Clinical Research Nurses Research Articles

Development and evaluation of a clinical research nursing module for undergraduate nursing schools: expanding Clinical Research Nurses' outreach.

Clinical Research Nurses (CRNs) care for study participants and manage clinical research studies; yet the CRN practice role is rarely covered in undergraduate nursing curricula in the United States. Despite a burgeoning need for CRNs, the pipeline of clinical research nurse positions remains sparse. The International Association of Clinical Research Nurses's (IACRN) strategic goal to "engage with nursing schools to heighten awareness and inclusion of the CRN role competencies in nursing education" prompted the development of an educational lecture module to be disseminated to nursing schools. This project is a pilot launch of the module. A task force of IACRN was formed to develop educational materials that could be used as outreach to undergraduate nursing schools. The content included a slide presentation covering an overview of clinical research, the CRN practice, three embedded videos showing CRN and study participant perspectives, and coverage of the care of participants of research by staff nurses. Due to COVID-19 we revised our live lecture approach using either a live synchronous webinar presentation, or an embedded asynchronous course module with YouTube videos for course learning management systems. We presented the content to 408 nursing students attending three academic programs. To evaluate effectiveness and satisfaction, an anonymous, post-presentation survey using web-based QualtricsXM was distributed to students. Content and delivery of the module was positively evaluated. There was an improvement in knowledge in each topic. Evaluation responses showed that the content could likely or very likely improve care for their patients (87.4%) and improve patient education for patients in clinical trials (95%). Delivering a synchronous or asynchronous module about the CRN practice role to nursing students in academic nursing programs is valuable to increasing awareness of the care of patients in clinical trials, the CRN role, and future professional development.

A survey on work status and competencies of Clinical Research Nurses in China.

The clinical trials industry in China has enjoyed robust growth; the demand for qualified personnel to conduct clinical trials with higher quality has increased. The Clinical Research Nurse has emerged as a new workforce in China. This study aimed to examine the current work status of Clinical Research Nurses in China and to investigate their competencies in knowledge and behavior associated with this profession. An online survey was analyzed. The current work status of Clinical Research Nurses in China was characterized. In addition, their competencies were self-assessed across nine competency categories and the "contribution to science" domain, based on the International Association of Clinical Research Nurses Scope and Standards of Practice. A total of 638 eligible questionnaires were included in the final analysis. Of whom, 98.28% (627/638) were females. The mean age was 35 years (range: 22-64 years). Over 80% of whom were working at the largest Chinese cities and the majority (78.2%) held a Bachelor's degree in nursing. The average time of clinical research experience was 5.67 years. Three quarters of the 638 had an annual income of <150,000 Yuan RMB. The average weekly working time was 45.46 h; clinical trial-related work accounted for 62.68% of their workload. There were some gaps between the Clinical Research Nurses' self-assessed competencies in knowledge and behavior, with the widest gaps along the ethical principles, leadership and professional development, protocol compliance, and document management categories. This is the first large-scale survey of Clinical Research Nurses in China. Our results profile this emerging workforce as a population of young, moderately trained/experienced, predominantly female nurses working in the largest Chinese cities. They performed well on most knowledge/behavior parameters; still, gaps exist. Therefore, there is a pressing need to enhance professional education and training for Clinical Research Nurses in China.

Capturing the value and core concepts of the Clinical Research Nurse.

As nurses, we identify our profession as a caring one, but how does this identity translate from a conceptual definition, to real-world practice for the Clinical Research Nurse? To offer a novel, four-point conceptual model that encapsulates the Clinical Research Nurse's intrinsic value, active leadership, and direct contribution to high quality, person-centered, safe care, addressing current misperceptions of research nursing. This paper describes the provision of 'care', safely delivered by the Clinical Research Nurse through a four-point conceptual model and case-driven example. Clinical research nursing is conceptualized within the domains of Care and Trust, Role, Impact, and Integration. The case example demonstrates real-world application of these domains and the expertise required to balance the complexities of clinical needs and research demands in a healthcare environment. This paper offers a mechanism for understanding the importance of the Clinical Research Nurse and their role in maintaining safety and a high-level view of the care arena. These reflections are considered with an international application for the role.

Extending the description of the clinical research nursing workforce.

The role of Clinical Research Nurses across the globe has not been evaluated to identify similarities or differences among specific activities. This study's aims were to determine differences in Clinical Research Nurses most frequently performed activities, if these activities are reflective of those previously described in the literature, and job titles Clinical Research Nurses use to self-identify. An online cross-sectional survey distributed via snowball sampling through email, social media, and research nurses' networks included questions on frequency of activities performed and information related to job titles. Pearson's chi-square test is analyzed for associations between the groups. Respondents returned 252 questionnaires, 233 were eligible for analysis. Research nurse activities performed internationally showed both similarities and differences. Any between country comparisons will be limited to the United States and the United Kingdom. The three most common tasks reported were recruitment 120 (51.5%), monitoring the research participant for potential adverse events 187 (80.2%) and providing nursing leadership within the interdisciplinary team 169 (72.5%). Considering the context and range of activities of the original Clinical Research Nursing Domain of Practice, broadening the framework to include the leadership domain will better serve as a foundation for the specialty practice.

Who's included? The role of the Clinical Research Nurse in enabling research participation for under-represented and under-served groups.

There is a global call for more inclusive clinical research that is representative of all populations, particularly those historically under-represented or under-served. A lack of broad representation results in disproportionate health outcomes and limits the applicability and translation of research findings. Identify and describe barriers to participation across the research lifecycle and consider the role of the Clinical Research Nurse (CRN) in promoting inclusivity, including for Aboriginal and Torres Strait Islander Peoples within Australia. Review of recent literature and best practice identified barriers to research participation across the research process; at system, participant and practitioner levels. This discussion paper explores the role of the CRN; acting as enablers, facilitators and navigators, to mitigate participation barriers. With their comprehensive understanding of the research process, clinical care pathways, reflective practices and participant-centred approaches, CRNs are uniquely positioned to advocate for greater equity in access to clinical research and to motivate stakeholders across the research enterprise to embed inclusive approaches in the design, conduct and dissemination of research. An in-depth understanding of the research process, self, and cultural norms of the populations they serve is essential for CRNs to effectively advocate for equity in access to research.

Commentary: Development and evaluation of a clinical research nursing module for undergraduate nursing schools: expanding Clinical Research Nurses' outreach.

Commentary: Development and evaluation of a clinical research nursing module for undergraduate nursing schools: expanding Clinical Research Nurses' outreach.

Multi-professional perceptions of clinical research delivery and the Clinical Research Nurse role: a realist review.

Introduction & BackgroundThe delivery of clinical research and the Clinical Research Nurse (CRN) role is fundamental to the wider health agenda, yet both remain misunderstood outwith research teams.MethodsA realist review was conducted to identify factors that influence how clinical research is perceived by healthcare professionals operating outside NHS clinical research teams. Keyword searches were undertaken across four healthcare databases including grey literature, with iterative snowball searching. Data were extracted from 42/387 sources. Coding generated 3664 extracts of text across 160 themes. Theories generated were presented as ‘If-Then’ statements.ResultsThirteen theory statements described factors that may influence how clinical research is perceived by healthcare professionals operating outside clinical research teams across three contextual levels: • Micro: Individual characteristics/behaviours/CRN perceptions• Meso: Interpersonal relationships at the interface between CRN roles and healthcare delivery• Macro: Systemwide/infrastructural/cultural issues impacting clinical research delivery. ConclusionFactors at micro, meso and macro level contexts may influence how clinical research is perceived by healthcare professionals operating outside clinical research teams. This has the potential to affect the success of clinical research delivery. Meso level theories regarding the perceptions of healthcare professionals outwith research teams may provide insight. Empirical testing of one such theory is underway.

Commentary: Development and evaluation of a clinical research nursing module for undergraduate nursing schools: expanding Clinical Research Nurses' outreach.

Commentary: Development and evaluation of a clinical research nursing module for undergraduate nursing schools: expanding Clinical Research Nurses' outreach.

The organization and staff of a centralized Clinical Trial Center: the Alessandria model.

The case study refers to the Clinical Trial Center (CTC) of the Public Hospital "SS. Antonio e Biagio and Cesare Arrigo" (AO AL) and the Local Health Authority of Alessandria (ASL AL), to which Clinical Research Coordinators (CRCs) and Clinical Research Nurses (CRNs) belong, unique in the regional panorama and a rarity into a public health organization not recognized as Scientific Institute for Research, Hospitalization and Healthcare (IRCCS).

Promoting a gender-affirming environment in research: implications for research nurses.

Background: Approximately 25 million people around the world identify as transgender, and the numbers are growing. While visibility of transgender communities has increased, significant healthcare disparities remain. Transgender individuals report being less inclined to share their sex assigned at birth due to fear of stigmatization and mistrust of the medical community. The mistrust and inequity experienced by transgender individuals are not limited to clinical care and may extend to clinical research as well. Aim and method: The aim of this paper is to start a conversation about barriers to participating in research and the role of research staff, specifically the Clinical Research Nurse, in promoting engagement of transgender individuals in clinical research trials. Discussion and conclusions: A discussion of safety considerations, data integrity, and implications for data management is included. Because disparities may result in large part from lack of education and knowledge on best practices for providing care for this population, recommendations for fostering a culture of competence and gender-affirming care among research professionals featuring the role of the research nurse will be discussed.

Commentary: Who's included? The role of the Clinical Research Nurse in enabling research participation for under-represented and under-served groups.

Commentary: Who's included? The role of the Clinical Research Nurse in enabling research participation for under-represented and under-served groups.

Commentary: Capturing the value and core concepts of the Clinical Research Nurse.

Commentary: Capturing the value and core concepts of the Clinical Research Nurse.

Commentary: A survey on work status and competencies of Clinical Research Nurses in China.

Commentary: A survey on work status and competencies of Clinical Research Nurses in China.

Commentary: Multi-professional perceptions of clinical research delivery and the Clinical Research Nurse role: a realist review.

Commentary: Multi-professional perceptions of clinical research delivery and the Clinical Research Nurse role: a realist review.

Creating Interdisciplinary Engagement Through a Hospital-Based Endowed Chair in Nursing Research: The "Conway Chair Conversations".

Although clinical nurses' involvement in research is a role expectation, efforts to engage clinical nurses in nurse-led research have had notably mixed results. These efforts have most typically been single discipline-focused (nursing), although nursing care is a collaborative, interdisciplinary practice. Adding an interdisciplinary strategy to multiple other efforts to engage clinical nurses in research may contribute to more nurse involvement. Here, we describe the use of a hospital-based endowed chair in nursing research to simultaneously engage nursing and other disciplines in a monthly dialogue about clinically relevant, research-related challenges and solutions. Outcomes indicate that the research-related dialogue among nurses and interprofessional colleagues would likely not have taken place without this approach.

Clinical research nurses, perspectives on recruitment challenges and lessons learnt from a large multi-site observational study.

Recruitment of large numbers of study participants within a designated time frame for multi-site clinical research studies is a significant challenge faced by researchers. If a study does not manage to recruit targeted number of participants, it could have a significant impact on the statistical significance of the research. This paper highlights the challenges of recruitment for a large multi-site UK-based tuberculosis observational study 'PREDICT'. It uses a case-study analysis from the research nurses, perspective, and descriptive information retrieved from non-recruitment log forms to understand reasons for potential recruits not participating. Some of the main challenges to recruitment included patients not attending their clinic appointments, time required to obtain site-specific permissions and courier timings for blood sample collection. This paper also outlines key reasons for potential recruits who did not participate. Some of the common barriers to participation for non-recruited participants were work and family commitments, additional blood tests and language barriers. Successful strategies which were implemented to overcome some of the challenges during the study are presented. This paper, therefore, aims to present the challenges faced, lessons learnt and successful strategies implemented to inform the planning of similar longitudinal studies of this scale in future.

Commentary: Clinical research nurses, perspectives on recruitment challenges and lessons learnt from a large multi-site observational study.

Commentary: Clinical research nurses, perspectives on recruitment challenges and lessons learnt from a large multi-site observational study.

Clinical Research Coordinator and Clinical Research Nurse: education and role at the Clinical Trial Center of Alessandria

The increasing complexity of clinical research makes it indispensable for an Institution that wants to conduct clinical trials to have an Organisational Structure and a dedicated multidisciplinary team. Since 2013, the public Hospital "SS Antonio and Biagio and C. Arrigo" of Alessandria (AO AL) has established a Clinical Trial Center (CTC), that has now become a centralized inter-company sector of the Research and Innovation Department. The CTC is part of the Research Infrastructure with its head office at AO AL and a further office at the Local Health Authority Territorial Hospital "S. Spirito" of Casale Monferrato (ASL AL). The CTC aims to design high standard clinical trials, ensuring better efficiency in their activation, management and data management according to the Good Clinical Practice (GCP) guidelines. Over the years, the CTC has grown and gained professional skills such as the Clinical Research Coordinator (CRC) and the Clinical Research Nurse (CRN), not yet officially recognized by the National Health System. These are skilled professional figures, that have been adequately trained even with post-graduate education through a 1st level Master in "Data Management and Coordination of Clinical Trials" which was activated by the University of Eastern Piedmont in collaboration with AO AL. The number and diversity of the activities carried out by CRCs and CRNs within the CTC has led them to develop a tool that strategically permits to recollect and record the time needed to perform these tasks with the aim of evaluating the different types of activities undertaken and assessing the needs of new staff. The organizational model adopted by the AO AL and the ASL AL through a centralized inter-company CTC represents a unique organizational model in the regional scenario and a peculiarity within the Public Health Authority not as yet recognized as Scientific Institutes for Research, Hospitalization and Healthcare.

Delivering Covid-19 research during the UK pandemic: Experiences of a local research taskforce.

During the COVID-19 pandemic in the UK, clinical research nurses had to work in new ways and under significant pressure to generate evidence for the developing health crisis. Research nurse support needs, personal and professional challenges have not been explored. This study addresses that gap, generating learning for continued support and development of the research nurse specialty and its ability to respond to public health priorities. We employed a qualitative exploratory approach through online open-ended interviews to explore research nurses' experiences of delivering research during the pandemic using principles of Grounded Theory. Fifteen research nurses in the local research taskforce were identified through purposive sampling. Qualitative interviews were conducted online between November 2020 and January 2021 and analysed using the principles of constructivist grounded theory. Three themes of adapting to uncertainty, inclusive leadership and finding validity in the stretch zone were generated in the analysis. A model of inclusive leadership and support can facilitate high-functioning performance in a research team, supporting a rapid, confident and efficient response to research needs. Research nurses, a previously invisible workforce, have proved critical to the pandemic response. This study explores the experiences of a team of redeployed research nurses and develops a theory of their experience as they were undertaking the rapid delivery of urgent public health studies during COVID-19. What was found was a process of adaptation and resilience through collaborative teamwork, a strong sense of purpose and role validation enabled by an inclusive leadership style. This work will drive future development of a model of research nursing with a focus on collaboration between research and clinical colleagues.

The role of clinical research nurses in minority recruitment to cancer clinical trials

Clinical trials (CTs) are the established research mechanism designed to examine how new medical therapies are tested for safety and effectiveness. Specifically, non-Hispanic White patients still account for most CT participants and Black patient participation has declined over the past decade. Clinical Research Nurses (CRNs) whose scope of practice includes the recruitment of participants for CTs, have the potential to significantly increase minority patients participation in cancer clinical trials (CCTs). The aim of this phenomenological study was to describe adult oncology CRNs' lived experiences of recruiting minority cancer patients to participate in CTs. A total of 19 nurses participated in semi-structured one-to-one interviews and data analysis was based on Colaizzi's method. The role of CRNs was described as advocates who coordinate care, establish trust, and provide education for CT patients within physician-driven recruitment structures. The CRN's role was also described as self-taught or learn on the go with no formalized recruitment training and lack of robust cultural training. To achieve diverse patient enrollment in CCTs, CRNs and study staff need to receive training on culturally competent clinical research care and the diversity of CRNs and study teams must be increased. Further, meaningful federal and hospital policy change must occur so that minority patients have equitable access to novel cancer therapies and the role of the CRN is delineated from other healthcare staff to optimize research patient care.