Individual Financial Conflict of Interest
A financial conflict of interest (FCOI) exists where a researcher's outside interests or activities could improperly affect, or give the appearance of affecting, the researcher's activities at Columbia.
Research at Columbia University is subject to the University-wide Policy on Financial Conflicts of Interest and Research, which was approved by the University Senate and took effect on July 1, 2009; the Policy was updated on August 24, 2012 in response to a revised federal regulation. Answers to Frequently Asked Questions about the Policy are available here. Information about the revised regulation, which applies to researchers funded by NIH, CDC and other U.S. Public Health Service (PHS) agencies can be found below.
University officers are required to report to the University any outside financial interest or commitment (including those of family members) that could give rise to a financial conflict of interest. The University requires all officers of instruction and officers of research to complete an annual Financial Interest Report through Rascal, and to update the annual disclosure throughout the year as appropriate. The form solicits information concerning outside activities and financial interests as they relate to an individual's research activities and other responsibilities at the University. The Committee on Financial Conflicts of Interest and Research reviews cases where there is a potential conflict of interest that may relate to the individual's research.
To file a Financial Interest Report, click here or go to Rascal and select "Conflict of Interest." Review the disclosure checklist prior to filing your disclosure.
At CUMC, the annual disclosure statement contains additional questions relating to conflicts of interest concerning clinical care and education. These issues are addressed by each school's dean's office; for P&S, more information is available at the P&S Office of Academic Affairs COI webpage.
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Personnel who plan to participate in the design, conduct or reporting of human subjects research must submit individual, protocol-specific conflict of interest disclosure forms. The Institutional Review Board (IRB) will not give final approval to any protocol until all conflicts of interest have been reviewed by the appropriate conflict of interest committee and addressed to the satisfaction of both that committee and the IRB.
To file a Financial Interest Report, click here or go to Rascal and select "Conflict of Interest."
Before any grant application may be submitted by Sponsored Projects Administration, all investigators must have completed a current conflict of interest disclosure form. Sponsored Projects Administration will not submit any applications until all individuals have completed their forms. In addition, Sponsored Projects Administration will not set up sponsored project accounts unless current Financial Interest Reports are on file in Rascal and potential conflicts have been resolved.
To file a Financial Interest Report, click here or go to Rascal and select "Conflict of Interest."
The Department of Health and Human Services has its own financial conflict of interest regulation - Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractor. The regulation, which took effect on August 24, 2012, governs research sponsored by NIH, CDC, AHRQ, and other Public Health Service (PHS) agencies (see below) and applies to all investigators on new awards, new proposals, non-competing renewals, and no cost extensions received or submitted on or after that date. The regulation, which is incorporated as an appendix to the University's FCOI and Research Policy, includes specific requirements for all PHS investigators, including:
A. Mandatory Training: All PHS researchers must complete training in Financial Conflicts of Interest in Research at least once every four years. PHS researchers have two options for completing their initial FCOI training in Rascal:
- Completing Rascal training for human subjects research – TC0087, which includes an FCOI component; or
- Taking Rascal course TC1450 - Financial Conflicts of Interest for PHS Researchers, a stand-alone FCOI course for researchers who do not take human subjects protection training.
- To remain compliant with the PHS FCOI 4-year training requirement, researchers whose training is expiring have two options:
- Staying up to date on human subjects protection training, TC0087, which is required every 3 years; OR
- Completing Rascal course TC1455 - Refresher FCOI Training for PHS Researchers, an abbreviated FCOI refresher course. [Note that TC1455 is refresher training only and does not satisfy the initial FCOI training requirement.]
B. Broader disclosure requirements of all financial interests that relate to an individual's institutional responsibilities, including compensation from non-profit entities and sponsored travel
C. A lower threshold of $5,000 for "significant financial interests"
PHS Agencies*
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control (CDC)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Indian Health Services (IHS)
- National Institutes of Health (NIH)
- Office of the Assistant Secretary for Health (OASH)
- Office of Assistant Secretary for Planning and Evaluation
- Office of the Assistant Secretary for Preparedness and Response (ASPR)
- Office of Global Affairs (OGA)
- Office of Public Health and Science
- Substance Abuse and Mental Health Services Administration (SAMHSA)
*Check with the funding agency for most up-to-date information on FCOI policies. Source: FDP FCOI Agency list
Related Webpages
Entrepreneurship among faculty and graduate students is an increasing trend, both at Columbia and at many of our peer institutions. Columbia offers a number of programs to support these initiatives, and you may learn about them at http://entrepreneurship.columbia.edu.
The establishment of a faculty or graduate student startup company may raise issues concerning potential conflicts of interest. If conflicts are not appropriately managed or reviewed, they could leave the researcher and the institution vulnerable to charges of bias in research, and may also raise regulatory concerns. For companies based on University intellectual property, the Office of Research Compliance and Training (RCT) works closely with Columbia Technology Ventures (CTV) to ensure that such issues are flagged early and addressed so that the startup can move forward as smoothly as possible.
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