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

Linda W. Peute; Valentina Lichtner; Melissa T. Baysari; Maria Hägglund; Juell Homco; Stephanie Jansen-Kosterink; Ignacio Jauregui; Johanna Kaipio; Craig E. Kuziemsky; Elin Christina Lehnbom; Francisca Leite; Blake Lesselroth; Daniel Luna; Carlos Otero; Rune Pedersen; Sylvia Pelayo; Raquel Santos; Nuno-André Silva; Mari Tyllinen; Lex Van Velsen; Wu Yi Zheng; Monique Jaspers; Romaric Marcilly

doi:10.1055/s-0040-1701979

Yearbook of Medical Informatics, Inhaltsverzeichnis

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

¹Centre for Human Factor Engineering of Health Information technology - Amsterdam UMC, University of Amsterdam, department of Medical Informatics, Amsterdam, The Netherlands

,

Valentina Lichtner

²Centre for Medication Safety and Service Quality, UCL School of Pharmacy, UK

,

Melissa T. Baysari

³The University of Sydney, Faculty of Medicine and Health, Sydney, Australia

,

Maria Hägglund

⁴Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden

,

Juell Homco

⁵Department of Medical Informatics, University of Oklahoma - Tulsa School of Community Medicine, USA

,

Stephanie Jansen-Kosterink

⁶Roessingh Research and Development, eHealth group, Enschede, The Netherlands

,

Ignacio Jauregui

⁷Health Informatics Department, Hospital Italiano de Buenos Aires, Argentina

,

Johanna Kaipio

⁸Department of Computer Science, Aalto University, Finland

,

Craig E. Kuziemsky

⁹MacEwan University, Edmonton, AB, Canada

,

Elin Christina Lehnbom

¹⁰Department 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

¹¹Hospital da Luz Learning Health, Portugal

,

Blake Lesselroth

⁵Department of Medical Informatics, University of Oklahoma - Tulsa School of Community Medicine, USA

,

Daniel Luna

⁷Health Informatics Department, Hospital Italiano de Buenos Aires, Argentina

,

Carlos Otero

⁷Health Informatics Department, Hospital Italiano de Buenos Aires, Argentina

,

Rune Pedersen

¹²Norwegian 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

¹³Univ. Lille, CHU Lille, ULR 2694 - METRICS: Évaluation des technologies de santé et des pratiques médicales, INSERM-CIC-IT 1403/Evalab, Lille, France

,

Raquel Santos

¹¹Hospital da Luz Learning Health, Portugal

,

Nuno-André Silva

¹¹Hospital da Luz Learning Health, Portugal

,

Mari Tyllinen

⁸Department of Computer Science, Aalto University, Finland

,

Lex Van Velsen

⁶Roessingh Research and Development, eHealth group, Enschede, The Netherlands

,

Wu Yi Zheng

³The University of Sydney, Faculty of Medicine and Health, Sydney, Australia

,

Monique Jaspers

¹Centre for Human Factor Engineering of Health Information technology - Amsterdam UMC, University of Amsterdam, department of Medical Informatics, Amsterdam, The Netherlands

,

Romaric Marcilly

¹³Univ. Lille, CHU Lille, ULR 2694 - METRICS: Évaluation des technologies de santé et des pratiques médicales, INSERM-CIC-IT 1403/Evalab, Lille, France

› Institutsangaben

Abstract

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.

Keywords

Ethical review - human factors - organizational factors - ergonomics - social sciences

Volltext

Referenzen

References
1 World Medical Association. WMA - The World Medical Association-WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects [Internet]. [cited 2019 Aug 5]. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethi-cal-principles-for-medical-research-involving-hu-man-subjects/
2 American Psychology Association. Ethical Principles of Psychologists and Code of Conduct [Internet]. https://www.apa.org . [cited 2019 Aug 5]. Available from: https://www.apa.org/ethics/code/index
3 Petersen C, Berner ES, Embi PJ, Fultz Hollis K, Goodman KW, Koppel R. , et al. AMIA's code of professional and ethical conduct 2018. J Am Med Inform Assoc 2018; 25: 1579-82
4 International Journal of Medical Informatics. International Journal of Medical Informatics -Author Information Pack [Internet]. Elsevier - Int J Med Inform [cited 2019 Aug 5]. Available from: https://www.elsevier.com/journals/international-journal-of-medical-informatics/1386-5056/guide-for-authors#5000
5 Duplancic C, Crough T, Bell SC. , for the Australian Non-tuberculous Mycobacteria in Cystic Fibrosis Study Group, Thomson R, Wainwright C. , et al. Multi-centre ethics and research governance review can impede non-interventional clinical research. Intern Med J 2019; 49: 722-8
6 Baysari MT, Westbrook JI, Richardson KL, Day RO. The influence of computerized decision support on prescribing during ward-rounds: are the decision-makers targeted?. J Am Med Inform Assoc 2011; 18: 754-9
7 Baysari MT, Westbrook JI, Richardson K, Day RO. Optimising computerised alerts within electronic medication management systems: A synthesis of four years of research. Stud Health Technol Inform 2014; 204: 1-6
8 Jaensch SL, Baysari MT, Day RO, Westbrook JI. Junior doctors’ prescribing work after-hours and the impact of computerized decision support. Int J Med Inform 2013; 82: 980-6
9 Santucci W, Day RO, Baysari MT. Evaluation of Hospital-Wide Computerised Decision Support in an Intensive Care Unit: An Observational Study. Anaesth Intensive Care 2016; 44: 507-12
10 The National Health and Medical Research Council the Australian Research Council and Universities Australia. National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). Commonwealth of Australia, Canberra; 2018
11 Code de la Santé Publique, Livre 1er, Titre II : Recherches impliquant la personne humaine. Loi Jardé n° 2012-300 du 5 mars 2012 modifiée par ordonnance n° 2016-800 du 16 juin 2016, décret d'application modificatif n° 2017-884 du 9 mai 2017 et textes subséquents incluant les arrêtés du 12 avril 2018
12 Arrêté du 12 avril 2018 fixant la liste des recherches mentionnées au 2° de l'article L. 1121-1 du code de la santé publique
13 Décret n° 2017-884 du 9 mai 2017 modifiant certaines dispositions réglementaires relatives aux recherches impliquant la personne humaine
14 Toulouse E, Masseguin C, Lafont B, McGurk G, Harbonn A, Roberts J. , et al. French legal approach to clinical research. Anaesth Crit Care Pain Med 2018; 37: 607-14
15 Cornford T, Hibberd R, Barber N. The evaluation of the electronic prescription service in primary care: inal report on the indings from the evaluation in early implementer sites. London, UK: University College London; 2014
16 Grady C. Quality improvement and ethical oversight. Ann Intern Med 2007; 146: 680-1
17 Shades of Gray in Human Research: 3 Steps to Determine if Human Factors & Usability Studies Need IRB Review [Internet]. Ximedica Your Med. Prod. Device Dev. Partn. 2013 [cited 2019 Dec 1]. Available from: https://www.ximedica.com/shades-of-gray-in-human-research-3-steps-to-determine-if-human-factors-usability-studies-need-irb-review/
18 The general data protection regulation [Internet]. [cited 2019 Dec 1]. Available from: http://www.consilium.europa.eu/fr/policies/data-protection-re-form/data-protection-regulation/
19 Linden JA, Schneider JI, Cotter A, Drexel S, Frosch E, Martin ND. , et al. Variability in Institutional Board Review for a Multisite Assessment of Resident Professionalism. J Empir Res Hum Res Ethics 2019; 14: 117-25
20 Marcilly R, Peute L, Beuscart-Zephir MC. From Usability Engineering to Evidence-based Usability in Health IT. Stud Health Technol Inform 2016; 222: 126-38
21 Page SA, Nyeboer J. Improving the process of research ethics review. Res Integr Peer Rev 2017; 2: 14