The Irving Institute is pleased to announce a new service for CUMC investigators – the CUMC IRB LiaisonSeeking support for IRB approval of your research protocol? We’re here to help! Learn more
Regulatory Knowledge and Ethics Support
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 Technology Ventures, RKSER facilitates collaborative interactions between CUMC investigators and industry.
RKSER Resources - Select Links below for more information
- Consultation on ethical issues
Health Literacy for Research
- Consent templates
- Consent training module – informed consent process
Human Research Protection Office (HRPO) - Institutional Review Boards (IRB)
- CUMC IRB Liaison Service – a new consultation service to improve the quality and efficiency of human subject research protocol submissions and responses to IRB requests
- Consultation hours
Clinical Trials Office (CTO)
- Investigational New Drug (IND)/Investigational Device Exemption (IDE) Assistance Program
Technology Ventures (TV) - Technology Transfer at Columbia University
Additional Resources - Columbia University Office of the Executive Vice President for Research
|Nancy S. Green, MD, Director
Professor of Pediatrics, Division of Hematology/Oncology/Stem Cell Transplantation
Associate Dean for Clinical Research Operations
Associate Director, Irving Institute for Clinical and Translational Research
- 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.
- Advanced training in bioethics is available for interested faculty, trainees and students through the Masters in Bioethics program, directed by Robert L. Klitzman, MD.
- 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 aimed at improving the consent process by simplifying consent forms, reducing therapeutic misconception, assessing the impact of unrealistic optimism and helping investigators deal with the implications of secondary findings.
|Paul S. Appelbaum, MD, Director
Elizabeth K. Dollard Professor of Psychiatry, Medicine, and Law
Director, Division of Psychiatry, Law, and Ethics
Department of Psychiatry
Health Literacy for Research
The Irving Institute’s Health Literacy Task Force developed health-literate consent form templates for minimal risk research with adults and children. The templates are publicly available on the CUMC’s IRB website under Protocol and Consent Document Templates.
Consent Module And Assessment
Informed Consent Process: Assuring that it is Valid and Informed
by Elizabeth Cohn PhD, RN, Elaine L. Larson PhD, RN, FAAN, CIC and Dodi Meyer, MD
- Understand the roles that health literacy, language and culture play in the informed consent process
- Provide practical tools to bridge the gap in health literacy, language and culture during informed consent
- Learn how to assess participant understanding using the playback technique
- CUMC IRB Liaison Service - jointly supported by the Human Research Protection Office (HRPO) and the Irving Institute, this free service is available to CUMC researchers seeking assistance with understanding and addressing IRB requirements and requests. The IRB Liaison will serve as a link between the IRB and CUMC investigators who have submitted a protocol for review by one of the Columbia University Medical Center IRBs. The primary objective for this service is to improve the quality and efficiency of human subject research protocol submissions and responses to IRB requests.
The IRB Liaison will provide consultation in preparing protocols to be compliant with IRB requirements. In addition, the IRB Liaison will provide support to investigators for responding to IRB reviews of research protocols, explanation of IRB requests and assistance in providing appropriate responses and/or implementing requested changes. Consultations from the IRB Liaison are in addition to existing consultation services provided by IRB staff.Examples of the kind of requests that the facilitator service might assist with include:
- What criteria will the IRB use for reviewing my protocol?
- What are the requirements of the CUMC data security policy, and how can I implement them appropriately for my research?
- What are requirements for clinical research stemming from CUMC/IRB policies? Such policies include the CUMC policy for incidental findings, genetic research, research with minors and other vulnerable populations?
- What are acceptable and appropriate recruitment methods?
- Where can I find recommended language that is appropriate for my consent document(s)?
Open Walk-In HoursSubmit an IRB Liaison Service request.
Location: 622 West 168 Street, PH-10-101A
- 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.
- IRB Consultation Hours
The CUMC IRB Office is pleased to announce continuation of IRB Consultation Hours. Implemented in Fall 2009, this service provides an opportunity for researchers to stop into the IRB office and meet with an IRB professional to discuss regulatory, policy, and procedural questions. The service provides regularly-scheduled hours as a means to increase IRB/investigator interactions.
The weekly sessions are scheduled Tuesdays for one (1) hour from 10-11a. No appointments are necessary.
154 Haven Avenue, Floor 1
The number of staff members available for consultation is dictated by the number of individuals who take advantage of this opportunity to have questions answered face-to-face. Attendees should sign in at the IRB receptionist desk and will meet with IRB staff on a first-come-first-served basis. If situations warrant, individual consultations may be limited to 15 minutes.
Important Note: If you have questions about a protocol that has already been submitted to the IRB, please contact the staff members who administer the IRB to which the protocol is assigned rather than bringing those questions to a Consultation Hours session. Staff contact information may be obtained on the IRB website: http://www.cumc.columbia.edu/dept/irb/
Researchers may also call during the IRB Consultation Hours for a consultation: (212) 305-5883.
We remain excited about this initiative as it will allow for efficient, personalized interaction with researchers on a more frequent basis
Executive Director, HRPO/IRB
Assistant Director of Operations, HRPO/IRB
- Consultation - expert consultation for CUMC faculty on Human Research Protection and interacting with the IRB is available from:
|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)
Dr. Larson also chairs one of the CUMC IRB Committees.
- 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.
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.
- Investigational New Drug(IND)/Investigational Device Exemption (IDE) Assistance Program (IAP) provides:
- Assistance in determining if there is a requirement for the submission of an investigator-sponsored IND or IDE.
- Education to investigators regarding the regulatory responsibilities as the sponsors of INDs or IDEs.
- Guidance in the preparation and submission of sponsor-investigator IND or IDE requirements.
- Regulatory assistance during FDA inspections of sponsor-investigator clinical trials.
Jane Cho, MS, MPH
- Consultation on matters relating to clinical trials is available through:
Rudina Odeh-Ramadan, PharmD
Helen Kim, PharmD
Technology Ventures (TV)
Technology Transfer at Columbia University
TV 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:
Ofra Weinberger, PhD
Director, Health Sciences
Science and Technology Ventures
Additional Resources -
Columbia University Office of the Executive Vice President for Research
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