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.

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

Research

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 reducing therapeutic misconception, assessing the impact of unrealistic optimism, and helping investigators deal with the implications of primary and secondary findings, including return of genetic findings.

Leadership and Team Members

  • Nancy S. Green, MD

    Director; Professor of Pediatrics

    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.
  • Helen Kim, PharmD

    Executive Director, Clinical Trial Office

  • Elaine Larson, RN, PhD, FAAN, CIC

    Professor of Pharmaceutical and Therapeutic Research; Professor of Epidemiology; Associate Dean for Research, School of Nursing

    Headshot of Elaine Larson.
  • 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