Lee Pomiecko began building a foundation in human subjects research protections in 2008, when she walked into her first institutional review board (IRB) office at MetroHealth with nerves, curiosity and the question, "What if?” Since then, she has developed a reputation for thoughtful regulatory expertise, serving investigators with good humor and a passion for exploring new ideas—the only espresso she ever needs!
While at the MetroHealth System, she helped expand an inter-institutional reliance agreement and develop a novel submission system ("The Hub") across all three Ohio CTSCs. It was so successful that Lee presented The Hub at a National Center for Advancing Translational Sciences (NCATS) meeting as a potential model for a future federally funded single-IRB system.
After transitioning to University Hospitals, Lee kept asking "What if?" She overhauled policy and streamlined the reporting system—freeing dozens of hours each month previously spent on manual metrics.
Since joining the CWRU IRB in 2018, she has continued to ask, "What if?" Her work has led to improvements in regulatory interpretation, a broadened exemption policy, and continual enhancements to educational resources—all reducing investigator and IRB burden. Lee continues to collaborate across teams and the campus to refine policies and expand educational efforts. She is now leading the IRB team through a major system upgrade.
Lee maintained her IRB professional certification (CIP) for over 13 years and enjoys mentoring early-career professionals. She’s endured four FDA audits and at least four Association for Accreditation of Human Research Protection Programs (AAHRPP) reaccreditations (she’s lost count). She has served on three IRBs and worked on national interinstitutional projects.
Lee loves challenging questions like those surrounding FDA, HIPAA and murky not human subjects determinations. She holds degrees in biopsychology and bioethics and is currently studying computer science to fuel her passion to learn and innovate.
Lee’s most important work skill, teamwork, came from her time as a server at Red Lobster, and she still brings that service to the table. If you’ve got a complex research question or technological project, reach out to Lee. She’s happy to help you find a clear, compliant path forward—and maybe make you laugh in the process!