Improving the health of Americans by bringing new medicines, treatments, and cures to people quickly, equitably, and in a cost-effective way is a major priority of the U.S. healthcare system. Meeting this goal requires collaboration among the many disciplines involved in the direct provision of care, the broader healthcare industry, private and not-for-profit organizations, academia, and agencies within the Federal government. Clinical research is essential to achieving this goal of meaningful and significant long-term improvements in the health of Americans. Clinical research, which involves the participation of human subjects, or research "volunteers," has as its aim the "development of generalizable knowledge useful for understanding and improving human health and well-being."1 Findings from clinical research provide the foundation for evidence-based healthcare practice.
Major changes are occurring in the way in which the Federal government conceptualizes and funds clinical research. Nurse leaders must understand the practical and logistical implications of these changes in the funding and conduct of clinical research in the various healthcare settings in which they work, and be prepared to address the regulatory, educational, ethical, staffing, and quality assurance issues that accompany them.
Federal financial support
The National Institutes of Health (NIH) is the primary Federal agency for conducting and supporting biomedical research. Although private industry and dedicated Clinical Research Organizations support more clinical research than the Federal government, the major supporter of academically based research is the NIH. The NIH has invested in clinical research through grants to individual investigators, establishment of disease-based clinical research centers such as the Comprehensive Cancer Centers funded by the National Cancer Institute, and the establishment of Clinical Trials Groups.
Historically, the NIH has also provided funding for discrete clinical research centers (General Clinical Research Centers or GCRCs) located at academic medical centers. In addition the NIH funds a full-service clinical research hospital (the NIH Clinical Center) on its campus in Bethesda, Md. In 2004, the NIH announced a strategic plan-the "Roadmap for Medical Research"-to stimulate and facilitate collaborations among federally funded agencies, academic centers, and private industry in the pursuit of clinical knowledge.2 The NIH Roadmap emphasized the need to reengineer the clinical research enterprise to accelerate the application of scientific findings to clinical care.3 The National Center for Research Resources (NCRR), a subdivision of the NIH, provides support to researchers to facilitate the movement of scientific knowledge from "the bench to the bedside."4
As part of its strategic plan to meet the goals of the NIH Roadmap initiatives, the NCRR has created a national consortium for clinical research. Members of the consortium are funded through the Clinical and Translational Science Awards (CTSAs). Funding for the CTSA program comes, in part, from recycling funds committed to the GCRC program and other NIH educational programs (K30, T32). A major goal of the CTSA consortium is to develop an interactive network of clinical research sites that work synergistically to enrich clinical research nationally. To date, 24 institutions across the United States, each unique in the services and resources it offers and in its administrative and fiscal structure, have received CTSAs. Though divergent in specific details, each of the awardees is committed to the development of new research methodology, the improvement of research training, the design of new clinical research informatics tools, and the forging of new partnerships with private and public healthcare organizations.5
An emerging specialty
Through the last several decades, nurses working at the NIH-funded GCRCs, the NIH Clinical Center, and in clinical settings conducting federally and privately funded research have developed specialized practice to implement clinical studies and provide care and support to research participants. Studies of this unique nursing role have focused most often on the roles of nurses in study coordination.6-8 This research also has examined the overall responsibilities of the clinical research nurses in the GCRCs.9 Two distinct practice roles have emerged: that of the Clinical Research Nurse (CRN), whose primary focus is clinical care and study implementation within a given clinical setting, and the Research Nurse Coordinator (RNC), whose responsibilities include study management, participant recruitment, informed consent, data management, and regulatory compliance.
RNCs are known by a variety of titles (study coordinator, research nurse, clinical trials coordinator), and the generic role of study coordinator is often filled by an individual who isn't a licensed practitioner. Both the CRN and the RNC are associated with a clinical research team, either working on a dedicated research unit or hired by the principal investigator. Their roles contrast sharply with the roles of general staff nurses who may be providing care on a patient care unit in which a study is being implemented and are expected to provide "research care," i.e., administration of a study drug, monitoring and documenting side effects, and assessing patient responses. (See "Distinction between the scope of practice of research nurses and RNs in clinical staff roles.")
Infrastructure changes
Institutions that have received CTSAs are the ones that have been creative in their proposed use of resources for clinical research. On a practical level, this means that clinical activities with research volunteers will be taking place in a wider variety of settings than in the past, including acute care settings, community health settings, and physician practices. It's hoped that innovative partnerships, with sharing of resources and expertise, will potentially emerge from this model.
Nurse leaders in a variety of settings will therefore need to become familiar with the ethical, regulatory, fiscal, and clinical issues around research involving human subjects, as staff nurses take on new roles in the implementation of clinical studies. As the emphasis on high-quality research grows and the pace of clinical research accelerates, nurse leaders will be expected to evaluate their resources to accommodate more research-related activities than they have in the past.
The impact that these changes will have on nursing education and performance evaluation is significant. It's the responsibility of nurse leaders to ensure staff competency and demonstrate quality research data collection within an organizational unit. Nurses participating in the conduct of federally funded clinical research must receive training in human subjects protection before they can perform any activities associated with the research study. This type of training isn't typically required of, or offered to, clinical staff nurses, and many institutions don't have the programs, personnel, or resources to provide it.
Nurses also need to demonstrate an understanding of the research protocol, including the purpose of the research; the inclusion, exclusion, and withdrawal criteria; and the risks and benefits to patients enrolled in the study. Additional training is also required if the study involves the administration of investigational drugs or the use of investigational devices. This training must be appropriately documented for regulatory purposes, and the institution should have a policy addressing the frequency with which this education should be undertaken and the staff members to whom it applies (nurses, ancillary staff, and students).
Documentation of the research-related activities performed by nursing staff is another new content area for nursing leadership. Research documentation must meet not only organizational and Joint Commission requirements, but also fulfill the requirements of the study itself. This may be more complicated than it sounds, in that research studies generally require "source documents," where data are originally recorded, to follow very specific guidelines driven by the protocol. Nurse leaders in organizations that use computerized hospital information systems will be challenged to find ways to interface research documentation with their standard nursing or interdisciplinary documentation model.
Nurse leaders should also consider the impact that the increasing presence of clinical research in the patient care environment will have on their nursing care model or philosophy of nursing practice, as staff members are expected to understand the distinctions between the provision of clinical care and the implementation of a clinical research protocol. Nurses who aren't comfortable with administering a placebo to an acutely ill patient, for example, or monitoring the efficacy of a new and unfamiliar device with an unknown risk profile, may experience significant professional or ethical stress when asked to do so as part of a research study. Although research-based care and patient care are linked, they're parallel, not identical processes.
Special requirements
For studies in which an investigational drug, device, or biologic is being tested, and for which there may not be a recognized standard of care, an international standard for clinical study implementation has been established, known as "Good Clinical Practices" or GCP. GCP is the agreed-upon standard within the clinical research industry and many academic settings. GCP addresses safety and ethics, informed consent, data collection and integrity, investigator responsibilities, delegation of duties, monitoring and reporting of adverse events, and documentation of training. GCP provides guidance regarding additional requirements for clinical practice beyond the normal standard of care when research studies are implemented in the clinical setting.
Among the standards, agencies, and regulatory documents that shape and inform GCP are The Belmont Report, the U.S. Food and Drug Administration (FDA), 21 CFR and 45 CFR 46, the U.S. Department of Health and Human Services (HHS), the Office for Human Research Protections, local or centralized institutional review boards (IRBs), and the International Conference on the Harmonization of Technical Requirements for Regulation of Pharmaceuticals for Human Use Guideline for Good Clinical Practice.10-14 Although not all settings in which clinical research is conducted currently require a GCP environment, pressure to standardize, streamline, and ensure quality data collection is causing institutions to reevaluate their systems and develop strategic plans for the implementation of GCP, if they hope to maintain a niche in the research landscape.
Available resources
Consideration of these issues may seem overwhelming, especially in the face of maintaining staff performance and competency and ensuring appropriate staffing for all of the usual organizational activities. Nurse leaders should identify resources both within and outside of their institutions that can provide support and guidance about specific clinical research studies and about research and the protection of human subjects. Among those resources are:
* CRNs and RNCs assigned to the study by the primary investigator
* IRB(s) responsible for the approval of protocols in the institution
* Clinical Research Officer
* hospital ethics committee
* Web sites maintained by the U.S. FDA, HHS, NIH, NCRR, and the CTSA consortium.
In addition, a National Clinical Research Nursing Consortium has been formed to create tools and documents to support clinical research nursing practice and make them available to the healthcare community. This group consists of nurse leaders from current CTSAs, GCRCs, and the NIH Clinical Center.15
The implementation of the most basic clinical research protocol requires the nurse to address specialized educational, ethical, staffing, regulatory, and quality assurance issues in his or her own practice. Because clinical research is vital to improving the health of Americans, you, as a nurse leader, should be aware of the changes occurring at a national level and encourage staff and your facility to actively guide the implementation of these changes at a local level, seeking advice from specialists as needed to promote patient safety and positive outcomes for research.
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