Meet CWRU’s champion for human research protection
Research Compliance Officer
Executive Director for the Human Research Protection Program (HRPP)
Area of Focus: Leads the Human Research Protection Program
Behind groundbreaking discoveries is a robust system dedicated to protecting human research participants. At the heart of this robust system at Case Western Reserve University is Kim Volarcik, whose leadership ensures research involving people is safe, ethical and compliant.
Volarcik is a CWRU research compliance officer and executive director for the Human Research Protection Program (HRPP), which reviews and monitors human research conducted by the university's faculty, staff and students. The HRPP is a network/ecosystem of entities, programs and individuals dedicated to ensuring the appropriate steps are taken to protect the rights and welfare of research participants.
Her days are a combination of strategy, collaboration and hands-on problem solving.
Volarcik manages the CWRU Institutional Review Board (IRB)—which reviews and approves research conducted by CWRU faculty members, staff and students—as well as the Quality Improvement Program that randomly selects for-cause audits of IRB protocols. She also manages the Reliant Review Agreement Office, which helps researchers collaborate with colleagues at other institutions for multi-site research to determine which institution's IRB the project will rely on.
All of these efforts support the HRPP's broader goal of ensuring scientifically and ethically sound research.
Case Western Reserve's HRPP is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), an independent, nonprofit accrediting body. The university was originally accredited in 2016 and most recently received a five-year renewal of its full accreditation status in 2024.
The accreditation indicates that CWRU "is committed to rigorous ethical standards and robust protections for human research participants," Volarcik said.
Before joining the research administration, Volarcik worked as a pediatric nurse, and then as a clinical coordinator in the Center for Human Genetics and Department of Genetics and Genome Sciences. She combines her clinical background with her research and administrative experiences in her current role.
Volarcik's work is also deeply collaborative. She meets regularly with colleagues at CWRU and its affiliated hospitals—including Cleveland Clinic, MetroHealth, University Hospitals and VA Northeast Ohio Healthcare System—to review, approve and oversee federally funded research studies. Throughout the year, she works to educate the research community at faculty member groups, graduate and undergraduate programs and classes—and at presentations across CWRU.
When a compliance matter arises, Volarcik works closely with the principal investigator and study team to review their study and takes appropriate next steps to ensure the incident is reviewed, proper steps are taken and compliance is maintained. "The HRPP and IRB offices are continuously reviewing our policies, procedures, guidance documents and IRB protocol templates to see how we can improve and/or automate our processes to help researchers and the research enterprise," Volarcik said.
In addition to research administration work, Volarcik is also a certified executive coach and an adjunct faculty member in the School of Medicine’s Department of Bioethics. She teaches a graduate course, “Research Ethics and Regulation,” with Don Hoepfer.
"Don and I are able to review the concepts of ethics and regulations in the lens of conducting human research and take each class [through a] deep dive into the topics [for] robust discussions," she said. "I enjoy helping faculty members, staff and students with their research endeavors and supporting them in creating studies and research procedures that will meet their needs and maintain compliance with the regulations."
