenos Aires, Argentina

Kaipio, Johanna (författare): Department of Computer Science, Aalto University, Finland

Kuziemsky, Craig E. (författare): MacEwan University, Edmonton, AB, Canada

Lehnbom, Elin C. (författare): Linnéuniversitetet,Institutionen för hälso- och vårdvetenskap (HV),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, Francisca (författare): Hospital da Luz Learning Health, Portugal

Lesselroth, Blake (författare): Department of Medical Informatics, University of Oklahoma - Tulsa School of Community Medicine, USA

Luna, Daniel (författare): Health Informatics Department, Hospital Italiano de Buenos Aires, Argentina

Otero, Carlos (författare): Health Informatics Department, Hospital Italiano de Buenos Aires, Argentina

Pedersen, Rune (författare): 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, Sylvia (författare): University of Lille, France,Univ. Lille, CHU Lille, ULR 2694 - METRICS: Évaluation des technologies de santé et des pratiques médicales, INSERM-CIC-IT 1403/Evalab, Lille, France

Santos, Raquel (författare): Hospital da Luz Learning Health, Portugal

Silva, Nuno-André (författare): Hospital da Luz Learning Health, Portugal

Tyllinen, Mari (författare): Department of Computer Science, Aalto University, Finland

Van Velsen, Lex (författare): Roessingh Research and Development, eHealth group, Enschede, The Netherlands

Zheng, Wu Yi (författare): The University of Sydney, Faculty of Medicine and Health, Sydney, Australia

Jaspers, Monique (författare): Centre for Human Factor Engineering of Health Information technology - Amsterdam UMC, University of Amsterdam, department of Medical Informatics, Amsterdam, The Netherlands

Marcilly, Romaric (författare): University of Lille, France,Univ. Lille, CHU Lille, ULR 2694 - METRICS: Évaluation des technologies de santé et des pratiques médicales, INSERM-CIC-IT 1403/Evalab, Lille, France

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2020-04-17
2020
Engelska.
Ingår i: IMIA Yearbook of Medical Informatics. - : Georg Thieme Verlag KG. - 0943-4747 .- 2364-0502. ; 29:1, s. 58-70

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Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

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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.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Health Care Service and Management, Health Policy and Services and Health Economy (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Annan medicin och hälsovetenskap -- Övrig annan medicin och hälsovetenskap (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Other Medical and Health Sciences -- Other Medical and Health Sciences not elsewhere specified (hsv//eng)

Nyckelord

ethical review
human factors
organizational factors
ergonomics
social sciences
Health Informatics
Hälsoinformatik
Medical Informatics

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