Regulatory Knowledge and Support and Ethics Resource (RKSER)

The Regulatory Knowledge and Support and Ethics Resource (RKSER) unifies a variety of research-related offices at Columbia University Irving Medical Center (CUIMC) to enhance regulatory education, compliance, and ethics. RKSER works closely with the Office of the Executive Vice-President for Research, the Clinical Trials Office, and the Human Research Protection Office (IRB) to provide investigators with assistance in moving the research process forward. 

Services

To assist in fulfilling the entire range of regulatory requirements for the conduct of clinical and translational research, RKSER is available to the entire research community at CUIMC.

RKSER provides one-on-one Research Ethics and Human Subjects Consultation

 

Leadership

  • Nancy S. Green, MD

    • Co-Director; Professor of Pediatrics, Associate Dean for Faculty Operations

  • Paul S. Appelbaum, MD

    • Co-Director; Elizabeth K. Dollard Professor of Psychiatry, Medicine, and Law

  • Sandra Soo-Jin Lee, PhD

    • Associate Director; Chief, Division of Ethics, Professor of Medical Humanities and Ethics

Faculty Collaborators and Team Members

Helen Kim, PharmD - Executive Director Clinical Trial Office

Jane Cho, MS, MPH - Associate Director of Regulatory Science at the Clinical Trials Office

Elaine Larson, RN, PhD, FAAN, CIC - Expert - HRPO Performance; Anna C. Maxwell Professor Emerita of Nursing Research and Professor Emerita of Epidemiology; Special Lecturer in Nursing

Brenda L. Ruotolo - Executive Director, Office for Human Research Protections, CUIMC IRB

Deborah Stiles, JD - Chief Operating Officer; and Vice President for Research Operations and Policy, Office of Executive Vice President for Research

William Berger - Assistant Vice President, Sponsored Projects Administration

Tasha Isles Smith, MA, MPH - Senior IRB Specialist, Liaison

Kristen Salmi - Regulatory Science Specialist

Eliza Skidgel - Recruitment Application Specialist