Art & science education
Developing good practice for clinical research nurses McDermott S et al (2014) Developing good practice for clinical research nurses. Nursing Standard. 28, 26, 40-44. Date of submission: October 8 2013; date of acceptance: November 29 2013.
Abstract This article outlines the role of clinical research in the UK government’s strategy for economic growth and the role of clinical research nurses in that research. The diverse skills and knowledge required by clinical research nurses to support a range of research studies in a number of research environments are described. The development and aim of the UK Clinical Research Facility Network is discussed, with particular focus on the role of the UK Clinical Research Facility Network Education Group in supporting clinical research nurses and research teams to acquire and maintain relevant research skills. The outcomes delivered by the UK Clinical Research Facility Network Education Group are outlined along with ongoing and future work. Recommendations to ensure that the workforce will be skilled appropriately to support future clinical research are provided.
Authors Shona McDermott Assistant director, education and training, Clinical Research Facility, NHS Greater Glasgow and Clyde, Glasgow. Kornelia Hathaway Education and training manager, NIHR/Wellcome Trust Clinical Research Facility, Cambridge University Hospitals NHS Foundation Trust. Caroline Saunders Head of clinical operations, NIHR/Wellcome Trust Clinical Research Facility, Cambridge University Hospitals NHS Foundation Trust; also deputy director, UK Clinical Research Facility Network. Correspondence to: [email protected]
Keywords Clinical research nurse, education, emergency scenario training guidance, research skills and knowledge, UK Clinical Research Facility Network
Review All articles are subject to external double-blind peer review and checked for plagiarism using automated software.
Online Guidelines on writing for publication are available at www.nursing-standard.co.uk. For related articles visit the archive and search using the keywords above.
40 february 26 :: vol 28 no 26 :: 2014
FOR HEALTHCARE PROFESSIONALS to deliver evidence-based medicine, robust evidence is required from reliable clinical research. Investment in supporting and conducting research has resulted in nurses having an integral role in clinical research studies. This article explores the role of clinical research nurses and the training and education they require to conduct clinical research. It also examines the role of the UK Clinical Research Facility (UKCRF) Network Education Group in identifying, developing and sharing best practice for training and developing these nurses in the workplace.
Background The government’s strategy for healthcare research in the UK is to encourage economic growth; to attract investment by the life sciences industries through world-class infrastructure for health research; to establish the NHS as an internationally recognised centre of research excellence; to attract, develop and retain the best clinical research professionals to conduct people-based research; and to create opportunities for patients and the public to participate in, and benefit from, research (National Institute for Health Research (NIHR) 2013). This is reinforced by the Health and Social Care Act 2012, which places a statutory duty on staff to promote research at all levels of the NHS. The NIHR in England and its equivalent, the Chief Scientist Office (CSO) in Scotland, have a vital role in this strategy (Department of Health (DH) 2006, CSO 2009). Part of the implementation plan of the strategy in England was to create an NIHR faculty to support individuals carrying out and participating in research, as well as an infrastructure to support the research environment (NIHR 2013). Since the establishment of the NIHR in 2006, there has been unprecedented investment (£1 billion) in clinical research infrastructure in terms of clinical research facilities (CRFs), clinical research networks, and biomedical research centres to deliver the national research agenda and to improve the health and wealth of the nation through research (NIHR 2013).
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Clinical research nurses are fundamental to conducting clinical research studies in the NHS. It has been difficult to establish precisely how many clinical research nurses there are working in the UK and Pidd (2011) referred to ‘a conservative estimate’ of around 10,000 by 2013. The clinical research nurse role is relatively new. Nurses are employed in specialist research centres such as CRFs where they work on translational research (applying knowledge from scientific research to practical situations at the bedside). Nurses also work in early phase drug studies in specialityspecific research networks such as the Diabetes Research Network. Clinical research nurses working in NHS and university settings facilitate research studies in primary and secondary care, for example on later phase drug trials and research in epidemiology. Those new to the role are required to have considerable clinical researchspecific knowledge and skills to perform their roles competently (National Institutes of Health Clinical Center and Nursing and Patient Care Services 2009). While there are international guidelines (European Clinical Trials Directive 2001/20/EC and Good Clinical Practice Directive 2005/28/EC), national legislation (Medicines for Human Use (Clinical Trials) Regulations 2004), and government frameworks (Scottish Executive Health Department 2006, DH 2008) in place to which clinical research nurses have to work, there is uncertainty about what is best practice regarding research-specific training and educational development (Coulson and Grange 2012). The UKCRF Network was established in 2008 by nurses to develop and share best practice with other nurses to support patients taking part in clinical research and improve their care. The UKCRF Network has subsequently expanded to include all professional groups working in this field and receives core funding from the DH and CSO to support experimental clinical research operational activity (the practical aspects of conducting research) through work groups and work streams. A work group is a group of members who meet on a regular basis to share best practice. A work stream is a smaller subgroup that forms to complete a specific piece of work. Members of work groups have relevant experience or a role in a specific area and contribute to the work of the group. The work streams and work groups identify, develop and share good practice in clinical research and experimental medicine infrastructure. Information about the work produced by the work groups and work streams is available on the UK CRF Network’s web portal (www.ukcrfnetwork.co.uk). The operational components of the UKCRF Network are the CRFs, which provide dedicated
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space for conducting clinical research in patients and healthy volunteers. Typically, CRFs comprise inpatient and outpatient, day-case and specialist facilities to support adults and children in research studies across a range of specialties. In the past decade, the number of CRFs across the UK has increased from around ten to approximately 40 in 2012 (19 of these are NIHR funded). Clinical research nurses form the largest staff group in CRFs and they play a crucial role in supporting and caring for patients in research studies, while at the same time maintaining the integrity of the studies. For many nurses, taking on this new role is a major challenge because it is quite different from the standard nursing role. To function as effective research professionals, nurses therefore require specialist on-the-job training and education on ethics, legislation and science of clinical research.
UK Clinical Research Facility Network Education Group In 2008, having consulted the relevant literature and a wide range of nursing colleagues working in clinical research roles, it became clear to the education leads of CRFs that there was a need for role-specific development for clinical research nurse and other staff working in CRFs. Consequently, nursing and other staff tasked with overseeing training and leading on education in their respective CRFs started an informal dialogue about how to best develop and support CRF staff education and training. These staff recognised that there was little generic guidance or accessible provision of education and training for clinical research staff. It was apparent that they could provide valuable support as well as strategic educational guidance for clinical research nurses and other staff groups in their CRFs. Subsequently, in 2009, the UKCRF Network Education Group was established to provide guidance on role-specific development. The group is supported and supervised by the UKCRF Network Strategic Management Team. Membership of the group comes from CRFs in England, Wales, Scotland and the Republic of Ireland, with 17 CRFs being represented by a designated member of staff. These staff members have a specific education role or, as part of their role, act as the education lead in the CRF. Group members represent a wide range of professional expertise, providing a good basis for cross-site developments to identify, share and guide good practice. The aims of the education group are to: Share expertise and establish best practice in training for clinical research professionals working in CRFs. Where they are missing but required, develop february 26 :: vol 28 no 26 :: 2014 41
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Art & science education relevant educational guidance and suitable resources that enhance continued professional development of staff working in CRFs and of associated clinical research professionals in other clinical research organisations within the NHS. Collaborate and liaise with other clinical research organisations to ensure that the work of the group is up to date, responsive and complementary to regional and national developments in training and education. The group meets three times per year to discuss and agree on specific projects, which are then delivered by a subgroup of members with the relevant expertise. Since 2009, the education group has developed and shared good practice, disseminating the group’s work on the UKCRF Network’s website. The following sections describe key areas of work that the group has undertaken.
Induction framework for clinical research staff
Healthcare professionals new to working in clinical research need to acquire knowledge that is specific to this field. The education group set out to investigate what core research-related knowledge new staff need from mentors during their induction period. After undertaking a detailed scoping process across the CRFs in the UK and the Republic of Ireland, as well as expert discussions with a range of research staff groups, the group developed and launched an induction framework for clinical research staff in 2011. This identified nine research themes, each with core components for which there is generic information and practical guidance produced as part of the framework. A revision followed in 2012 with expansion to ten research themes (UKCRF Network 2012a) (Box 1). The framework is suitable for all clinical research professionals to guide mentors and education staff in the UK.
Emergency scenario training guidance
In clinical research, the research participant’s safety is safeguarded. Regular and robust training for clinical research nurses in dealing with potential clinical emergency situations is advocated, but
BOX 1 Themes of the induction framework for clinical research staff Understanding clinical research. Research governance and ethics. Consent and recruiting participants. Study management. Resource management. Information governance (data protection and management). Quality control systems and quality assurance in clinical research. Laboratories and samples. Role of the National Institute for Health Research. Role of the UK Clinical Research Facility Network.
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there has been no easily identifiable external guidance. The education group therefore used expertise from within the group to establish a generic guidance document that contains sample scenarios for clinical research nurses to adapt for use in their workplace. In 2012 guidance was produced focusing on emergency scenario training involving adult research participants. The guidance document aims to encourage clinical research nurse teams to develop emergency scenario training programmes for staff (UKCRF Network 2012b). The scenario training guidance was developed to assist CRFs to establish robust emergency training to complement the trust’s resuscitation training. The original focus on adult research participants was intended to be expanded and developed to meet the needs of staff providing care for other patient groups. There are currently ten CRFs in the UK that conduct clinical research studies involving children. Therefore, to support and train staff caring for paediatric research participants and their respective family and carers, the education group and the UKCRF Network Paediatric Group identified and developed three simulation training scenarios specific to paediatric emergency situations. Subsequently, the original 2012 emergency scenario training guidance was reviewed, updated and expanded to include emergency simulation scenarios and guidance on how to apply these in a clinical paediatric research setting. The updated guidance, Emergency Scenario Training Guidance Version 2: 2013 aims to support nursing staff who work in an area where children could be present, to deliver safe quality care (UKCRF Network 2013). Box 2 contains the first section of a single emergency scenario to illustrate the content of the guidance.
Web-based education resource
A website (www.crts.org.uk/national) that was created initially to provide relevant research training information in Scotland provided an ideal platform with open access for the education group to add information about accredited and non-accredited education courses. These courses were used by and, at times, developed with input from clinical research nurses working in CRFs across the UK. The website is updated regularly by members of the education group to provide information about training that might be useful for clinical research nurses.
Workshop and poster presentations
Members of the education group take an active role in conferences aimed at clinical research nurses. They may act as ambassadors for disseminating information about the induction framework for clinical research staff and emergency scenario
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training guidance in clinical research settings, or present posters on the work of the education group. Conferences that members have attended include the third annual International Association of Clinical Research Nurses in 2011 in Bethesda, Maryland, United States; the Irish Research Nurses Network conference in 2012 in Dublin; and the Celebrating Clinical Research Nurses’ Day organised by the NIHR in 2013 in London.
Work in progress
The education group recognises that ensuring and sharing good practice is a continual process requiring ongoing expansion of collaboration, review and improvement of the work delivered and development of new initiatives to support staff working in CRFs. Clinical research staff in CRFs will often undertake sample processing and storing of various types of samples. This activity is often the responsibility of the clinical research nurse, and it is essential that a level of competence is demonstrated to ensure correct handling procedures. The UKCRF Network laboratory managers work stream identified the need to develop a set of laboratory competencies that would be appropriate to support staff who access laboratory areas and equipment, but who are not designated laboratory personnel. Members of the education group are therefore developing two generic competency assessment templates for specific research activities that can be adapted for various activities and disciplines. These templates and the corresponding guidance, are being developed and once finalised will be adapted, in collaboration with the UKCRF Network Laboratory Group, to deliver a laboratory competency framework.
Future work
The role of the education group is to share best practice and provide support through developing appropriate tools and collaborating with other UKCRF work streams and research colleagues. The education group recognises that sharing best practice is not confined to the CRFs but also has the potential to be used by staff in other research environments. The education group aims to: Adapt the generic competency assessment template, discussed above, to provide an informed consent competency tool. This competency will be developed following a structured process that involves review of the literature, review of best practice already delivered by CRF staff, and subsequent development of a tool that supports clinical research nurses and research staff to ensure research participants are fully informed and
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provide consent appropriately when taking part in a research project. Continue to support the development of staff working in CRFs and in other research environments across the UK. To achieve this goal, the education group will share best practice and frameworks, and review and recommend suitable training and education tools and, where needed, design new ones. Members of the education group share information with staff working in CRFs and with other NHS clinical research organisations by presenting at relevant conferences, meetings and workshops. The group will also ensure that all tools and guidance developed will be disseminated through relevant media and via publication.
National Institute for Health Research and clinical research nurses In the UK, the NIHR is the largest funder of clinical research activity in the NHS. In May 2013, inspired by the concept of International Nurses Day, the NIHR held the first nationwide meeting specifically for clinical research nurses in London.
BOX 2 Example case scenario for emergency training guidance Recognition and treatment of anaphylaxis Intended clinical (technical) learning objectives: ABCDE approach to assessing and treating a participant with anaphylaxis. Appropriate use of emergency equipment, drugs and monitoring. Intended non-technical learning objectives: Communication. Structured and effective teamwork. Leadership. Decision making. Participant: Andy, a 32-year-old male. Learner information pre-scenario (narrative case description): Use only if scenario is announced Andy is a healthy volunteer who has been enrolled into a Phase I trial. He has no past medical history. He has had baseline observations of temperature, pulse, blood pressure and respirations recorded and these are all within normal ranges. He is cannulated and has been commenced on an intravenous infusion of an investigational medicinal product – a new antibiotic. Five minutes after the infusion was started, Andy begins to complain that he feels dizzy and that his throat feels tight. Facilitator information pre-scenario (narrative case description): Andy is experiencing severe anaphylaxis related to the study drug. He has no past medical history. His condition will continue to deteriorate, up until the point of adrenaline administration. Use SBAR (situation, background, assessment, recommendations): Recognition and treatment should be based on Resuscitation Council (UK) (2008) guidance.
february 26 :: vol 28 no 26 :: 2014 43
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Art & science education Entitled Celebrating Clinical Research Nurses, the day was held in recognition of ‘the contribution clinical research nurses make to improving patient care and the work of the NIHR’ (NIHR Central Commissioning Facility 2013). At this meeting, Susan Hamer, director for organisational and workforce development at the NIHR Clinical Research Network, announced the following strategic priorities for the NIHR CRN clinical research nurse workforce, which are in accord with the aims of the education group (Hamer 2013): Enhanced patient experience. Improved standards of research delivery and practice. Improved awareness of research activity and support.
Recommendations To ensure there is a viable, appropriately skilled workforce in the future to support clinical research, the clinical and research communities need to recognise the value of clinical research nurses. This means that it is necessary to support training and education for these nurses so that they are sufficiently skilled and knowledgeable to meet the needs of the research environment. While high-level initiatives around research workforce development (Hamer 2013) and clinical academic training opportunities (Association of UK University Hospitals 2012, DH 2012) are in place, there is a need to provide practical skills and operational role-specific training for
clinical research nurses to enable them to support patients participating in research. The UKCRF Network Education Group aims to share best practice and develop guidance and frameworks to support clinical research nurses as well as other research staff. The group is ideally placed to liaise with all relevant professional groups and higher education institutions to collaborate on identifying areas and skills that could be enhanced to develop clinical research nurses and support them.
Conclusion The UKCRF Network Education Group works to share best practice and support clinical research nurses to deliver safe quality care to research participants. It provides a collaborative approach with other disciplines and professionals working in CRFs and other research organisations across the UK. Clinical research nurses have a significant role in clinical research and are integral to recruiting patients into studies and supporting research at every stage of the process. Recognition and acknowledgement of the clinical research nurse’s role was highlighted at an NIHR meeting entitled Celebrating Clinical Research Nurses. For nurses to continue to develop expertise in clinical research, education and training is vital, as is a co-ordinated approach to sharing and developing best practice. The UKCRF Network Education Group will continue to develop relevant tools to support clinical research nurses and other CRF staff NS
References Association of UK University Hospitals (2012) Report of the AUKUH National Clinical Academic Careers Development Group for Nurses and Midwives. www.aukuh. org.uk/index.php/affiliate-groups/ nmahps/progress-report (Last accessed: January 27 2014.) Chief Scientist Office (2009) Investing in Research. Improving Health: The Research Strategy for Health and Healthcare. www. cso.scot.nhs.uk/wp-content/ uploads/2013/02/research.pdf (Last accessed: January 27 2014.) Coulson C, Grange A (2012) Developing clinical research nurses. Nursing Times. 108, 22/23, 23-25. Department of Health (2006) Best Research for Best Health: A New National Health Research Strategy. tiny.cc/BRBH (Last accessed: January 27 2014.) Department of Health (2008)
Research Governance Framework for Health and Social Care: Annex (Updated September 2008). tiny.cc/Res_Gov_Frame (Last accessed: January 27 2014.) Department of Health (2012) Developing the Role of the Clinical Academic Researcher in the Nursing, Midwifery and Allied Health Professions. tiny.cc/CAR_role (Last accessed: January 27 2014.)
Facility (2013) Celebrating Clinical Research Nurses: An NIHR Meeting to Celebrate International Nurses Day 2013. www.ccf.nihr.ac.uk/ ClinicalResearchNurses/Pages/ default.aspx (Last accessed: February 10 2014.)
Hamer S (2013) Strategic Priorities for the NIHR CRN Clinical Research Nurse Workforce. tiny.cc/strategic_ priorities (Last accessed: February 10 2014.)
National Institutes of Health Clinical Center, Nursing and Patient Care Services (2009) Building the Foundation for Clinical Research Nursing: Domain of Practice for the Specialty of Clinical Research Nursing. www.cc.nih.gov/nursing/crn/ DOP_document.pdf (Last accessed: February 11 2014.)
National Institute for Health Research (2013) 1.1 The National Institute for Health Research Version 8 (July 2013). tiny.cc/ NIHR_2013 (Last accessed: January 27 2014.)
Pidd H (2011) Maximising the Nursing Contribution to the UK Clinical Research Agenda (Version 2). www.researchacademy.co.uk/ the_uk_clinical_research_agenda (Last accessed: January 27 2014.)
National Institute for Health Research Central Commissioning
Resuscitation Council (UK) (2008) Emergency Treatment
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of Anaphylactic Reactions: Guidelines for Healthcare Providers. RCUK, London. Scottish Executive Health Department (2006) Research Governance Framework for Health and Community Care. Second edition. www.cso.scot.nhs.uk/ Publications/ResGov/Framework/ RGFEdTwo.pdf (Last accessed: January 27 2014.) UKCRF Network (2012a) Induction Framework for Clinical Research Staff. tiny.cc/ UKCRF_framework (Last accessed: February 10 2014.) UKCRF Network (2012b) Emergency Scenario Training Guidance Document. tinyurl.com/kY7QQRY (Last accessed: February 10 2014.) UKCRF Network (2013) Emergency Scenario Training Guidance Version 2: 2013. www.ukcrfnetwork.co.uk (Last accessed: February 10 2014.)
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Developing good practice for clinical research nurses McDermott S et al (2014) Developing good practice for clinical research nurses. Nursing Standard. 28, 26, 40-44. Date of submission: October 8 2013; date of acceptance: November 29 2013.
Abstract This article outlines the role of clinical research in the UK government’s strategy for economic growth and the role of clinical research nurses in that research. The diverse skills and knowledge required by clinical research nurses to support a range of research studies in a number of research environments are described. The development and aim of the UK Clinical Research Facility Network is discussed, with particular focus on the role of the UK Clinical Research Facility Network Education Group in supporting clinical research nurses and research teams to acquire and maintain relevant research skills. The outcomes delivered by the UK Clinical Research Facility Network Education Group are outlined along with ongoing and future work. Recommendations to ensure that the workforce will be skilled appropriately to support future clinical research are provided.
Authors Shona McDermott Assistant director, education and training, Clinical Research Facility, NHS Greater Glasgow and Clyde, Glasgow. Kornelia Hathaway Education and training manager, NIHR/Wellcome Trust Clinical Research Facility, Cambridge University Hospitals NHS Foundation Trust. Caroline Saunders Head of clinical operations, NIHR/Wellcome Trust Clinical Research Facility, Cambridge University Hospitals NHS Foundation Trust; also deputy director, UK Clinical Research Facility Network. Correspondence to: [email protected]
Keywords Clinical research nurse, education, emergency scenario training guidance, research skills and knowledge, UK Clinical Research Facility Network
Review All articles are subject to external double-blind peer review and checked for plagiarism using automated software.
Online Guidelines on writing for publication are available at www.nursing-standard.co.uk. For related articles visit the archive and search using the keywords above.
40 february 26 :: vol 28 no 26 :: 2014
FOR HEALTHCARE PROFESSIONALS to deliver evidence-based medicine, robust evidence is required from reliable clinical research. Investment in supporting and conducting research has resulted in nurses having an integral role in clinical research studies. This article explores the role of clinical research nurses and the training and education they require to conduct clinical research. It also examines the role of the UK Clinical Research Facility (UKCRF) Network Education Group in identifying, developing and sharing best practice for training and developing these nurses in the workplace.
Background The government’s strategy for healthcare research in the UK is to encourage economic growth; to attract investment by the life sciences industries through world-class infrastructure for health research; to establish the NHS as an internationally recognised centre of research excellence; to attract, develop and retain the best clinical research professionals to conduct people-based research; and to create opportunities for patients and the public to participate in, and benefit from, research (National Institute for Health Research (NIHR) 2013). This is reinforced by the Health and Social Care Act 2012, which places a statutory duty on staff to promote research at all levels of the NHS. The NIHR in England and its equivalent, the Chief Scientist Office (CSO) in Scotland, have a vital role in this strategy (Department of Health (DH) 2006, CSO 2009). Part of the implementation plan of the strategy in England was to create an NIHR faculty to support individuals carrying out and participating in research, as well as an infrastructure to support the research environment (NIHR 2013). Since the establishment of the NIHR in 2006, there has been unprecedented investment (£1 billion) in clinical research infrastructure in terms of clinical research facilities (CRFs), clinical research networks, and biomedical research centres to deliver the national research agenda and to improve the health and wealth of the nation through research (NIHR 2013).
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Clinical research nurses are fundamental to conducting clinical research studies in the NHS. It has been difficult to establish precisely how many clinical research nurses there are working in the UK and Pidd (2011) referred to ‘a conservative estimate’ of around 10,000 by 2013. The clinical research nurse role is relatively new. Nurses are employed in specialist research centres such as CRFs where they work on translational research (applying knowledge from scientific research to practical situations at the bedside). Nurses also work in early phase drug studies in specialityspecific research networks such as the Diabetes Research Network. Clinical research nurses working in NHS and university settings facilitate research studies in primary and secondary care, for example on later phase drug trials and research in epidemiology. Those new to the role are required to have considerable clinical researchspecific knowledge and skills to perform their roles competently (National Institutes of Health Clinical Center and Nursing and Patient Care Services 2009). While there are international guidelines (European Clinical Trials Directive 2001/20/EC and Good Clinical Practice Directive 2005/28/EC), national legislation (Medicines for Human Use (Clinical Trials) Regulations 2004), and government frameworks (Scottish Executive Health Department 2006, DH 2008) in place to which clinical research nurses have to work, there is uncertainty about what is best practice regarding research-specific training and educational development (Coulson and Grange 2012). The UKCRF Network was established in 2008 by nurses to develop and share best practice with other nurses to support patients taking part in clinical research and improve their care. The UKCRF Network has subsequently expanded to include all professional groups working in this field and receives core funding from the DH and CSO to support experimental clinical research operational activity (the practical aspects of conducting research) through work groups and work streams. A work group is a group of members who meet on a regular basis to share best practice. A work stream is a smaller subgroup that forms to complete a specific piece of work. Members of work groups have relevant experience or a role in a specific area and contribute to the work of the group. The work streams and work groups identify, develop and share good practice in clinical research and experimental medicine infrastructure. Information about the work produced by the work groups and work streams is available on the UK CRF Network’s web portal (www.ukcrfnetwork.co.uk). The operational components of the UKCRF Network are the CRFs, which provide dedicated
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space for conducting clinical research in patients and healthy volunteers. Typically, CRFs comprise inpatient and outpatient, day-case and specialist facilities to support adults and children in research studies across a range of specialties. In the past decade, the number of CRFs across the UK has increased from around ten to approximately 40 in 2012 (19 of these are NIHR funded). Clinical research nurses form the largest staff group in CRFs and they play a crucial role in supporting and caring for patients in research studies, while at the same time maintaining the integrity of the studies. For many nurses, taking on this new role is a major challenge because it is quite different from the standard nursing role. To function as effective research professionals, nurses therefore require specialist on-the-job training and education on ethics, legislation and science of clinical research.
UK Clinical Research Facility Network Education Group In 2008, having consulted the relevant literature and a wide range of nursing colleagues working in clinical research roles, it became clear to the education leads of CRFs that there was a need for role-specific development for clinical research nurse and other staff working in CRFs. Consequently, nursing and other staff tasked with overseeing training and leading on education in their respective CRFs started an informal dialogue about how to best develop and support CRF staff education and training. These staff recognised that there was little generic guidance or accessible provision of education and training for clinical research staff. It was apparent that they could provide valuable support as well as strategic educational guidance for clinical research nurses and other staff groups in their CRFs. Subsequently, in 2009, the UKCRF Network Education Group was established to provide guidance on role-specific development. The group is supported and supervised by the UKCRF Network Strategic Management Team. Membership of the group comes from CRFs in England, Wales, Scotland and the Republic of Ireland, with 17 CRFs being represented by a designated member of staff. These staff members have a specific education role or, as part of their role, act as the education lead in the CRF. Group members represent a wide range of professional expertise, providing a good basis for cross-site developments to identify, share and guide good practice. The aims of the education group are to: Share expertise and establish best practice in training for clinical research professionals working in CRFs. Where they are missing but required, develop february 26 :: vol 28 no 26 :: 2014 41
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Art & science education relevant educational guidance and suitable resources that enhance continued professional development of staff working in CRFs and of associated clinical research professionals in other clinical research organisations within the NHS. Collaborate and liaise with other clinical research organisations to ensure that the work of the group is up to date, responsive and complementary to regional and national developments in training and education. The group meets three times per year to discuss and agree on specific projects, which are then delivered by a subgroup of members with the relevant expertise. Since 2009, the education group has developed and shared good practice, disseminating the group’s work on the UKCRF Network’s website. The following sections describe key areas of work that the group has undertaken.
Induction framework for clinical research staff
Healthcare professionals new to working in clinical research need to acquire knowledge that is specific to this field. The education group set out to investigate what core research-related knowledge new staff need from mentors during their induction period. After undertaking a detailed scoping process across the CRFs in the UK and the Republic of Ireland, as well as expert discussions with a range of research staff groups, the group developed and launched an induction framework for clinical research staff in 2011. This identified nine research themes, each with core components for which there is generic information and practical guidance produced as part of the framework. A revision followed in 2012 with expansion to ten research themes (UKCRF Network 2012a) (Box 1). The framework is suitable for all clinical research professionals to guide mentors and education staff in the UK.
Emergency scenario training guidance
In clinical research, the research participant’s safety is safeguarded. Regular and robust training for clinical research nurses in dealing with potential clinical emergency situations is advocated, but
BOX 1 Themes of the induction framework for clinical research staff Understanding clinical research. Research governance and ethics. Consent and recruiting participants. Study management. Resource management. Information governance (data protection and management). Quality control systems and quality assurance in clinical research. Laboratories and samples. Role of the National Institute for Health Research. Role of the UK Clinical Research Facility Network.
42 february 26 :: vol 28 no 26 :: 2014
there has been no easily identifiable external guidance. The education group therefore used expertise from within the group to establish a generic guidance document that contains sample scenarios for clinical research nurses to adapt for use in their workplace. In 2012 guidance was produced focusing on emergency scenario training involving adult research participants. The guidance document aims to encourage clinical research nurse teams to develop emergency scenario training programmes for staff (UKCRF Network 2012b). The scenario training guidance was developed to assist CRFs to establish robust emergency training to complement the trust’s resuscitation training. The original focus on adult research participants was intended to be expanded and developed to meet the needs of staff providing care for other patient groups. There are currently ten CRFs in the UK that conduct clinical research studies involving children. Therefore, to support and train staff caring for paediatric research participants and their respective family and carers, the education group and the UKCRF Network Paediatric Group identified and developed three simulation training scenarios specific to paediatric emergency situations. Subsequently, the original 2012 emergency scenario training guidance was reviewed, updated and expanded to include emergency simulation scenarios and guidance on how to apply these in a clinical paediatric research setting. The updated guidance, Emergency Scenario Training Guidance Version 2: 2013 aims to support nursing staff who work in an area where children could be present, to deliver safe quality care (UKCRF Network 2013). Box 2 contains the first section of a single emergency scenario to illustrate the content of the guidance.
Web-based education resource
A website (www.crts.org.uk/national) that was created initially to provide relevant research training information in Scotland provided an ideal platform with open access for the education group to add information about accredited and non-accredited education courses. These courses were used by and, at times, developed with input from clinical research nurses working in CRFs across the UK. The website is updated regularly by members of the education group to provide information about training that might be useful for clinical research nurses.
Workshop and poster presentations
Members of the education group take an active role in conferences aimed at clinical research nurses. They may act as ambassadors for disseminating information about the induction framework for clinical research staff and emergency scenario
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training guidance in clinical research settings, or present posters on the work of the education group. Conferences that members have attended include the third annual International Association of Clinical Research Nurses in 2011 in Bethesda, Maryland, United States; the Irish Research Nurses Network conference in 2012 in Dublin; and the Celebrating Clinical Research Nurses’ Day organised by the NIHR in 2013 in London.
Work in progress
The education group recognises that ensuring and sharing good practice is a continual process requiring ongoing expansion of collaboration, review and improvement of the work delivered and development of new initiatives to support staff working in CRFs. Clinical research staff in CRFs will often undertake sample processing and storing of various types of samples. This activity is often the responsibility of the clinical research nurse, and it is essential that a level of competence is demonstrated to ensure correct handling procedures. The UKCRF Network laboratory managers work stream identified the need to develop a set of laboratory competencies that would be appropriate to support staff who access laboratory areas and equipment, but who are not designated laboratory personnel. Members of the education group are therefore developing two generic competency assessment templates for specific research activities that can be adapted for various activities and disciplines. These templates and the corresponding guidance, are being developed and once finalised will be adapted, in collaboration with the UKCRF Network Laboratory Group, to deliver a laboratory competency framework.
Future work
The role of the education group is to share best practice and provide support through developing appropriate tools and collaborating with other UKCRF work streams and research colleagues. The education group recognises that sharing best practice is not confined to the CRFs but also has the potential to be used by staff in other research environments. The education group aims to: Adapt the generic competency assessment template, discussed above, to provide an informed consent competency tool. This competency will be developed following a structured process that involves review of the literature, review of best practice already delivered by CRF staff, and subsequent development of a tool that supports clinical research nurses and research staff to ensure research participants are fully informed and
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provide consent appropriately when taking part in a research project. Continue to support the development of staff working in CRFs and in other research environments across the UK. To achieve this goal, the education group will share best practice and frameworks, and review and recommend suitable training and education tools and, where needed, design new ones. Members of the education group share information with staff working in CRFs and with other NHS clinical research organisations by presenting at relevant conferences, meetings and workshops. The group will also ensure that all tools and guidance developed will be disseminated through relevant media and via publication.
National Institute for Health Research and clinical research nurses In the UK, the NIHR is the largest funder of clinical research activity in the NHS. In May 2013, inspired by the concept of International Nurses Day, the NIHR held the first nationwide meeting specifically for clinical research nurses in London.
BOX 2 Example case scenario for emergency training guidance Recognition and treatment of anaphylaxis Intended clinical (technical) learning objectives: ABCDE approach to assessing and treating a participant with anaphylaxis. Appropriate use of emergency equipment, drugs and monitoring. Intended non-technical learning objectives: Communication. Structured and effective teamwork. Leadership. Decision making. Participant: Andy, a 32-year-old male. Learner information pre-scenario (narrative case description): Use only if scenario is announced Andy is a healthy volunteer who has been enrolled into a Phase I trial. He has no past medical history. He has had baseline observations of temperature, pulse, blood pressure and respirations recorded and these are all within normal ranges. He is cannulated and has been commenced on an intravenous infusion of an investigational medicinal product – a new antibiotic. Five minutes after the infusion was started, Andy begins to complain that he feels dizzy and that his throat feels tight. Facilitator information pre-scenario (narrative case description): Andy is experiencing severe anaphylaxis related to the study drug. He has no past medical history. His condition will continue to deteriorate, up until the point of adrenaline administration. Use SBAR (situation, background, assessment, recommendations): Recognition and treatment should be based on Resuscitation Council (UK) (2008) guidance.
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Art & science education Entitled Celebrating Clinical Research Nurses, the day was held in recognition of ‘the contribution clinical research nurses make to improving patient care and the work of the NIHR’ (NIHR Central Commissioning Facility 2013). At this meeting, Susan Hamer, director for organisational and workforce development at the NIHR Clinical Research Network, announced the following strategic priorities for the NIHR CRN clinical research nurse workforce, which are in accord with the aims of the education group (Hamer 2013): Enhanced patient experience. Improved standards of research delivery and practice. Improved awareness of research activity and support.
Recommendations To ensure there is a viable, appropriately skilled workforce in the future to support clinical research, the clinical and research communities need to recognise the value of clinical research nurses. This means that it is necessary to support training and education for these nurses so that they are sufficiently skilled and knowledgeable to meet the needs of the research environment. While high-level initiatives around research workforce development (Hamer 2013) and clinical academic training opportunities (Association of UK University Hospitals 2012, DH 2012) are in place, there is a need to provide practical skills and operational role-specific training for
clinical research nurses to enable them to support patients participating in research. The UKCRF Network Education Group aims to share best practice and develop guidance and frameworks to support clinical research nurses as well as other research staff. The group is ideally placed to liaise with all relevant professional groups and higher education institutions to collaborate on identifying areas and skills that could be enhanced to develop clinical research nurses and support them.
Conclusion The UKCRF Network Education Group works to share best practice and support clinical research nurses to deliver safe quality care to research participants. It provides a collaborative approach with other disciplines and professionals working in CRFs and other research organisations across the UK. Clinical research nurses have a significant role in clinical research and are integral to recruiting patients into studies and supporting research at every stage of the process. Recognition and acknowledgement of the clinical research nurse’s role was highlighted at an NIHR meeting entitled Celebrating Clinical Research Nurses. For nurses to continue to develop expertise in clinical research, education and training is vital, as is a co-ordinated approach to sharing and developing best practice. The UKCRF Network Education Group will continue to develop relevant tools to support clinical research nurses and other CRF staff NS
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of Anaphylactic Reactions: Guidelines for Healthcare Providers. RCUK, London. Scottish Executive Health Department (2006) Research Governance Framework for Health and Community Care. Second edition. www.cso.scot.nhs.uk/ Publications/ResGov/Framework/ RGFEdTwo.pdf (Last accessed: January 27 2014.) UKCRF Network (2012a) Induction Framework for Clinical Research Staff. tiny.cc/ UKCRF_framework (Last accessed: February 10 2014.) UKCRF Network (2012b) Emergency Scenario Training Guidance Document. tinyurl.com/kY7QQRY (Last accessed: February 10 2014.) UKCRF Network (2013) Emergency Scenario Training Guidance Version 2: 2013. www.ukcrfnetwork.co.uk (Last accessed: February 10 2014.)
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