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. We also provide consultations and offer seminars on topics of ethics and research. The HRPO (IRB) and the Clinical Trials Office (CTO) each offer consultations and trainings in “how to” on several relevant topics.


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. In addition to the above services, RKSER provides one-on-one consultations through:


RKSER faculty and senior staff are involved in projects aimed at improving the consent process by simplifying consent forms (templates, partnering with the Health Literacy service). Original research focuses on improving informed consent, assessing capacity to consent to research, and helping investigators deal with the implications of primary and secondary findings, including return of genetic findings.

Support for Subject Recruitment - RecruitMe



  • Nancy S. Green, MD

    • Co-Director; Professor of Pediatrics, Associate Dean for Faculty Operations
    Headshot of Nancy Green.
  • Paul S. Appelbaum, MD

    • Co-Director; Elizabeth K. Dollard Professor of Psychiatry, Medicine, and Law
    Headshot of Paul S. Appelbaum, MD.
  • Sandra Soo-Jin Lee, PhD

    • Associate Director; Chief, Division of Ethics, Professor of Medical Humanities and Ethics
    Headshot of Sandra Soo-Jin Lee
  • Sheila M. O’Byrne, PhD

    • Senior Program Manager

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