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Nurs Outlook. Author manuscript; bachelor in PMC 2013 May ane.

Published in terminal edited grade equally:

PMCID: PMC3348260

NIHMSID: NIHMS333736

Clinical Research Nursing: A Critical Resource in the National Inquiry Enterprise

Clare E. Hastings, RN, PhD, FAAN, Cheryl A. Fisher, RN, EdD, Margaret A. McCabe, RN, DNSc, and The National Clinical Research Nursing Consortium*

Clare East. Hastings

NIH Clinical Heart

Cheryl A. Fisher

NIH Clinical Center

Margaret A. McCabe

Boston Children's Hospital

Abstract

Translational clinical research has emerged equally an of import priority for the national research enterprise, with a clearly stated mandate to deliver prevention strategies, treatments and cures based on scientific innovations faster to the public. Within this national endeavour, a lack of consensus persists apropos the need for clinical nurses with expertise and specialized training in study implementation and the delivery of care to inquiry participants. This paper reviews efforts to define and document the role of practicing nurses in implementing studies and analogous clinical research in a variety of clinical settings and differentiates this clinical role from the function of nurses every bit scientists and principal investigators. We advise an agenda for building testify that having nurses provide and coordinate study treatments and procedures can potentially improve enquiry efficiency, participant condom, and the quality of research data. We also provide recommendations for the development of the emerging specialty of clinical enquiry nursing.

Translational Clinical Inquiry: A New Arena for Nursing Practice

Clinical and translational inquiry has emerged as an important, crosscutting priority for the national research enterprise. Calls for the acceleration of translational research initially focused on the "valley of death" between laboratory discoveries and clinical innovation and the testing and application of promising findings in clinical trials 1. The concept of translation was extended to include the concern that too ofttimes promising interventions were successfully tested in clinical trials, only that this transfer from bench to bedside but resulted in a transfer from "bedside to the academic bookshelf," 2, folio 229, with no perceptible alter in clinical practice or patient outcomes. Translational research is at present construed as a continuum with translation steps occurring from theories and discoveries in the basic sciences, through man testing, and then through multiple translation steps to application in a customs setting and evaluation of long term outcomes and comparative effectiveness3–6.

Nurses have important roles beyond the knowledge cosmos and translation procedure, from concept development and basic scientific discovery through evaluation and dissemination research. However when nurses' contributions to inquiry are discussed, the conversation within the discipline is primarily about 2 basic roles: the office of the nurse scientist who leads the discovery side of the procedure, and the role of clinical nurses and their professional leadership in assessing, testing, applying and adopting practices based on enquiry bear witness ("evidence-based practice"). In that location has been very little explicit attention over the past 30 years given in mainstream nursing to the roles, required qualifications and impact of nurses who practice in the clinical research setting providing and coordinating the care of inquiry participants. The purpose of this paper is to articulate the important contribution of clinical nursing to the care of research participants, coordination of clinical studies, and overall functioning of the clinical research enterprise.

What is the Clinical Specialty of Clinical Research Nursing?

Clinical research nursing is nursing practice with a specialty focus on the care of research participants in which nursing care delivery parallels the process of clinical research study implementation (Figure i). In add-on to providing and coordinating clinical intendance, clinical research nurses take a key office in assuring participant prophylactic, maintenance of informed consent, integrity of protocol implementation, accuracy of data collection and recording, and appropriate follow upward. Nursing care provided to enquiry participants is driven by study requirements and the collection of inquiry data as well as clinical indications. Patient cess and clinical data collection may include clinical observations, clinical measurements, specimen collection and preparation, and documentation of research participant reported outcomes. Interventions and study procedures may include administration of investigational drugs, performance of an experimental or investigational surgical or radiological procedure, detailed clinical evaluation or phenotyping to narrate the natural history and etiology of a disease, or delivery of a psychosocial intervention. The participant's response to the study intervention may make additional nursing care necessary. These intendance requirements range from educating the participant about self-monitoring to comprehensive physiological monitoring and life support in an intensive care unit of measurement. Because clinical inquiry is an interdisciplinary process, the potential contribution of the clinical research nurse includes coordination of research and care equally well as management of the interface between study-based care and community services.

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Care and Enquiry in Clinical Research

Because of the intertwined link between intendance and research in the clinical research process, clinical research nurses must continually balance the requirements of the report with the clinical needs of private participants7–11. This balance betwixt clinical and research priorities is essential to the ethical implementation of clinical studies as well as the consistency, accuracy and efficiency of information collection12. Ultimately, achieving and maintaining this balance may be a significant factor in the participant's perception of the integrity of the unabridged clinical inquiry enterprise.

Nurses who do in clinical research are ofttimes the first to experience and work with research participants on the actual delivery and management of a new therapy, drug or device. They may be the kickoff to have a hint of implications that later become important to the general use of the new intervention – either an agin event or a needed modification in commitment or implementation that is of import to patient tolerance and adherence. Observations made by nurses who are the agents of implementation in a clinical trial may therefore have straight bearing on the speed with which translation to the next level of testing and use tin occurxiii,14.

In order to attain the best possible outcomes for research participants and the research process, clinical research nurses must not simply have expert clinical skills and well adult critical thinking skills, but must also exist well versed in the complex regulatory, upstanding, and scientific aspects of clinical inquiry. Past managing study activities, monitoring participants for anticipated and unanticipated events, supporting and educating participants, interpreting and rephrasing descriptions of study-related care for participant and family, the clinical research nurse ensures that the study objectives are attained while upholding all the principles of participant rights, patient safety and continuity of care. Nurses amend recruitment of participants fifteen, and back up individuals to make informed decisions about clinical trials participation xvi.

The highest priority of clinical research is to protect human subjects from undue harm17 and undue burden from the research. The clinical enquiry enterprise has special obligations to those willing to volunteer to participate in clinical studies and potentially place themselves in impairment's way for the benefit of others. The power to behave clinical studies depends upon individuals being willing to participate, so public trust is crucial. The public's perception of both the safety of the studies and the integrity of the inquiry enterprise are disquisitional contributors to the public trust.

Clinical research nurses may serve as the commencement line of communication to participants and family members about study progress, evolving concerns and adjacent steps. Because clinical research nurses play a vital function in detecting and documenting adverse events, their vigilance, clinical astuteness, and knowledge of the clinical context of the written report are of import factors in decreasing risks to participants. Identifying adverse events at the earliest fourth dimension bespeak requires disciplined training and an in-depth understanding of the scientific basis of the research and, where applicable, the investigational agent or device.

As the telescopic of clinical inquiry is broadened to include more community-based sites, in that location will exist greater reliance on local clinicians to deliver intendance in back up of the research intervention besides as to monitor participant compliance and response to treatment. This expansion has implications for the roles of nurses coordinating studies in these sites also as for nurses providing the care to research participants who may or may not have formal preparation in research implementation and human discipline protection. It has been suggested eighteen that equally clinical intendance moves from the hospital setting to community-based settings, threats to patient safety shift from being handling related to being diagnosis related. Greater reliance must be placed on adherence to therapy as opposed to direct delivery and oversight of care. This parallels the shift in handling implementation responsibility from the care provider squad to the patient in convalescent settings, and has implications for the clinical enquiry nurse's role in promotion of adherence to an experimental protocol too as the prevention of adverse events.

Part Development in Clinical Research Nursing

Although nurses are integral and assumed to exist essential to the clinical research squad, there is no more often than not accepted, standardized definition of the part of the clinical enquiry nurse 8,12,nineteen–22. The most full-bodied effort to define the role of nurses in clinical research care has been the longstanding effort within the specialty of oncology nursing, beginning in the early on 1980's 23–28. This work resulted in an organizational focus within the Oncology Nursing Society: the Clinical Trials Special Interest Grouping 29, and the development of a survey instrument which is one of the few role contour instruments available for clinical research nursing 8.The effort culminated in a transmission for clinical trials nursing and the formal development of clinical trials nursing competencies 30. During this aforementioned time period, there has been work in the United Kingdom defining and describing the roles and competencies of clinical research nurses. The National Health Service (NHS) initiated Agenda for Change in 2004 with associated chore descriptions and profiles in an effort to standardize terms and atmospheric condition for all not-medical jobs in the NHS across the United Kingdom (United kingdom of great britain and northern ireland) 31. In association with the new UK Clinical Research Facility Network, a working grouping including the Imperial Higher of Nursing and the National Cancer Research Network later on developed the Competency Framework for Clinical Enquiry Nurses 32. For the first time research nurses working in the UK had conspicuously described and relevant competencies linked to their roles with performance criteria and contextual factors to guide their professional development. More contempo proposals have been made by members of the UKCRF Network equally part of the United kingdom Clinical Research Nurse Consortium, comprised of the Chief Executive and Registrar of the Nursing & Midwifery Quango (the UK broad professional registration body), GCP Training Manager from the NIHR Clinical Inquiry Network, Research & Development Advisor of the Royal Higher of Nursing, Directors and senior managers of UK Research Networks and facilities. Their position paper outlines the need for a more coordinated and strategic approach that will maximise the nursing, midwifery and health visiting contribution to improving the health and wealth of the United kingdom of great britain and northern ireland through research. The paper acknowledges the fiscal constraints inherent in the enquiry process and need to have clarity of roles inside the multi-disciplinary squad 33. This work builds on the premise that "well trained, competent, supervised, permanently employed research nurses are the best means of mitigating against poor clinical and enquiry do" 34. Evolution of clinical research nursing in other specialties, such as HIV care 35,36, gastroenterology 37, and urology 38 has added some conceptual clarity to current agreement of the practice, as has work in other countries with a loftier concentration of clinical trials such equally Canada and New Zealand 39,forty.

In spite of considerable attempt to standardize terminology and communicate the roles of nurses within the clinical research infrastructure, confusion of titles and roles has persisted over the years with respect to nurses who provide direct clinical care in a setting in which clinical research is conducted or who coordinate a study in a clinical setting. It is therefore non surprising that an internal assessment conducted in 2007 at the NIH Clinical Heart found 5 formal and 39 breezy titles associated with nurses practicing on the clinical research patient care units or coordinating studies on behalf of private NIH Found chief investigators 41,42. Additionally, many titles applied to nurses in clinical inquiry, such as Clinical Research Acquaintance (CRA) or Clinical Research Coordinator (CRC), are also used for non-nurses who coordinate or support clinical inquiry. Indeed certification for these titles does not require registered nurse licensure 43,44. It has been acknowledged that although roles such as a CRA may be filled past a nurse or a non-nurse, a staffing decision to utilise a nurse may be the virtually practical decision for a modest research program, since a nurse can do both the clinical support activities as well as the study coordination and compliance direction activities 45. Considering clinical requirements vary significantly across studies, clarifying the scope and championship for these roles is necessary to assure that the almost qualified clinical research staff members are selected for a given study or inquiry program.

Defining the Conceptual Domain of Practice for Clinical Research Nursing

It was recognized early on in the exploration of conceptual definitions for clinical research nursing that the scope of practice for clinical enquiry nurses extended beyond the dimension of direct clinical intervention to include study management, homo discipline protection, intendance coordination within the context of inquiry participation, and contributions to clinical scientific discipline every bit an agile research team member 46,47. These elements became the basis for a five dimensional taxonomy of activities (see Table 1) proposed to depict the domain of practice of clinical research nurses, which was developed at the NIH Clinical Center and validated in a national sample of nurses involved with providing clinical inquiry nursing services 7. This taxonomy is intended to serve as a blueprint for competency and core curriculum development for the specialty, and later potentially for certification standards.

Table one

The Domain of Clinical Research Nursing Practice

The overall domain of practice includes intendance provided to research participants, also as coordination of intendance and services and activities to back up protocol implementation, data collection, human subject protection and participation in team science

Dimension Definition
Clinical Do Provision of nursing care, education, and support, using the nursing process, to participants in clinical inquiry and their families and pregnant others. Intendance requirements are determined by the scope of report participation, the clinical condition of the patient, and the requirements and clinical effects of research procedures and data collection
Study Management Direction of clinical and research support activities in order to clinch patient condom, accost clinical needs and assure protocol integrity and authentic data collection
Care Coordination and Continuity Coordination of research and clinical activities to meet clinical needs, complete study requirements and manage linkage with referring and primary care providers
Man Subjects Protection Facilitation of informed participation past various participants in clinical research
Contributing to the Science Contributions as a research team member to the development of new ideas for study, explorations of innovations arising for clinical inquiry and application of clinical enquiry findings to practise

The clinical research nursing practice domain was further conceptualized to cover in its telescopic two primary roles assumed by nurses practicing in clinical inquiry settings. These roles stand for the ends of a continuum with i part primarily concerned with patient care (Clinical Enquiry Nurse or CRN) and the other role primarily concerned with study coordination (Enquiry Nurse Coordinator or RNC). Actual roles vary forth this continuum. The practice domain taxonomy was the basis for a role delineation survey instrument that was used in a survey of nurses in RNC and CRN roles at the NIH Clinical Centre 48. The large sample size (due north=412), and the power of the role delineation instrument to differentiate roles focused on clinical implementation from roles focused on study coordination, supports broader awarding to characterize the roles of nurses practicing in clinical research across the spectrum of inquiry settings.

Clinical research nurses are clinical staff nurses with a central focus on intendance of research participants. They support written report implementation inside the context of the care commitment setting and are primarily located in dedicated clinical inquiry settings, such as the NIH Clinical Centre, research units within the Clinical and Translational Science Award (CTSA) sites, clinical research programs within academic medical centers (such as designated NCI Cancer Centers), community based research programs and networks, or clinical enquiry units run by manufacture or under contract to a sponsor. Staff nurses practicing in such clinical inquiry settings are part of the permanent infrastructure of the inquiry unit, and are available to any investigator or sponsor accessing the facility for support of research implementation and research participant clinical intendance.

Research nurse coordinators on the other mitt are often hired by and study to a main investigator and may be funded but for the support of a specific study or group of studies. Inquiry nurse coordinators are primarily responsible for study coordination and data management, with a central focus on managing subject recruitment and enrollment, consistency of study implementation, data management and integrity, and compliance with regulatory requirements and reporting. They may rely on clinical staff to deliver "hands on" care including assistants of investigational drugs or interventions.

The roles of clinical inquiry nurse and research nurse coordinator are considered function of a career path in clinical inquiry that in some cases could extend, with advanced pedagogy and experience, to the role of nurse scientist or principle investigator (Figure two). There are several examples of this progression at the NIH Clinical Center which probably has the largest consolidated clinical inquiry workforce in the U.Due south. However not all clinical research nurses are interested in condign scientists and clinical scientists certainly practice not accept to showtime in enquiry by providing care to inquiry participants. There are many entry and exit points into and out of the clinical research career progression shown in Figure ii. It is important to note that the conceptual definition of clinical research nursing every bit a specialty is a clinical exercise definition with a focus on research participant care and care coordination, and is non intended to refer to the role of nurse scientist as a clinical researcher.

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Nursing Career Path in Research at the NIH Clinical Center

Clinical Research Nursing in the Federally Funded United states of america Clinical Research Enterprise

Clinical nursing resources have been a major part of two meaning investments made past the NIH in the "critical mass" concept for clinical enquiry. Ane of these investments is the NIH Clinical Heart, the 240-bed clinical enquiry hospital in Bethesda, Maryland, opened in 1952 49,l, and updated with a new state-of-the-fine art facility in 2005 51,52. The 2d was the national network of General Clinical Research Centers (GCRCs) located primarily in academic medical centers 53–55, and recently transformed into broader networks of linked research resources through the CTSAs. For over fifty years, the NIH Clinical Center and GCRC / CTSA programs provided a variety of clinical facilities and back up services for investigators to bear clinical research and correspond a substantial investment in the clinical infrastructure to support ongoing implementation of clinical studies56. This investment included facilities, equipment and interdisciplinary staff, the bulk of whom are specialty practice clinical research nurses.

Historically, the NIH Clinical Center and GCRCs / CTSA network provided a stable base upon which new researchers are able to build programs of research18,55,57. They have also provided enquiry training for new investigators from every discipline. Even so, because of their full-bodied and fixed cost, both structures have come under repeated scrutiny, which has intensified in the recent fiscal climate. As the NIH budget shrinks in terms of aggrandizement-adjusted dollars, the NIH Clinical Center and newly funded CTSAs are facing financial pressures resulting in fiscal tension between the cadre clinical infrastructure and specific investigator-driven research. This state of affairs puts particular pressure on the employ of loftier cost resource such as registered nurses in the coordination and execution of clinical studies. Thus, there is an urgent need to clearly delineate the benefits of having highly skilled clinical enquiry nurses as an integral office of the clinical inquiry procedure.

The reengineering of federally funded clinical research driven by the NIH Roadmap initiative 58 and the launch of the CTSA plan in 2006 59, fundamentally changed the clinical research infrastructure as it existed in academic medical centers and their communities of practice. The initial focus within nursing was to assure that nursing had a vocalism in the developing CTSA scientific and operational structures and facilitate inclusion of nurse scientists in emerging translational science interdisciplinary teams. Nursing leaders were urged to become actively involved in setting the research calendar within individual CTSAs and influence the scientific focus within the evolving CTSA network 60. As the transformational modify catalyzed by the CTSA program gained momentum, the contribution of nurses to the interdisciplinary science agenda and the translation of research findings from early phase experiments to community practice settings became more visible61–63.

During the emergence of the CTSAs, the clinical practice environment of nurses working within the research infrastructure was not an area of focus and has not been formally articulated. The CTSA mechanism emphasizes interdisciplinary research and creation of networks of collaborating sites and resources that can reduce the time from discovery to application and extend findings quickly to the community64,65. At that place was silence in calls for proposals, and in many of the CTSA grant responses, on the topic of how clinical resources would be supplied to research teams, or whether funded research back up would include clinical nursing. This contrasts with the GCRC machinery in which a structured presence of nursing services was specifically required 66,67. The allotment and employ of clinical resources, including nurses, was left up to individual CTSA networks to make up one's mind, and has varied substantially as these entities have evolved. Lack of consensus has persisted within the clinical inquiry community almost the need for and use of clinical nurses with expertise and specialized grooming in clinical research practice to provide care and intendance coordination for research study participants.

Efforts inside the NIH Clinical Eye and the national network of GCRCs to define the roles and contributions of clinical research nurses took on a new urgency with the rapidly escalating pace of change in the clinical research environs. A Position Newspaper from the GCRC Nurse Managers Association posted on their website in February, 2006, and at present available as an unpublished manuscript from the International Clan of Clinical Inquiry Nurses (IACRN) 68, called for a synthesis of the knowledge and feel from 45 years of GCRC clinical inquiry nursing exercise into the emerging innovative structures for clinical research, specifically calling for the memory of dedicated funded sites for clinical research that could sustain the kind of embedded expertise available in the GCRCs. The Position Paper called particular attention to the ongoing tension between clinical needs for interventions and research information collection requirements confronting clinicians attempting to combine care and inquiry in 1 setting. This is a factor in defended enquiry centers only becomes fifty-fifty more than of an issue when clinical inquiry is dispersed into an acute care or primary care environment69–78.

In 2006, nursing at the NIH Clinical Center launched a four-twelvemonth strategic initiative, called CRN2010, to ascertain clinical research nursing as a practice specialty. This included evolution and dissemination of tools and resource needed to support specialty exercise and build the knowledge base needed for specialty practice certification. In 2007, these 2 efforts came together and the "National Clinical Research Nursing Consortium" was created, consisting of nurse managers from several GCRCs, nearly half of which had been funded every bit CTSAs and were in the process of transition, and nursing leadership from the NIH Clinical Center. This group met three times at Rockefeller University in New York, with the goal of outlining the bug related to the definition and use of clinical nursing resources which were urgently facing the clinical research enterprise. One outcome of these discussions was the cosmos of the International Clan of Clinical Inquiry Nurses in 2009 79. In the years since the first convening of the Consortium, meaning progress has been made in defining the domain of clinical research nursing exercise and laying the background for core competency assessment, curriculum development and ultimately professional person certification in the specialty.

Regulatory influences on Clinical Research Nursing

Standards of clinical research known as Good Clinical Practice (GCP) were developed to harmonize global efforts to protect human subjects every bit they participate in research and clinch bones principles of quality control so that results from clinical research are reliable and valid80,81. Compliance with GCP provides the public and regulatory government with assurances that the rights, safety, and well existence of research subjects are being protected. Furthermore, it helps to ensure that quality information can be submitted to regulatory government. The principles of GCP have been standard in manufacture-sponsored research for many years, and indeed set an international standard for the conduct of inquiry involving human subjects. These standards do not specifically accost the roles of clinical research nurses in supporting clinical research. Additional guidance and application of GCP principles take also been proposed by clinical societies, such as the American Society for Clinical Oncology, for use by their members in setting standards and institutional policy 82. As adherence to these standards becomes an expectation across all settings, information technology is important to certificate the contribution of clinical research nurses and their role in meeting these standards.

In add-on to the overall guidance for conducting clinical research found in GCP guidelines, the practice of nurses is regulated past state licensing authorities and farther delineated by institutional policy, including those working with homo subjects in the context of clinical enquiry. Every bit licensed professionals, it is expected that nurses are informed about the scope of do in the state in which they piece of work, including delegation authorities. Activities such equally medication administration vary by state in terms of who is allowed to administer, supervise administration and consul administration of medications. This issue tin can cause pregnant confusion when research teams discuss, for example, assignment of the part of dosing and monitoring healthy subjects in a stage ane trial or performing follow-upwardly phone evaluations to find and document possible adverse reactions.

The Global Practise Surround for Clinical Research Nurses

Nurses accept historically been integral to the behave of industry sponsored trials on new drugs and devices within the U.S. and abroad. However the clinical research nursing workforce supporting pharmaceutical and device development is essentially invisible. Although nurses are evident in the leadership of international clinical research organizations such as the Association for Clinical Research Professionals (ACRP), Society for Clinical Research Associates (SoCRA), Association of Clinical Pharmacology Units (ACPU) and others, nurses are not specifically differentiated or counted in the membership of these organizations, which have a multidisciplinary, sponsor and product focused orientation, and which are currently the merely providers of specialty certification in clinical research management. There is no reliable way in the nursing professional demographics information bases to find nurses who identify themselves as practicing in inquiry (as opposed to conducting inquiry), since that data is not specifically nerveless in surveys such as the National Sample Survey of Registered Nurses 83 or data collected by country boards of nursing. Anecdotal data from nurses practicing in commercial sites suggests that the FDA and its international counterparts, including the World Health Organization, are the chief drivers of standards and that scope of practice is primarily influenced by institutional policy and country regulations of nursing do, which vary widely.

There is no denying the fact that clinical research has get a global enterprise. This has been driven in part past the escalating cost of bringing new drugs and treatments to market combined with investments in applied science and clinical research infrastructure in speedily developing countries such as China and Bharat84,85. At the cease of the 20th century, there was a growing understanding that the development and distribution of new pharmaceuticals and devices was a rapidly growing industry, generating its own financial, upstanding and political growing pains 86. Globalization of the drug and device development industry has increased dramatically since and so, with the U.S., Canada, the Great britain and Europe still property the lead in terms of accented book of trials and participants, but with the greatest growth existence seen in the developing countries of Asia 87, and more than recently, South America 88. In addition to the opportunity presented by big numbers of potentially handling-naïve participants that could be accessed in international sites, the opportunity to significantly increase accrual and bear large-calibration multisite studies of interventions is attractive to investigators 89. Every bit the global clinical inquiry enterprise grows, questions about the role of staff to support research, including the roles of clinical research nurses, become of import. The Association of Clinical Research Professionals has a wide international membership, and has featured articles in its professional publications about the developing clinical research infrastructure in India ninety, Austria and Hungary 91, and Due south Africa 92. Within this developing global enterprise, concerns about Good Clinical Practice standards being upheld, ethical treatment of human subjects, the clinical context of inquiry done in international communities, and the quality of enquiry data have all been raised 93–96. These issues create a dynamic environs for the emergence of an identity for clinical research nursing internationally.

Challenges Today

Information technology is best-selling that advances in the bones sciences in the U.S take exceeded the capacity of the clinical research infrastructure to answer with translational studies and clinical trials 4. A major limiting factor is the cost and complication of implementing clinical studies, peculiarly studies that cantankerous institutions, address questions relevant to vulnerable populations, or extend into community care settings. Such studies require careful screening of participants for eligibility and clinical ceremoniousness as well as intensive monitoring for compliance with written report requirements, accurate information collection and documentation of adverse effects. Therapeutic trials using novel agents in specialties such as oncology, critical care, and obstetrics pose special challenges since they require nurses with advanced specialty skills, and often such nurses do non also have training in clinical researchxx,97,98.

As resources get increasingly constrained, and the focus for clinical translational research expands to include customs and practice-based settings, we believe the infrastructure supporting clinical inquiry must exist redefined, including the potential roles and contributions of practicing clinical nurses in research. Even more important, the potential benefits must be outlined and demonstrated if these costly resources are used. Issues related to scope of do and advisable licensure and competency to assume principle investigator-delegated clinical tasks must as well be addressed. In the most contempo dramatic shift in Federal funding that is accompanying severe national financial constraints, at that place is acute sensation within the clinical research enterprise that resources are likely to exist constrained or reduced for some time to come. In this environment, it is essential for nursing to be able to reply the following questions:

  1. What unique contributions are made by a clinical nurse providing and coordinating clinical services for research participants? How are these services different from care driven by the clinical needs of the patient and service delivery mandate of a health providing organization? How is nursing intendance and coordination of care for research participants unlike from the work of a not-licensed clinical research coordinator?

  2. What regulatory requirements affect the nature of work that tin be delegated by a principal investigator to diverse licensed and unlicensed members of a clinical enquiry squad?

  3. What is the do good to having clinical nurses as part of a study team in terms of study efficiency, participant recruitment, satisfaction and retention, participant safety or other measurable outcomes?

  4. What career paths and educational services need to be developed and offered to set up a workforce that can run into the need? How early in the trajectory of nursing educational programs should information be provided to students most the clinical inquiry enterprise and the potential roles of clinical nurses in providing care to participants and analogous clinical studies?

A credible effort to answer these questions must be based on an understanding of the telescopic and contributions of nurses currently working within the clinical research enterprise likewise equally shared conceptual tools to describe their practice. In add-on to understanding on specialty exercise definitions, a basic agreement of the points in the clinical research process where nurses can make a difference, and on the nurse sensitive outcomes at those primal contribution points is needed. These core steps are the foundation for defining the specialized practice of nurses in clinical research and assessing the sensitivity of clinical and operational outcomes of the research procedure to nursing involvement. This provides the basis for building show of the touch of professional person nursing on the effectiveness of research teams, the safety and subjective feel of participants, and the quality and integrity of resulting data.

The Impact of Nurses Practicing in Clinical Enquiry: Agenda for Edifice the Bear witness

There is essentially no formal evaluation research that demonstrates the impact of nurses equally study coordinators and care givers in a research setting on specific quality, safety or efficiency outcomes. Beyond the xxx year history of writing on this topic, at that place are themes that have emerged anecdotally as outcomes afflicted by clinical research nurses, including early assessment of adverse events, subject field identification and recruitment, subject educational activity, study direction to improve efficiency, improved field of study retention, improve adherence of written report subjects to treatment regimen, extension of PI effectiveness and availability (serving as PI-extender), maintenance of adequate informed consent, alerting research team to protocol violations, adapting clinical technology to support study implementation, training clinical staff, and facilitating the management and analysis of data.

Table 2 displays a possible starting time list of points of contribution and potential performance outcomes that may be influenced by clinical enquiry nursing. These outcomes could become the basis for further work in describing and measuring the impact of clinical inquiry nurses on the effectiveness of the clinical research enterprise. They could besides provide the basis for a cost benefit assay of staffing decisions.

Table 2

Potential Outcomes of Clinical Research Nursing

Contribution Expanse Potential Upshot(due south)
Intervention design and implementation planning within the clinical setting Efficiency; intervention fidelity
Participant recruitment and consenting Report accrual; adherence to human being subjects protection standards
Participant didactics and back up regarding self managed study procedures and evaluation Participant condom; treatment fidelity; efficiency; subject retention; data quality
Direct administration of study treatments and evaluations Participant prophylactic; treatment fidelity; efficiency; information quality
Participant monitoring for response and adverse events Participant safety; adherence to human subjects protection standards; data quality
Information grooming and management Information quality; human subjects protection; efficiency; speed of dissemination

Reengineering the clinical and translational research surroundings is imperative to achieving national scientific discipline priorities. Clinical research nurses have a unique skill prepare and knowledge base that positions them to make meaning and essential contributions to the clinical enquiry enterprise. As institutions strive to provide quality clinical and translational enquiry programs within the current financial climate the of import principles of quality patient care and research integrity must remain a critical element. Maintaining equilibrium between the clinical and research needs in the intendance of the clinical research participant is vital. Nurses with clinical inquiry expertise are a unique resource largely limited to academic medical centers. Every bit the agenda for clinical and translational research broadens to include a variety of healthcare and community settings, ongoing work to conspicuously articulate this specialty practice will ensure the expertise of this unique group of nurses is readily accessible to those who will do good from it about.

Acknowledgments

Grant Information:

This piece of work was supported in part past the Intramural Research Program of the NIH, Clinical Center (Hastings and Fisher), Grant Number MO1-RR02172, from the National Center for Inquiry Resource, a component of the National Institutes of Health, and the Children's Infirmary Boston, General Clinical Research Center (McCabe).

The following members of The National Clinical Research Nursing Consortium were also authors:

  • Wellcome Trust Clinical Research Facility, Southampton, England, UK - J. Allison;

  • The Rockefeller University, New York, N.Y. - D. Brassil and (formerly) M. Offenhartz

  • Georgetown University Medical Center, Washington, D.C. - S. Browning

  • New York Academy Langone Medical Eye, New York, N.Y. - E. DeCandia and R. Medina;

  • Irving Institute for Clinical and Translational Research Columbia University, New York, North.Y. - J. Duer-Hefele;

  • Consultant in Clinical Research Nursing, Switzerland - Thousand. McClary;

  • University of California, Davis Clinical and Translational Science Center, Sacramento, CA, - North. Mullen;

  • University of Texas Wellness Science Centre, Houston, TX- Thousand. Ottosen;

  • Yale- New Haven Hospital, New Oasis, CT – S. Britt and T. Sanchez;

  • Partners HealthCare, Boston, MA - V. Turbini

Contributor Information

Clare Eastward. Hastings, NIH Clinical Center.

Cheryl A. Fisher, NIH Clinical Centre.

Margaret A. McCabe, Boston Children's Infirmary.

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