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

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

Design and Implementation of a Medication Reconciliation Kiosk: the Automated Patient History Intake Device (APHID)

Errors associated with medication documentation account for a substantial fraction of preventable medical errors. Hence, the Joint Commission has called for the adoption of reconciliation strategies at all United States healthcare institutions. Although studies suggest that reconciliation tools can reduce errors, it remains unclear how best to implement systems and processes that are reliable and sensitive to clinical workflow. The authors designed a primary care process that supported reconciliation without compromising clinic efficiency. This manuscript describes the design and implementation of Automated Patient History Intake Device (APHID): ambulatory check-in kiosks that allow patients to review the names, dosage, frequency, and pictures of their medications before their appointment. Medication lists are retrieved from the electronic health record and patient updates are captured and reviewed by providers during the clinic session. Results from the roll-in phase indicate the device is easy for patients to use and integrates well with clinic workflow