Annual Announcement

Memorandum

To: VP&S Faculty and Researchers

From: Anne L. Taylor, MD

Vice Dean for Academic Affairs for the Vagelos College of Physicians and Surgeons

Senior Vice President for Faculty Affairs and Career Development for CUIMC

Date: January 14, 2020

Because of several changes in conflict of interest (COI) administration at the national level, we convened a CUIMC committee to review our policies and procedures. The recommendations from the committee for changes to CUIMC policies and VP&S procedures are below. We recognize this is a lengthy list of updates, but the changes may affect your reporting or external activities so please read this carefully.

Management:

For future COI filings:

  • VP&S is now comparing payments reported in CMS Open Payments to those reported on physicians’ Rascal-based COI disclosure forms. We advise faculty to review what is reported on Open Payments. If after their review of CMS data there are significant variances between the two, faculty may want to go in to Rascal and update their Rascal disclosure forms.
  • You are required to disclose in your annual COI filing royalties, license fees, or other payments related to intellectual property rights, even if paid through Columbia University.

Policy:

For 2019, please be aware of the following changes (in italics) to the Conflict of Interest Policy on Education, Clinical Care, and Administration for Faculty and Researchers at Columbia University Irving Medical Center regarding:

  • Conflict of Interest Disclosure
  • Conflict of Commitment
  • Executive Positions, or Other Special Relationships
  • National and International Research Studies
  • Use of Confidential Information

Conflict of Interest Disclosure: In addition, commercial support should be appropriately disclosed to trainees, students, patients, professional audiences, staff, and colleagues.

Conflict of Commitment: Full-time Faculty and Researchers “may not participate in any outside activities, for or without compensation, that will absorb an undue amount of their time and thereby interfere with the performance of their duties as Officers of the University.” Moreover, “Faculty may not engage in outside activities that directly compete with the mission and interests of the University or are in conflict with their University responsibilities, regardless of the time they require.” (Faculty Handbook: Obligations and Responsibilities of Officers of Instruction and Research). “…An officer should not accept a regular and continuing position with significant responsibilities for the management of an outside commercial enterprise or without appropriate approvals [from their department chair or the VP&S Office of Academic Affairs] accept any other outside position that would impair the officer’s ability to fulfill his or her obligations to the University.” (Faculty Handbook Appendix E: Conflict of Commitment. A conflict of commitment may exist even when a faculty member observes the time limit for outside activities set by the University (ordinarily not more than one day a week), and even if the activities are limited to the summer months, if the outside activities are in conflict with their University responsibilities. Outside activities may not adversely affect the faculty’s independence or compromise the integrity of the University. [Faculty Handbook, Obligations and Responsibilities of Office of Instruction and Research – Outside Interests and Employment.]

Executive Positions, or Other Special Relationships: Full-time Faculty and Researchers may not hold executive positions with outside companies or organizations.

“Executive Position” means any position, whether compensated (through salary, fees, equity, etc.) or uncompensated, that includes responsibility for a material segment of the operation or management of a Business. This term includes any management role, such as a regular salaried, un-salaried, or otherwise compensated position (e.g., chief executive or another officer position with responsibilities for management, strategy, operations, finances, informatics, or personnel) that involves day-to-day management of a material segment of the Business. This term also pertains to Board of Director or Board of Trustees positions that involve operational responsibilities.

See also the Conflict of Commitment policy above.

National and International Research Studies: Service in a leadership position (e.g. as national or international principal investigator), or as other key personnel (or equivalent) in a national or international research study, is considered a University activity and, in general, must be subject to an appropriate research agreement between the sponsor or other relevant party and the University. This requirement must be met regardless of whether Columbia otherwise participates in the research study, e.g., as a clinical site for enrollment.

Use of Confidential Information: Faculty or Researchers “should not accept employment or engage in any business or outside activity which he or she might expect would require or induce him or her to disclose confidential information acquired by reason of his or her University position.”  In addition, Faculty or Researchers, whether in formal or informal settings, “must not disclose confidential information acquired by reason of his or her University position, or use such information for his or her or another’s gain or benefit” (Faculty Handbook, Appendix E). Faculty and Researchers must bear in mind that this prohibition includes disclosure of research results that have not been made public by publication or presentation. 

When Faculty or Researchers engage in external activities (e.g. consultation, speaking, any paid or unpaid positions external to the University or its clinical affiliates), they are responsible for avoiding the communication, whether deliberate or inadvertent, of any confidential data (i.e. not published or otherwise publicly available). Particular care must be taken when interacting with external entities such as “hedge funds” or other businesses, for profit or not-for-profit, which could benefit from unpublished data.

 

Regarding the change in the policy on National and International Research Studies, the University’s Sponsored Projects Administration (SPA) or the Clinical Trials Office (CTO) may be consulted to set up a research agreement with the University.

The updated CUIMC COI policy and resources are available at: https://www.ps.columbia.edu/administration/academic-affairs/policies-tools-and-resources/conflict-interest-compliance/cuimc-coi.

If you have any questions about these policy changes, please feel free to contact our office via email at ps-coi@cumc.columbia.edu. 

Thank you for your ongoing commitment to compliance with Columbia University policies on COI.