Conflict of Interest FAQs

The questions and answers in this FAQ relate to the 2012 Columbia University Policy on Financial Conflicts of Interest and Research, and as such, are applicable to all Columbia University researchers. Where appropriate, the answers contain additional information that is relevant to specific funders, such as the U.S. Public Health Service (PHS). Questions specifically related to PHS-funded researchers are addressed in the FAQ Frequently Asked Questions for PHS Investigators. Questions related to the Conflict of Interest Policy Regarding Education and Clinical Care for P&S Faculty and Researchers can be found here.

Overview

A financial conflict of interest (FCOI) is a situation in which an individual’s private financial interest might interfere or appear to interfere with his or her professional obligations to Columbia or the conduct of the research. Such situations do not necessarily imply wrongdoing or inappropriate activities. However, in a research university setting, they can compromise, or be perceived as compromising, important academic values, research integrity, or the university mission.

Financial conflicts of interest in research have the potential to increase bias in research or create the appearance that research has been biased, regardless of whether or not that is the case. They also can present risk to human subjects participating in research.

The Policy requires:

  • Disclosure of any relevant financial interests to peers and to the public in any publications, reports, presentations.
  • Completion of conflict of interest disclosure forms, called Financial Interest Reports, at least annually, for University review.
  • Compliance with any management plan or other actions required by the FCOI Committee to address possible conflicts.

Currently, training is required only for PHS investigators, who must complete training on financial conflicts of interest and research prior to engaging in PHS-funded research, by completing either Rascal course TC1450 - Financial Conflicts of Interest for PHS Researchers, or Rascal course TC0087 – Human Subjects Protection Training (Basic or Refresher) on or after July 16, 2013.

Columbia’s COI Policy requires individuals to disclose outside financial interests that relate to any of their research (including unfunded research) to peers and members of the public. These disclosures must be made when discussing or reporting your research in publications, reports, talks and other presentations.

Financial Interest reports

Financial Interest Reports are required of all Officers of Instruction, Research, or Libraries, students, fellows, research staff or others involved in research. This includes technical staff who have direct access either to research data or to human subjects, and are in a position to influence the design, conduct or results of the research and/or have non-public information as to the outcome of such research.

Individuals who are purely advisory or are not sufficiently independent to be in a position to influence design, conduct or results of the research are not included. Under some circumstances, external consultants may be required to file a Financial Interest Report

Students in some circumstances may act with sufficient independence as to be required to file Financial Interest Reports. It is the PI’s responsibility to identify such students as “Student-Investigators” in Rascal Proposal Tracking.

No, provided that the consultant is serving in a purely advisory role, or is not sufficiently independent to be in a position to influence design, conduct or results of the research. However, any consultant listed as key personnel on a Columbia PHS-funded sponsored project is required to file a Financial Interest Report. At the time of proposal, the consultant may file a paper form (available from SPA upon request). At the time of just-in-time notification, a Columbia UNI should be obtained for the consultant so that he/she can file an electronic form in Rascal before any funds are expended on the award.

For any particular research project, the Principal Investigator is responsible for identifying which study personnel are required to file a Financial Interest Report. For example, the PI is responsible for ensuring that study personnel are assigned the correct role in Rascal Proposal Tracking so that SPA can confirm that disclosure, and where necessary, training requirements, have been completed. In any particular case, SPA and/or the Office of Research Compliance and Training may require additional information to confirm an individual’s status on a project.

To Conduct Research means to perform or otherwise participate in research, including:

  • Designing or directing research
  • Enrolling research subjects (including obtaining informed consent)
  • Making decisions related to eligibility or risks of participating
  • Collecting, analyzing or reporting data
  • Contributing to manuscripts for publication

Individuals who participate in any of these activities are required to file an annual Financial Interest Report.

Reporting Process

All financial interest reporting is made through Rascal, the University’s research administration software system. You will need to log in with your UNI and password. You may access the Rascal Conflict of Interest module here: https://www.rascal.columbia.edu/coilogin.html.

Any individual who conducts research at Columbia must file an Annual Financial Interest Report upon hire and each subsequent year. You will be prompted by Rascal to file on an annual basis.

In addition, key personnel on studies reviewed by the IRB must complete separate protocolspecific Financial Interest Reports during the IRB submission process

Your annual disclosure covers your Financial Interests held or received in the 12 months preceding the date of your disclosure and those expected over the following 12 months.

Yes. You must update your disclosure throughout the year whenever your situation changes. This could occur due to either a change in your or your family’s financial interests or in the nature of your research. Some examples include:

  • You receive a new financial interest;
  • You conduct or plan to conduct new research that relates to an existing financial interest held by you or your family.

If, at any time during the course of the year, you need to update your disclosure, log into Rascal and select Amend Most Recent Annual Disclosure or Start New Annual Disclosure.

Note: PHS-funded researchers must update their Financial Interest Report within 30 days of a new financial interest.

What to Report

You must disclose financial interests of any amount that are related to your institutional responsibilities, and that are held or received by you or your family (see What counts as family for purposes of disclosure?).

The phrase “Institutional Responsibilities” is understood to mean all of the activities that you are required to perform in fulfilling your obligations to Columbia University, including your sponsored activities (such as sponsored research or service projects), teaching, University administrative duties, clinical practice, and other University activities.

To understand what is meant by “related to your institutional responsibilities,” you should think about your outside activities that are associated with your area of professional expertise, or that are related to your role at the University. Ask yourself, “Am I being asked to participate in this outside activity because I am a professional in my field at Columbia University?” If the answer is “Yes,” then it may reasonably appear that the requested activity is “related to your institutional responsibilities.” By this measure, any consultation in your area of professional expertise should be disclosed. On the other hand, if, for example, you are an orthopedist with a family business that imports rugs, that would not need to be disclosed. Keep in mind that “relatedness” is not always a bright-line determination. You should use your judgment when deciding what needs to be disclosed; but when in doubt, err on the side of transparency.

Financial Interests that must be disclosed include:

  • Compensation/Remuneration
  • Equity Interests
  • Royalty Payments
  • Special Relationships
  • Sponsored Travel
  • Other Financial Interests (e.g., certain intellectual property rights)

You must disclose any payments to you or your family from intellectual property rights that reasonably appear to be related to your institutional responsibilities, such as royalties, license fees, or similar payments. Be sure to include royalty payments received either directly from an outside entity, which includes not-for-profit as well as for-profit entities, or through the University (such as through a University license agreement).

Note regarding publishing royalties: PHS researchers must include royalties or other income received from an independent publishing company arising out of authoring, editing or reviewing publications (print or electronic). Researchers who do not participate in PHS-funded research are not required to disclose such royalties.

Yes. If you are reimbursed for travel by an entity that is related to your research, you must disclose that on your Financial Interest Report.

Note: PHS researchers must disclose all reimbursed or sponsored travel that reasonably appears to be related to your institutional responsibilities. You may report anticipated travel prospectively in your annual Financial Interest Report, to the extent it is known at the time. You must update your annual financial interest report within 30 days of any undisclosed sponsored travel by sending your updated travel information to [email protected] or by filing a new annual Financial Interest Report in Rascal that includes the new travel information.

Yes. Financial Interests include remuneration from, and other relationships with, not-for-profit as well as for-profit entities.

No. Financial holdings that are not controlled, influenced or managed by you (such as mutual funds) are excluded from the definition of “Financial Interest.”

With regard to FCOI disclosure, your Family includes: Your spouse or domestic partner; your dependent children; your grown children, grandchildren, parents and grandparents (but only for those financial interests that are known to you); and any trust, organization or enterprise over which you, alone or together with your family, exercise a controlling or significant interest.

With regard to your spouse or domestic partner and dependent children, because these relationships are so close, you are deemed to know about their financial interests and should therefore inquire if you do not already have the information. With regard to your parents, adult children, grandparents and grandchildren, you need only report those financial interests of which you are already aware. There is no duty to inquire about the interests of those family members.

Yes. Researchers involved with the design, conduct or reporting of any human subjects research protocol must submit a protocol-specific disclosure in addition to the Annual Financial Interest Report. All Financial Interests must be disclosed to the Institutional Review Board (“IRB”). And, notwithstanding FCOI Committee resolution, the IRB may impose its own requirements on your research if it involves human subjects. For example, the IRB might require particular language disclosing financial interests in informed consent forms, even if the interests are below the $5,000 threshold.

After Disclosure

Disclosures are made electronically through Rascal, a restricted research administration database. The completed forms are available to the staff in the Office of Research Compliance and Training, which conducts initial review of the disclosure forms, and, where appropriate, to members of the FCOI Committee, who are obligated to keep the information confidential.

Where a disclosure relates to human subjects research, it also will be shared with the Institutional Review Board. In addition, disclosure forms may be shared on a case-by-case basis with other University officials or committees with conflict of interest responsibilities, who also are obligated to keep the information confidential. Note: conflict of interest issues that are not related to research are addressed by the relevant school or center within the University.

In general, the University recognizes that disclosed information may be sensitive and limits access accordingly. However, in some circumstances, information about a conflict of interest must be made publicly available in accordance with Public Health Service regulations. See Under what circumstances does the University make information from my disclosure form available to the general public? below.

Your Financial Interest Reports remain in the confidential Rascal system where access is restricted. The Office of Research Compliance and Training reviews any reports that disclose financial interests related to your research. If a reported financial interest exceeds specific thresholds, it is considered a Significant Financial Interest (SFI) and must be reviewed by the Financial Conflict of Interest Committee. Note: conflict of interest issues that are not related to research are addressed by the relevant school within the University.

A Significant Financial Interest is defined as any one of the following:

  • Income greater than $5,000 per year
  • An equity stake in a public company greater than 5%, or with a value of more than $5,000
  • Any equity interest in a private company
  • All royalties that exceed $5,000 per year

For PHS researchers, the information on your form is kept confidential, unless the FCOI committee determines that an FCOI relates to your PHS-funded research. Under the PHS regulations, the University is required to make accessible to the public information about the financial interests of senior/key personnel that are found to be conflicts of interest as defined by the regulations.

Schools may choose to make some disclosed information publicly available through a publicly accessible website or other mechanism.

Reporting outside financial relationships is a responsibility every member of the Columbia University community must view with the utmost seriousness. While full disclosure may sometimes require a review of financial records or other efforts by you, it is nonetheless critical to the conflict of interest review process. In addition, only full disclosure avoids post hoc revelations that have the potential to lessen public confidence in the objectivity of research, not to mention embarrass researchers who have not fully disclosed. In some cases, failure to complete an accurate disclosure form may even lead to criminal prosecution.

Sponsored Projects Administration will not submit any application unless each individual who would conduct research under the proposal has a current Annual Financial Interest Report on file. Also, no sponsored research agreement may be finalized unless each individual who would Conduct Research under the proposal has a current Annual Financial Interest Report on file. Similarly, the Institutional Review Boards will not grant final approval of human subjects research protocols until any potential conflict issues are resolved. Deliberate non-disclosure or repeated failures to disclose are subject to the full extent of University penalties, as set forth in the policy. Such penalties may include imposing additional reporting obligations on the researcher or requiring the researcher to return excess compensation.

Note: PHS regulations contain specific additional requirements applicable in situations in which a Financial Conflict of Interest is not identified or managed in a timely manner, due either to a failure by the investigator to disclose the FCOI or of the institution to review or manage it.

General

The University permits officers of instruction to consult for an average of one day a week, provided that the consulting does not interfere with University obligations and is appropriately approved. See The Faculty Handbook, Outside Interests and Employment. Under the FCOI Policy, consulting payments exceeding $5,000 per year from a Business that funds or otherwise relates to your research must be reviewed by the Financial Conflict of Interest Committee.

The University would initially take the lead in responding to any such investigation. The University supports personnel who are subject to external investigations, provided that the personnel have complied with University policy and were acting within the scope of their employment. Ultimately, however, it is the responsibility of each individual to avoid conflicts of interest with respect to his or her research.

Yes. Once you log into Rascal, you can view all of your disclosures.

Not necessarily. The Financial Interest Report addresses conflicts of interest and research along with other issues such as administrative conflicts and conflicts of commitment. In addition, for faculty of the College of Physicians and Surgeons (P&S), the form contains additional questions related to the P&S Conflict of Interest Policy on Education and Clinical Care. University faculty with administrative responsibilities may also be required to fill out a separate conflict of interest form regarding their administrative activities.

Yes. You must disclose this information to the members of the research team (including graduate students, research colleagues and collaborators within and outside the University). While a written disclosure to these individuals is not required, it provides you with a record of your compliance, and protects you should questions arise about your notification of others about your conflict of interest. In addition, you must disclose outside financial interests that relate to any of your research (including unfunded research) to peers and members of the public when discussing or reporting your research in publications, reports, talks and other presentations.

No, the annual disclosure form in Rascal has been updated to reflect the new regulatory requirements. However, after August 24, 2012, SPA will not submit new PHS proposals for funding or set up new awards or continuations until all Investigators on the project have filed a new disclosure using the updated form in Rascal. For questions related to PHS FCOI regulations, refer to the Frequently Asked Questions for PHS Investigators.