Challenges and Best Practices in Ethical Review of Human and Organizational Factors Studies in Health Technology: a Synthesis of Testimonies
AuthorPeute, Linda W.; Lichtner, Valentina; Baysari, Melissa T.; Hägglund, Maria; Homco, Juell; Jansen-Kosterink, Stephanie; Jauregui, Ignacio; Kaipio, Johanna; Kuziemsky, Craig E.; Lehnbom, Elin; Leite, Francisca; Lesselroth, Blake; Luna, Daniel; Otero, Carlos; Pedersen, Rune; Pelayo, Sylvia; Santos, Raquel; Silva, Nuno-André; Tyllinen, Mari; Van Velsen, Lex; Zheng, Wu Yi; Jaspers, Monique; Marcilly, Romaric
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.