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

Authors
  • Peute, Linda W1
  • Lichtner, Valentina2
  • Baysari, Melissa T3
  • Hägglund, Maria4
  • Homco, Juell5
  • Jansen-Kosterink, Stephanie6
  • Jauregui, Ignacio7
  • Kaipio, Johanna8
  • Kuziemsky, Craig E9
  • Lehnbom, Elin Christina10
  • Leite, Francisca11
  • Lesselroth, Blake5
  • Luna, Daniel7
  • Otero, Carlos7
  • Pedersen, Rune12
  • Pelayo, Sylvia13
  • Santos, Raquel11
  • Silva, Nuno-André11
  • Tyllinen, Mari8
  • Van Velsen, Lex6
    • And 3 more
  • 1 Centre for Human Factor Engineering of Health Information technology - Amsterdam UMC, University of Amsterdam, department of Medical Informatics, Amsterdam, The Netherlands. , (Netherlands)
  • 2 Centre for Medication Safety and Service Quality, UCL School of Pharmacy, UK.
  • 3 The University of Sydney, Faculty of Medicine and Health, Sydney, Australia. , (Australia)
  • 4 Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden. , (Israel)
  • 5 Department of Medical Informatics, University of Oklahoma - Tulsa School of Community Medicine, USA.
  • 6 Roessingh Research and Development, eHealth group, Enschede, The Netherlands. , (Netherlands)
  • 7 Health Informatics Department, Hospital Italiano de Buenos Aires, Argentina. , (Argentina)
  • 8 Department of Computer Science, Aalto University, Finland. , (Finland)
  • 9 MacEwan University, Edmonton, AB, Canada. , (Canada)
  • 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. , (Norway)
  • 11 Hospital da Luz Learning Health, Portugal. , (Portugal)
  • 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. , (Norway)
  • 13 Univ. Lille, CHU Lille, ULR 2694 - METRICS: Évaluation des technologies de santé et des pratiques médicales, INSERM-CIC-IT 1403/Evalab, Lille, France. , (France)
Type
Published Article
Journal
Yearbook of medical informatics
Publication Date
Aug 01, 2020
Volume
29
Issue
1
Pages
58–70
Identifiers
DOI: 10.1055/s-0040-1701979
PMID: 32303100
Source
Medline
Language
English
License
Unknown

Abstract

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. 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. 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. 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. Georg Thieme Verlag KG Stuttgart.

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine. This record was last updated on 04/28/2021 and may not reflect the most current and accurate biomedical/scientific data available from NLM. The corresponding record at NLM can be accessed at https://www.ncbi.nlm.nih.gov/pubmed/32303100
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