Clinical research nurses perceive their role as being like the hub of a wheel without real power: Empirical qualitative research.

AIM: This study aimed to explore the experiences of being a clinical research nurse (CRN), in Sweden. DESIGN: A qualitative study analysing individual interview data. METHODS: Interviews with 10 participants were conducted in April 2017 and repeated with five participants in May 2022. A semi-structured interview guide was used to cover topics such as experiences of working in a new role and professional challenges related to the role. The transcribed interviews were analysed inductively using qualitative content analysis. RESULTS: The main theme revealed that the CRNs experienced their work role as being like a hub in a wheel, using an ethical compass, but without real power. The six themes identified showed that CRNs worked independently and relied on clinical experiences as nurses but needed more education. They not only had a sense of duty but also too large responsibilities. Furthermore, they viewed their work as valuable and important. However, they needed an accentuated ethical compass and were also affected by power relations that negatively impacted work. CONCLUSION: Working as a CRN means being in a central position and working independently, which requires diverse skills and competencies. CRNs, however, face and manage complex ethical and practical challenges without real power. They experience huge responsibilities but need education and acknowledgement, indicating a need for improvement. This is an important message to stakeholders and managers about the necessity of taking adequate action to support CRNs who are crucial resources in clinical research. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Clarifying the role of clinical research nurses working in Sweden, using the Clinical Trial Nursing Questionnaire - Swedish version.

AIM: To explore the role of CRNs in Sweden and differences in competences and tasks, using the Clinical Trial Nursing Questionnaire - Swedish version (CTNQ-SWE). DESIGN: A cross-sectional survey. METHODS: Participants were identified through strategic sampling. Data were analysed by descriptive and comparative statistics. RESULTS: The respondents were experienced nurses who felt proficient in their role, they felt more acceptance by the principal investigators than by nursing colleagues. A majority of CRNs are involved in all procedures specified in the CTNQ-SWE. The most often performed tasks, also rated as the most important by the CRNs, concerned informed consent and management of investigational products. The education was often informal: with a lack of job descriptions and professional development plans. Need of formal specialist education was expressed. CONCLUSIONS: Knowledge about the role description can be used by clinical research enterprise internationally and healthcare organizations aiming to support CRNs in their role.

Translation and validation of the Clinical Trial Nursing Questionnaire in Swedish-A first step to clarify the clinical research nurse role in Sweden.

AIM AND OBJECTIVES: To translate the Clinical Trial Nursing Questionnaire (CTNQ) into Swedish and test it for face and content validity as well as internal consistency and reproducibility using test-retest procedures. INTRODUCTION/BACKGROUND: In many countries, as in Sweden, a registered nurse can be involved in research by becoming a clinical research nurse. The clinical research nurse plays a pivotal role in clinical studies as a part of the research team. Scales have been developed and used with the objective to clarify the role of clinical research nurses: one of them is the CTNQ. METHODS: A quantitative cross-sectional design with a test-retest procedure was applied to validate the translated questionnaire. By using a snowball sampling method, relevant participants were identified and 49 registered nurses working in the field of research as clinical research nurses answered the questionnaire on two occasions. An expert panel of three clinical research nurses evaluated the questionnaire for face and content validity. The STROBE checklist for observational research has been followed for presenting the research (see File S1). RESULTS: Face and content validity was agreed upon in the expert panel group. Tests for internal consistency of the CTNQ was calculated and showed a high Cronbach's alpha for both the frequency and importance subscales. The test-retest correlation analysis (reproducibility) also revealed a high correlation coefficient for both subscales. CONCLUSION: The CTNQ-SWE is a valid and robust instrument in a Swedish version. The instrument can be of importance in assessing the role of clinical research nurses in Sweden in future studies. RELEVANCE TO CLINICAL PRACTICE: Use of the CTNQ-SWE in future research can be of value for clarification and professional development of the clinical research nurse role in Sweden. The further use of the CTNQ in Sweden can be of value in understanding the process where licensed nurses make a transition into becoming a clinical research nurse, and to identify needs for customised education.