Clinical research nursing: A critical resource in the national research enterprise

doi:10.1016/j.outlook.2011.10.003

Nursing Outlook

Volume 60, Issue 3, May–June 2012, Pages 149-156.e3

https://doi.org/10.1016/j.outlook.2011.10.003 Get rights and content

Abstract

Translational clinical research has emerged as an important priority for the national research enterprise, with a clearly stated mandate to more quickly deliver prevention strategies, treatments and cures based on scientific innovations to the public. Within this national effort, a lack of consensus persists concerning the need for clinical nurses with expertise and specialized training in study implementation and the delivery of care to research participants. This paper reviews efforts to define and document the role of practicing nurses in implementing studies and coordinating clinical research in a variety of clinical settings, and differentiates this clinical role from the role of nurses as scientists and principal investigators. We propose an agenda for building evidence that having nurses provide and coordinate study treatments and procedures can potentially improve research efficiency, participant safety, and the quality of research data. We also provide recommendations for the development of the emerging specialty of clinical research nursing.

Section snippets

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 1). In addition to providing and coordinating clinical care, clinical research nurses have a central role in assuring participant safety, maintenance of informed consent, integrity of protocol implementation, accuracy of data collection and recording, and appropriate follow-up. Nursing

Role Development in Clinical Research Nursing

Although nurses are integral and assumed to be essential to the clinical research team, there is no generally accepted, standardized definition of the role of the clinical research nurse.8, 12, 19, 20, 21, 22 The most concentrated effort to define the role of nurses in clinical research care has been the long-standing effort within the specialty of oncology nursing, beginning in the early 1980s.23, 24, 25, 26, 27, 28 This work resulted in an organizational focus within the Oncology Nursing

Defining the Conceptual Domain of Practice for Clinical Research Nursing

It was recognized early in the exploration of conceptual definitions for clinical research nursing that the scope of practice for clinical research nurses extended beyond the dimension of direct clinical intervention to include study management, human subject protection, care coordination within the context of research participation, and contributions to clinical science as an active research team member.46, 47 These elements became the basis for a 5-dimensional taxonomy of activities (Table 1)

Clinical Research Nursing in the Federally Funded US Clinical Research Enterprise

Clinical nursing resources have been a major part of 2 significant investments made by the NIH in the “critical mass” concept for clinical research. One of these investments is the NIH Clinical Center, the 240-bed clinical research hospital in Bethesda, Maryland, which opened in 195249, 50 and was updated to a new state-of-the-art facility in 2005.51, 52 The second was the national network of General Clinical Research Centers (GCRCs) located primarily in academic medical centers53, 54, 55 and

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 as they participate in research and ensure basic principles of quality control so that results from clinical research are reliable and valid.80, 81 Compliance with GCP provides the public and regulatory authorities with assurances that the rights, safety, and well-being of research subjects are being protected. Furthermore, it helps to ensure that quality

The Global Practice Environment for Clinical Research Nurses

Nurses have historically been integral to the conduct of industry-sponsored trials on new drugs and devices within the US 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

Challenges Today

It is acknowledged that advances in the basic sciences in the US have exceeded the capacity of the clinical research infrastructure to respond with translational studies and clinical trials.⁴ A major limiting factor is the cost and complexity of implementing clinical studies, particularly studies that cross institutions, address questions relevant to vulnerable populations, or extend into community care settings. Such studies require careful screening of participants for eligibility and

The Impact of Nurses Practicing in Clinical Research: Agenda for Building the Evidence

There is essentially no formal evaluation research that demonstrates the impact of nurses as study coordinators and caregivers in a research setting on specific quality, safety, or efficiency outcomes. Across the 30-year history of writing on this topic, there are themes that have emerged anecdotally as outcomes affected by clinical research nurses, including early assessment of adverse events, subject identification and recruitment, subject education, study management to improve efficiency,

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: This work was supported in part by the Intramural Research Program of the NIH, Clinical Center (Hastings and Fisher), Grant Number MO1-RR02172, from the National Center for Research Resources, a component of the National Institutes of Health, and the Children’s Hospital Boston, General Clinical Research Center (McCabe).

^†: Members of the National Clinical Research Nursing Consortium are listed in the Appendix.

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ArticleResearchClinical research nursing: A critical resource in the national research enterprise

Abstract

Section snippets

What is the Clinical Specialty of Clinical Research Nursing?

Role Development in Clinical Research Nursing

Defining the Conceptual Domain of Practice for Clinical Research Nursing

Clinical Research Nursing in the Federally Funded US Clinical Research Enterprise

Regulatory Influences on Clinical Research Nursing

The Global Practice Environment for Clinical Research Nurses

Challenges Today

The Impact of Nurses Practicing in Clinical Research: Agenda for Building the Evidence

Nurs Outlook

Nurs Clin North Am

Am Heart J

Nurs Clin North Am

Semin Oncol Nurs

J Assoc Nurses AIDS Care

Can J Cardiol

Contemp Clin Trials

Translational research: Crossing the valley of death

Nature

National Institutes of Health eliminates funding for national architecture linking primary care research

J Am Board Fam Med

Central challenges facing the national clinical research enterprise

JAMA

Five next steps for a new national program for comparative-effectiveness research

N Engl J Med

The meaning of translational research and why it matters

JAMA

Validating the clinical research nursing domain of practice

Oncol Nurs Forum

Development of a measure to delineate the clinical trials nursing role

Oncol Nurs Forum

The clinical research nurse

Am J Nurs

Nursing and realities of clinical research

Nurs Manage

The role and potential contribution of clinical research nurses to clinical trials

J Clin Nurs

Part II: Nursing implications of administering chemotherapy in interventional radiology or the operating room

Clin J Oncol Nurs

Part I: Regional chematherapy clinical studies in nontraditional clinical settings

Clin J Oncol Nurs

Central role of the research nurse in improving accrual of older persons to cancer treatment trials

J Clin Oncol

Decision making for cancer clinical trial participation: A systematic review

Oncol Nurs Forum

Near misses and research subjects

Qual Saf Health Care

Patient safety beyond the hospital

N Engl J Med

Issues in clinical research manager education and training

Research Practitioner

Describing the role of the clinical research nurse

Research Practitioner

The nurse clinical trial coordinator: Benefits and drawbacks of the role

Res Theory Nurs Pract

The involvement of nurses in clinical trials. Results of the EORTC Oncology Nurses Study Group survey

Cancer Nurs

Implementation and management of clinical trials

Clin J Oncol Nurs

The role of the nurse in clinical cancer research

Cancer Nurs

The research nurse role in a clinic-based oncology research setting

Cancer Nurs

Developing clinical research nurses

Nurs Manage (Harrow)

Patient care and research at the NIH Clinical Center

AIDS Patient Care

The role of nursing in clinical research trials

Gastroenterol Nurs

The essential role of the clinical research nurse (CRN)

Urol Nurs

Towards clarification of the role of research nurses in New Zealand: A literature review

Nurs Prax N Z

Basic steps to building a research program

J Oncol Pract

Putting Clinical Research Nursing on the NIH Roadmap

Article
Research
Clinical research nursing: A critical resource in the national research enterprise