Aim: This article aims to provide a comprehensive overview of the educational pathways and responsibilities of research nurses in Europe, particularly focusing on their essential role in conducting research in clinical settings, including clinical trials, while adhering to ethical and regulatory standards.
Background: Research nurses play a crucial role in clinical research settings, especially in clinical trials, ensuring adherence to ethical and regulatory standards. Understanding their educational pathways and responsibilities is essential for promoting consistency and quality in research practices across Europe.
Design: Between October and November 2022, relevant European nursing education authorities, including those focused on research nursing, were contacted to participate in an online cross-sectional survey. The survey aimed to gather information about research nurse education and training in their respective countries.
Methods: The study followed a cross-sectional design. Contacts were made with European nursing education authorities based on recommendations from the VACCELERATE National Coordinators and the VACCELERATE Site Network. Participating organizations were invited to complete an online survey regarding research nurse education in their countries.
Results: Responses were obtained from 37 European countries, a response rate of 74%. The most common terms used to refer to nurses involved in clinical trials and epidemiological studies were "study nurse" (62%) and "clinical research nurse" and "research nurse" (43% each). The requirements to become a research nurse varied across countries, with a nursing degree necessary in 87% of countries and Good Clinical Practice (GCP) courses mandatory in 81%. Local providers of research nurse courses existed in 84% of countries, coordinated by online organisations (51%) or universities/hospitals (46%). The most common tasks assigned to research nurses were the administration of investigational medicinal products (from 78% in observational studies to 89% in phase IV trials) and blood sample processing (84% in phase II and IV trials).
Conclusions: This study provides valuable insights into research nurse education and tasks in European countries. It highlights the need for standardisation to enhance consistency and quality of training across Europe.
Keywords: Clinical trial; Education; Europe; Good Clinical Practice; Research nurse; Study nurse; Training.
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