Lexington, Ky. (April 10, 2017) – Throughout the University of Kentucky, a special group of nurses work not only to provide the best possible care, but also to make discoveries that advance health care altogether. As clinical research nurses, these are the individuals who carry out the clinical procedures and care for participants of research studies that seek to develop new treatments and knowledge across a spectrum of health issues.
Nurses have long been at the heart of health research, but only in late 2016 did the American Nurses Association (ANA) recognize clinical research nursing as nursing specialty practice.
According to the International Association of Clinical Research Nurses, which was instrumental in facilitating ANA's designation, "clinical research nursing is the specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity to the research protocol. This specialty practice incorporates human subjects protection; care coordination and continuity; contribution to clinical science; clinical practice; and study management throughout a variety of professional roles, practice settings and clinical specialties."
For Linda Rice, a registered nurse and director of clinical operations for the clinical services core (CSC) of the UK Center for Clinical and Translational Science (CCTS), ANA's designation of a clinical nursing specialty for research recognizes the unique demands, expertise, and contributions of the type of nursing she's been practicing for 28 years.
"It means a lot to me that my colleagues recognize our specialty — that all the time and effort and years of training are acknowledged by our board and peers. I've enjoyed seeing my profession grow, and knowing that the decisions we make to take care of our patients are based on evidence-based research," Rice said. "It does take nurses to conduct successful clinical research, and they have to specifically trained — it's a body of knowledge and experience."
Rice oversees and trains a team of specialized nurses who assist in conducting research in the CCTS inpatient and outpatient research units for adults and children. They also provide additional clinical research services, like study coordination. Over the last three years, the CCTS CSC has averaged between 1,200 and 1,500 inpatient bed-nights per year, 1,600 to 1,800 outpatient days per year, and 500 to 700 offsite visits per year. During this time they've also seen an increase in study complexity, including performing euglycemic clamps, oral glucose tolerance tests, muscle/bone biopsies, a large variety of infusions (such as monoclonal antibodies and immunotherapies), pediatric care and off-site care.
In total, approximately 56 research nurses work in research across medical specialties at UK, such as cancer, neurology (e.g. ALS, Alzheimer’s disease, epilepsy, Parkinson’s disease), surgery (e.g. sepsis, ICU studies), neonate/pediatrics (e.g. cystic fibrosis, preterm birth, diabetes, PKU, hemophilia), cardiology, behavior science and substance use disorders, emergency care and infectious diseases.
Rice entered the field after encountering research nursing in her undergraduate training. Hoping to utilize this aspect of her education, she applied for a research coordinator job. The possibility of finding ways to improve patient care has motivated her work for nearly three decades.
"I love being on the cutting edge. I love knowing, as a nurse, what other things are out there that are being trialed to improve care for patients. I was drawn to this profession because I wanted to help people. And what better way than to be on the front end of trying to make things better?" she said. "Someone told me once that without research, there is no hope. Research is the hope of the future, for better health. And to help facilitate that is such a reward."
The primary task is the same in research nursing as in standard clinical nursing — to care for people, in this case research participants. But research nurses must possess a repertoire of knowledge and skills far beyond clinical practice. They must also know the complex tiers of institutional and federal regulations that govern health research in general, as well as the intricate protocols and diverse clinical skills required by each specific research study.
Kathy Holbrook is a registered nurse and is a clinical research coordinator who also works with the CCTS. She's been a research nurse for 13 years, but said that when she started in the field, she didn't know exactly what she was getting into. These were the days long before the ANA recognized specialty and established a scope of practice for it.
"I learned as I went along," she said. "But you're still a nurse first. That means you're ensuring the health and safety of whomever you're taking care of. For me, it's research volunteers."
Holbrook finds the breadth of her work in research nursing to be invigorating, and appreciates that no two days are ever alike. At any given time she might be working on several research studies in different medical specialties that require her to perform an array of tasks.
"We do a lot of data collection and we make a lot of observations to support the thesis of the protocol. We educate our participants and volunteers on what it means to be a participant in research. And research protocols have you do procedures you might not often do in bedside or clinic nursing. The variety is endless, and that's one of the things that keeps it fresh and interesting. I don't know anybody who has left research nursing because they were bored," she said.
Working closely with study volunteers and researchers is another highlight of the job, according to Holbrook and Rice.
"People in research studies volunteer," Rice said. "And these are special people, because many times what we're doing won't benefit them directly, but will help us improve care for others in the future."
"You develop personal relationships as well, especially in long-term studies," Holbrook said. "It's very heartwarming to know that people are willing to give of themselves for altruistic reasons. And in working with the researchers, we get to see people being creative and thinking outside of the box to really look at something differently and ask how we can do something better."
Holbrook also appreciates the professional independence that comes with research nursing.
"There's an independence and freedom that you don’t get when you're out on the floor. You're an independent practitioner, and I was drawn to that initially."
For Melanie Tillery, a registered nurse, transitioning into research nursing required a "totally different mindset." She previously worked in the emergency department, trauma care, and with chronically ill and hospice patients. Now her work involves a mix of processing labs, overseeing studies, and providing an array or research-related care.
"Your thinking has to change with each protocol, and every protocol has so many different components depending on what they're researching or what the goal is," she said.
What she finds most rewarding about her work as a research nurse is the element of hope.
"A majority of the research volunteers are all hopeful, and the ones that aren't sick at all, they're in the studies just to help someone else, and that's amazing to me," she said. "I was dealing with tragedy a lot of the time, but now I'm doing something to try to change things down the line."
Kathy Edwards, registered nurse, works as a pediatric diabetes research nurse at the Barnstable Brown Diabetes and Obesity Center. A nurse for more more than 30 years and a research nurse for 17, she says that working towards a better future is why she considers research nursing her "dream job."
"There's an endocrine medicine now available that we helped do research on, and we also helped to get an existing insulin approved for pediatric populations. I get to say, 'I was involved in getting that approved.' I feel fortunate to say that during my career I have been involved in research projects that ultimately resulted in new medications becoming available to pediatric patients".
Are you a researcher who would like to know more about clinical services available through the CCTS? Learn more here.
Would you like to learn more about opportunities to participate in research, including a list of studies at UK and access to studies nationwide? Please visit ukclinicalresearch.com
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