Clinical Research Nurses Research Articles

Nursing students and clinical nurses’ perception of research and the role of the clinical research nurse

Background: The nursing profession has made great strides during the last century. Roles such as the clinical research nurse (CRN) have been developed and research is widely recognised as a vital component of the healthcare field. Hospitals involved in clinical nursing research can improve patient outcomes, increase staff and patient satisfaction and reduce hospital costs. Aim: The aim of this literature review is to analyse nurses and nursing students’ perception towards research, with focus on the available career progression for nurses in research. Method: A comprehensive search of literature on ASSIA, CINAHIL, PubMed and Web of Science electronic databases was conducted to obtain relevant articles related to the perception of nurses and nursing students towards research. Results: A total of 31 articles were selected for analysis following review. Three key themes were identified: nurses’ perception towards research; nursing students’ perception towards research; and career progression and job satisfaction. Conclusions: Involvement in research has helped nurses integrate evidence-based practice into their work. This has helped empower nurses to make positive change and develop their skills and knowledge. Unfortunately, research is still considered by many to be a ‘doctor’ field, and nurses have various difficulties accessing funding and education. Research education is vital to building the basic principles of nursing research and creating a positive attitude and perception around research. A change in culture is required to standardise research into university education, increase students’ perceptions and confidence in research, and help nurses incorporate valid evidence-based recommendations into practice.

Current status and influencing factors of nurses’ knowledge and attitudes towards clinical research ethical in China: a province-wide cross-sectional survey

BackgroundNurses’ competence in clinical research is a key element in promoting high quality in the discipline of nursing, and the ethical aspects of research are of paramount importance. Therefore, nurses need to have a comprehensive understanding of the ethics associated with clinical research, which is an integral part of safeguarding the safety of subjects, ensuring the quality of nursing clinical research, and improving the ethical standardization of clinical research.MethodsA cross-sectional survey was conducted on 304 nurses in a province of China between April 2023 and September 2023, utilizing convenience sampling. The survey questionnaire comprised two sections: a general information form and a questionnaire focusing on nurses’ knowledge and attitudes towards clinical research ethics. Data analysis encompassed descriptive statistics, t-tests, one-way ANOVA, and multiple linear regression.ResultsA total of 320 questionnaires were distributed, of which 304 were valid. The ethical attitude of nurses in clinical research was better (91.17 ± 15.96), while the cognitive score was lower (63.08 ± 12.30). The results of multiple linear regression analysis showed that degree, grade of hospital (I, II or III), technical title, number of clinical projects chaired in one year and whether the respondent has ever participated in an ethics training were the five factors influencing the knowledge of clinical research ethics (F = 9.341, P < 0.001, R2 = 18.0%); degree, grade of hospital (I, II or III), technical title, number of clinical research projects chaired in one year, whether the hospital has an ethics committee and whether the respondent has ever participated in an ethics training were the six factors affecting ethical attitudes towards clinical research (F = 8.919, P < 0.001, R2 = 17.3%).ConclusionsNurses in a Chinese province scored low on the cognitive dimension of clinical research ethics, but their attitudes were at a relative high level, with many influencing factors. Degree, technical title, and grade of hospital, all affect cognitive and attitude scores. It is also worth noting that whether the hospital has an ethics committee affects the attitude scores, but has no effect on the cognitive scores.Nursing administrators and educators should consider providing effective and targeted strategies (e.g., ongoing training, scholarly seminars, and scholarly exchanges) to enhance nurses’ knowledge and competence in clinical research ethics to protect subject rights as well as to ensure the quality of clinical research.

A frailty census of older adults in the emergency department and acute inpatient settings of a model 4 hospital in the Mid-West of Ireland

Abstract Background Frailty is a risk factor for presentation to the ED, in-hospital mortality, prolonged hospital stays and functional decline at discharge. Profiling the prevalence and level of frailty within the acute hospital setting is vital to ensure evidence-based practice and service development within the construct of frailty. The aim of this cross-sectional study was to establish the prevalence of frailty and co-morbidities among older adults in an acute hospital setting. Methods Data collection was undertaken by clinical research nurses and advanced nurse practitioners experienced in assessing older adults. All patients aged ≥ 65 years and admitted to a medical or surgical inpatient setting between 08:00 and 20:00 and who attended the ED over a 24-h period were screened using validated frailty and co-morbidity scales. Age and gender demographics, Clinical Frailty Scale (CFS), Charlson Co-morbidity Index (CCI) and admitting specialty (medical/surgical) were collected. Descriptive statistics were used to profile the cohort, and p values were calculated to ascertain the significance of results. Results Within a sample of 413 inpatients, 291 (70%) were ≥ 65 years and therefore were included in the study. 202 of these 291 older adults (70%) were ≥ 75 years. Frailty was investigated using validated clinical cut-offs on the CFS (not frail &lt; 5; frail ≥ 5). Comorbidities were investigated using the Charlson Comorbidity Index (mild 1–2; moderate 3–4; severe ≥ 5). The median CFS was 6 indicating moderate frailty levels, and the median CCI score was 3 denoting moderate co-morbidity. In the inpatient cohort, 245 (84%) screened positive for frailty, while 223 (75%) had moderate-severe co-morbidity (CCI Mod 3–4, severe ≥ 5). No significant differences were observed across genders for CFS and CCI. In the ED, 81 patients who attended the ED were ≥ 65 years. The median CFS was 6 (moderate frailty), and the median CCI was 5 (severe co-morbidity level). Seventy-four percent (60) of participants screened positively for frailty (CFS ≥ 5), and 31% (25) had a CFS of 7 or greater (severely frail). Ninety-six percent (78) of patients had a moderate-severe level of comorbidity. No significant associations were found between the CFS and CCI and ED participants age, gender, and medical/surgical speciality usage. Conclusion There is a high prevalence of frailty and co-morbidity among older adults who present to the ED and require inpatient care. This may contribute to increased waiting times, lengths of stay, and the need for specialist intervention. With an increased focus on the integration of care for older adults across care transitions, there is a clear need for expansion of frailty-based services, staff training in frailty care and multidisciplinary team resources across the hospital and community setting.

The status quo and influencing factors of clinical research nurses' participation in preoperative blood sampling in patients with pulmonary nodules.

Under-recruitment in clinical trials has become a worldwide problem, and has many causes that need to be understood. Clinical Research Nurses (CRNs) provide a new research perspective. To understand the current situation about the informed consent rate after the participation of CRNs and analyse the possible influencing factors. This cross-sectional study was conducted at a hospital. A convenience sample was used to study patients with pulmonary nodules who underwent day surgery from March to May 2023. Patients first received information from doctors and a second session by CRNs was provided for those who initially were hesitant about the research. A questionnaire survey was conducted using an online survey platform to collect information. After education by doctors, 208 patients were hesitant and CRNs conducted a second education session, the CICARE model was used for communication. Following this session a further 161 patients were willing to participate. Finally, 374 patients were willing to participate. Related factors include age, education level and the attitude of self-assessed family members towards their participation in clinical projects. CRNs' participation can improve patients' willingness to participate. It is crucial to pay attention to the role of CRNs and propose a new model of CRNs involvement in clinical research based on identifying factors.

Commentary: The status quo and influencing factors of clinical research nurses' participation in preoperative blood sampling in patients with pulmonary nodules.

Commentary: The status quo and influencing factors of clinical research nurses' participation in preoperative blood sampling in patients with pulmonary nodules.

Abstract PO5-10-06: A Pilot Study for Clinical Research Nurse Navigation at an Urban NCI-Designated Comprehensive Cancer Center

Abstract Background: Breast cancer is now the leading cause of cancer death for non-Hispanic Black women in Georgia with non-Hispanic Black women 40% more likely to die of breast cancer compared to White women. Inadequate representation of patients in clinical trials may contribute to health care inequity, though prior work has also shown disparate outcomes on similar clinical trials at Emory, suggesting differences in tumor biology may also be contributing to the disparity. Improving diversity in trial participation is imperative to better understand these differences, particularly with newer molecularly targeted therapies. We aimed to utilize Clinical Trials Nurse Navigation to increase clinical trial enrollment at an urban NCI-designated comprehensive care center in Atlanta, Georgia. Methods: A prospective pilot study was conducted investigating the role of a Clinical Research Nurse as a dedicated Clinical Trials Nurse Navigator to identify, pre-screen, and refer potential patients to both breast and next generation sequencing (NGS)-driven basket clinical trials at the Winship Cancer Institute at Emory University. The role also included centralizing all molecular data from patients with stage IV breast cancer into a database as a tool to refer patients to NGS-driven clinical trials. This role expands upon the Institute’s current research nursing scope to better meet the needs of our diverse patient population. Our catchment area is 35% non-Hispanic Black or African American. The nurse prescreened patients with stage IV breast cancer from breast oncology clinic templates and the breast NGS database to match them with clinical trials, with a particular emphasis on patients with stage IV triple negative breast cancer. The study began in January 2022 and is currently ongoing. Results: Since study initiation in January 2022, there has been a 27% increase in breast cancer clinical trial enrollment over a 12-month period. Over the last 6 months from January 2023, this has increased even further with 57 patients enrolled onto breast cancer clinical trials compared to a total enrollment of 70 patients onto breast cancer clinical trials in 2022 (Table 1). Of these patients, 11% enrolled in NGS-driven clinical trials in 2022 to present compared to 0% in 2021. Twenty-two (31.4%) non-Hispanic Black women enrolled onto breast cancer clinical trials in 2022 with another 21 (36.8%) non-Hispanic Black women enrolled thus far in 2023 (Table 1). Conclusion: Disparities in clinical trial enrollment may contribute to racial inequities in breast cancer outcomes. Implementation of clinical research nurse navigation has successfully improved clinical trial enrollment and diversity in clinical trial enrollment at our urban cancer center. Through increasing clinical trial prescreening, centralizing an NGS database, and dedicated nurse support to allow patients to navigate onto clinical trials, we achieved a 21% improvement in clinical trial enrollment from 2021 to 2022 and are on track to increase enrollment by 200% by the end of 2023. Clinical trials nurse navigators serve as an essential link between clinical trial patients and their providers, and should strongly be considered a key component of all clinical trials programs. Table 1 Breast Working Group Patient Enrollment by Race and Ethnicity, 2019-2023 Citation Format: Lizzie Huckaby, Maisey Ratcliffe, Madison Canning, Demetria Smith-Graziani, Kevin Kalinsky, Manali Bhave. A Pilot Study for Clinical Research Nurse Navigation at an Urban NCI-Designated Comprehensive Cancer Center [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-10-06.

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

This study aimed to explore the experiences of being a clinical research nurse (CRN), in Sweden. A qualitative study analysing individual interview data. 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. 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. 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. No patient or public contribution.

Advancing Health Equity Through Artificial Intelligence: An Educational Framework for Preparing Nurses in Clinical Practice and Research.

The integration of artificial intelligence (AI) into health care offers the potential to enhance patient care, improve diagnostic precision, and broaden access to health-care services. Nurses, positioned at the forefront of patient care, play a pivotal role in utilizing AI to foster a more efficient and equitable health-care system. However, to fulfil this role, nurses will require education that prepares them with the necessary skills and knowledge for the effective and ethical application of AI. This article proposes a framework for nurses which includes AI principles, skills, competencies, and curriculum development focused on the practical use of AI, with an emphasis on care that aims to achieve health equity. By adopting this educational framework, nurses will be prepared to make substantial contributions to reducing health disparities and fostering a health-care system that is more efficient and equitable.

A day in the life of a clinical research nurse

Have you ever wondered, what does a clinical research nurse (CRNs) do from day-to-day or week-to-week? This article will attempt to answer those questions by including what defines research, clinical research and a CRN. Topics will also include the roles in which CRNs are responsible for or can complete, the challenges they face and their importance in clinical trials. In additional, advantages of being a CRN will be reviewed and how this can powerfully change your view on the career and then stories from CRNs at two major academic research institutes will be reported and how lives are changed because of research nurses. If you read this article and determine that this path may be what you want to pursue or learn more about, the writer has included a section about training and certification which can be reviewed and explored. Also included is knowledge which is helpful to learn when exploring this topic.

121 Impacting Clinical Research Nurses’ Intent to Stay Through Mentoring

OBJECTIVES/GOALS: Clinical Issue/ Practice Problem: A high turnover rate for research nurses was identified between 2017-2022 in the clinical research center at an urban Midwest academic health center. Inexperienced staff and high turnover are barriers to maintaining high-quality research integrity, efficacy, and safety for research projects and participants. METHODS/STUDY POPULATION: Project Implementation: A formal mentorship program was developed based on a curriculum from the International Association of Clinical Research Nursing Scope and Standards of Practice. The six-week project was implemented for research nurses with less than 2 years of experience. Mentees were paired with senior research nurses and met one-on-one weekly. Mentees completed the Anticipated Turnover Scale (ATS) survey in week 1 and week 6. All program participants completed a final evaluation survey. RESULTS/ANTICIPATED RESULTS: Outcomes: There was a one-point average reduction in pre- and post-ATS survey scores. This result supports the theory that mentees were less likely to leave their research role after a formal mentorship program. Qualitative results from the final evaluation survey demonstrate the program had a positive impact and benefits for both the mentees and the mentors. DISCUSSION/SIGNIFICANCE: Clinical Implications: By decreasing turnover rates, a highly competent and knowledgeable research nursing staff is attained to ensure appropriate nursing action and safety profiles for novel therapies.

Enhancing competency of clinical research nurses: A comprehensive training and evaluation framework

The Sun et al 's training program for clinical research nurses (CRNs) in the World Journal of Clinical Cases is a comprehensive and scientific approach. It includes structured frameworks for CRN training, aiming to improve CRN competency. This program emphasizes practical abilities, updates training content, and improves evaluation methods. The cultivation of CRN talents focuses on enhancing the training system, establishing a multifaceted evaluation framework, and continuously refining the training programs. Regular feedback and evaluation are essential to improve CRNs' competency in practical settings.

The role of the clinical research nurse in kidney settings

The ANN UK clinical research nurse survey offers a snapshot into the roles of clinical research nurses working within kidney care, and some of the main challenges they face

A novel research competency framework for clinical research nurses and midwives.

Clinical research nurses and midwives (CRN/Ms) are highly specialised registered nurses. They combine their clinical nursing expertise with research knowledge and skills to aid in the delivery of rigorous, high-quality clinical research to improve health outcomes, the research participant's experience and treatment pathways ( Beer et al 2022 ). However, there is evidence that the transition into a CRN/M role is challenging for registered nurses. To discuss the development of a competency framework for CRN/Ms. The authors identified a gap in their organisation for standards that would support the development of CRN/Ms new to the role. The standards needed to be clear and accessible to use while encompassing the breadth of scope of CRN/Ms' practice. The authors used a systematic and inclusive process drawing on Benner's ( 1984 ) theory of competence development to develop a suitable framework. Stakeholders engaged in its development included research participants, inclusion agents and CRN/Ms. The project identified 15 elements that are core to the CRN/M role and the knowledge, skills and behaviours associated with it. A large NHS trust has implemented the framework. It is also being shown to national and regional networks. Evaluation is under way.

Reimagining the joint task force core competency framework for rural and frontier clinical research professionals conducting hybrid and decentralized trials.

Introduction: Clinical research professionals (i.e., clinical research assistants, clinical research nurses, clinical research coordinators, etc.), as outlined by the Joint Task Force (JTF) Core Competency Framework, are highly trained to support the breadth of clinical trial operations and manage participant care. Clinical research professionals are uniquely equipped with a scope of practice that permits product administration, participant assessments, and data management. As clinical trials grow in complexity and their management expands beyond traditional, site-based operations models to decentralized and/or hybrid models, the need becomes great to ensure adequate staffing. However, rural hospitals frequently lack the research staff or patient recruiters that would allow them to support decentralized clinical trials across a sizeable rural geographic demographic. Methods: This paper examines the contributory factors of the clinical research professional workforce contraction and response efforts at professional and organizational levels within a large, Magnet-designated healthcare system in the rural northwestern United States. Perspectives are shared on adapting the Core Competency Framework to reflect the unique strengths and opportunities towards decentralized trials in rural regions of the United States and areas of priority for workforce cultivation and retention. A descriptive survey was used to gather initial data identifying the current research perspectives of healthcare workers working across a rural community. Participants were asked to complete questions about the JTF Competency domains and behavior-based questions. Analysis: Both competency and behavior-based questions were asked and related to roles. These were then cross-referenced using a Rasmussen Ladder system. Descriptive statistics were conducted for sample characteristics, self-reported competency domain questions, and behavior questions. Results and discussion: Survey findings suggest that although healthcare workers and clinical research teams interact, they are unlikely to ask their patients to participate in research. Based on the limited response rate, results suggest that better education throughout the rural community could benefit from decentralized research efforts. Increased use of technology was also highlighted as an area of interest.

Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses’ experiences

BackgroundClinical research nurses (CRNs) have first-hand experience with ethical challenges and play a crucial role in upholding ethical conduct and adherence to the principles of informed consent in clinical research. This study explores the ethical challenges encountered by CRNs in the process of obtaining informed consent for clinical research.MethodsA qualitative exploratory design. Semistructured interviews (n = 14) were conducted with diverse CRNs in Sweden. These CRNs covered a wide range of research fields, including pharmaceutical and academic studies, interventions, and observational research, spanning different trial phases, patient categories, and medical conditions. The interviews were analysed using inductive qualitative content analysis.ResultsThe analysis identified three main categories: (i) threats to voluntariness, (ii) measures to safeguard voluntariness, and (iii) questionable exclusion of certain groups. CRNs face challenges due to time constraints, rushed decisions, information overload, and excessive reliance on physicians’ recommendations. Overestimating therapeutic benefits in stages of advanced illness emerged as a risk to voluntariness. CRNs outlined proactive solutions, such as allowing ample decision-making time and offering support, especially for terminally ill patients. Concerns were also voiced about excluding certain demographics, such as those with language barriers or cognitive impairments.ConclusionsIn conclusion, upholding ethical research standards requires recognising various factors affecting patient voluntariness. Researchers and CRNs should prioritise refining the informed consent process, overcoming participation challenges, and aligning scientific rigour with personalised care. Additionally, a concerted effort is vital to meet the diverse needs of patient populations, including equitable inclusion of individuals with language barriers or cognitive limitations in clinical studies. These findings have significant implications for enhancing the ethics of clinical research and advancing person-centred care.

How surgical Trainee Research Collaboratives achieve success: a mixed methods study to develop trainee engagement strategies

ObjectivesThis study aimed to understand the role of surgical Trainee Research Collaboratives (TRCs) in conducting randomised controlled trials and identify strategies to enhance trainee engagement in trials.DesignThis is a mixed...

Clinical Research Nursing.

These nurses conduct activities to support clinical research.

Clinical research stakeholders’ experiences of clinical research during COVID-19: a qualitative study

BackgroundThe COVID-19 pandemic created a complex high-risk clinical research environment with clinical research activities significantly impacted. Clinical research stakeholders adapted rapidly to new clinical practices; PPE, infection control policies, all while engaging with a more unwell patient demographic. The aim of this study is to explore the experiences of conducting clinical research during COVID-19 with clinical research stakeholders.MethodsThis qualitative study of semi-structured interviews conducted with clinical research stakeholders in an acute Hospital setting across a variety of disciplines; Consultant Geriatrician, Clinical Research Nurse, Occupational Therapy, Physiotherapy. Interviews were fully transcribed prior to reflexive thematic analysis. NVivo software was used to support data management and analysis.ResultsThree main themes were produced; (1) The challenging COVID-19 clinical research landscape, (2) COVID-19 clinical research communication barriers, and (3) Adaptations and learnings from clinical research during COVID-19.ConclusionsThis study explored the experiences of conducting clinical research during COVID-19 with clinical research stakeholders examining challenges faced and adaptations required. The findings inform, equip and support clinical research stakeholders in the event of future adverse public health events.

Expert consensus on clinical research nurse management in China

ObjectiveWith the rising number of clinical trials conducted in China, the role of clinical research nurses (CRNs) within clinical trial organizations has become increasingly crucial. However, in the absence of industry guidelines, the management of CRNs lacks clarity. This study aims to address this gap by establishing a consensus on CRN management. MethodsThe International Association of Clinical Research Nurses (IACRN)-Shanghai Chapter assembled a panel of experts to develop a consensus on the management of clinical research nurses. This consensus was formulated through an extensive literature review, expert evaluations, and collaborative conference discussions. ResultsThe consensus document offers a comprehensive professional definition of CRNs and provides detailed insights into their management. It covers aspects such as job settings, qualifications, responsibilities, training, assessment, workload management, staffing allocation, performance evaluation, and career progression. ConclusionsEstablishing a professional definition for CRNs creates a standardized reference point for clinical trial institutions to effectively manage these professionals. Consistency in CRNs’ roles, training, staffing, and corresponding assessments is essential for promoting their sustainable and healthy development within the field of clinical research.

Exploration of Lived Experiences and Measurement of Burnout Among US Clinical Research Nurses.

The aims of this study were to explore the experiences of US clinical research nurses supporting the conduct of clinical trials before and during the COVID-19 pandemic and assess dimensions of burnout among these nurses using the Maslach Burnout Inventory-Human Services Survey. Clinical research nurses are a subspecialty of nursing that supports clinical trial conduct. Postpandemic clinical research nurse well-being, including indicators of burnout, has not been established. A cross-sectional descriptive study via online survey was conducted. A sample of US clinical research nurses scored overall high for the Maslach category of Emotional Exhaustion, moderate for Depersonalization, and moderate for Personal Achievement. Themes included together or apart, rewarding but challenging, and surviving or thriving. Supportive measures such as workplace appreciation and consistent change communication may benefit clinical research nurse well-being and reduce burnout during times of unpredicted crisis and beyond.