Formation of the Office of Research Quality Assurance (ORQA)

Posted in Announcement

We are pleased to announce the creation of the Office of Research Quality Assurance (ORQA). ORQA will promote overall regulatory compliance to ensure the protection of the rights, welfare, and safety of human research subjects and others at the University.

This office will facilitate the expansion of Georgetown University’s robust and growing research enterprise by maximizing the reputation and integrity of Georgetown University through delivery of quality research. ORQA will serve the research community by assisting study teams in establishing best practices and processes for the conduct of clinical research in their sites, provide training and education to the clinical research community, conduct post­approval monitoring, and conduct both for­cause and routine audits to improve upon current processes and ensure research quality.

ORQA will be part of a larger Office of Research Oversight, ORO, that will be established over the coming months to oversee all regulatory and compliance responsibilities associated with the conduct of research across the university. ORO will report jointly to both the Dean for Research at GUMC and the Vice Provost for Research on the Main Campus.

ORQA will be directed by Shaunagh Browning, MS, RN, FNP­BC. Shaunagh has over 25 years of experience in clinical research and is committed to quality clinical research at the University. She will be responsible for quality assurance and quality improvement initiatives necessary to improve compliance with research regulatory requirements, including but not limited to, the Institutional Review Board (IRB), federal/state regulations and guidance, and University policies and procedures. Shaunagh is eager to collaborate with study teams to achieve the goals of the office.

We look forward to growing this critical office as we continue our commitment to outstanding research and compliance.