Abstract
Background
The role of Clinical Research Nurses across the globe has not been evaluated to identify similarities or differences among specific activities.
Aims
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.
Methods
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.
Results
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%).
Conclusion
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.
Keywords: clinical research nurse activities; clinical research nurse global, clinical research nurse profile; clinical research nurse role title; clinical research nurse workforce
Introduction
Clinical research nursing, as a specialty nursing practice, focuses on the care of research participants and the management of clinical trials (Showalter et al., 2017). In 1998, an Oncology Nursing Society (ONS) position statement on cancer research and cancer clinical trials recognized the importance of including registered nurses as integral personnel on research teams (ONS, 1998). Over the ensuing decades, several validated tools were developed for exploring perceptions of Clinical Research Nurse roles and research coordinator roles filled by nurses (Fowler and Stack, 2007; Gibbs and Lowton, 2012; Jones and Wilson, 2013; Kao et al., 2015; Poston and Buescher, 2010) and for delineating the clinical trials’ nurse role in cancer care (Ehrenberger and Lillington, 2004; Hastings, 2012; Mueller, 2001). Meanwhile, the description of career trajectories available in clinical research nursing proved foundational for those Clinical Research Nurses (CRNs) interested in extending the scope of their professional pathway (Bevans et al., 2011; Castro et al., 2011). In 2011, nurse scientists from the National Institutes of Health (NIH) Clinical Center located in Bethesda, Maryland, United States of America (US) conducted a non-experimental, cross-sectional survey to describe activities performed by research nurses and to validate a proposed conceptual framework known as the Clinical Research Nursing Domain of Practice (Bevans et al., 2011). The development and testing of the Clinical Research Nursing Domain of Practice was a turning point in the articulation of clinical research nursing practice. A taxonomy of five distinctive theoretical dimensions (Figure 1) within the domain of practice (Figure 2) resulted from this study: Clinical Practice, Contributing to the Science, Study Management, Human Subjects Protection, and Care Coordination and Continuity (Bevans et al., 2011; Castro et al., 2011).
Figure 1.
Taxonomy structure for the specialty practice of clinical research nursing CRN 2010 Domain of Practice Committee (2009).
Figure 2.
Clinical research nursing domain of practice
The Clinical Research Nursing Domain of Practice includes 56 individual activities conducted by both clinical research nurses providing research-based clinical care and nurses working as study coordinators who manage the protocol specifics (Bevans et al., 2011). With the 2016 publication of the Clinical Research Nursing Scope and Standards of Practice, the five categories within the domain of practice, formally referenced as theoretical dimensions, are now identified as domains (American Nurses Association and International Association of Clinical Research Nurses, 2016).
Clinical Research Nurses are clinical care nurses with the dual accountability of providing and coordinating care of research participants and assuring participant safety, while maintaining integrity of protocol implementation, accuracy of data collection, data recording, and follow-up (Castro et al., 2011). Research participant care is driven by protocol requirements and clinical responses. Study procedures may include detailed clinical assessments, phenotyping to characterize the natural history and etiology of a disease, administration of investigational drugs, performance of investigational surgical and radiological procedures, and delivery of psychosocial interventions (Castro et al., 2011).
Clinical nursing care may be necessitated by participant responses to the study intervention or implications related to their existing disease. Delivering care may be complicated for those nurses working in blended roles who may be responsible for quality assurance of both the research administrative and clinical care of the patient (Larkin et al., 2019; Offenhartz et al., 2008). The nursing workforce within the clinical research nursing specialty has a complex responsibility to ensure that research participants are clinically safe and that the research conducted is of the highest quality (Menzies et al., 2020).
While important steps were taken to isolate and describe the five dimensions within the Domain of Practice and to publish the Clinical Research Nursing Scope and Standards (ANA and IACRN, 2016), few studies to date have been published within the field utilizing the clinical research nursing domain of practice conceptual framework, and none have had an international scope. To build upon previous foundational work, members of the International Association of Clinical Research Nurses (IACRN) designed a study survey to gather data for further describing the current characteristics and role of the clinical research nursing workforce globally by identifying practice settings, geographic locations, and the nature and scope of CRN work. This study’s aims were to determine differences in CRNs’ most frequently performed activities, and to determine if these activities are reflective of those previously described in the literature. It also was seeking to determine job titles CRNs used to self-identify.
Methodology
A cross-sectional study using an online questionnaire via Research Electronic Data Capture (REDCap®) collected data between July 2019 and January 2020. The questionnaire incorporated the 56 items from Bevan’s validated tool (Bevans et al., 2011). Ten demographic questions were used for characterization of the respondents related to gender, age, academic degree preparation, and workplace. CRN respondents then assessed frequency of activities performed and information related to job titles. The data collected was de-identified, not linked to any personally identifiable information and was reported in aggregate. Informed consent was implied when the participant submitted the questionnaire. A pilot study was conducted in 2018 with 10 respondents to ensure feasibility of the survey. Following the pilot, some questions were adapted to reflect the international nature of the CRN workforce.
Inclusion/Exclusion Criteria/Sampling Plan
The inclusion criteria were as follows: nurses licensed/registered to practice according to their country and/or institutional requirements and had completed their job orientation; nurses involved in clinical research study activities in any specialty; and administration or education related to research studies. Exclusion criteria for this study were as follows: nurses who were actively receiving orientation for their current role or not currently working in a research setting or supporting clinical research.
Historically, CRNs are a difficult group to identify and access. These difficulties are accentuated because of diverse work settings and lack of clarity among job titles. Some CRNs practice in dual roles, as a staff nurse and as a clinical research nurse, further blurring identities (American Nurses Association and International Association of Clinical Research Nursing, 2016; Hernon et al., 2020). The CRN can also be referred to as the clinical nurse or staff nurse in the US. Additionally, the research nurse coordinator (RNC) is commonly known as the study coordinator or clinical trials nurse or research nurse (Bevans et al., 2011). Frequently, CRNs function in a blended role, focusing attention on both the patient’s clinical needs and the protocol requirements. Some do not necessarily identify as either CRN or RNC (Larkin et al., 2019).
Given the nature of the group, the full scope of job titles, and the difficulties in accessing CRNs, a snowball sampling approach was deemed to be most effective to obtain the highest number of respondents (Newell and Burnard, 2016). The sampling plan is illustrated in Figure 3.
Figure 3.
Recruitment sampling plan
Data Collection
The membership list of the IACRN was the initial distribution point to potential survey respondents. The IACRN members were requested to forward the information contained in the email to their non-IACRN affiliated CRN/RNC colleagues. The email contained the purpose of, and link to, the questionnaire, directions for completing the survey, instructions on how to re-access the survey if it was not completed in one sitting and how to get help or ask questions if needed. Social media (including LinkedIn, Facebook, and Twitter) were used to maximize the reach of the survey. Additionally, directors in high volume clinical research hospitals and clinics in academic, governmental, community and NIH funded facilities, Centers for Clinical and Translational Science Awards (CTSA) were also contacted with a request to forward the study recruitment information to the local CRNs/RNCs. To further access international colleagues, the study information was sent for posting and distribution to IACRN contacts at the Global Health Research Network, Irish Research Nurse & Midwives, UK Research Nurse Networks and research nurse networks in Africa, Europe, the Middle East, China, and Taiwan.
All collected data were stored electronically in an encrypted file on a secure server at the University of Washington with access limited to the principal investigator and designee. Data were downloaded from REDcap® into a Microsoft Excel file. The dataset was checked for inconsistences and then imported in the IBM® SPSS® Statistics, version 25 for analysis. All data are presented as numbers with their accompanying percentages. Pearson’s chi-square test explored differences between groups. To avoid a type 1 error (also known as a false positive), due to the multiple analyses, a p value of <.001 was required to achieve statistical significance.
Results
Overall, 261 questionnaires were returned through REDcap® from the US, UK, Africa, Asia, Europe, and Oceania. Thirteen questionnaires were lacking responses to ≥10% of the questions and recorded as incomplete. One hundred eighty-three (78.5%) respondents were based in the US followed by 50 (21.4%) from the UK. Responses from countries other than the US and UK returned 15 (Africa (n = 9), Asia (n = 4), Europe (n = 4), and Oceania (n = 2)) leaving 233 responses for analysis. For the remainder of the paper, we will focus on the findings from the US and UK only as the sample sizes for the other locations are too small to allow for meaningful comparisons.
In the UK, 34 (68.0%) of respondents were listed as Clinical Research Nurses compared to 69 (37.7%) of nurses in the US. Eleven nurse educators were based in the US. Bachelor of Nursing was reported by 25 (50.0%) in the UK and US 112 (61.2%). There were four respondents with a PhD in nursing, three working in the US and one in the UK (Table 1).
Table 1.
Profile of survey respondents: N (%).
| All | US | UK | |
|---|---|---|---|
| Gender | |||
| N = 233 | N = 183 | N = 50 | |
| Female | 220 (94.4%) | 175 (95.6%) | 45 (90.0%) |
| Age | |||
| 18–24 years | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| 25–30 years | 16 (6.8%) | 13 (7.1%) | 3 (6.0%) |
| 31–40 years | 42 (18.0%) | 34 (18.6%) | 8 (16.0%) |
| 41–50 years | 74 (31.7%) | 50 (27.3%) | 24 (48.0%) |
| 51+ years | 101 (43.3%) | 86 (47.0%) | 15 (30.0%) |
| Nursing degree | |||
| Bachelor of nursing | 137 (58.7%) | 112 (61.2%) | 25 (50.0%) |
| Master of nursing | 46 (19.7%) | 43 (23.5%) | 3 (6.0%) |
| PhD | 4 (1.7%) | 3 (1.6%) | 1 (2.0%) |
| Workplace | |||
| Academic medical center for outpatient | 45 (19.3%) | 38 (20.8%) | 7 (14.0%) |
| Academic medical center clinical research center for in/outpatient | 100 (42.9%) | 90 (49.2%) | 10 (20.0%) |
| Education—clinical support | 3 (1.2%) | 2 (1.1%) | 1 (2.0%) |
| Other | 21 (9.0%) | 8 (44.0%) | 13 (26.0%) |
| Nursing skills maximized | |||
| No, not at all | 17 (7.3%) | 15 (8.2%) | 2 (4.0%) |
| Less than I would like | 58 (24.9%) | 40 (21.9%) | 18 (36.0%) |
| Usually | 51 (21.8%) | 43 (23.5%) | 8 (16.0%) |
| Most of the time | 75 (32.1%) | 64 (35.0%) | 11 (22.0%) |
| Yes, all the time | 32 (13.7%) | 21 (11.5%) | 11 (22.0%) |
| Role regularly involves | |||
| Recruitment | 120 (51.5%) | 77 (42.1%) | 43 (86.0%) |
| Monitoring for an adverse event | 187 (80.2%) | 143 (78.1%) | 44 (88.0%) |
| Leadership | 169 (72.5%) | 129 (70.5%) | 40 (80.0%) |
USA: United States of America; UK: United Kingdom; CRN: Clinical Research Nurse; RNC: research nurse coordinator.
Of all US and UK respondents, 103 (44.2%) stated that their current role is ‘clinical research nurse’ and 32 (13.7%) listed their current role as “other.” Overall, 137 (58.7%) have a Bachelor of Nursing degree; 45 (19.3%) worked in an academic medical center for outpatients; and 100 (42.9%) in academic medical-clinical research centers for both in patients and outpatients. Two hundred and twenty respondents were female [220 (94.4%)] and 101 (43.3%) were at least 51 years of age. Table 1 describes demographic characteristics.
The majority, 183 (78.5%), of respondents were based in the US followed by the UK 50 (21.4%). The remaining 19 participants came from Africa (n = 9), Asia (n = 4), Europe (n = 4), and Oceania (n = 2). For the remainder of the paper, we will focus on the findings from the US and UK only as the sample sizes for the other locations are too small to allow for meaningful comparisons. In the UK, 34 (68.0%) of respondents were listed as clinical research nurses compared to 69 (37.7%) of nurses in the US. Eleven nurse educators were based in the US. Bachelor of nursing was reported by 25 (50.0%) in the UK and US 112 (61.2%). There were four respondents with a PhD in nursing, three working in the US and one in the UK, Table 1.
Of the 56 activities surveyed, the three most common occurring multiple times per day included: monitoring study participants for potential adverse events 187 (80.2%), collecting study endpoint data 100 (42.9%), and providing nursing leadership within the interdisciplinary team 169 (72.5%). Specific activities that were not part of their role included: serving as an Institutional Review Board (IRB)/Ethics Committee member 202 (86.7%), performing secondary data analysis to contribute to the development of new ideas 125 (53.6%), and supporting study budget development 105 (45.1%).
Comparing the three most common activities performed among the role groups, 13 (72.2%) of RNC and 24 (68.6%) of the combined CRN/RNC engaged in participant recruitment more than once a month and up to multiple times each day. The difference in recruitment activities reported between the US and the UK could be based on role differences (i.e., nurse practitioner versus research nurse coordinator) of the respondents. Most respondents monitor research participants for potential adverse events more than once a month and up to multiple times each day: RNC 18 (100%); CRN 96 (93.2%); and CRN/RNC combined 31 (88.6%). All respondents identifying as nurse managers/clinical managers (100%) indicated they provide nursing leadership within the interdisciplinary team compared to respondents from other roles who were not working in leadership roles.
Seventy-five respondents (32.1%) reported that their clinical research nursing skills were fully maximized within their scope of practice “most of the time”. Fifty-eight (24.9%) replied “somewhat but less than I would like” and 51 (21.8%) selected “usually”. When compared against title of current role, both research nurse coordinators, 5 (27.8%) and others 8 (25.0%) reported that their clinical research nursing skills were “somewhat but less than I would like” in their current setting. Three nurse educators (27.3%) and nine (26.5%) nurse managers/clinical managers reported that their nursing skills were “fully maximized all the time”.
There were large differences in role activities completed by respondents based on country. Most UK respondents 43 (86.0%) participate in research participant recruitment ranging from more than once a month up to multiple times each day compared to 77 (42.1%) US respondents who stated recruitment was not part of their role. There were no differences for the role of “monitoring study participants for potential adverse events more than once a month to multiple times per day” for 44 (88.0%) of UK and 143 (78.1%) of US respondents, respectively. Respondents indicated that “providing nursing leadership within the interdisciplinary team” was part of their role more than once a month to multiple times each day by 40 (80.0%) of UK and 129 (70.5%) of US respondents, respectively. However, 28 (15.3%) of US respondents indicated that “leadership” did not form part of their role.
Other activities relative to indirect nursing care (participation in clinical, unit, and/or protocol rounds: scheduling study-related tests, etc. in the context of research participation) were acknowledged as part of their role by 145 (79.2%) of US and 47 (94%) of UK respondents. Similarly, other activities including documentation of research data and participant responses in approved source documents and administration of an investigational research product was reported by 152 (83.1%) of US and 49 (98.0%) of UK respondents. Obtaining informed consent, an activity integral to the research process, was reported by 114 (62.3%) of US and 47 (94.0%) of UK respondents as part of their role.
Discussion
Results from this study suggest that the activities described within the domains of practice vary among respondents based on work settings. The activities most frequently identified included leadership, safety reporting and recruitment. The leadership activity varied by practice setting and was not consistently reported. However, 70% of the US and 80% of the UK respondents reported that leadership is a function they provide with the interdisciplinary team. According to the White House Report (2018) an additional domain within the original domains of practice could be the addition of “meaningful oversight” which includes team management and leadership.
Some studies from Asia (Liu et al., 2007; Yoshida et al., 2012) reported tasks for CRNs included updating trial documents, informing patients of study visits and patient education, and collecting data relative to adverse events. In Australia (Wilkes et al., 2012), the focus of the CRN is on data management, subject recruitment, informed consent, study implementation, and assisting with treatments. These findings within the literature demonstrate the many similarities of tasks conducted by Clinical Research Nurses globally.
The results from this study reflect the growing body of literature that indicates that the CRN role has diversified and grown in stature over the last 20 years (Hernon et al, 2019, 2020; Hill and MacArthur 2006; Gibbs and Lowton 2012; Ledger et al. 2008). This includes some CRNs who have developed a career trajectory that has culminated in research leadership (e.g., Clinical Research Management or taking on co-investigator status) (Brinkman-Denney, 2013). Importantly, this study confirms that these attributes appear to be trans-national and reflect the importance of the role globally in clinical research.
The job titles reported by respondents included clinical research nurse, research nurse coordinator, CRN/RNC, manager, educator, associate director, nurse navigator, regulator nurse specialist, research specialist, research monitor, quality assurance nurse, and auditor. Nurses commonly have assigned job titles fitting their current role in the research setting in which they work and there does not appear to be standardization. However, specific responsibilities of the nurse can often be categorized under the umbrella of the job description for the Clinical Research Nurse or the research nurse coordinator. Again, this is reflected in international literature (Rickards and Roberts, 2008; Smith et al., 2018). A consequence of the wide variety of job titles could be that transition into the role and career progression could be problematic (Hernon et al, 2020). It can also make estimates of how many nurses are filling such a role very difficult to ascertain.
While many similarities in participation of protocol related activities and patient care activities were noted, the divergence of activities could be explored more fully in depth to determine if the differences are in fact related to country or role. Some differences could be due to regulatory differences by country, or stipulations set out by study sponsors. Nevertheless, this again identifies some differences in the roles and responsibilities internationally.
The information obtained from this study provides the opportunity to further refine the description of the specialty practice of clinical research nursing as a whole and serves as a foundation to further delineate specialty activities across roles and practice settings globally. By further refining and communicating the role and the value that the research nurse brings to the research enterprise, the more research teams will be better informed of the importance this role fills. Since many teams are trying to fill research roles with non-nurses in order to reduce cost, it can be a risk to omit the nurse when patient care and nursing assessments are critical to maintaining patient safety. The results of this study provide implications for future work to focus on international research nurses to gain a deeper understanding of their demographics, research activities and training opportunities. The results of this study indicate that there are differences in activities performed by research nurses based on geographic location and practice setting. The additional category of leadership identified by Purdom et al. (2011), which was not included as a dimension in the original Domain of Practice, was found to be an activity that should be considered as an additional domain for practice.
Limitations
Limitations of this study include aspects of the sample recruitment plan and the survey instrument. The snowball sampling plan was not as effective in reaching CRNs outside the US. Specifically, in reaching CRNs in Asia and other countries thereby losing the opportunity for making stronger comparisons. Access to CRNs in general has been discussed as difficult because of diverse work settings and the many job titles used by CRNs. This difficulty was reflected in the low number of responses.
A limitation of the survey instrument surfaced in the area of identifying areas of specialty practice and resources for education. Midwifery and nurse anesthetist are two specialties not listed where nurses are involved in clinical research. Nurse anesthetist-led care is available in the US and midwifery-led care is available in the EU, UK, Australia, and New Zealand. Both specialties should be explored in future research.
Conclusion
Building on previous studies (Bevans et al. (2011) and Purdom et al. (2017)), this study found that nurses working in clinical research settings across the globe participate in activities described in the original Domain of Practice model. The information obtained provides the opportunity to further refine the description of the CRN workforce and to consider revising it to include a leadership domain in future research. Opportunities exist to replicate or further explore the CRN role within a broader sample. A broader domain of practice will better serve as a foundation for the specialty practice. From the results of this study, targeted opportunities for role-based training can be developed to focus specifically on role-based competencies.
Key points for policy, practice and/or research
• This is the first international role delineation study on the job titles, training, and role descriptions for CRNs across the globe.
• Nurses play an important role in caring for clinical research participants and ensuring integrity of clinical research studies.
• Differences in Clinical Research Nurse activities vary by country.
Acknowledgments
The lead author would like to thank the members of the International Association of Clinical Research Nurses (IACRN) for their encouragement and interest in the topic.
Biography
Cheryl Fisher, EdD, RN, Associate Professor, University of Maryland Baltimore, School of Nursing in Baltimore, Maryland. Research interests include topics involving clinical research nurses and education.
Catherine A Griffith, Ph.D, RN is an Advisor to the MUNN Center Clinical Research Nurse Collaborative at Massachusetts General Hospital, Boston, MA. USA. Catherine's research interest includes role delineation and the diffusion of innovation.
Hyacinth Lee, PhD, RN is a Clinical Research Nurse Manager and oversees day to day operations of the Translational Research Unit at the University of Washington Medical Center, Seattle, Washington
Hazel A Smith, PhD, RM, is a member of the research committee of the International Association of Clinical Research Nurses (IACRN) and is Past Chair of the Irish Research Nurses & Midwives (IRNM).
Carolynn T Jones, DNP, MSPH, RN, FAAN is Associate Professor of Clinical Nursing at College of Nursing at The Ohio State University and Co-Director of Workforce Development at the OSU CCTS.
Kathleen A Grinke, MSN, RN is a Senior Clinical Research Nurse at the Translational and Clinical Research Center, Massachusetts General Hospital, Boston, MA. Member IACRN Research Committee and IRB Member.
Rosemary Keller PhD, FNP-BC RN, Clinician Director Global Product Development Pfizer, Inc. Research experience includes study coordinator, managing research sites and working in clinical development in the pharmaceutical industry.
Georgie Cusack, MS, RN, AOCNS, Director of Education and Patient Safety, the National Heart, Lung and Blood Institute, Adjunct Nurse leader in Nursing Research and Translational Science, NIH Clinical Center
Shaunagh Browning, DNP, RN, FNP-BC Director of the Office of Research Quality Assurance, and adjunct instructor at Georgetown University. Over 30 years of experience in various roles throughout the research process.
Gordon Hill, ProfD, MSc, BA, RGN, Senior Lecturer, Glasgow Caledonian University. Research interests include roles and responsibilities of Clinical Research Nurses, Research Ethics and Research Methodologies.
Footnotes
Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Carolynn T Jones is funded, in part, by NIH-Clinical Translational Science Award Grant.
Ethics: On 2019, July 22, this study, (IRB ID: STUDY00007936), was assessed and approved through the Human Subjects Division (HSD) of the University of Washington, Seattle, Washington, USA. HSD determined that this study qualified for exempt status.
ORCID iDs
Cheryl A Fisher https://orcid.org/0000-0002-2884-8113
Hazel A Smith https://orcid.org/0000-0001-5538-0897
Carolynn T Jones https://orcid.org/0000-0002-0669-7860
Shaunagh Browning https://orcid.org/0000-0002-9321-4993
Gordon Hill https://orcid.org/0000-0002-8633-5172
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