Art & science | literature review
An international comparison of the clinical trials nurse role While some countries accord research clinicians the status of advanced specialist practitioners, there is no universal consensus. Sandra Brinkman‑Denney reports on a study to investigate the similarities and differences worldwide Correspondence sandra.brinkman-denney@ comcast.net Sandra Brinkman-Denney was a graduate student (US)/postgraduate student (UK) at Drexel University, Philadelphia, Pennsylvania, at the time of writing Date of submission February 2 2013 Date of acceptance November 2 2013 Peer review This article has been subject to doubel-blind review and checked using antiplagiarism software Author guidelines nm.rcnpublishing.com
Abstract The collaborative role of clinical trials nurses (CTNs) is crucial to the management of research protocols in clinical settings. As part of a literature review of ten articles, comparisons were made of CTN roles in countries across North America, Europe and the Asia‑Pacific region. The research looked at collaborative competencies relating to issues ranging from protocol assessment and informed consent to the research team and study site management. It found that this aspect of CTNs’ advanced specialty role in clinical trials research meets the requirements of standards of professional nursing practice in the US, but that in some nations CTNs have different scopes of practice, so more research is needed to clarify and standardise the role. Key words Advanced specialty role, clinical research, clinical trials nurse, collaborative competencies, nursing competencies, role of collaboration WITH ADVANCES in clinical science, the generic nursing role has developed into a number of advanced specialties (American Nurses Association (ANA) 2010a). One of these is the clinical trials nurse (CTN), a role that has evolved due to growing opportunities for nurses to become involved in research. Over the past few decades, there have been attempts to define the role formally worldwide; although this has occurred to a greater degree in the UK and the US (Offenhartz et al 2008, Spilsbury et al 2008), descriptions vary (Box 1), and the definitions continue to evolve.
32 December 2013 | Volume 20 | Number 8
Despite the development of the CTN role as a discrete advanced specialty, underpinned by the growth of graduate nursing programmes in clinical trials nursing, the role has not been recognised formally by the ANA. However, in accordance with the definitions outlined in Box 1, the author considers it to be an advanced specialty role and that it should be recognised as such. For the purpose of this article, CTN refers to any nurse who works in clinical research and has collaborative responsibilities in relation to conducting clinical trials (Oncology Nursing Society (ONS) 2010).
Scope of practice The ANA identifies 16 standards of professional nursing practice that address behaviours for registered nurses, postgraduate specialty nurses or advanced practice registered nurses (ANA 2010a). Standard 13, on collaboration, includes several competencies that apply to CTNs. In research, CTNs collaborate and communicate with study participants, the principal and co-investigators, institutional review boards (IRBs) and independent ethics committees (IECs), the sponsors, staff nurses and physicians on the research team, laboratory staff, and any other members of the team (Food and Drug Administration (FDA) 1996, Green 2011). In accordance with the scope and standards of nursing practice (ANA 2010a), CTNs are in a position to educate and share knowledge with all members of research teams, study participants and their families, and the wider community. These roles serve to ensure good outcomes for research participants, research teams and communities at large, which ultimately benefit NURSING MANAGEMENT
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Box 1 Definitions of the role of clinical trials nurses Each organisation has its own titles for the role. These include clinical trials nurse (CTN), clinical research nurse and research nurse co-ordinator. National Institutes of Health Clinical Center
The scope of the role is subdivided into two aspects: – Clinical research nurses, who are clinical staff nurses with a ‘central focus on care of research participants’. – Research nurse co-ordinators, who are ‘primarily responsible for study co-ordination and data management, with a central focus on managing participant recruitment and enrolment, consistency of study implementation, data management and integrity, and compliance with regulatory requirements and reporting’.
Royal College of Nursing
Clinical trials nurses are staff who collaborate with all team members for the purpose of successful research projects and they should be recognised, therefore, as having an advanced specialty role. They should be proficient and practised resources for research participants, staff and researchers.
UK Clinical Research Collaboration
A clinical research nurse is defined as any nurse ‘employed to principally undertake research in the clinical environment’.
US Oncology Nursing Society
Clinical trials nursing is a ‘specialty nursing role requiring a unique framework of knowledge for working with study participants involved in clinical research trials’. The society also recognises that the CTN role has many titles, including clinical trials co-ordinator, clinical research nurse and protocol co-ordinator.
(UK Clinical Research Collaboration 2007, Clincial Research Nursing 2010 Domain of Practice Committee 2009, US Oncology Nursing Society 2010, Royal College of Nursing 2011)
from better clinical care. Clinical trials nurses are essential to maintaining studies and ensuring their success, and they do this through collaboration (Rath et al 2003).
Literature search A database search was conducted using the Summon search interface. The search terms were used in varying combinations to identify the relevant literature and included: ‘clinical research nurse’, ‘clinical drug trials nurse’, ‘clinical trials coordinator’, ‘nursing roles’, ‘nursing competencies’ and ‘collaboration’. This was a multi-country comparison specific to the collaborative role of CTNs, so the literature was limited to ten articles covering the countries listed in Box 2. Articles were selected for their relevance to the CTN role from the perspective of collaboration. The similarities and differences in the role across countries were assessed, according to areas based on studies by the ONS (2010) and Poston and Buescher NURSING MANAGEMENT
Box 2
Articles by country
Country
Article
Australia
Rath et al 2003
Canada
Oberle and Allen 2006
India
Bisht and Mahendra 2011
Italy
Catania et al 2012
Japan
Yanagawa et al 2008
New Zealand
Bell 2009
South Korea
Jeong et al 2007
United Kingdom
Royal College of Nursing 2011
United States
Offenhartz et al 2008, Poston and Buescher 2010 December 2013 | Volume 20 | Number 8 33
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Art & science | literature review
India
Italy
Japan
UK
US
Acts as a central contact for study participants
x
x
x
x
x
x
x
x
x
Acts as a central contact for research team
x
x
x
x
x
x
x
x
x
Documents study participants’ data
x
x
x
x
x
x
x
x
x
Monitors safety of study participants
x
x
x
x
x
x
x
x
x
Serves as study participants’ advocate
x
x
x
x
x
x
x
x
x
Collaborates with research team
x
x
x
x
x
x
x
x
Organises protocol management
x
x
x
x
x
x
x
x
Helps solve conflicts collaboratively
x
x
x
x
x
x
x
Educates research team on roles
x
x
x
x
x
x
x
x
x
Represents site at study meetings Serves as co-investigator
New Zealand South Korea
Collaborative roles of the clinical trials nurse
Canada
Principal investigators and research teams Australia
Table 1
x
Manages medications and specimens
x
(2010). Poston and Buescher (2010) identify CTNs as having a central role in managing clinical trials, with their responsibilities revolving around: ■■ Principal investigators. ■■ Research participants. ■■ Sponsors. ■■ Ancillary departments and staff. ■■ Site administration. ■■ IRBs. In addition, the ONS (2010) also considers the following competencies necessary for the CTN role: ■■ Protocol compliance. ■■ The informed consent process. ■■ Patient management. 34 December 2013 | Volume 20 | Number 8
■■ Communication with all research team members. ■■ Documentation. As part of the study, the following areas were investigated: ■■ The principal investigator and the research team. ■■ The IRB and/or IEC, and informed consent development. ■■ Protocol assessment. ■■ Study participants. ■■ Study site management, with the focus on the collaborative role of CTNs. Comparisons of the specific roles identified for each nation are discussed below and summaries are provided in Tables 1-5 (pages 34-37). The scholarly literature on the subject is limited and more research is needed to clarify further the role definitions and standards of practice if clinical trials nursing is to be recognised as an advanced specialty area (ANA 2010a). Research team The principal investigator is ultimately responsible for the conduct of a clinical trial (FDA 1996). The team consists of co-investigators, CTNs, staff nurses and other healthcare professionals, such as nutritionists, laboratory technicians and radiologists (Stephens‑Lloyd 2004, ONS 2010). Table 1 shows the countries where CTNs were identified as having a collaborative role with principal investigators and research teams. The collaborative competencies required of CTNs include: ■■ Organising and executing plans to ensure that study protocols are followed. ■■ Ensuring that the documentation is an accurate record of study participants’ assessment visits. The need for these skills is discussed in all the literature reviewed. These responsibilities allow CTNs to monitor participants’ safety using their clinical skills and by acting as patient advocates. Clinical trials nurses collaborate with principal investigators and research teams, assisting them with study duties; they also work with principal investigators on managerial aspects of research protocols (Rath et al 2003, Stephens‑Lloyd 2004, Oberle and Allen 2006, Jeong et al 2007, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, ANA 2010a, Poston and Buescher 2010, Bisht and Mahendra 2011). In addition, the CTN is the contact person for participants wishing to raise concerns with principal investigators and the liaison link between all team members (Rath et al 2003, Stephens‑Lloyd 2004, Oberle and Allen 2006, Jeong et al 2007, Offenhartz et al 2008, Yanagawa et al 2008, NURSING MANAGEMENT
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Informed consent Clinical trials nurses promote co-operation and trust between research teams and IRBs and/or IECs (Clinical Research Nursing (CRN) 2010 Domain of Practice Committee 2009, ANA 2010a, ONS 2010); collaborative competencies are used to plan follow up with IRBs and/or IECs and to correspond with principal investigators, the IRBs and/or IECs and study sponsors. NURSING MANAGEMENT
Table 2
Institutional review board/independent ethics committee and informed consent development
India
Italy
Japan
UK
US
Educates study participants
x
x
x
x
x
x
x
x
x
Participates in the informed consent process
x
x
x
x
x
x
x
x
x
Facilitates protocol submissions
x
x
x
x
x
Serves as IRB/ IEC board member
x
x
x
x
x
Ensures informed consent has necessary elements
x
x
x
x
x
Advocates for safe and ethical protocols
x
x
x
x
x
Minimal role in the informed consent process
x
x
New Zealand South Korea
Canada
Collaborative roles of the clinical trials nurse
Australia
Bell 2009, ANA 2010a, Poston and Buescher 2010, Bisht and Mahendra 2011, Catania et al 2012). Clinical trials nurses educate other research team members, such as staff nurses, laboratory, pharmacy, radiology staff, healthcare providers, registration staff and staff working in billing departments, as to their duties in a particular study protocol and what roles they have regarding the study subjects (Rath et al 2003, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, ANA 2010b, Poston and Buescher 2010, Bisht and Mahendra 2011, RCN 2011). The departments involved vary according to study protocol. If there are any questions, the CTN is the main point of contact and has a responsibility for follow up with all personnel (Rath et al 2003, Stephens-Lloyd 2004, Oberle and Allen 2006, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, ANA 2010a, Poston and Buescher 2010, Bisht and Mahendra 2011, RCN 2011). An important part of collaboration is the ability to resolve conflicts and negotiate compromises to safeguard participants (ANA 2010a), and these skills are necessary to deal with difficulties arising between departments involved in a study. For example, CTNs work with principal investigators and staff in all participating departments to find solutions to organisational issues (Rath et al 2003, Stephens-Lloyd 2004, Oberle and Allen 2006, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, ANA 2010a, Poston and Buescher 2010, Bisht and Mahendra 2011, RCN 2011). A broader form of collaboration for CTNs is representing their organisations at study meetings, alone or in conjunction with principal investigators and other team members (Rath et al 2003, Stephens‑Lloyd 2004, Jeong et al 2007, Poston and Buescher 2010). Attending meetings promotes interprofessional activities and enables CTNs, by working with study sponsors, other study sites and ancillary members of research teams, to establish close working relationships (ANA 2010a). The networking, education and leadership skills of CTNs are vital to ensure projects are completed successfully and failures are avoided (Rath et al 2003, Poston and Buescher 2010).
x
x
Table 2 identifies the collaborative roles used by the CTN regarding the IRB and/or IEC and the development of informed consent. Clinical trials nurses use collaborative competencies to help resolve ethical controversies during the informative consent development and approval processes (CRN 2010 Domain of Practice Committee 2009, ANA 2010b, ONS 2010, RCN 2011). They also are obliged to act as advocates for study participants and ensure that informed consent meets the requirements outlined by the various organisations that recognise the role of CTNs (CRN 2010 Domain of Practice Committee 2009, ANA 2010a, ONS 2010, RCN 2011). In addition, CTNs often draw up plans, in conjunction with research teams, to develop informed consent forms, to ensure they include all the necessary elements. They may assist or lead the IRB and/or IEC submission and approval process, and may participate in regulatory review boards as committee members (Rath et al 2003, Stephens-Lloyd 2004, Oberle and Allen 2006, Offenhartz et al 2008, Poston and Buescher 2010, Bisht and Mahendra 2011, RCN 2011). In some countries, CTNs use their leadership and organisational skills to communicate December 2013 | Volume 20 | Number 8 35
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Art & science | literature review
UK
US
x
South Korea
x
New Zealand
Japan
x
Italy
x
India
Collaborative roles of the clinical trials nurse
Canada
Protocol assessment Australia
Table 3
Documents plan for protocol review
x
x
x
Assesses protocol feasibility
x
x
x
Reviews and may write protocols
x
x
x
Participates in submission and approval process
x
x
x
Highly responsible for protocol review
x
No participation in protocol review
x
Review role is not yet defined Table 4
x
Study participants Canada
India
Italy
Japan
New Zealand
South Korea
UK
Assists in obtaining informed consent
x
x
x
x
x
x
x
x
x
Schedules visits by participants
x
x
x
x
x
x
x
x
x
Assesses study participants
x
x
x
x
x
x
x
x
x
Develops rapport with participants
x
x
x
x
x
x
x
x
x
Communicates with participants
x
x
x
x
x
x
x
x
x
Serves as patient advocate
x
x
x
x
x
x
x
x
x
Reports issues or adverse experiences
x
x
x
x
x
x
x
x
x
Ensures participants are eligible for protocol
x
x
x
x
x
x
x
x
Collaborates with principal investigator on recruitment
x
x
x
x
x
x
x
x
Ensures informed consent is achieved
x
x
x
x
x
x
x
x
36 December 2013 | Volume 20 | Number 8
US
Australia
Collaborative roles of the clinical trials nurse
NURSING MANAGEMENT
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Study participants Clinical trials nurses are responsible for the recruitment, enrolment, screening, support, management and follow up of participants (Rath et al 2003, Stephens-Lloyd 2004, Oberle and Allen 2006, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, Poston and Buescher 2010, Bisht and Mahendra 2011). Many are also responsible for publicising the study to recruit participants and review information about applicants to ensure they meet eligibility criteria (Rath et al 2003, Stephens-Lloyd 2004, Oberle and Allen 2006, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, Poston and Buescher 2010, Bisht and Mahendra 2011). They then work with the principal investigators and co-investigators, and any other staff assisting with recruitment, to ensure that participants meet the eligibility criteria (Rath et al 2003, StephensLloyd 2004, Oberle and Allen 2006, Jeong et al 2007, Offenhartz et al 2008, Yanagawa et al 2008, NURSING MANAGEMENT
Study site management
Italy
Japan
UK
US
Monitors study participants
x
x
x
x
x
x
x
x
x
Accurately documents care
x
x
x
x
x
x
x
x
x
Ensures communication
x
x
x
x
x
x
x
x
x
Assesses protocols to maintain safety
x
x
x
x
x
x
x
x
Designs data collection tools
x
x
x
x
x
New Zealand South Korea
India
Collaborative roles of the clinical trials nurse
Canada
Protocol assessment This is the process by which CTNs determine whether protocols are written ethically. They also work with principal investigators and other team members to ensure that study sites have the necessary resources, such as staffing. Clinical trials nurses’ affiliation with the clinical site, study sponsor and principal investigators puts them in an ideal position to assess the fit of the protocol for that clinical site (ONS 2010, Poston and Buescher 2010). Collaborative leadership skills are used to create plans for reviewing study protocols and for sharing knowledge with research team about the feasibility of studies (Bell 2009, ANA 2010a). The information presented in Table 3 shows how CTNs’ greatly responsibility in this area varies from country to country, ranging from full to no participation, although this seems to be a developing role that requires clarification.
Table 5
Australia
and manage study protocols, rather than taking a role in the informed consent development process, to ensure compliance and focus on participants’ safety and outcomes (Jeong et al 2007, Yanagawa et al 2008, Bell 2009, ANA 2010a, Cantania et al 2012). Educating participants about various elements of consent documentation and helping to obtain informed consent are universal roles across all the countries reviewed (Rath et al 2003, StephensLloyd 2004, Oberle and Allen 2006, Jeong et al 2007, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, Poston and Buescher 2010, Bisht and Mahendra 2011, Cantania et al 2012).
Manages study budgets
x
x
x
x
Negotiates study budgets
x
x
x
x
Orders supplies
x
x
x
x
x
x
x
x
x
Processes and sends off specimens
x
x
x
x
x
x
x
x
x
No involvement in administrative tasks
x
Bell 2009, Poston and Buescher 2010, Bisht and Mahendra 2011). Table 4 identifies ten collaborative roles of the CTN shown to be significant in working with the study participants as well as the variations between countries. In keeping with nursing codes of conduct and ethics, and through collaboration, CTNs help participants and their families understand the protocol information (ANA 2010a), so they can take part in the research with full understanding of the risks, benefits and design. The role of educators and communicators ensures that informed consent is complete and thoroughly understood by participants (Rath et al 2003, Stephens-Lloyd 2004, Oberle and Allen 2006, Jeong et al 2007, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, Poston and Buescher 2010, Bisht and Mahendra 2011, Cantania et al 2012). This aspect of collaboration requires effective working relationships with participants, which means that CTNs need the relevant communication skills to engage and develop a rapport with them (Rath et al 2003, Oberle and Allen 2006, Offenhartz et al 2008, Bell 2009, ANA 2010a). Poston and Buescher (2010) report that the retention of participants depends on December 2013 | Volume 20 | Number 8 37
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Art & science | literature review
US
effective and ongoing education throughout studies so it is vital to ensure that they understand the process and remain safe. UK
New Zealand South Korea
Japan
Italy
India
Collaborative roles of the clinical trials nurse
Canada
Collaborative roles used by all nations Australia
Table 6
Monitors study participants
x
x
x
x
x
x
x
x
x
Accurately documents care
x
x
x
x
x
x
x
x
x
Ensures communication
x
x
x
x
x
x
x
x
x
Study site management Management of the study site is crucial to the success of clinical trials and involves various tasks such as accurate documentation of care, monitoring participants, managing study budgets, designing data collection documents, and ensuring communication between all parties. Table 5 (page 37) shows ten collaborative tasks identified as being important in managing the study site. According to the ANA (2010a), the documentation of care needed by participants, the rationales behind the care and the decision making about it are collaborative competencies used by CTNs in research practice. These competencies are necessary to manage research protocols successfully and produce valid results. The responsibility of CTNs for accomplishing these tasks was found to be universal across the literature reviewed (Rath et al 2003, Stephens‑Lloyd 2004, Oberle and Allen 2006, Jeong et al 2007, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, Poston and Buescher 2010, Bisht and Mahendra 2011, Catania et al 2012). Budget and grant management for studies are cited in the literature from New Zealand, South Korea, the UK and the US as CTN responsibilities, and involve creating, documenting and submitting budgets to study sponsors. The cost of supplies and staffing is established through communication and collaboration with administrative staff, and negotiated with study sponsors (Stephens‑Lloyd 2004, Jeong et al 2007, Bell 2009, Poston and Buescher 2010). Another aspect of site management identified in the literature includes designing data collection records. Ensuring that the methods used are consistent increases the validity of studies and protects participants. Ongoing protocol assessment to maintain safety is also essential, and many CTNs are responsible for ordering supplies, and processing or shipping specimens (Rath et al 2003, Stephens-Lloyd 2004, Jeong et al 2007, Offenhartz et al 2008, Poston and Buescher 2010). In India, CTNs are not involved in some of the administrative tasks such as ordering supplies or designing data collection forms (Bisht and Mahendra 2011).
Orders supplies
x
x
x
x
x
x
x
x
x
Conclusion
Processes and sends off specimens
x
x
x
x
x
x
x
x
x
Principal investigator and research team Acts as central contact for study participants
x
x
x
x
x
x
x
x
x
Acts as central contact for research team
x
x
x
x
x
x
x
x
x
Documents study participants’ data
x
x
x
x
x
x
x
x
x
Monitors study participants’ safety
x
x
x
x
x
x
x
x
x
Serves as study participants’ advocate
x
x
x
x
x
x
x
x
x
Institutional review boards/independent ethics committees and informed consent Educates study participants
x
x
x
x
x
x
x
x
x
Participates in the informed consent process
x
x
x
x
x
x
x
x
x
Study participants Schedules visits by study participants
x
x
x
x
x
x
x
x
x
Assesses study participants
x
x
x
x
x
x
x
x
x
Develops rapport with participants
x
x
x
x
x
x
x
x
x
Communicates with participants
x
x
x
x
x
x
x
x
x
Serves as patient advocate
x
x
x
x
x
x
x
x
x
Reports issues or adverse experiences
x
x
x
x
x
x
x
x
x
Study site management
38 December 2013 | Volume 20 | Number 8
The literature review shows that, globally, evidence suggests that collaboration is an important competency in CTNs’ advanced specialty roles in NURSING MANAGEMENT
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NURSING MANAGEMENT
UK
US
New Zealand South Korea
Japan
Italy
Collaborative roles of the clinical trials nurse
India
Collaborative roles used by at least half the nations Canada
Table 7
Australia
clinical research settings, with the necessary skill to ensure the effectiveness of clinical trials. However, more research is recommended to define further the many aspects of the CTN role in relation to the ANA scope and standards of practice (ANA 2010a, 2010b). There are many similarities in the collaborative competencies used by CTNs in North America, Europe and the Asia-Pacific region, including teamwork, education, communication and negotiation skills to manage research projects, some of which are summarised in Tables 6 and 7. The data presented in these tables show that, in the majority of the countries surveyed, most of the collaborative competencies are already used to: ■■ Liaise with principal investigators and research teams. ■■ Plan, develop and obtain informed consent, and ensure co-operation in line with the requirements of IRBs and/or IECs. ■■ Recruit and manage study participants. ■■ Ensure appropriate study site management in terms of data collection, supplies and documentation. This illustrates that CTNs across the globe are using collaborative competencies, underlining the case for them to be considered part of essential and valid standards of practice. The competencies allow CTNs to ensure that study participants, research teams and the other healthcare professionals involved are united in meeting the goals of the research protocols, as well as protecting study participants. The main differences between nations appear to be variations in the scope of the job rather than the importance accorded to, and use of, collaborative competencies. For example, India has a broad definition of the role of CTNs, who sometimes serve as principal investigators and, therefore, have greater responsibility than other members of the research teams. Meanwhile, in Italy, the CTN role is more task oriented and has a greater focus on patient monitoring and handling specimens. The other nations fall somewhere between, but the collaborative role is a necessity, regardless of its scope in any of the countries examined. As shown in Table 3 (page 36), protocol assessment was the least applied set of competencies across the nations. In the author’s opinion, reviewing protocols falls under the category of protecting participants before studies begin and this task should be considered part of the CTN role. More research is needed to clarify further whether the protocol assessment competencies should be considered to be within the scope and standards of practice for CTNs.
Collaborates with research team
x
x
x
x
x
x
x
x
Organises protocol management
x
x
x
x
x
x
x
x
Helps solve conflicts collaboratively
x
x
x
x
x
x
x
Educates research team on roles
x
x
x
x
x
x
Principal investigator and research ream
Institutional review boards/independent ethics committees and informed consent Facilitates the protocol submission
x
x
x
x
x
Serves as IRB/IEC board member
x
x
x
x
x
Ensures informed consent has necessary elements
x
x
x
x
x
Advocates for safe and ethical protocol
x
x
x
x
x
Protocol assessment No participation in protocol review
x
x
x
x
x
Study participants Ensures participants are eligible for protocol
x
x
x
x
x
x
x
x
Collaborates with principal investigator on recruitment
x
x
x
x
x
x
x
x
Ensures informed consent is achieved
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Study site management Assesses protocols to maintain safety
x
x
Designs data collection tools
x
x
x
December 2013 | Volume 20 | Number 8 39
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Art & science | literature review Relevance to clinical practice The purpose of this literature review was to provide evidence that the scope of CTNs’ advanced specialty role meets the requirements of the ANA’s Standard 13, which centres on collaboration, for US nurses. It is this author’s opinion that the findings provide sufficient evidence that this competency is important and necessary in the context of CTNs’ advanced specialty roles. It is hoped that recognising the significance of Standard 13 for all CTNs will lead towards documenting and validating this standard of practice, and encourage the research necessary for the other nursing standards of practice for CTNs worldwide. Once these are defined and documented, formal recognition of this advanced specialty nursing
role can take place. The process of defining the domains of practice for the CTN has begun, and the author encourages CTNs in all nations to pursue further research, to work towards establishing clear domains of practice for the role and to strive for its certification as an advanced specialty practice in nursing. Establishing clear domains of practice will allow the nursing profession internationally to ensure that CTNs have the guidelines and education that will lead to excellence in practice.
Online archive For related information visit our online archive and search using the keywords
Conflict of interest None declared
References American Nurses Association (2010a) Guide to the Code of Ethics for Nurses: Interpretation and Application. ANA, Silver Spring MD. American Nurses Association (2010b) Nursing: Scope and Standards of Practice. Second edition. ANA, Silver Spring MD. Bell J (2009) Towards clarification of the role of research nurses in New Zealand: a literature review. Nursing Praxis in New Zealand. 25, 1, 4-16. Bisht S, Mahendra P (2011) Clinical trial and data management. International Journal of Pharmaceutical Sciences Review and Research. 7, 2, 46-52. Catania G, Poirè I, Bernardi M et al (2012) The role of the clinical trial nurse in Italy. European Journal of Oncology Nursing. 16, 1, 87-93. doi:10.1016/j.ejon.2011.04.001
Clinical Research Nursing 2010 Domain of Practice Committee (2009) Building the Foundation for Clinical Research Nursing: Domain of Practice for the Specialty of Clinical Research Nursing. National Institutes of Health Clinical Center, Nursing and Patient Care Services, Bethesda MD. www.cc.nih.gov/nursing/crn/DOP_ document.pdf (Last accessed: October 31 2013.)
Offenhartz M, McClary K, Hastings C (2008) Nursing and realities of clinical research. Nursing Management. 39, 34-39. doi: 10.1097/01. NUMA.0000340817.28894.46 Oncology Nursing Society (2010) Oncology Clinical Trials Nurse Competencies. tinyurl. com/ons-ctn-competencies (Last accessed: October 31 2013.)
Food and Drug Administration (1996) ICH Harmonized Tripartite Guideline: Guideline for Good Clinical Practice E6(R1). www.fda.gov/ regulatoryinformation/guidances/ucm12
Poston R, Buescher C (2010) The essential role of the clinical research nurse (CRN). Urologic Nursing. 30, 1, 55-77.
Green L (2011) Explaining the role of the nurse in clinical trials. Nursing Standard. 25, 22, 35-39.
Rath L, Hitchcock A, Oakley M et al (2003) Clinical drug trials and the role of the nurse. Australian Nursing Journal. 10, 10, 1-3.
Jeong I, Kang H, Kim W (2007) Clinical research nurses: roles and qualifications in South Korea. Drug Information Journal. 41, 2, 251-256. Oberle K, Allen M (2006) Ethical considerations for nurses in clinical trials. Nursing Ethics. 13, 2, 180-186. doi: 10.1191/0969733006ne836oa
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Royal College of Nursing (2011) Competency Framework for Clinical Research Nurses. RCN, London.
Spilsbury K, Petherick E, Cullum N et al (2008) The role and potential contribution of clinical research nurses to clinical trials. Journal of Clinical Nursing. 17, 4, 549-557. doi:10.1111/ j.1365-2702.2006.01872.x Stephens-Lloyd A (2004) The extended role of the clinical research nurse: building an evidence base for practice. Nursing Times Research. 9, 1, 18-27. doi: 10.1177/136140960400900104 UK Clinical Research Collaboration (2007) Developing the Best Research Professionals. Qualified Graduate Nurses: Recommendations for Preparing and Supporting Clinical Academic Nurses of the Future. UKCRC, London. Yanagawa H, Akaishi A, Miyamoto T et al (2008) Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients. International Archives of Medicine. 1, 1, 1-4. doi: 10.1186/1755-7682-1-26
NURSING MANAGEMENT
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An international comparison of the clinical trials nurse role While some countries accord research clinicians the status of advanced specialist practitioners, there is no universal consensus. Sandra Brinkman‑Denney reports on a study to investigate the similarities and differences worldwide Correspondence sandra.brinkman-denney@ comcast.net Sandra Brinkman-Denney was a graduate student (US)/postgraduate student (UK) at Drexel University, Philadelphia, Pennsylvania, at the time of writing Date of submission February 2 2013 Date of acceptance November 2 2013 Peer review This article has been subject to doubel-blind review and checked using antiplagiarism software Author guidelines nm.rcnpublishing.com
Abstract The collaborative role of clinical trials nurses (CTNs) is crucial to the management of research protocols in clinical settings. As part of a literature review of ten articles, comparisons were made of CTN roles in countries across North America, Europe and the Asia‑Pacific region. The research looked at collaborative competencies relating to issues ranging from protocol assessment and informed consent to the research team and study site management. It found that this aspect of CTNs’ advanced specialty role in clinical trials research meets the requirements of standards of professional nursing practice in the US, but that in some nations CTNs have different scopes of practice, so more research is needed to clarify and standardise the role. Key words Advanced specialty role, clinical research, clinical trials nurse, collaborative competencies, nursing competencies, role of collaboration WITH ADVANCES in clinical science, the generic nursing role has developed into a number of advanced specialties (American Nurses Association (ANA) 2010a). One of these is the clinical trials nurse (CTN), a role that has evolved due to growing opportunities for nurses to become involved in research. Over the past few decades, there have been attempts to define the role formally worldwide; although this has occurred to a greater degree in the UK and the US (Offenhartz et al 2008, Spilsbury et al 2008), descriptions vary (Box 1), and the definitions continue to evolve.
32 December 2013 | Volume 20 | Number 8
Despite the development of the CTN role as a discrete advanced specialty, underpinned by the growth of graduate nursing programmes in clinical trials nursing, the role has not been recognised formally by the ANA. However, in accordance with the definitions outlined in Box 1, the author considers it to be an advanced specialty role and that it should be recognised as such. For the purpose of this article, CTN refers to any nurse who works in clinical research and has collaborative responsibilities in relation to conducting clinical trials (Oncology Nursing Society (ONS) 2010).
Scope of practice The ANA identifies 16 standards of professional nursing practice that address behaviours for registered nurses, postgraduate specialty nurses or advanced practice registered nurses (ANA 2010a). Standard 13, on collaboration, includes several competencies that apply to CTNs. In research, CTNs collaborate and communicate with study participants, the principal and co-investigators, institutional review boards (IRBs) and independent ethics committees (IECs), the sponsors, staff nurses and physicians on the research team, laboratory staff, and any other members of the team (Food and Drug Administration (FDA) 1996, Green 2011). In accordance with the scope and standards of nursing practice (ANA 2010a), CTNs are in a position to educate and share knowledge with all members of research teams, study participants and their families, and the wider community. These roles serve to ensure good outcomes for research participants, research teams and communities at large, which ultimately benefit NURSING MANAGEMENT
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Box 1 Definitions of the role of clinical trials nurses Each organisation has its own titles for the role. These include clinical trials nurse (CTN), clinical research nurse and research nurse co-ordinator. National Institutes of Health Clinical Center
The scope of the role is subdivided into two aspects: – Clinical research nurses, who are clinical staff nurses with a ‘central focus on care of research participants’. – Research nurse co-ordinators, who are ‘primarily responsible for study co-ordination and data management, with a central focus on managing participant recruitment and enrolment, consistency of study implementation, data management and integrity, and compliance with regulatory requirements and reporting’.
Royal College of Nursing
Clinical trials nurses are staff who collaborate with all team members for the purpose of successful research projects and they should be recognised, therefore, as having an advanced specialty role. They should be proficient and practised resources for research participants, staff and researchers.
UK Clinical Research Collaboration
A clinical research nurse is defined as any nurse ‘employed to principally undertake research in the clinical environment’.
US Oncology Nursing Society
Clinical trials nursing is a ‘specialty nursing role requiring a unique framework of knowledge for working with study participants involved in clinical research trials’. The society also recognises that the CTN role has many titles, including clinical trials co-ordinator, clinical research nurse and protocol co-ordinator.
(UK Clinical Research Collaboration 2007, Clincial Research Nursing 2010 Domain of Practice Committee 2009, US Oncology Nursing Society 2010, Royal College of Nursing 2011)
from better clinical care. Clinical trials nurses are essential to maintaining studies and ensuring their success, and they do this through collaboration (Rath et al 2003).
Literature search A database search was conducted using the Summon search interface. The search terms were used in varying combinations to identify the relevant literature and included: ‘clinical research nurse’, ‘clinical drug trials nurse’, ‘clinical trials coordinator’, ‘nursing roles’, ‘nursing competencies’ and ‘collaboration’. This was a multi-country comparison specific to the collaborative role of CTNs, so the literature was limited to ten articles covering the countries listed in Box 2. Articles were selected for their relevance to the CTN role from the perspective of collaboration. The similarities and differences in the role across countries were assessed, according to areas based on studies by the ONS (2010) and Poston and Buescher NURSING MANAGEMENT
Box 2
Articles by country
Country
Article
Australia
Rath et al 2003
Canada
Oberle and Allen 2006
India
Bisht and Mahendra 2011
Italy
Catania et al 2012
Japan
Yanagawa et al 2008
New Zealand
Bell 2009
South Korea
Jeong et al 2007
United Kingdom
Royal College of Nursing 2011
United States
Offenhartz et al 2008, Poston and Buescher 2010 December 2013 | Volume 20 | Number 8 33
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Art & science | literature review
India
Italy
Japan
UK
US
Acts as a central contact for study participants
x
x
x
x
x
x
x
x
x
Acts as a central contact for research team
x
x
x
x
x
x
x
x
x
Documents study participants’ data
x
x
x
x
x
x
x
x
x
Monitors safety of study participants
x
x
x
x
x
x
x
x
x
Serves as study participants’ advocate
x
x
x
x
x
x
x
x
x
Collaborates with research team
x
x
x
x
x
x
x
x
Organises protocol management
x
x
x
x
x
x
x
x
Helps solve conflicts collaboratively
x
x
x
x
x
x
x
Educates research team on roles
x
x
x
x
x
x
x
x
x
Represents site at study meetings Serves as co-investigator
New Zealand South Korea
Collaborative roles of the clinical trials nurse
Canada
Principal investigators and research teams Australia
Table 1
x
Manages medications and specimens
x
(2010). Poston and Buescher (2010) identify CTNs as having a central role in managing clinical trials, with their responsibilities revolving around: ■■ Principal investigators. ■■ Research participants. ■■ Sponsors. ■■ Ancillary departments and staff. ■■ Site administration. ■■ IRBs. In addition, the ONS (2010) also considers the following competencies necessary for the CTN role: ■■ Protocol compliance. ■■ The informed consent process. ■■ Patient management. 34 December 2013 | Volume 20 | Number 8
■■ Communication with all research team members. ■■ Documentation. As part of the study, the following areas were investigated: ■■ The principal investigator and the research team. ■■ The IRB and/or IEC, and informed consent development. ■■ Protocol assessment. ■■ Study participants. ■■ Study site management, with the focus on the collaborative role of CTNs. Comparisons of the specific roles identified for each nation are discussed below and summaries are provided in Tables 1-5 (pages 34-37). The scholarly literature on the subject is limited and more research is needed to clarify further the role definitions and standards of practice if clinical trials nursing is to be recognised as an advanced specialty area (ANA 2010a). Research team The principal investigator is ultimately responsible for the conduct of a clinical trial (FDA 1996). The team consists of co-investigators, CTNs, staff nurses and other healthcare professionals, such as nutritionists, laboratory technicians and radiologists (Stephens‑Lloyd 2004, ONS 2010). Table 1 shows the countries where CTNs were identified as having a collaborative role with principal investigators and research teams. The collaborative competencies required of CTNs include: ■■ Organising and executing plans to ensure that study protocols are followed. ■■ Ensuring that the documentation is an accurate record of study participants’ assessment visits. The need for these skills is discussed in all the literature reviewed. These responsibilities allow CTNs to monitor participants’ safety using their clinical skills and by acting as patient advocates. Clinical trials nurses collaborate with principal investigators and research teams, assisting them with study duties; they also work with principal investigators on managerial aspects of research protocols (Rath et al 2003, Stephens‑Lloyd 2004, Oberle and Allen 2006, Jeong et al 2007, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, ANA 2010a, Poston and Buescher 2010, Bisht and Mahendra 2011). In addition, the CTN is the contact person for participants wishing to raise concerns with principal investigators and the liaison link between all team members (Rath et al 2003, Stephens‑Lloyd 2004, Oberle and Allen 2006, Jeong et al 2007, Offenhartz et al 2008, Yanagawa et al 2008, NURSING MANAGEMENT
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Informed consent Clinical trials nurses promote co-operation and trust between research teams and IRBs and/or IECs (Clinical Research Nursing (CRN) 2010 Domain of Practice Committee 2009, ANA 2010a, ONS 2010); collaborative competencies are used to plan follow up with IRBs and/or IECs and to correspond with principal investigators, the IRBs and/or IECs and study sponsors. NURSING MANAGEMENT
Table 2
Institutional review board/independent ethics committee and informed consent development
India
Italy
Japan
UK
US
Educates study participants
x
x
x
x
x
x
x
x
x
Participates in the informed consent process
x
x
x
x
x
x
x
x
x
Facilitates protocol submissions
x
x
x
x
x
Serves as IRB/ IEC board member
x
x
x
x
x
Ensures informed consent has necessary elements
x
x
x
x
x
Advocates for safe and ethical protocols
x
x
x
x
x
Minimal role in the informed consent process
x
x
New Zealand South Korea
Canada
Collaborative roles of the clinical trials nurse
Australia
Bell 2009, ANA 2010a, Poston and Buescher 2010, Bisht and Mahendra 2011, Catania et al 2012). Clinical trials nurses educate other research team members, such as staff nurses, laboratory, pharmacy, radiology staff, healthcare providers, registration staff and staff working in billing departments, as to their duties in a particular study protocol and what roles they have regarding the study subjects (Rath et al 2003, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, ANA 2010b, Poston and Buescher 2010, Bisht and Mahendra 2011, RCN 2011). The departments involved vary according to study protocol. If there are any questions, the CTN is the main point of contact and has a responsibility for follow up with all personnel (Rath et al 2003, Stephens-Lloyd 2004, Oberle and Allen 2006, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, ANA 2010a, Poston and Buescher 2010, Bisht and Mahendra 2011, RCN 2011). An important part of collaboration is the ability to resolve conflicts and negotiate compromises to safeguard participants (ANA 2010a), and these skills are necessary to deal with difficulties arising between departments involved in a study. For example, CTNs work with principal investigators and staff in all participating departments to find solutions to organisational issues (Rath et al 2003, Stephens-Lloyd 2004, Oberle and Allen 2006, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, ANA 2010a, Poston and Buescher 2010, Bisht and Mahendra 2011, RCN 2011). A broader form of collaboration for CTNs is representing their organisations at study meetings, alone or in conjunction with principal investigators and other team members (Rath et al 2003, Stephens‑Lloyd 2004, Jeong et al 2007, Poston and Buescher 2010). Attending meetings promotes interprofessional activities and enables CTNs, by working with study sponsors, other study sites and ancillary members of research teams, to establish close working relationships (ANA 2010a). The networking, education and leadership skills of CTNs are vital to ensure projects are completed successfully and failures are avoided (Rath et al 2003, Poston and Buescher 2010).
x
x
Table 2 identifies the collaborative roles used by the CTN regarding the IRB and/or IEC and the development of informed consent. Clinical trials nurses use collaborative competencies to help resolve ethical controversies during the informative consent development and approval processes (CRN 2010 Domain of Practice Committee 2009, ANA 2010b, ONS 2010, RCN 2011). They also are obliged to act as advocates for study participants and ensure that informed consent meets the requirements outlined by the various organisations that recognise the role of CTNs (CRN 2010 Domain of Practice Committee 2009, ANA 2010a, ONS 2010, RCN 2011). In addition, CTNs often draw up plans, in conjunction with research teams, to develop informed consent forms, to ensure they include all the necessary elements. They may assist or lead the IRB and/or IEC submission and approval process, and may participate in regulatory review boards as committee members (Rath et al 2003, Stephens-Lloyd 2004, Oberle and Allen 2006, Offenhartz et al 2008, Poston and Buescher 2010, Bisht and Mahendra 2011, RCN 2011). In some countries, CTNs use their leadership and organisational skills to communicate December 2013 | Volume 20 | Number 8 35
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Art & science | literature review
UK
US
x
South Korea
x
New Zealand
Japan
x
Italy
x
India
Collaborative roles of the clinical trials nurse
Canada
Protocol assessment Australia
Table 3
Documents plan for protocol review
x
x
x
Assesses protocol feasibility
x
x
x
Reviews and may write protocols
x
x
x
Participates in submission and approval process
x
x
x
Highly responsible for protocol review
x
No participation in protocol review
x
Review role is not yet defined Table 4
x
Study participants Canada
India
Italy
Japan
New Zealand
South Korea
UK
Assists in obtaining informed consent
x
x
x
x
x
x
x
x
x
Schedules visits by participants
x
x
x
x
x
x
x
x
x
Assesses study participants
x
x
x
x
x
x
x
x
x
Develops rapport with participants
x
x
x
x
x
x
x
x
x
Communicates with participants
x
x
x
x
x
x
x
x
x
Serves as patient advocate
x
x
x
x
x
x
x
x
x
Reports issues or adverse experiences
x
x
x
x
x
x
x
x
x
Ensures participants are eligible for protocol
x
x
x
x
x
x
x
x
Collaborates with principal investigator on recruitment
x
x
x
x
x
x
x
x
Ensures informed consent is achieved
x
x
x
x
x
x
x
x
36 December 2013 | Volume 20 | Number 8
US
Australia
Collaborative roles of the clinical trials nurse
NURSING MANAGEMENT
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Study participants Clinical trials nurses are responsible for the recruitment, enrolment, screening, support, management and follow up of participants (Rath et al 2003, Stephens-Lloyd 2004, Oberle and Allen 2006, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, Poston and Buescher 2010, Bisht and Mahendra 2011). Many are also responsible for publicising the study to recruit participants and review information about applicants to ensure they meet eligibility criteria (Rath et al 2003, Stephens-Lloyd 2004, Oberle and Allen 2006, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, Poston and Buescher 2010, Bisht and Mahendra 2011). They then work with the principal investigators and co-investigators, and any other staff assisting with recruitment, to ensure that participants meet the eligibility criteria (Rath et al 2003, StephensLloyd 2004, Oberle and Allen 2006, Jeong et al 2007, Offenhartz et al 2008, Yanagawa et al 2008, NURSING MANAGEMENT
Study site management
Italy
Japan
UK
US
Monitors study participants
x
x
x
x
x
x
x
x
x
Accurately documents care
x
x
x
x
x
x
x
x
x
Ensures communication
x
x
x
x
x
x
x
x
x
Assesses protocols to maintain safety
x
x
x
x
x
x
x
x
Designs data collection tools
x
x
x
x
x
New Zealand South Korea
India
Collaborative roles of the clinical trials nurse
Canada
Protocol assessment This is the process by which CTNs determine whether protocols are written ethically. They also work with principal investigators and other team members to ensure that study sites have the necessary resources, such as staffing. Clinical trials nurses’ affiliation with the clinical site, study sponsor and principal investigators puts them in an ideal position to assess the fit of the protocol for that clinical site (ONS 2010, Poston and Buescher 2010). Collaborative leadership skills are used to create plans for reviewing study protocols and for sharing knowledge with research team about the feasibility of studies (Bell 2009, ANA 2010a). The information presented in Table 3 shows how CTNs’ greatly responsibility in this area varies from country to country, ranging from full to no participation, although this seems to be a developing role that requires clarification.
Table 5
Australia
and manage study protocols, rather than taking a role in the informed consent development process, to ensure compliance and focus on participants’ safety and outcomes (Jeong et al 2007, Yanagawa et al 2008, Bell 2009, ANA 2010a, Cantania et al 2012). Educating participants about various elements of consent documentation and helping to obtain informed consent are universal roles across all the countries reviewed (Rath et al 2003, StephensLloyd 2004, Oberle and Allen 2006, Jeong et al 2007, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, Poston and Buescher 2010, Bisht and Mahendra 2011, Cantania et al 2012).
Manages study budgets
x
x
x
x
Negotiates study budgets
x
x
x
x
Orders supplies
x
x
x
x
x
x
x
x
x
Processes and sends off specimens
x
x
x
x
x
x
x
x
x
No involvement in administrative tasks
x
Bell 2009, Poston and Buescher 2010, Bisht and Mahendra 2011). Table 4 identifies ten collaborative roles of the CTN shown to be significant in working with the study participants as well as the variations between countries. In keeping with nursing codes of conduct and ethics, and through collaboration, CTNs help participants and their families understand the protocol information (ANA 2010a), so they can take part in the research with full understanding of the risks, benefits and design. The role of educators and communicators ensures that informed consent is complete and thoroughly understood by participants (Rath et al 2003, Stephens-Lloyd 2004, Oberle and Allen 2006, Jeong et al 2007, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, Poston and Buescher 2010, Bisht and Mahendra 2011, Cantania et al 2012). This aspect of collaboration requires effective working relationships with participants, which means that CTNs need the relevant communication skills to engage and develop a rapport with them (Rath et al 2003, Oberle and Allen 2006, Offenhartz et al 2008, Bell 2009, ANA 2010a). Poston and Buescher (2010) report that the retention of participants depends on December 2013 | Volume 20 | Number 8 37
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Art & science | literature review
US
effective and ongoing education throughout studies so it is vital to ensure that they understand the process and remain safe. UK
New Zealand South Korea
Japan
Italy
India
Collaborative roles of the clinical trials nurse
Canada
Collaborative roles used by all nations Australia
Table 6
Monitors study participants
x
x
x
x
x
x
x
x
x
Accurately documents care
x
x
x
x
x
x
x
x
x
Ensures communication
x
x
x
x
x
x
x
x
x
Study site management Management of the study site is crucial to the success of clinical trials and involves various tasks such as accurate documentation of care, monitoring participants, managing study budgets, designing data collection documents, and ensuring communication between all parties. Table 5 (page 37) shows ten collaborative tasks identified as being important in managing the study site. According to the ANA (2010a), the documentation of care needed by participants, the rationales behind the care and the decision making about it are collaborative competencies used by CTNs in research practice. These competencies are necessary to manage research protocols successfully and produce valid results. The responsibility of CTNs for accomplishing these tasks was found to be universal across the literature reviewed (Rath et al 2003, Stephens‑Lloyd 2004, Oberle and Allen 2006, Jeong et al 2007, Offenhartz et al 2008, Yanagawa et al 2008, Bell 2009, Poston and Buescher 2010, Bisht and Mahendra 2011, Catania et al 2012). Budget and grant management for studies are cited in the literature from New Zealand, South Korea, the UK and the US as CTN responsibilities, and involve creating, documenting and submitting budgets to study sponsors. The cost of supplies and staffing is established through communication and collaboration with administrative staff, and negotiated with study sponsors (Stephens‑Lloyd 2004, Jeong et al 2007, Bell 2009, Poston and Buescher 2010). Another aspect of site management identified in the literature includes designing data collection records. Ensuring that the methods used are consistent increases the validity of studies and protects participants. Ongoing protocol assessment to maintain safety is also essential, and many CTNs are responsible for ordering supplies, and processing or shipping specimens (Rath et al 2003, Stephens-Lloyd 2004, Jeong et al 2007, Offenhartz et al 2008, Poston and Buescher 2010). In India, CTNs are not involved in some of the administrative tasks such as ordering supplies or designing data collection forms (Bisht and Mahendra 2011).
Orders supplies
x
x
x
x
x
x
x
x
x
Conclusion
Processes and sends off specimens
x
x
x
x
x
x
x
x
x
Principal investigator and research team Acts as central contact for study participants
x
x
x
x
x
x
x
x
x
Acts as central contact for research team
x
x
x
x
x
x
x
x
x
Documents study participants’ data
x
x
x
x
x
x
x
x
x
Monitors study participants’ safety
x
x
x
x
x
x
x
x
x
Serves as study participants’ advocate
x
x
x
x
x
x
x
x
x
Institutional review boards/independent ethics committees and informed consent Educates study participants
x
x
x
x
x
x
x
x
x
Participates in the informed consent process
x
x
x
x
x
x
x
x
x
Study participants Schedules visits by study participants
x
x
x
x
x
x
x
x
x
Assesses study participants
x
x
x
x
x
x
x
x
x
Develops rapport with participants
x
x
x
x
x
x
x
x
x
Communicates with participants
x
x
x
x
x
x
x
x
x
Serves as patient advocate
x
x
x
x
x
x
x
x
x
Reports issues or adverse experiences
x
x
x
x
x
x
x
x
x
Study site management
38 December 2013 | Volume 20 | Number 8
The literature review shows that, globally, evidence suggests that collaboration is an important competency in CTNs’ advanced specialty roles in NURSING MANAGEMENT
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NURSING MANAGEMENT
UK
US
New Zealand South Korea
Japan
Italy
Collaborative roles of the clinical trials nurse
India
Collaborative roles used by at least half the nations Canada
Table 7
Australia
clinical research settings, with the necessary skill to ensure the effectiveness of clinical trials. However, more research is recommended to define further the many aspects of the CTN role in relation to the ANA scope and standards of practice (ANA 2010a, 2010b). There are many similarities in the collaborative competencies used by CTNs in North America, Europe and the Asia-Pacific region, including teamwork, education, communication and negotiation skills to manage research projects, some of which are summarised in Tables 6 and 7. The data presented in these tables show that, in the majority of the countries surveyed, most of the collaborative competencies are already used to: ■■ Liaise with principal investigators and research teams. ■■ Plan, develop and obtain informed consent, and ensure co-operation in line with the requirements of IRBs and/or IECs. ■■ Recruit and manage study participants. ■■ Ensure appropriate study site management in terms of data collection, supplies and documentation. This illustrates that CTNs across the globe are using collaborative competencies, underlining the case for them to be considered part of essential and valid standards of practice. The competencies allow CTNs to ensure that study participants, research teams and the other healthcare professionals involved are united in meeting the goals of the research protocols, as well as protecting study participants. The main differences between nations appear to be variations in the scope of the job rather than the importance accorded to, and use of, collaborative competencies. For example, India has a broad definition of the role of CTNs, who sometimes serve as principal investigators and, therefore, have greater responsibility than other members of the research teams. Meanwhile, in Italy, the CTN role is more task oriented and has a greater focus on patient monitoring and handling specimens. The other nations fall somewhere between, but the collaborative role is a necessity, regardless of its scope in any of the countries examined. As shown in Table 3 (page 36), protocol assessment was the least applied set of competencies across the nations. In the author’s opinion, reviewing protocols falls under the category of protecting participants before studies begin and this task should be considered part of the CTN role. More research is needed to clarify further whether the protocol assessment competencies should be considered to be within the scope and standards of practice for CTNs.
Collaborates with research team
x
x
x
x
x
x
x
x
Organises protocol management
x
x
x
x
x
x
x
x
Helps solve conflicts collaboratively
x
x
x
x
x
x
x
Educates research team on roles
x
x
x
x
x
x
Principal investigator and research ream
Institutional review boards/independent ethics committees and informed consent Facilitates the protocol submission
x
x
x
x
x
Serves as IRB/IEC board member
x
x
x
x
x
Ensures informed consent has necessary elements
x
x
x
x
x
Advocates for safe and ethical protocol
x
x
x
x
x
Protocol assessment No participation in protocol review
x
x
x
x
x
Study participants Ensures participants are eligible for protocol
x
x
x
x
x
x
x
x
Collaborates with principal investigator on recruitment
x
x
x
x
x
x
x
x
Ensures informed consent is achieved
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
x
Study site management Assesses protocols to maintain safety
x
x
Designs data collection tools
x
x
x
December 2013 | Volume 20 | Number 8 39
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Art & science | literature review Relevance to clinical practice The purpose of this literature review was to provide evidence that the scope of CTNs’ advanced specialty role meets the requirements of the ANA’s Standard 13, which centres on collaboration, for US nurses. It is this author’s opinion that the findings provide sufficient evidence that this competency is important and necessary in the context of CTNs’ advanced specialty roles. It is hoped that recognising the significance of Standard 13 for all CTNs will lead towards documenting and validating this standard of practice, and encourage the research necessary for the other nursing standards of practice for CTNs worldwide. Once these are defined and documented, formal recognition of this advanced specialty nursing
role can take place. The process of defining the domains of practice for the CTN has begun, and the author encourages CTNs in all nations to pursue further research, to work towards establishing clear domains of practice for the role and to strive for its certification as an advanced specialty practice in nursing. Establishing clear domains of practice will allow the nursing profession internationally to ensure that CTNs have the guidelines and education that will lead to excellence in practice.
Online archive For related information visit our online archive and search using the keywords
Conflict of interest None declared
References American Nurses Association (2010a) Guide to the Code of Ethics for Nurses: Interpretation and Application. ANA, Silver Spring MD. American Nurses Association (2010b) Nursing: Scope and Standards of Practice. Second edition. ANA, Silver Spring MD. Bell J (2009) Towards clarification of the role of research nurses in New Zealand: a literature review. Nursing Praxis in New Zealand. 25, 1, 4-16. Bisht S, Mahendra P (2011) Clinical trial and data management. International Journal of Pharmaceutical Sciences Review and Research. 7, 2, 46-52. Catania G, Poirè I, Bernardi M et al (2012) The role of the clinical trial nurse in Italy. European Journal of Oncology Nursing. 16, 1, 87-93. doi:10.1016/j.ejon.2011.04.001
Clinical Research Nursing 2010 Domain of Practice Committee (2009) Building the Foundation for Clinical Research Nursing: Domain of Practice for the Specialty of Clinical Research Nursing. National Institutes of Health Clinical Center, Nursing and Patient Care Services, Bethesda MD. www.cc.nih.gov/nursing/crn/DOP_ document.pdf (Last accessed: October 31 2013.)
Offenhartz M, McClary K, Hastings C (2008) Nursing and realities of clinical research. Nursing Management. 39, 34-39. doi: 10.1097/01. NUMA.0000340817.28894.46 Oncology Nursing Society (2010) Oncology Clinical Trials Nurse Competencies. tinyurl. com/ons-ctn-competencies (Last accessed: October 31 2013.)
Food and Drug Administration (1996) ICH Harmonized Tripartite Guideline: Guideline for Good Clinical Practice E6(R1). www.fda.gov/ regulatoryinformation/guidances/ucm12
Poston R, Buescher C (2010) The essential role of the clinical research nurse (CRN). Urologic Nursing. 30, 1, 55-77.
Green L (2011) Explaining the role of the nurse in clinical trials. Nursing Standard. 25, 22, 35-39.
Rath L, Hitchcock A, Oakley M et al (2003) Clinical drug trials and the role of the nurse. Australian Nursing Journal. 10, 10, 1-3.
Jeong I, Kang H, Kim W (2007) Clinical research nurses: roles and qualifications in South Korea. Drug Information Journal. 41, 2, 251-256. Oberle K, Allen M (2006) Ethical considerations for nurses in clinical trials. Nursing Ethics. 13, 2, 180-186. doi: 10.1191/0969733006ne836oa
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Royal College of Nursing (2011) Competency Framework for Clinical Research Nurses. RCN, London.
Spilsbury K, Petherick E, Cullum N et al (2008) The role and potential contribution of clinical research nurses to clinical trials. Journal of Clinical Nursing. 17, 4, 549-557. doi:10.1111/ j.1365-2702.2006.01872.x Stephens-Lloyd A (2004) The extended role of the clinical research nurse: building an evidence base for practice. Nursing Times Research. 9, 1, 18-27. doi: 10.1177/136140960400900104 UK Clinical Research Collaboration (2007) Developing the Best Research Professionals. Qualified Graduate Nurses: Recommendations for Preparing and Supporting Clinical Academic Nurses of the Future. UKCRC, London. Yanagawa H, Akaishi A, Miyamoto T et al (2008) Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients. International Archives of Medicine. 1, 1, 1-4. doi: 10.1186/1755-7682-1-26
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