Suchergebnisse

With ageing, travel becomes more and more complex. Physical and cognitive abilities may decline, and thus, elderly people may experience several problems that hinder them from travelling independently. One of the most difficult issues when addressing the problem of age-related travel restrictions is the heterogeneity of the ageing population. SOULMATE offers a non-intrusive and personalized mobility package that evolves with the end-user across his/her different life stages to ensure him/her to make secure trips. SOULMATE aggregates three types of mobility support: Indoor virtual training of a route, active routing during trips and monitoring by a coach at a distance during trips. For each individual, the desired or necessary functionalities can be chosen, based on his/her specific abilities and travel needs. The SOULMATE solution will be developed iteratively, in co-creation with end-users and stakeholders, and the package will be tested intensively, and evaluated in three countries (Belgium, The Netherlands and Austria) based on usability, technical and business aspects. ; The SOULMATE project is co-founded by the AAL Programme of the European Union; and by the funding authorities Agentschap Innoveren en Ondernemen (Flanders, Belgium), Austrian Ministry for Transport, Innovation and Technology (Austria) and ZonMw, the Netherlands Organization for Health Research & Development (The Netherlands). The SOULMATE consortium consists of partners from: ABEONAconsult, Eindhoven University of Technology, University of Applied Science FH JOANNEUM GmbH, Activ84Health, Roessingh Research and Development, Happy Aging, Slimmer Leven, GEFAS STEIERMARK, c.c.com Moser GmbH and FRAISS – IT Consulting & Mediendesign. The authors want to thank all partners involved in the consortium.

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.