Clinical Research: 1 Hat or 2?

VBCR - August 2014, Volume 3, No 4 - The Rheumatology Nurse
Sheree C. Carter, PhD, RN, RN-BC
Past President
Rheumatology Nurses Society
Birmingham, AL

There is a growing need for dedicated healthcare providers from rheumatology private practice to step into the role of researcher and participate in clinical trials to evaluate treatment regimens and therapies.

In addition, there is a widening gap in the rheumatology nursing literature and a great need exists for healthcare practitioners to produce and publish studies for rheumatology nurses on the best practices of patient care. However, funding obstacles, finding passionate mentors, as well as the lack of scientifically exciting and rigorous environments, are frequently heralded as barriers for researchers in private practice.

The pathway for practitioner/scientist in private practice requires protected research time, passionate mentors, and loyal advocacy. It is equally and vitally important for nurses to step into the role of researcher/investigator to develop strategies and evaluate outcomes of care, and to create, inform, and evaluate evidence-based practice in rheumatology.

Creating the Right Environment
The 2010 Institute of Medicine Future of Nursing report1 and research by Benner and colleagues2 strongly advise academic nursing programs to encourage faculty to require students to follow-through on the care of their patients by examining patient outcomes. In addition, student nurses must be able to comfortably access the literature, be able to discern relevant research, and critically evaluate patient population-based evidence for care of their patients before and after their clinical assignments.

The passion for research and scholarly evaluation skills must be fostered in nursing school so it can nurture and grow in clinical practice. Nurses should be expected to acquire and consummate practice research skills, if for no other reason than to advance the art and science of nursing.

There is benefit to private practice performing clinical research studies if properly planned, supported, and maintained. In an article published in the Journal of Medical Practice Management, Christine Pierre suggested that private practices considering the clinical research arena should primarily determine if they have a sufficient patient population base to recruit from, as well as adequate space for protocol materials, to perform any laboratory aspects of the clinical trials, and space for pharmaceutical monitors to visit, and for work related to the evaluation of a trial.3

Points to Consider
In addition, personnel responsible for clinical trials should be completely dedicated to that service. Ideally, they should not require a dual role in maintaining an office or infusion room clinical practice along with the conduction of clinical trials. Dedicated staff, protected time, and a large clinical base of patients from which to obtain potential volunteers is the very basis for success.

Realizing it is not ideal in all cases to have dedicated staff for clinical trials, nurses in particular must be cognizant of wearing 2 hats. Nurses have the trust of the patient and must maintain a balance when working between clinical and investigator/researcher responsibilities. They should be able to differentiate between the nurse-patient and researcher-participant relationship.

Nurse researchers must be aware of power relationships that affect the decision of patients whether to participate in a research trial.4 Nurses in researcher roles must be cognizant of the possibility that study participants may have unexpressed concerns. Think of these concerns as an exacerbation of therapeutic misconception. When the nurse functions in the role of a healthcare provider as well as a principal investigator, the patient may misunderstand this dual role. For example, the patient may confuse the preexisting trusting relationship with the nurse as a healthcare provider and be fearful of losing that relationship when approached by that same nurse in a researcher role.

It is important that the nurse pre­sents the duality of role concretely to the patient to eliminate therapeutic misconception. The nurse must make clear to the patient that the right to refuse to participate in a research study is always an option at any point during the study and carries no adverse consequences or ill feelings and will not affect care in any way.

Following a Code of Practice
Nursing practice is primarily dedicated to patient care and is governed by a distinct code of ethics by the American Nurses Association. Rheumatology nurses follow a newly designed Scope and Standards of Practice for Rheumatology Nurses.5

The US Food and Drug Administration Guidance on Investigator Responsibilities relates to patient protection, safety concerns, and ethical standards found in the Code of Ethics for Nurses.6 Clinical trial research also follows many distinct codes and documents such as the Belmont Report and Code of Federal Regulations, 21 Part 50.7 Nurses in research must critically adjust to the guidance and codes involved, and maintain the ethics and safety of the nursing profession when assuming a dual role in practice.

In an academic setting, there has been an increase in strategies for fostering research and evidence-based nursing practice in the clinical setting. Nurse researchers must be adequately prepared through formal education in nursing research. Benner and colleagues1 suggest that research is a skill set that all nurses must come to realize. More rheumatology clinical nurses are needed to embrace a researcher role, not only for clinical trial research, but also for the sake of evidence-based practice.

Sadly, there is little research in the literature to support evidence-based practice in rheumatology nursing. Nurses in private practice can address many practical issues within nursing research with the expectations that conclusions derived from their studies can be applied to infusion suites and other practices. Share your ideas, knowledge, and triumphs. Share equally the failures so that others do not repeat the mistakes. In rheumatology nursing today, there is a tendency for care and practice decisions to be based on experience, recalling outcomes from previous trial-and-effort situations with patients. Providing nursing research conducted in an ethical and scientific manner, specifically for rheumatology nursing practice, provides validation to the profession.

Participation in clinical trials may add prestige to your practice. It can increase networking with other investigators to compare and contrast treatment modalities. The personal reward for an investigator is the knowledge that participation in a clinical trial can add to the body of the science of medicine. Equally important is the advancement of nursing knowledge and an impact on demonstrating how the profession cares specifically for rheumatology patients. If you have the luxury of 1 hat as a researcher, you are fortunate. If you must wear 2 hats, make sure you are very clear to your patients which hat you are wearing in your different encounters. Wear only 1 hat at a time by focusing on priorities. Diligence and attention to the care of the patient comes first, and in some cases may override the research role.

Dr Carter is Assistant Clinical Professor, The University of Alabama in Huntsville; and President, Rheumatology Nurses Society (RNS).


  1. Institute of Medicine of the National Academies. The Future of Nursing: Leading Change, Advancing Health. Published October 5, 2010. Accessed August 11, 2014.
  2. Benner PE, Sutphen M, Leonard V, Day L. Educating Nurses: A Call for Radical Transformation. 1st ed. San Francisco, CA: Jossey-Bass; 2010.
  3. Pierre C. Physician to investigator: clinical practice to clinical research—ethical, operational, and financial considerations. J Med Pract Manage. 2008;24:9-12.
  4. Judkins-Cohn TM, Kielwasser-Withrow K, Owen M, Ward J. Ethical principles of informed consent: Exploring nurses’ dual role of care provider and researcher. J Contin Educ Nurs. 2014;45:35-42.
  5. Rheumatology Nursing: Scope and Standards of Practice. American Nurses Association, Rheumatology Nurses Society. Published 2013.
  6. Guidance for Industry: Investigator responsibilities, protecting the rights, safety, and welfare of study subjects. US Department of Health & Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Published October 2009. Accessed August 11, 2014.
  7. US Department of Health, Education, and Welfare. The Belmont Report. Published April 18, 1979. Accessed August 11, 2014.
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