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How to Report My Annual COI
Effective July 2019, COI disclosures are no longer due by May 15th. We have adopted a “rolling review” process whereby reporters will have 365 days from when they submit before they will need to submit another disclosure. If a reporter has a need to update due to a change in COI status (PHS grant, change in SFI, etc.) then the new COI approval will reset the clock.
Dr. CAM the Ram has their COI approved on August 12th 2019, so they will not have to submit again until August 11th 2020. They receive a new grant and have to update their COI on October 15th 2019, so now they will not have to resubmit again until October 14th 2020.
CSU policy requires that all Faculty and Administrative Professional employees complete an annual disclosure, including those who are part-time, temporary, off-campus or on leave. Those who are listed as a PI, Co-PI or key personnel on a PHS agency research grant are also required to complete a disclosure regardless of the employee type (for example a postdoc may need to disclose as key personnel). Other employees may be asked to complete a disclosure as deemed necessary by their unit head. See the CSU policy on Conflict of Interest and Conflict of Commitment in the Academic Faculty & Administrative Professional Manual:
An external significant financial interest consisting of one or more of the following interests of an Investigator (and those of the Investigator’s Immediate Family Members) related to their Institutional Responsibilities, when aggregated for the 12 months preceding the disclosure date exceeds $5,000 from a single Entity:
- Remuneration, compensation, and/or other payments for services (e.g., consulting, speaking)
- Equity interests in a publicly-traded entity
- Equity interests in a non-publicly-traded entity (e.g., a start-up company)
- Any Intellectual property rights and interests
- Sponsored or reimbursed travel — unless the travel is sponsored, reimbursed, or paid by a federal, state or local government agency, a qualifying institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with a qualifying institution of higher education.
- Salary, royalties or other remuneration paid by CSU to the Investigator if the Investigator is currently employed or otherwise appointed by the University
- Intellectual property rights assigned to CSU and agreements to share in royalties related to such rights
- Equity interests through investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles
- Income from seminars, lectures or teaching engagements sponsored by a federal, state or local government agency, a qualifying institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with a qualifying institution of higher education
- Income from service on advisory committees or review panels for a federal, state or local government agency, a qualifying institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with a qualifying institution of higher education
- Sponsored or reimbursed travel sponsored or paid by a federal, state or local government agency, a qualifying institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with a qualifying institution of higher education
Within 30 days of its occurrence, you must report sponsored or reimbursed travel taken by you, your spouse, or dependent children that is related to your institutional responsibilities, unless the travel is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a) (see note #6 under “What is not a SFI”), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
The following activities, when they are related to the normal course of work as a faculty/AP employee, do not count as outside professional commitments. The activities listed below do not need to be reported unless they are compensated by a business entity beyond expense reimbursement. Receipt of royalties for scholarly publications does not constitute “compensation by a business entity” for purposes of this policy. Regardless of compensation, these activities must not interfere with the performance of regular employment duties or compete with coursework offered by the University or services offered by the employee’s unit.
- Preparing scholarly or artistic works
- Peer review of articles and grant proposals
- Attendance and presentations at professional meetings (and other similar gatherings)
- Serving on advisory committees or evaluation panels for governmental agencies, non-profit higher education institutions or non-profit entities organized solely for educational, religious, philanthropic, or research purposes (with the exception of non-profit entities created by for-profit corporations)
- Giving occasional lectures and speeches, participation in colloquia, symposia, site visits, study sections, and similar gatherings sponsored by governmental agencies, non-profit higher education institutions or non-profit entities organized solely for educational, religious, philanthropic, or research purposes (with the exception of non-profit entities created by for-profit corporations)
- Ad hoc refereeing of manuscripts
Management plans are implemented when there appears to be overlap between an individual’s outside relationships and/or interests and their CSU responsibilities. The purpose of a management plan is to enhance transparency and create separation between CSU work and the work an individual may be doing outside of the university in order to avoid even the appearance that decision making was biased or influenced by that outside interest. Management plans strategies can vary depending on the circumstance. If a Financial Conflict of Interest determination is made, the conflict of interest sub- committee (working with Investigators and others as needed) develop a conflict of interest management plan to manage, reduce, or eliminate the Financial Conflict of Interest. Conflict of interest management plans are strategies designed to mitigate the potential for an Investigator’s Significant Financial Interests to impact or bias research objectivity and/or the safety or welfare of human research participants.
Conflict of interest management plans could include:
- Recusal from decisions involving the outside company the person has a relationship with
- Parameters around using Northwestern resources for activities with an outside entity
- Restrictions on using direct reports or trainees in those outside activities without proper agreements and/or reporting line changes in place
- Disclosure to collaborators and team members,
- Disclosure in publications, presentations, and press releases
- Disclosure in informed consent documents (as applicable)
Additional conflict of interest management strategies may be employed depending on the nature of the Financial Conflict of Interest and the nature of the research activity. In extreme cases, an Investigator may be prohibited from participating in research due to the level and extent of Significant Financial Interests deemed to present a Financial Conflict of Interest relative to specific research activity.
Some external sponsors, such as PHS, require CSU to provide initial and ongoing reports relative to Investigator’s Financial Conflict of Interest determinations as they relate to specific research activities. For Financial Conflicts of Interests relative to PHS-funded research, CSU must perform the required conflict of interest reporting prior to the expenditure of funds for new projects, within 60 days of newly-determined Financial Conflicts of Interest identified during the life of a project, and on an annual basis thereafter prior to progress report submission during the life of a project. In addition, PHS requires CSU to make available to the public, upon request, specific information regarding Financial Conflicts of Interest determined for senior and key personnel relative to PHS-funded research. CSU is required to provide specific information relative to such public requests within five business days of the request.