Conflict of Interest and Research
A conflict of interest (COI) 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. 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 here.
An appendix regarding requirements for research funded or proposed for funding by the U.S. Public Health Service is available here. An FAQ regarding startup companies is available here. Answers to other Frequently Asked Questions are available here. You can link here to view other University resources related to conflict of interest. For training concerning the Policy, go to the Rascal Training Center.
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 conflict of interest. The University requires all officers of instruction and officers of research to complete an annual Financial Interest Report through Rascal, the University's on-line research compliance system, 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.
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.
Research with Human Subjects
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.
Sponsored Project Proposals
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.
Questions about conflict of interest issues can be addressed to Michael Klein in the Office of Research Compliance and Training.
Fall 2014, the Columbia University Senate approved a companion policy
to the University’s Policy on Individual Financial Conflict of
Interests and Research. The new policy, entitled the Columbia
University Policy on Institutional Conflict of Interest (ICOI) in
Research, protects the objectivity of University research from
potential conflicts that may result from financial interests held by
the University itself or by its officials who have responsibility for
research oversight. Such financial interests could include, for
example, royalties paid to the University by research sponsors;
ownership interests in start-up companies whose products are the
subject of University research; or certain large corporate gifts.
Implementation of the Policy is being administered by the Office of Research Compliance and Training and will be automated in part through the University’s research administration software system, Rascal. Potential institutional conflicts of interest are reviewed by the University’s Institutional Conflict of Interest Committee, an interdisciplinary faculty committee that also includes non-voting members from Columbia TechVentures and the Office of Alumni & Development. The Policy provides that “[t]he ICOI Committee and the University should make every attempt to resolve institutional conflicts in a manner that enables research to proceed at the University. However, if the ICOI Committee finds that an ICOI cannot be managed, and divestment is not feasible, then the affected research should not proceed at the University.”
Anyone with questions about the new Policy should contact the Office of Research Compliance and Training at email@example.com.