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Clinical Nurse Specialists as Research Team Members

FULTON, JANET S. PhD, RN

NURSING PRACTICE: EDITORIAL
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From the College of Nursing and Health, Wright State University, Dayton, Ohio.

Corresponding author: Janet S. Fulton, PhD, RN, Associate Professor, College of Nursing and Health, Wright State University, Dayton, OH 45435 (e-mail: janet.fulton@wright.edu).

A thesis, project, comprehensive examination. During the past 10 or so years, many nursing programs have moved away from requiring a master's thesis, replacing that capstone requirement with a project or a comprehensive examination. A research-focused thesis has become optional, if not eliminated all together, leaving some educators to contemplate the adequacy of research education at the master's level.

Ward-Smith's article brings to focus the important contributions clinical nurse specialists (CNSs) can make to research teams. CNSs, by virtue of their clinical expertise, understanding of systems, and backgrounds in research, historically have been valued members of research teams, serving on nursing and multidisciplinary research teams. As members of a research team, a CNS can fill important gaps. Scientists may have limited clinical expertise for dealing directly with study participants, lack familiarity with medical records or other data sources, and not recognize the nuances of the healthcare delivery system that can make or break a study. The article also calls into focus the debate about just what may be at stake as we answer the question What is the best way to prepare CNSs in the area of research?

The emergence of nursing doctoral programs is realigning expectations for research at all levels of nursing practice. Practical issues related to research can only be learned through experience. Most educators agree that a thesis or other project involving the individual conduct of research, or participation in the conduct of another's research, is a good learning experience. Lately, it appears that the debate about research education at the master's level has shifted to defending a position that an advanced practice nurse (APN) does not need an in-depth understanding of research and/or practical research experience. Perhaps this shift was accelerated by a movement to more practitioner-based programs where the emphasis is on differential diagnosis and management of disease/physiologic problems. Nursing has retooled master's-level education away from research experiences, so it may be failing to prepare the APN as a member of a research team.

CNSs should understand the study purpose, design, and intended use of the results. Some famously nefarious studies, namely the Tuskegee syphilis study that denied syphilis treatment to black men, the Willowbrook study that injected mentally handicapped children with the hepatitis virus, and the cancer study at the Jewish Chronic Disease Hospital that injected patients with live cancer cells, no doubt occurred with the support of nurses who believed that they were faithfully executing their duties in helping the researchers. To be ethically responsible, a CNS must know what he or she needs to know about a study. Anything less than the ability to ask the right questions about the research runs the risk of a dutiful nurse becoming an unwitting and unwilling member of a research team, perhaps contributing to a questionable activity.

In part, as a result of the aforementioned studies, research studies involving human subjects are subject to regulation under the National Research Act (Public Law 93-348). Most CNSs recognize the need for human subject review in situations where subjects are directly recruited. CNSs should always inquire about institutional review board (IRB) approval status of research being conducted in the clinical setting, whether or not the CNS has any direct responsibility for the study. CNSs should work with the system to create policies that will inform all providers about the study, such as placing a copy of the informed consent in the medical record and/or requiring researchers to make a study summary available to staff.

Recently, a colleague shared a situation in which a CNS asked for assistance with data analysis. At the urging of a community health center, the CNS wanted to publish results of a survey conducted by students assigned to the center. The data were collected as part of a school assignment. Although studies frequently use existing data sources, such as individual health records or government reports, data collected for one purpose should not be used as research data without attention to regulations governing human subjects. The use of retrospective data may be exempt from human subject regulation; however, it is the role of an IRB to make that determination, not an individual researcher or clinician. When the CNS initially balked at using the data, she was subtly accused by center staff of not being a team player. Fortunately, my colleague was able to negotiate an ethical conclusion—and the data were eventually analyzed and published. Being a member of a team does not mean stepping over established boundaries for the purposes of group interests. Again, those who do not know the questions to ask are vulnerable to the interests of others.

One more example of vulnerability was seen at a recent professional meeting where a nurse practitioner argued that she should be considered a principal investigator for an industry-sponsored drug study, stating that she understood the research process and could communicate with subjects as well as a physician. This practitioner's eager and impassioned plea to take on the role of principal investigator for an industry-sponsored study is an interesting situation. Research partnerships with industry can be extremely beneficial to both parties, but even seasoned researchers will admit that there are unique issues to consider when serving on a industry-based research team. Who owns the data? What if the results show the product to be ineffective or even harmful? What happens to a researcher who publishes results that create financial risk for the industry? Under the watchful eye of a marketing executive, the pressure to get the right answer can be heavy.

In my experience, CNSs willingly to take on loads of work on behalf of other's research and forget to negotiate for their own interests. In addition to compensation for work, CNSs should consider negotiating for authorship on abstracts, publications, or grants that are generated by the research. Consider authorship in the initial negotiations with the researcher, before taking any responsibility for the study. Authorship leads to greater understanding of the science behind the research. For too long, CNSs were not acknowledged for the type of contributions identified in Ward-Smith's article. As the author points out, CNSs can be very helpful in obtaining informed consent and mediating consent issues. Informed consent is the responsibility of the principal investigator. If delegated, it should be to a coinvestigator or someone with intimate knowledge of the study. If a CNS is not contributing to the study at a level that deserves authorship, then the CNS's ability to adequately obtain informed consent or to support the participant's consent decision is called into question.

APN programs in general, and CNS programs in particular, should consider the disadvantages of not offering a rigorous research experience. CNSs should go beyond using their skills to support the research of others; they should be full participants in research teams, with all the attendant responsibilities and rewards. We need to have CNSs prepared to “ask the right questions.” To that end, more than a multiple-choice understanding of research is needed. A thesis requirement may not be the answer, but practical experience is necessary to function as a member of a research team.

© 2002 Lippincott Williams & Wilkins, Inc.