Section: Research Policy Number: 6-11 Policy Name: Conflict of Interest Policy and Procedures for Faculty and Professional Staff Date: November 15, 1989 Revisions: March 1, 1996; February 18, 2002; January
18, 2008; August 11, 2008; August 23, 2012
The purpose of this policy is to promote objectivity in research and education activities by requiring that significant financial interests of faculty and professional staff be disclosed and by providing means for managing conflicts of interest if they arise.
CONFLICT OF INTEREST
A potential conflict of interest (COI) occurs when there is a divergence between an individual's private interests and his or her professional obligations, such that an independent observer might reasonably question whether the individual's professional judgment, commitment, actions, or decisions could be influenced by considerations of personal gain, financial or otherwise. Whether a conflict of interest exists depends on the circumstances, and should be determined on a case by case basis.
Involvement of faculty and professional staff with appropriate commercial enterprises is an important part of the transfer of knowledge and it is encouraged by the University to enhance both teaching and research programs. Association of faculty or professional staff with commercial enterprises should be such that it benefits all the parties involved, including the University. All faculty and professional staff members are expected to conduct their professional and personal duties with maximum integrity, and to avoid association with any activities that could diminish or could be perceived as diminishing the effectiveness of their commitment to the University. It is the responsibility and obligation of faculty and professional staff to disclose all significant financial interests that may affect, or appear as if they could affect, their professional responsibilities.
The following definitions apply to this policy:
Financial Conflict of Interest (FCOI) refers to a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research.
Significant Financial Interest (SFI) refers to a financial interest, as described in section V of this policy that reasonably appears to be related to the employee’s institutional responsibilities.
SFI does not include income, payment, or sponsorship received from: a federal, state, or local government agency, an institution of higher education as defined in 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
Investigator refers to the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research (may include collaborators and consultants).
Remuneration includes salary and any payment not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship, etc.).
Equity interest includes any stock, stock option, or other ownership interests as determined through reference to public determination or other reasonable measures of fair market.
SFIs (including those of the employee’s spouse and dependent children) must be disclosed on an annual basis. On or before February 15, and within 30 days of any changes in their previously disclosed interests, faculty and professional staff are obligated to submit complete written disclosure to the chair, dean, unit head, or supervisor for all of the following:
With regard to any publicly traded entity: any remuneration during the previous 12 months received from the entity, and the value of any equity interest in the entity that when aggregated exceeds $5,000; and/or any equity interest that represents more than 5% ownership in a single entity.
With regard to any non-publicly traded entity: any remuneration during the previous 12 months received from the entity that when aggregated exceeds $5,000; and/or any equity interest.
Intellectual property rights and interests (e.g., patents, author’s rights, etc.), other than those assigned to UD and shared through proper agreements (Policy 6-6), upon receipt of related income that when aggregated exceeds $5,000.
Any reimbursed or sponsored travel during the previous 12 months by an entity different from those listed in the definition of SFI (section IV of this policy).
Any arrangements that involve a consulting agreement or other outside professional activities.
Participation in, or personal sponsorship from, any entity that invests in, or provides financial support for, activities related to the employee's University areas of responsibility.
An appointment as an officer, director, or any other managerial position in a commercial enterprise; participation in the day-to-day operations, including serving on the scientific advisory board, of a commercial enterprise.
Any situation that has the potential for, or could be perceived as, a conflict of interest (i.e., might interfere with the employee’s institutional responsibilities).
Information to be disclosed about any and all SFI(s) previously identified shall include details of:
the nature of the relationship;
the name and address of the enterprise, the type of business, and its relationship with the University;
the expected benefits to the enterprise, the University, and the faculty or professional staff member in terms of professional growth, technology transfer, and commercial feedback;
basis for avoiding conflict of interest between the SFI and professional obligations to the University;
With respect to a disclosed travel event: (a) the purpose of the trip, (b) the identity of the sponsor or organizer, (c) the destination, (d) the duration of the trip, and (e) if known, the monetary value of the reimbursement or sponsorship.
Disclosures of SFIs must be directed to the appropriate chair, dean, unit head, or supervisor for review, COI determination, approval, and direct management, and forwarded to the Research Office for compliance monitoring.
CONFLICT OF INTEREST MANAGEMENT
The chair, dean, unit head, or supervisor shall review the SFI disclosure to determine if any of the SFIs disclosed could generate a COI. A COI exists when an SFI is related to a specific research project and/or any other institutional responsibility of the employee, and could have a significant and direct effect on it.
If, after reviewing the facts, an SFI is deemed to be a COI, the chair, dean, unit head, or supervisor shall develop and implement a management plan jointly with the faculty or staff member. Examples of conditions or restrictions that might be imposed to manage a COI include, but are not limited to:
Public disclosure of the conflict (e.g., when presenting or publishing affected research);
Appointment of an independent monitor capable of taking measures to protect against bias resulting from COI;
Change of personnel or personnel responsibilities, and/or modification of the research plan;
Reduction or elimination of a financial interest;
Severance of relationships that create the conflict(s).
If the situation remains unresolved following this review, the chair, dean, unit head, or supervisor may submit the matter to a Conflicts Advisory Committee appointed by the dean (or equivalent). This committee will consider the situation and recommend steps necessary to resolve the matter. The dean (or equivalent) may accept, reject, or modify the committee's recommendations.
If the faculty or staff member objects to the resolution offered by the dean (or equivalent), the matter shall be referred to the Provost (or equivalent) who shall appoint, convene, and seek advice from a university level ad hoc Conflicts Committee. The Committee, which shall include no less than five members representing the colleges and other constituencies as appropriate, shall serve as a resource in the identification and resolution of the specific conflict of interest. The Provost (or equivalent) shall make a final decision regarding the resolution of any conflicts.
Management plans will be monitored for compliance during the life of the COI by the chair, dean, unit head, or supervisor with the assistance of the Research Office. Failure to disclose an SFI which is later determined to be a COI, failure by the University to review and manage such COI, or failure to comply with a management plan, would be considered a noncompliance event.
If a noncompliance event is identified, then, within 120 days of such determination, the appropriate supervisor, with the assistance of the Research Office, will perform a retrospective review of the employee’s activities to determine if any bias occurred during the noncompliance time period. The retrospective review will be documented including all the following as applicable: the project number, project title, project director, name of the investigator with the SFI/COI, name of entity with which the SFI/COI exists, reason for the retrospective review, detailed methodology used for the review process, compositions of the review panel, and findings and conclusion of the review.
If bias is found, the University will promptly inform the appropriate sponsor and submit a mitigation report. The mitigation report will include the key elements from the retrospective review and a description of the impact of the bias, and the University’s plan of action or actions taken to eliminate or mitigate the bias.
Records of financial disclosures and all decisions and actions taken by the University will be maintained by the Research Office for three years from effort closeout.
AGENCY SPECIFIC REQUIREMENTS
As provided by federal regulation (42 C.F.R. Part 50, Subpart F, and 45 C.F.R. Part 94), COI policy compliance for research projects funded by, or requesting funding from, any awarding component of the Public Health Service (PHS) will be monitored as follows:
Prior to the expenditure of any funds under a PHS-funded research project, the disclosures of SFIs from all involved investigators will be evaluated according to this policy for determination of a potential FCOI relevant to that PHS-funded project based on the following criteria:
An SFI is related to PHS-funded research if the SFI could be affected by that research.
An FCOI exists when it is determined that the SFI could directly and significantly affect the design, conduct or reporting of the PHS-funded research.
Whenever the University identifies an SFI not disclosed timely, or not previously reviewed, the dean (or equivalent) shall within 60 days evaluate the SFI and determine if it is an FCOI, in which case a management plan will be implemented.
In an event of noncompliance (i.e., FCOI not identified or managed in a timely manner, and/or failure to comply with a management plan), the University shall, within 120 days, complete a retrospective review to determine whether bias occurred during the noncompliance period.
If bias is found, the University is required to notify the PHS awarding component promptly and submit a mitigation report, including a description of the impact of the bias on the research project and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias.
Elements to include in the retrospective review and the mitigation reports can be found in 42 C.F.R. §50.605.
In any case in which HHS determines that a PHS-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been affected by a FCOI not properly managed or reported the University shall require the Investigator involved to:
Disclose the FCOI in each public presentation of the results of the research, and
Request an addendum to previously published presentations.
As required by the regulations, SFI(s) disclosed to the University and related to PHS-funded research will be made available to the funding agency within five days of a formal request.
Disclosures related to federally funded projects, records will be kept for three years from the date of submission of the financial closeout documentation.
Advice and guidance concerning this policy can be obtained from the Vice Provost for Research.