Research Nursing as a Specialty: Roles, Skills & Retention

Introduction: The Nursing Shortage and Specialization

One of the most critical strategic challenges currently facing hospitals — now and for the foreseeable future — is the national nursing shortage (Corning, 2002). The current nursing shortage is causing great concern and was expected to peak between the years 2010 and 2015 (Woods & Cardin, 2002). According to Woods and Cardin (2002), "Unlike prior shortages, this one is not cyclical in nature and the solutions will require different and innovative approaches to avert a national public health crisis" (p. 326).

A great deal of attention has been paid to the root causes of the current and future nursing shortage: aging baby boomers, alternative professional opportunities for women (Woods & Cardin, 2002), intense assignments, extra shifts, burnout, and little job satisfaction (Inglis, 2004). In order to fully appreciate this situation, one must understand that the nursing shortage is, in part, also related to the trend toward greater specialization within the profession of nursing. The purpose of this paper is two-fold: (1) to demonstrate that clinical research nursing has evolved into a specialty in its own right, and (2) to provide a strategic plan for ensuring the retention and future development of research nurses as leaders.

Roles and Core Competencies of the Research Nurse

There are a variety of roles that nurses perform in support of clinical trials, with the three most common being clinical research coordinator (CRC), clinical research associate (CRA), and research nurse (Zimmerman, 1999). The research nurse possesses the same innate basic nursing characteristics as all nurses — a desire to help other people and a caring spirit. However, a research nurse must also have core competency skills in order to perform the role safely and effectively. These include a sound knowledge base of federal, state, and institutional regulations, policies, and procedures; a high level of autonomy; the ability to set daily priorities; exceptional organizational skills; enhanced psychological assessment skills; meticulous attention to detail; and honed critical thinking skills.

A research nurse may function as a direct care provider, coordinator of care, educator, patient advocate, and data manager, or may fulfill many of these roles simultaneously. Although the research nurse must wear many hats and perform a wide range of duties and responsibilities that can vary from trial to trial, the level of core competency skills required remains the same (Grofsik & Sauers, 1997).

The research nurse is involved in the daily, hands-on tasks of conducting research for a physician, while the physician's role is that of principal investigator — the person ultimately responsible for overseeing the management of the study at the site (Sauers & Grofsik, 2000). While the principal investigator is ultimately responsible for the health and welfare of the study participants, the research nurse manages the logistical and clinical details of the study (Sauers & Grofsik, 2000). There are three major areas for which the research nurse is typically responsible when assigned to managing a study: clinical practice, financial matters, and administrative tasks. Some research nurses become involved early, when the protocol concept is being created, and are asked by the principal investigator to provide input from a nursing perspective during the writing process. Others become involved later, once the study has been approved and is ready to accrue patients. Overall, the primary focus and responsibility of the research nurse is to conduct and manage the clinical trial.

There are three distinct stages of a clinical trial that require the research nurse's involvement: (1) pre-study, (2) study implementation, and (3) post-study.

Stages of Clinical Trial Involvement

The following are some of the research nurse's initial responsibilities during the pre-study preparation phase: reviewing the protocol for clarity and consistency; identifying study collaborators and sponsors; coordinating protocol-related activities (special labs, specimens, treatments); developing pre-printed protocol materials, teaching materials, patient calendars, inpatient and outpatient orders, prescriptions, special lab requests, and diagnostic imaging requests. The nurse also verifies that all regulatory forms and documents are completed, including Form 1572 (the agreement between the investigator and the Food and Drug Administration), Financial Disclosure Forms, Investigator Agreement Forms, Investigator Confidentiality Forms, Supplemental Data Forms, signed and dated CVs, and the medical licenses of research personnel involved in the study.

Additional pre-study responsibilities include writing the informed consent and study abstract, processing all study documents and submitting them to the Institutional Review Board (IRB) for approval, and developing, designing, and negotiating budget issues in collaboration with the principal investigator or study drug sponsor.

Once the study is approved by the IRB, the research nurse works with a high degree of autonomy to conduct the daily, hands-on work of the assigned study. This involves recruiting and screening potential participants, reviewing medical records to ensure patient eligibility, obtaining informed consent (including reviewing the content of the consent form with the patient and obtaining signatures), coordinating, evaluating, and following patient participation in the clinical trial, and documenting the informed consent process and study entry.

Further duties include ordering pertinent tests, scheduling procedures, collecting specimens, monitoring responses, administering medications, providing ongoing education to the patient and family, entering and reviewing study data and performing basic statistics, and planning, designing, and providing in-service training to professional and ancillary staff on the study overview. If a study sponsor is involved — either financing the study, providing a drug, or providing a device — there are usually case report forms that must be completed and reviewed by a study monitor hired by the sponsor. The research nurse is responsible for arranging and scheduling visits with the study monitors, which can be as frequent as weekly to monthly depending on study accrual and complexity.

During the post-study phase, the research nurse follows the patient as described by the study endpoint (e.g., recurrence, survival, end of treatment). The nurse is responsible for collecting and entering data where applicable, ordering tests, assessing patients, and contacting patients via telephone or during clinic visits as specified in the study protocol. If a sponsor is involved, there may be a close-out meeting that requires coordination of schedules among the principal investigator, collaborators, and other pertinent medical personnel.