From delegation to specialization: nurses and clinical trial co-ordination

Authors


  • 1

    A social history of the changes in the organization of biomedical research, and its impact on the role and work activities of physician-researchers, nurses, and other healthcare workers, has yet to be written. Renee C. Fox (1996) provides a useful and insightful starting point for just such an analysis.

  • 2

    A limitation of this analysis is that the data were collected over a long period of time and within the context of three research projects. A strength of the analysis, however, is that the data were collected prior to the establishment of advanced training programs for nurses in clinical trial management. As such, the analysis captures some of the informal processes by which novel work activities come to be established.

  • 3

    The educational emphasis on nursing, rather than clinical, research is evident in the title of a widely used 1997 text by D.F. Polit and B.P. Hungler: Essentials of nursing research: Methods, appraisal and utilization, 4th edn.

  • 4

    It is also not uncommon to find descriptions of the social organization of clinical research in published articles on the role of trial co-ordinator (Eaton and Pratt 1990; Chadwick 1992; Hutchins and Eckes 1996). In the United States, clinical trials are funded by public (government) and private (pharmaceutical industry, foundations) entities. Funds are competitively awarded under a variety of conditions, from studies conducted under the direction of a single investigator in a single setting to studies directed by multiple investigators (and co-investigators) across two or more sites. Funding agencies, or sponsors, employ a host of ‘associate’ medical, nursing and administrative workers to oversee and ‘monitor’ trial activities at local practice sites, specifically to insure that trials are conducted in compliance with the terms set forth in the protocols and with governmental standards and regulations (Caramanica et al. 1996). The division of clinical trial labor, as instituted in local practice sites, is hierarchically ordered and arranged by tasks: physician-investigators do not engage with the ‘routine’ aspects of trial implementation, but instead focus on the other activities, such as attending to administrative duties, providing information on new trials to house staff and community physicians, and monitoring patient morbidity and mortality; and occupational workers, such as nurse trial co-ordinators, engage with the ‘routine’, and ‘hands on’ aspects of protocols; and occupational workers, such as pharmacists, laboratory technicians, data managers, clerical staff, and administrators provide support services to protocol implementation. The on-site division of labor is oftentimes referred to as a ‘research team’ in printed publications (Chadwick 1992; Hutchins and Eckes 1996) as well as by some of the nurses interviewed in this research.

  • 5

    I thank Renee C. Fox for pointing out nursing's ‘culture of caring’, specifically the connection between the actions of nurse trial co-ordinators and the actions of nurses in other novel work situations.

Mary-Rose Mueller, Hahn School of Nursing and Health Science, University of San Diego, 5998 Alcala Park, San Diego, CA 92110–2492, USA. E-mail: <mmueller@sandiego.edu>

From delegation to specialization: nurses and clinical trial co-ordination

This paper considers an area of clinical research that has been delegated by physician-researchers to nurses and others in the United States, that of clinical trials co-ordination. It uses interviews with nurse trial co-ordinators to explore the occupational processes by which the boundaries of work enactment and the definition of work have been established by nurses and others. It then discusses the occupational processes that have been established to formalize a role for nurses in clinical research. It raises the question of (and offers speculation on) whether specialization alone will distinguish nursing from other occupational groups engaged in clinical research work.

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