TY - JOUR
T1 - Challenges and Best Practices in Ethical Review of Human and Organizational Factors Studies in Health Technology
T2 - a Synthesis of Testimonies
AU - Peute, Linda W.
AU - Lichtner, Valentina
AU - Baysari, Melissa T.
AU - Hägglund, Maria
AU - Homco, Juell
AU - Jansen-Kosterink, Stephanie
AU - Jauregui, Ignacio
AU - Kaipio, Johanna
AU - Kuziemsky, Craig E.
AU - Lehnbom, Elin Christina
AU - Leite, Francisca
AU - Lesselroth, Blake
AU - Luna, Daniel
AU - Otero, Carlos
AU - Pedersen, Rune
AU - Pelayo, Sylvia
AU - Santos, Raquel
AU - Silva, Nuno André
AU - Tyllinen, Mari
AU - Van Velsen, Lex
AU - Zheng, Wu Yi
AU - Jaspers, Monique
AU - Marcilly, Romaric
PY - 2020/8/1
Y1 - 2020/8/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85089810872&partnerID=8YFLogxK
U2 - 10.1055/s-0040-1701979
DO - 10.1055/s-0040-1701979
M3 - Article
C2 - 32303100
AN - SCOPUS:85089810872
SN - 0943-4747
VL - 29
SP - 58
EP - 70
JO - Yearbook of Medical Informatics
JF - Yearbook of Medical Informatics
IS - 1
ER -