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To assist in fulfilling the entire range of regulatory requirements for the conduct of clinical and translational research RKSER is available to the research community at CUMC. It provides support through educational programming, training and consultation.
- Education - an extensive series of educational sessions are offered ranging from topics of broad general interest such as ethical and regulatory issues surrounding the informed consent process and conflict of interest to more narrowly-focused areas such as the regulatory and reimbursement issues for clinical trials with drugs and devices.
- Training - Columbia offers a variety of training courses on topics such as Human Subjects Protection, Research Compliance, Financial Oversight, Environmental Health and Safety, and Columbia University online system for research compliance and administration, RASCAL. Course listings can be found at CU Office of Research Compliance and Training. One such program is the Human Subjects Protection training program, which uses online human subjects protection training modules from the national Collaborative Institutional Training Initiative (CITI).
- Consultation - available to investigators with questions about processes or procedures in regulatory affairs or about ethics issues that arise in the conduct of their research such as IRB and HIPAA issues, investigator initiated IND and IDE filings, research relationships with industry, design of clinical trials, informed consent, and protection of subjects. Working with both the Clinical Trials Office and CUMC office of Science and Technology Ventures, RKSER facilitates collaborative interactions between CUMC investigators and industry.
RKSER Resources
Ethics ResourceHuman Subjects Protection - Institutional Review Board (IRB)
Clinical Trials Office (CTO)
Consultation for Clinical Trials
Science and Technology Ventures (STV) - Technology Transfer at Columbia University
Additional Resources - Columbia University Office of the Executive Vice President for Research
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Nancy S. Green, MD, Director Associate Professor of Clinical Pediatrics, Division of Hematology Associate Dean for Clinical Research Operations Associate Director, Irving Institute for Clinical and Translational Research nsg11@columbia.edu |
Ethics Resource serves the CUMC community in three ways:
- Education - integrated with the curriculum on regulatory issues, a comprehensive series of educational sessions on research ethics explores ethical aspects of clinical and translational research, including informed consent, roles and responsibilities of research staff, study design, conflict of interests, and issues in emerging areas of research. Education offerings are also available through the Office of Research Compliance and Training.
- Consultation on ethical issues - available to investigators as they plan and implement studies, including assistance with IRB submissions and consulting on ethical dilemmas that arise before, during and after their studies.
- Research - original projects are aimed at improving the consent process by simplifying consent forms, reducing therapeutic misconception, standardizing assessment of constraints on voluntariness, and improving understanding of conflicts of interest.
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Paul S. Appelbaum, MD, Director Elizabeth K. Dollard Professor of Psychiatry, Medicine, and Law Director, Division of Psychiatry, Law, and Ethics Department of Psychiatry psa21@columbia.edu |
The Ethics Resource works closely with Columbia's Center for Bioethics directed by:
Ruth L. Fischbach, PhD, MPE
Professor of Bioethics
Director and Co-Founder, Center for Bioethics
rf416@columbia.edu
Human Subjects Protection - Institutional Review Board (IRB)
- Education - an extensive series of educational sessions are offered ranging from topics of broad general interest -- such as ethical and regulatory issues surrounding the informed consent process and conflict of interest -- to more narrowly-focused areas -- such as the regulatory and reimbursement issues for clinical trials with drugs and devices. Integrated with the curriculum on regulatory issues a comprehensive series of educational sessions on research ethics explores ethical aspects of clinical and translational research, including informed consent, roles and responsibilities of research staff, study design, conflict of interests, and issues in emerging areas of research. Education offerings are also available through the University Office of Research Compliance and Training.
- Consultation - expert consultation for CUMC faculty on Human Subject Protection and interacting with the IRB is available from:
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Elaine Larson, RN, PhD, FAAN, CIC Professor of Pharmaceutical and Therapeutic Research Associate Dean for Research, School of Nursing Professor of Epidemiology, Mailman School of Public Health Director, Center for Interdisciplinary Research to Reduce Antimicrobial Resistance (CIRAR) ell23@columbia.edu Dr. Larson also chairs one of the CUMC IRB Committees. |
Clinical Trials Office (CTO)
- Service - the mission of the CTO is to facilitate quality clinical trial research - the effective and efficient evaluation of new pharmaceuticals and medical devices by providing administrative services that help move trials quickly from initial proposal through contract execution.
The CTO serves the research community of Columbia University College of Physicians & Surgeons - New York Presbyterian Hospital. Services include study placement, protocol development, IRB and other regulatory guidance, comprehensive budget preparation and contract negotiation, Spanish translation and review services, centralized database access to achieve target recruitment, and the Research Pharmacy. - Consultation on matters relating to clinical trials is available through:
Rudina Odeh-Ramadan, PharmD
Executive Director, Clinical Trials Office
ro133@columbia.edu
ctodirector@columbiaclinicaltrials.org
Consultation for Clinical Trials
Consultation on clinical studies and study design for faculty is available upon request from Dr. Elizabeth Stoner at stonere@gmail.com. Dr. Stoner is a special consultant to the Irving Institute for Clinical and Translational Research, an endocrinologist and former Senior Vice President of Global Clinical Development Operations at Merck.
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Elizabeth Stoner, MD Special Consultant Irving Institute for Clinical and Translational Research stonere@gmail.com |
Science and Technology Ventures (STV)
Technology Transfer at Columbia UniversitySTV works with faculty to:
- Identify and patent or copyright new inventions;
- Interact with industry to negotiate collaborative Sponsored Research Agreements (SRAs);
- Advise industry of new inventions and negotiate license agreements;
- Apprise venture capital groups and other investors of new inventions and facilitate startup of new companies based on Columbia faculty research;
- Facilitate the Material Transfer Agreements (MTAs) that enable researchers to advance their work and,
- Negotiate inter-institutional agreements to facilitate collaborative research projects.
Consultations on matters relating to Technology Transfer are available through:
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Ofra Weinberger, PhD Director, Health Sciences Science and Technology Ventures ofra.weinberger@columbia.edu |
Additional Resources -
Columbia University Office of the Executive Vice President for Research
RASCAL
Columbia University online system for research compliance and administration. Inquiries about use of RASCAL should be directed to the RASCAL Help Service.
Sponsored Projects Handbook. Created by the Office of the Executive Vice President for Research to give practical guidance to faculty and administrative staff of Columbia University in the management of sponsored projects funded by both governmental and private organizations. This will enable faculty and staff to administer research and other externally funded projects in accordance with University and sponsor policies.
Office of Research Compliance and Training. Helps ensure that Columbia faculty and staff are in compliance with the complex web of regulatory requirements that govern research and fosters an integrated research compliance program.
Office of Research Initiatives
Institute of Comparative Medicine (ICM)
Institutional Animal Care and Use Committee (IACUC)
Environmental Health and Safety
Sponsored Projects Administration
Office of Postdoctoral Affairs
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