Conducting Research with Human Subjects? The Clinical Research Center Can Help

Clinical research is a key step in translating scientific advances into new therapies and patient care. For decades, the Clinical Research Center (CRC) has supported inpatient and outpatient studies at the University of Rochester, making it a clinical trials powerhouse.

Making Clinical Research Happen

“The CRC helps research teams gets clinical research done, plain and simple,” said Carrie Dykes, PhD, director of Research Services at UR CTSI. “It facilitates safe and controlled inpatient and outpatient studies, providing the environment, infrastructure, and staff expertise for conducting studies with human subjects.”

Johanna Hamel, MD, an associate professor of Neurology, Pathology, and Laboratory Medicine, has been studying muscular dystrophy, including overseeing clinical trials at the CRC, building on its track record of success. Hamel sees the capabilities and ongoing legacy of the CRC as an asset to her work.

“For decades, a lot of work has been done at the University on muscular dystrophy,” Hamel said. “We were quite excited for the opportunity to test and develop some of the therapies, many of which were spearheaded here. We were one of the first sites to be ready. We conducted all these natural history studies at the CRC that were so important to prepare for the clinical trials, and then it was natural to conduct the clinical trials themselves at the CRC.”

Expert Nursing Staff

Credentialed nurses who have research experience are a valuable resource. Some studies require RNs because of the types of study activities they must perform, such as infusions. But technical knowledge alone does not make a nurse a clinical trials expert. Safety and patient care, including soft skills, makes all the difference. The CRC's research nursing team boasts this expertise.

“I’m proud to say that our experienced nurses bring a wealth of knowledge from areas like cardiology, medical-surgical nursing, pediatrics, and research,” said Ann Miller, RN, MS, CCRC, nurse manager. “This allows us to provide exceptional patient care while also contributing to the development of safe, effective research protocols that truly impact clinical trials.”

For the CRC’s nursing staff, it all starts with safety and a personal approach.

“We ensure patients feel comfortable and supported while upholding high standards of care and ethics,” Miller said. “Our focus on safety goes beyond protocols—it is about building trust with the patients and conducting studies with compassion and integrity. This commitment allows the CRC to take on complex research studies while always protecting the well-being of those we care for.”

Nutrition Research

The CRC offers laboratory collection and processing, DXA scans, and a Nutrition Research service in addition to its standard services. Nutrition Research in turn offers an array of comprehensive services through the planning, development, implementation, and analysis of a study’s nutrition elements.

“Whether nutrition is a small or a major component of a study, I work closely with investigators and their study teams to provide a high standard of nutrition services—with a key focus on participant satisfaction—to enhance recruitment/retention and to produce quality data,” said Nellie Wixom, RD, nutrition manager for the CRC.

Wixom has supported a wide variety of research projects, including those for autism, pregnancy, weight control, diabetes, breast cancer, cardiovascular disease, hypertension, nephrology, neurological, and pulmonary disorders. Each study and study subject presents their own unique nutrition needs.

“We provide specialized nutrition services that include developing and conducting nutrition interventions and creating research diets,” Wixom said. “We assist investigators in identifying and implementing appropriate tools for nutrition assessment and analysis. My expertise in nutrition research provides investigators with a valuable resource to achieve the nutrition goals and support the success of their studies.”

Full-Spectrum Clinical Research Support and Success

Since its creation, the CRC has helped the University of Rochester become a clinical research powerhouse—one that capitalizes on the power of top-tier health care and research expertise, funding, and expertise.

Christopher Palma, MD, ScM, is the strategic director of Research Services, the branch that oversees the CRC.

“When you work with us, we are going to do everything within our power to make your clinical trial successful,” Palma said. “We encourage research teams to reach out with questions early in their planning process so we can figure out the best way forward.”

Contact the Research Help Desk to get started with the CRC or with any questions about clinical research support.

Jonathan Raab | 5/29/2025