I magine for a moment that you're a staff nurse beginning a night shift on a busy, fully staffed unit. You've been assigned to an acutely ill child who's on a research protocol. The specific tasks to be performed are well within your scope of practice. However, the patient is receiving an experimental therapy that neither you nor your colleagues are familiar with. The RN on the previous shift briefed you on the child and gave you an information sheet on the protocol and how to collect data, but you still have questions about adverse effects, and you're not sure how to follow a research protocol. How would you respond?
Clinical research nurses are specially trained staff nurses responsible for safeguarding research subjects and maintaining the integrity of the research protocol in settings ranging from ambulatory to inpatient, with healthy to acutely ill subjects. These nurses must balance patients' clinical needs with the needs of the research protocol. This requires knowledge of the research process and experience in carrying out a protocol.
Caring for research subjects is often costly, and the federal government is changing how funds that support clinical research in academic medical centers are distributed. Funding has been tied to the support of a dedicated research unit, but this will not be required under the new plan. This change has forced health care facilities to find ways to manage these expenses, which could result in the elimination of the clinical research nurse on dedicated units. This could have serious implications for the quality of the research and the safety of subjects.
Some facilities are dispersing research subjects into the general clinical population. This means that staff nurses, some of whom have little or no experience in conducting research, are caring for subjects and implementing research protocols. This is akin to a hospital deciding to eliminate a cardiac unit and the cardiac patients being sent to other units. While the nurses on these different units can certainly provide basic care, the subtleties of caring for this specific population are lost, and the risk of error increases. Not having staff specially trained in caring for patients on a research protocol shifts the balance of clinical and research concerns strongly toward the clinical. Thus, the blend of clinical and research skills that is unique to the clinical research nurse is lost or marginalized, and the quality of the research suffers. Additionally, a nonclinician trained solely in research may be responsible for implementing research protocols. In such a case, she or he may be unable to meet the subject's clinical needs because the priority is data collection.
Nurses can take the following actions:
* Staff nurses who are not involved in research should advocate research volunteers' receiving care in an appropriate setting by properly trained providers.
* All nurses can lobby for funding that includes clinical research nursing and promotes a safe clinical environment.
* Research nurses should teach staff nurses the basics of research methodology and protocols and enhance congruence between research and clinical care. They can also teach staff nurses how to care for the clinical research patient in academic and clinical settings.
For more information on the role of clinical research nurses, go to http://www.gcrconline.org/nursing.