Preparing Nurses to Care for Patients in Clinical Research Projects

All nurses are expected to advance the profession of nursing by participating in research and scholarly inquiry. Nurses can carry out this task by functioning in various roles, including nurse researcher, member of a research team, caregiver, and educator. Nurses in a clinical setting may not directly be involved in the research process, but are in a position to advocate for their patients, collaborate with members of the research team, and educate their patients and family members about various aspects of the research process. All research activities in the U.S. must comply with federal regulations, and are approved/monitored at the local level by an Institutional Review Board (IRB).

In order for clinical nurses to adequately care for patients involved in clinical research, there are many aspects of research in which they need to be informed. The rights of all patients must be honored throughout their care. The main role of the IRB is to protect patient rights, which is why all research must be approved. The clinical nurse also needs to be familiar with the research process, so they can understand what the patient is experiencing, respond to general questions, know where to find further information, and collaborate when appropriate and necessary with the various members of the research team.

Questions to consider regarding this topic include: at what level of nursing education should students be introduced to the research process; how can research findings be incorporated into evidence-based nursing practice; what is the role of nurse executives/administrators and organizational leadership in creating a research-friendly environment?

Ethical principles and standards at the national and international levels guide research, and form the basis for IRB review and approval of research. For many nursing students familiar with their local IRB, they may not have a positive attitude about the approval process because it can be a serious effort to understand the role of the IRB and to gain their approval. Some clinical nurses may not be familiar with the research process, and may question the need for some key activities they are asked to perform.

And so how can we prepare all clinical nurses to provide ideal care to their patients involved in a research study, and answer some of these important questions? This presentation will include several cases in which nurses did not appropriately carry out their clinical role, which resulted in research protocol deviations or violations, or significant clinical events that affected the patient’s status. All of these cases were then reported to the local IRB, where the decisions were made as to their ethical perspective and how to proceed.

In order to prevent serious events, how can we educate nursing students at all levels, and nurses working in various settings, to provide ethical care for patients involved in research? And what resources are available to help us with that task?