CC BY-NC-ND 4.0 · Yearb Med Inform 2020; 29(01): 058-070
DOI: 10.1055/s-0040-1701979
Special Section: Ethics in Health Informatics
Working Group Contributions
Georg Thieme Verlag KG Stuttgart

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

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
Linda W. Peute
1  Centre for Human Factor Engineering of Health Information technology - Amsterdam UMC, University of Amsterdam, department of Medical Informatics, Amsterdam, The Netherlands
,
Valentina Lichtner
2  Centre for Medication Safety and Service Quality, UCL School of Pharmacy, UK
,
Melissa T. Baysari
3  The University of Sydney, Faculty of Medicine and Health, Sydney, Australia
,
Maria Hägglund
4  Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden
,
Juell Homco
5  Department of Medical Informatics, University of Oklahoma - Tulsa School of Community Medicine, USA
,
Stephanie Jansen-Kosterink
6  Roessingh Research and Development, eHealth group, Enschede, The Netherlands
,
Ignacio Jauregui
7  Health Informatics Department, Hospital Italiano de Buenos Aires, Argentina
,
Johanna Kaipio
8  Department of Computer Science, Aalto University, Finland
,
Craig E. Kuziemsky
9  MacEwan University, Edmonton, AB, Canada
,
Elin Christina Lehnbom
10  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
,
Francisca Leite
11  Hospital da Luz Learning Health, Portugal
,
Blake Lesselroth
5  Department of Medical Informatics, University of Oklahoma - Tulsa School of Community Medicine, USA
,
Daniel Luna
7  Health Informatics Department, Hospital Italiano de Buenos Aires, Argentina
,
Carlos Otero
7  Health Informatics Department, Hospital Italiano de Buenos Aires, Argentina
,
Rune Pedersen
12  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
,
Sylvia Pelayo
13  Univ. Lille, CHU Lille, ULR 2694 - METRICS: Évaluation des technologies de santé et des pratiques médicales, INSERM-CIC-IT 1403/Evalab, Lille, France
,
Raquel Santos
11  Hospital da Luz Learning Health, Portugal
,
Nuno-André Silva
11  Hospital da Luz Learning Health, Portugal
,
Mari Tyllinen
8  Department of Computer Science, Aalto University, Finland
,
Lex Van Velsen
6  Roessingh Research and Development, eHealth group, Enschede, The Netherlands
,
Wu Yi Zheng
3  The University of Sydney, Faculty of Medicine and Health, Sydney, Australia
,
Monique Jaspers
1  Centre for Human Factor Engineering of Health Information technology - Amsterdam UMC, University of Amsterdam, department of Medical Informatics, Amsterdam, The Netherlands
,
Romaric Marcilly
13  Univ. Lille, CHU Lille, ULR 2694 - METRICS: Évaluation des technologies de santé et des pratiques médicales, INSERM-CIC-IT 1403/Evalab, Lille, France
› Author Affiliations
Further Information

Publication History

Publication Date:
17 April 2020 (online)

Summary

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.