In October 2016, I met clinical research nursing leaders from the UK as we shared best practices at the International Association of Clinical Research Nursing (IACRN) in Orlando, Florida.
Following that event I was invited to spend a week in the UK visiting Guy’s and St Thomas’ NHS Foundation Trust in London and University Hospital Southampton NHS Foundation Trust; two of the UK’s leading research-focused hospitals.
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Clinical research nursing care and coordination continue to present challenges for the profession, both in the UK and the US.
But what struck me during my UK visit in March was that, despite differences in our healthcare systems, our research aims are similar - and both countries are still striving to develop a nursing workforce with specialty competencies to achieve those aims.
Some of the questions that still need exploring are whether all clinical studies require specialty-trained clinical research nurses (CRNs)? What the financial cost is of building those specialist nursing staff into the research enterprise? And what the optimal management mode is – placing those staff within a nursing department or having CRNs receive direct supervision by principal investigators, who are usually physicians?
In 2016 the American Nurses Association took a major step towards solving some of these problems - it published its Clinical Research Nursing Scopes and Standards, recognising that clinical research nursing is indeed a specialty.
”Some of the questions that still need exploring are whether all clinical studies require specialty-trained clinical research nurses”
This followed work in 2011 by the US National Institutes of Health Clinical Center that defined two major functions within the domain of practice of a CRN: one that is focused on the clinical care of research participants and the other on study coordination. Depending on the institution this may also be a blended role.
The ANA’s standards include assessment, diagnosis, outcomes identification, planning, implementation (coordination of care, health teaching and health promotion) and evaluation.
These are arguably what make the role of the CRN a specialty that is not easily transferrable to non-clinicians on the research team.
However, the research enterprise is vast and complex, so there is also a need for what we call non-licensed research team members (known in the UK as clinical research practitioners). These are typically graduates with a science degree who have chosen to work within a clinical research environment, but are not nurses or other registered healthcare professionals.
Their contribution is important to augment the capacity for research coordination. But the debate over their differing role in relation to CRNs continues in both countries.
It is clear there needs to be deliberate attention given to the specific clinical competencies that CRNs and clinical research practitioners bring to their research roles, particularly when it comes to first-in-humans studies.
”There needs to be deliberate attention given to the specific clinical competencies that CRNs bring to their research roles”
CRN skills such as assessment and diagnosis would not be expected from clinical research practitioners who often provide strong skills in data management and study coordination. However, standardisation across institutions has yet to be established.
The next important step will be setting up a method of certification for CRNs. The IACRN is actively pursuing this at the moment, by using the ANA’s standards.
This will be equally important in the UK as well as other countries with large clinical research portfolios.
The US and UK’s nursing professions have a shared ambition of securing the crucial place of CRNs within research teams; I look forward to continuing exchange our expertise and learning along the way.
Gwenyth R. Wallen, a clinical nurse scientist and acting chief nurse officer at the US National Institutes of Health Clinical Center
The content of this publication is the author’s opinion and does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government.
Find out more about clinical research nursing in the UK via the National Institute for Health Research.