In August 2016, the International Association of Clinical Research Nurses announced that the American Nurses Association (ANA) formally recognized the specialty practice of clinical research nursing. The approved scope of practice for the clinical research nurse (CRN) specialty notes that most educational nursing programs do not expose students to this specialty practice. Further, most CRNs learn of the specialty by chance during their careers and obtain knowledge and skills necessary to perform in this role through on-the-job training (ANA, 2016). No research has been published assessing the level of awareness and understanding of the CRN role and clinical research among nursing students.
Although CRNs support research, they are not the same as nurse researchers or nurse scientists who lead and conduct programs of research to advance the practice of nursing (ANA, 2016). The CRN role emphasizes the care of research participants and the coordination of research activities to support clinical trials (ANA, 2016; Hastings, Fisher, & McCabe, 2012), and CRNs bring a holistic patient care approach to a clinical trial (Gibbs & Lowton, 2012). Clinical research nurses are vital members of clinical research teams (Gibbs & Lowton, 2012; Poston & Buescher, 2010) and are a link between the patient, investigator, study sponsor, and other administrative and ancillary staff (Caselgrandi, Guaraldi, Cottafavi, Artioli, & Ferri, 2016). Highly trained and skilled CRNs can take on many of the responsibilities of a clinical study, function as subinvestigators, and perform clinical study tasks to alleviate the recognized shortage of physician investigators (Sung et al., 2003).
Success as a CRN requires the proper education and experience to become competent in the specialty (Ledger, Pulfrey, & Luke, 2008). Training and education programs must focus on professional competency to develop an effective CRN workforce (Sonstein et al., 2014). The Clinical Research Nursing Scope and Standards of Practice recommends a baccalaureate degree as the minimum education criterion for a CRN but suggests that many new nurses from baccalaureate programs are unaware of the specialty (ANA, 2016). Nurses often learn about the CRN role during their careers when they interact with CRNs in a clinical setting or when they are asked to take on clinical study responsibilities while working as staff nurses, which has led to a practice of on-the-job learning and a reliance on protocol-specific training provided by clinical study sponsors (ANA, 2016).
Experienced CRNs who have transitioned from staff nurses to the CRN role in an on-the-job training manner have described a difficult transition period characterized by uncertainty, frustration, and a lack of motivation (Hemingway & Storey, 2013; Micklos, 2016; Spilsbury et al., 2008). Carter, Jester, and Jones (2007) noted the ad hoc learning of many CRNs is highly variable and not based on a defined body of knowledge. Galassi et al. (2014) found that nurse executives and staff development directors believed that clinical research knowledge and skills are important for practicing nurses, and nursing school deans acknowledged that knowledge and skills in clinical research are becoming essential for nurses to be safe practitioners.
As clinical studies become more complex and prevalent throughout health care environments and community settings, a nursing workforce that is knowledgeable and competent in clinical research is needed. However, the clinical research nursing specialty is relatively unknown, and new nurses are often unaware of the importance of clinical research to professional practice (Galassi et al., 2014). Lack of awareness of the CRN role negatively affects CRN job satisfaction and causes many CRNs to feel invisible in their organizations (Kunhunny & Salmon, 2017). Nursing students should be exposed to the CRN role so they can consider it as a viable and rewarding career pathway (Kunhunny & Salmon, 2017) and pursue clinical research nursing education and training. Nursing students who pursue clinical specialties should also understand the role of a CRN so they can effectively communicate and work with practicing CRNs to promote safe and ethical clinical research. Whitehouse (2017) found that when nursing students complete clinical placements with research teams for as little as half a day, they feel more confident in their ability to identify potential research participants and refer them to study teams. Therefore, the purpose of this study was to assess the current level of awareness and understanding of the clinical research nursing specialty and the effect of clinical studies on nursing practice in fourth-year students in baccalaureate nursing programs.
Participants of this quantitative, descriptive, pilot study were recruited from baccalaureate nursing programs in the United States. A cover letter was e-mailed to the faculty of nursing programs based on convenience and availability of online contact information. The letter requested that the faculty distribute the survey link to eligible students. Students accessed the online survey, reviewed the informed consent statement, and completed two eligibility questions. Students deemed eligible could proceed with the survey.
Nursing students were eligible for the study if they indicated that they were in the final year of a baccalaureate nursing program. Participants were required to review the participant statement on the first page of the survey and they were considered to have voluntarily consented if they proceeded past this page. Participation in the study also required access to a computer with Internet, and the survey was only available in English. The A.T. Still University Institutional Review Board approved this research project.
A novel survey instrument was developed for the study. The content of this survey was derived from the expertise of the researcher, the Clinical Research Nursing Scope and Standards of Practice (ANA, 2016), and information about clinical research education identified by Galassi et al. (2014). The survey included six demographic items to capture relevant participant characteristics. The questionnaire portion of the survey started with two yes-or-no questions to assess awareness of the specialty. This was followed by 22 Likert-type questions that assessed understanding of the specialty practice and understanding of the effect of clinical trial participation on nursing practice. Responses were collected on a 5-point scale ranging from strongly disagree to strongly agree. An initial version of the survey was distributed to experienced CRNs for feedback to establish content validity. Feedback from an experienced biostatistician was also obtained and incorporated into the final survey design. The final online survey was then pilot tested by experienced nurses to establish face validity, ensure the language in the survey was clear and understandable for the target population, and validate the functionality of the online survey in SurveyMonkey® prior to distribution of the survey link to potential participants.
Statistical analyses were performed using SPSS® version 24 software. Descriptive statistics (e.g., mode, minimum, maximum, frequency, percentage) were calculated for participant characteristics. Frequencies and percentages were calculated for questionnaire items. Chi-square, Spearman's rho, and rank–biserial correlation tests were performed to assess correlations between participant characteristics and questionnaire responses, with significance set at an alpha level of .05, two-tailed.
From April 10 to May 31, 2017, 102 participants attempted the online survey. Four participants were deemed ineligible after completing the screening questions. Five eligible participants completed some demographics questions but skipped all items on the questionnaire portion of the survey. These nine participants were removed from the data set, resulting in 93 participants with data available for analysis.
Participants were from 13 states and the District of Columbia, representing 14 of the 51 schools of nursing that were asked to distribute the survey to eligible students. The median participant age was 25 years, with a minimum age of 20 and a maximum age of 59 years. Many of the participants were female (95.7%). Students in traditional Bachelor of Science in Nursing (BSN) programs made up 43% of the sample (n = 40), with 30.1% (n = 28) in RN-to-BSN programs, 23.7% (n = 22) in second-degree or accelerated BSN programs, and 3.2% (n = 3) in Licensed Practical Nurse/Licensed Vocational Nurse-to-BSN programs. Most participants did not have a nursing license (n = 59). For the 33 participants who did have a nursing license, 10.8% (n = 10) had fewer than 2 years of nursing experience, 7.5% (n = 7) had 2 to 5 years, 18.3% (n = 17) had more than 5 years, and one participant did not respond (Table 1).
Participant Characteristics (N = 93)
Two survey questions were used to assess awareness of the clinical research nursing specialty practice. Most participants (82.8%) indicated that they were aware that some nurses specialize in the care of patients who participate in clinical studies. When participants were asked if they were aware that the ANA recognizes clinical research nursing as a specialty practice, 51.6% responded yes (Table 2).
Items Assessing Clinical Research Nursing Awareness
The detailed results for each Likert-type item are provided in Table 3. For reporting purposes, those who indicated that they strongly disagreed or disagreed with an item were classified as disagreed. Those who indicated that they agreed or strongly agreed with an item were classified as agreed. All neutral responses were classified as neither agreed nor disagreed. Cronbach's alpha for the 22 Likert-type items in the questionnaire was .725, indicating adequate reliability.
Items Assessing Understanding of Clinical Research and the Effect of Clinical Trials on Nursing Practice
Most participants agreed that they are familiar with the clinical research process (72.5%) and that they understand the role of a CRN (61.9%). When asked if they understood the difference between a CRN role and the roles of nurse investigators or nurse researchers, 40.2% disagreed and 32.6% agreed. Forty-three percent of participants disagreed that they understand how to effectively collaborate with CRNs, and 36.6% indicated that they agreed.
Nearly all participants (99%) agreed that nurses play a role in protecting the rights and welfare of patients in clinical studies. Most participants (89.1%) agreed that it is important for them to know if their patients are participating in clinical studies, and that understanding clinical research is important to their future nursing practice (93.5%). When asked about research ethics, 80.7% agreed that they understand the ethical considerations related to clinical research, and 71.3% agreed that they had received sufficient training in research ethics and human subjects protection.
Although most survey participants (64.6%) agreed that they were interested in learning more about clinical research, 29% agreed that they were interested in a career as a CRN with 37.6% disagreeing. When participants were asked if they understand enough about clinical research to support research teams, 38.2% disagreed and 31.5% neither agreed or disagreed. Finally, 85.9% of participants agreed nurses play an important role in clinical study recruitment, and 74.2% disagreed it was unlikely they would encounter clinical study participants in their future nursing practice.
A chi-square analysis of nursing license status and the responses to both awareness questions yielded no statistically significant results. A Spearman's rho test found that years of nursing experience was associated with responses to the item “I understand how to effectively collaborate with CRNs when caring for patients who are participating in clinical studies” (rs = .229, p = .027). There was also a significant correlation between years of nursing experience and the item “I am interested in a career as a clinical research nurse” (rs = .256, p = .013) . A rank–biserial correlation test found that nursing license status was associated with the item “I am interested in a career as a clinical research nurse” (rrb = .294, p = .004), and an association between nursing license status and the item “I understand how to effectively collaborate with CRNs when caring for patients who are participating in clinical studies approached statistical significance” (rrb = .189, p = .071). No other statistically significant correlations were observed.
Well-trained clinical research nurses play an important role in maintaining quality in clinical studies (Ledger et al., 2008). The International Association of Clinical Research Nurses and ANA suggest that new nurses from baccalaureate programs are unaware of the clinical research nursing specialty (ANA, 2016). Results from this study indicate that most nursing students are aware that some nurses specialize in the care of clinical study participants, but only half are aware that the specialty is formally recognized by the ANA. This may be because the specialty was only recently recognized. With only one third of participants indicating that they understand the difference between a CRN role and the role of nurse investigators or nurse researchers, it appears nursing students do not fully comprehend the unique and important work CRNs perform. This lack of understanding may partially explain why less than one third of nursing students are interested in a career as a CRN.
Nearly all respondents agreed that nurses play an important role in the protection of clinical study participants and that an understanding of clinical research is important to nursing practice. This is consistent with the beliefs of nurse executives, educators, and staff development directors, but these results are surprising given reported evidence that new nurses often do not fully recognize the importance of clinical research knowledge to nursing practice (Galassi et al., 2014). It is unclear whether nursing students fully appreciate the importance of clinical research knowledge to nursing practice, but it seems they are aware it is important to some extent.
Despite being aware of the CRN role and understanding that clinical research knowledge is important to nursing practice, only one third of respondents indicated that they know how to effectively collaborate with CRNs and less than half agreed that they understand how to support research teams. Hastings et al. (2012) pointed out that clinical research is expanding into community and practice-based environments where the contributions of nonresearch staff to clinical studies is becoming more important. It is likely that nurses in all specialties and settings will interact with clinical study participants (Galassi et al., 2014). If new nurses do not understand how to partner with CRN colleagues and other members of research teams, the ability to implement more pragmatic clinical studies that integrate research into clinical practice will be hindered. The observed association between years of nursing experience and an understanding of how to collaborate with CRNs may suggest a gap in current nursing education programs.
To increase awareness and understanding of clinical research and the CRN role, nurse educators might consider a variety of strategies. The research elements of nursing education curricula could be revised to include an overview of good clinical practices and principles of research ethics. Nurse educators could present relevant case studies and facilitate interactive group discussions that focus on ways in which nurses can protect the rights and welfare of clinical study participants. The purpose of a clinical study protocol could be described, with an emphasis on the key role nurses play in balancing protocol requirements with patient care needs to ensure research fidelity. Finally, preceptorships could be arranged for students interested in a career as a CRN, giving them opportunities to gain experience on a clinical study team. Implementing these strategies would help to build a nursing workforce that is better prepared to safely care for patients in clinical studies and fill critical roles on research teams.
This research has three important limitations. First, the low response rate may inhibit the generalizability of the study findings. Second, the survey tool is new and additional validation could enhance the precision of the survey items and allow for the calculation of meaningful summary scores. Finally, the survey assesses self-reported perceptions but does not measure true levels of knowledge and understanding of concepts. Additional research is needed to determine the key knowledge that all nurses should have to safely care for clinical study participants and effectively collaborate with research teams.
Nurses play a critical role in the conduct of clinical research. The results of the current study suggest that nursing students are aware of clinical research and they understand the importance of clinical research knowledge to nursing practice. However, they are not fully aware of the role of clinical research nurses, and they do not have the necessary training to support clinical research teams. As clinical research becomes more prevalent throughout all areas of health care, nursing education programs should better prepare students to effectively interact with research teams, assume CRN roles, and protect the rights and welfare of patients who participate in clinical trials.
- American Nurses Association. (2016). Clinical research nursing: Scope and standards of practice. Silver Spring, MD: Author.
- Carter, S.C., Jester, P.M. & Jones, C.T. (2007). Issues in clinical research manager education and training. Research Practitioner, 8, 48–72.
- Caselgrandi, A., Guaraldi, G., Cottafavi, K., Artioli, G. & Ferri, P. (2016). Clinical research nurse involvement to foster a community based trans-cultural research in RODAM European study [Supplemental material]. Acta Bio-Medica: Atenei Parmensis, 87, 80–87.
- Galassi, A.L., Grady, M.A., O'Mara, A.M., Ness, E.A., Parreco, L.K., Belcher, A.E. & Hastings, C.E. (2014). Clinical research education: Perspectives of nurses, employers, and educators. Journal of Nursing Education, 53, 466–472. https://doi.org/10.3928/01484834-20140724-04 doi:10.3928/01484834-20140724-04 [CrossRef]
- Gibbs, C.L. & Lowton, K. (2012). The role of the clinical research nurse. Nursing Standard, 26(27), 37–40. https://doi.org/10.7748/ns.26.27.37.s54 doi:10.7748/ns.26.27.37.s54 [CrossRef]
- Hastings, C.E., Fisher, C.A. & McCabe, M.A. (2012). Clinical research nursing: A critical resource in the national research enterprise. Nursing Outlook, 60, 149–156, e3. https://doi.org/10.1016/j.outlook.2011.10.003 doi:10.1016/j.outlook.2011.10.003 [CrossRef]
- Hemingway, B. & Storey, C. (2013). Role of the clinical research nurse in tissue viability. Nursing Standard, 27(24), 62–68. doi:10.7748/ns2013.02.27.24.62.e7113 [CrossRef]
- Kunhunny, S. & Salmon, D. (2017). The evolving professional identity of the clinical research nurse: A qualitative exploration. Journal of Clinical Nursing, 26, 5121–5132. https://doi.org/10.1111/jocn.14055 doi:10.1111/jocn.14055 [CrossRef]
- Ledger, T., Pulfrey, A. & Luke, J. (2008). Developing clinical research nurses. Nursing Management, 15(2), 28–33. https://doi.org/10.7748/nm2008.05.15.2.28.c8217 doi:10.7748/nm2008.05.15.2.28.c8217 [CrossRef]
- Micklos, L. (2016). The nephrology clinical research nurse role: Potential role conflicts. Nephrology Nursing Journal, 43, 257–261.
- Poston, R.D. & Buescher, C.R. (2010). The essential role of the clinical research nurse (CRN). Urologic Nursing, 30, 55–63, 77. doi:10.7257/1053-816X.2010.30.1.55 [CrossRef]
- Sonstein, S.A., Seltzer, J., Li, R., Silva, H., Jones, C.T. & Daemen, E. (2014). Moving from compliance to competency: A harmonized core competency framework for the clinical research professional. Journal of Clinical Research Best Practices, 10(6), 1–12.
- Spilsbury, K., Petherick, E., Cullum, N., Nelson, A., Nixon, J. & Mason, S. (2008). The role and potential contribution of clinical research nurses to clinical trials. Journal of Clinical Nursing, 17, 549–557. https://doi.org/10.1111/j.1365-2702.2006.01872.x
- Sung, N.S., Crowley, W.F., Genel, M., Salber, P., Sandy, L., Sherwood, L.M. & Rimoin, D. (2003). Central challenges facing the national clinical research enterprise. Journal of the American Medical Association, 289, 1278–1287. https://doi.org/10.1001/jama.289.10.1278 doi:10.1001/jama.289.10.1278 [CrossRef]
- Whitehouse, C.L. (2017). Nursing students' experience of research during clinical placements. Nursing Standard, 31(38), 47–55. https://doi.org/10.7748/ns.2017.e10539 doi:10.7748/ns.2017.e10539 [CrossRef]
Participant Characteristics (N = 93)
| Traditional BSN||40||43|
| Second degree/ABSN||22||23.7|
|Current nursing license|
| Yes (RN)||31||33.3|
| Yes (LPN/LVN)||2||2.2|
|Nursing experience (years)a|
| N/A (no nursing license)||59||63.4|
| Fewer than 2||10||10.8|
| 2 to 5||7||7.5|
| More than 5||17||18.3|
| District of Columbia||2||2.2|
| North Carolina||8||8.6|
| New Mexico||4||4.3|
| West Virginia||14||15.1|
Items Assessing Clinical Research Nursing Awareness
|Questionnaire Item||Yes % (n)||No % (n)|
|Prior to participating in this survey, were you aware that some nurses specialize in clinical research and the care of patients who participate in clinical studies?||82.8 (77)||17.2 (16)|
|Prior to participating in this survey, were you aware that clinical research nursing is a specialty practice officially recognized by the American Nurses Association?||51.6 (48)||48.4 (45)|
Items Assessing Understanding of Clinical Research and the Effect of Clinical Trials on Nursing Practicea
|Questionnaire Item||Valid % (n)|
|Strongly Disagree||Disagree||Neutral||Agree||Strongly Agree|
|I am familiar with the clinical research process.||3.3 (3)||8.8 (8)||15.4 (14)||60.4 (55)||12.1 (11)|
|I understand the role of clinical research nurses.||3.3 (3)||13 (12)||21.7 (20)||57.6 (53)||4.3 (4)|
|I understand the roles of nurse investigators and nurse researchers, and how these are different from a CRN role.||9.8 (9)||30.4 (28)||27.2 (25)||28.3 (26)||4.3 (4)|
|I understand how to effectively collaborate with CRNs when caring for patients who are participating in clinical studies.||5.4 (5)||37.6 (35)||20.4 (19)||31.2 (29)||5.4 (5)|
|It is important for me to know if my patients are participating in clinical studies.||2.2 (2)||2.2 (2)||6.5 (6)||46.7 (43)||42.4 (39)|
|I understand the difference between clinical research procedures and medical treatment.||3.2 (3)||7.5 (7)||9.7 (9)||58.1 (54)||21.5 (20)|
|An understanding of clinical research is important to my future nursing practice.||1.1 (1)||1.1 (1)||4.3 (4)||62 (57)||31.5 (29)|
|Nurses play a role in protecting the rights and welfare of patients who participate in clinical studies.||1.1 (1)||0 (0)||0 (0)||36.6 (34)||62.4 (58)|
|I would be comfortable caring for a patient who is participating in a clinical study.||1.1 (1)||2.2 (2)||5.4 (5)||62.4 (58)||29 (27)|
|I understand the ethical considerations related to clinical research and the care of patients in clinical studies.||1.1 (1)||3.2 (3)||15.1 (14)||44.1 (41)||36.6 (34)|
|I am interested in learning more about clinical research.||3.2 (3)||5.4 (5)||26.9 (25)||49.5 (46)||15.1 (14)|
|I am interested in a career as a clinical research nurse.||8.6 (8)||29 (27)||33.3 (31)||20.4 (19)||8.6 (8)|
|I have received sufficient training in research ethics and human subjects protection to ensure the rights and welfare of patients who are participating in clinical studies are respected.||3.2 (3)||19.4 (18)||16.1 (15)||45.2 (42)||16.1 (15)|
|I would feel comfortable talking to patients about potential opportunities and disadvantages of participating in clinical studies.||0 (0)||16.1 (15)||16.1 (15)||53.8 (50)||14 (13)|
|I feel clinical research work is not patient-centered work.||18.3 (17)||67.7 (63)||9.7 (9)||2.2 (2)||2.2 (2)|
|I feel clinical research work is limited to only a few specific areas such as oncology and the pharmaceutical industry.||22.8 (21)||56.5 (52)||10.9 (10)||6.5 (6)||3.3 (3)|
|I feel there are too few opportunities available in clinical research to choose this as a viable career path.||10.8 (10)||32.3 (30)||32.3 (30)||20.4 (19)||4.3 (4)|
|I understand enough about clinical research to support research teams.||4.3 (4)||23.9 (22)||31.5 (29)||33.7 (31)||6.5 (6)|
|Understanding the drug and medical device development process can help me to better understand the risks and side effects of drugs and medical devices.||1.1 (1)||3.3 (3)||4.3 (4)||65.2 (60)||26.1 (24)|
|Understanding clinical research can help me to better answer questions of patients enrolled in clinical studies.||1.1 (1)||0 (0)||4.3 (4)||63 (58)||31.5 (29)|
|Nurses may play an important role in the identification and recruitment of patients for clinical studies.||1.1 (1)||1.1 (1)||12 (11)||62.0 (57)||23.9 (22)|
|I believe it is unlikely that I will encounter clinical study participants in my future nursing practice.||31.2 (29)||43 (40)||15.1 (14)||7.5 (7)||3.2 (3)|