Nursing and Clinical Research

Nursing and Clinical Research

I have a passionate interest in developing research that aims to validate the contributions of nursing to the care of patients in clinical research.  The legacy of Florence Nightingale, who is the founder of professional nursing practice was also an astute epidemiologist and statistician.  Her contributions mark the first for nursing in clinical research.  More recently, a group of nurses from the NIH Clinical Center and NIH-funded General Clinical Research Centers (GCRC) performed role delineation work that led to the development of the Clinical Research Nurse Domain of Practice.

My research and my involvement in committees of the International Association of Clinical Research Nurses continue to explore the impact of nursing in the Clinical Research Enterprise.  As a member of the IACRN Scopes and Standards Committee, documents that validate the specialty practice of clinical research nursing will be submitted to the American Nurses Association.  My work with the Research Comittee of IACRN has culminated in the vision of two major research projects, that are now ongoing, that are visioning studies on workforce and clinical research metrics, to measure the impact of nursing on study process and endpoint outcomes.

Three publications of mine have contributed to the work in role delineation for clinical research nurses and research nurse coordinators, including setting policy for how clinical research work is delegated within the clinical research site:

• Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators
• Role Perceptions of nurse clinical research coordinators
• Clinical research nurse perspectives on unsupervised, non-nurse clinical research coordinators

The Clinical Research Enterprise includes interdisciplinary teams engaged in planning, implementing, evaluating and disseminating clinical research for better diagnostics, prevention, treatment and cures for disease afflicting the population.  The IOM has called for robust development of the clinical research enterprise, including principal investigators (T1-T4) to “implementers”, including a wide variety of clinical research professionals (many positions held by RNs).

As a leader in clinical research, I have focused my research efforts on not only nursing roles but all clinical research roles.  As a founding member of the Joint Task Force for Harmonized Core Competencies, our research culminated in defining 8 core competencies for clinical research professionals.  This work evolved from delphi studies and stakeholder meetings, resulting in a publication in 2014 that defined core competencies.  These continue to be studied; however, since 2014, the JTF Framework has become widely adopted and used to map undergraduate, and graduate curricula;  define parameters for accreditation for academic programs in clinical research; certification domains; influence role and training mapping for the UK National Health Service and informing pathways for revising clinical research position descriptions and advancement plans.

Through my work as a nurse working in clinical research, I have developed a framework that illustrates several factors that make up the role of nurses who are clinical research professionals that I think best articulates the practice of nursing in this area.  I hope to do some research to link Clinical Nurse Leader to Clinical Research Nursing (CRN) in the future.

Framework Components

I.   As professional members of interdisciplinary research enterprise, acquiring knowledge, skills and abilities of the Harmonized Core Competencies for Clinical Research Professionals

• Scientific Concepts & Research Design
• Ethical & Participant Safety Considerations
• Medicines Development & Regulation
• Clinical Trials Operations
• Study & Site Management
• Data Management & Informatics
• Leadership & Professionalism
• Communication & Teamwork

II.  Focusing additional nursing competencies of the Domain of Practice for CRNs:

• Clinical Practice
• Human Subject Protection
• Contributing to the Science
• Care Coordination and Continuity
• Study Management

III.  As nurses enter into clinical research roles, they are:

• They have a nursing degree (at least BSN) and embrace a spirit of inquiry
• They are licensed to practice
• They are authorized to carry out clinical research activities for the protocol by the PI and the IRB
• Use nursing concepts:  Nursing Process, Advocacy, Vigilance, Autonomy
• Manage complexity across: clinical issues, ethical issues, research protocols and environments

Nurses working in clinical research in this framework are major contributors to evidence-based practice, as clinical research takes on a translational approach to care delivery from bench, to bedside to the community.

I’ve illustrated this framework below:

[Labyrinth Intersections]