Financial Conflict of Interest in Research
This policy presents and discusses circumstances which can create real or perceived financial conflicts of interest in research and establishes requirements for annual certifications and financial disclosures.
B. Revision history
Originally issued: March 2000
Revised : August 2012
C. Persons affected
All Northwestern Health Sciences University faculty, staff and students responsible for the design, conduct or reporting of federally funded research, and their immediate family. Collaborators, subrecipients, and subcontractors from other academic or not-for-profit institutions must either comply with this policy or provide a certification from their institutions that they are in compliance with Federal policies regarding investigator significant financial interest disclosure.
D. Related research policy documents
Financial Conflict of Interest (FCOI) Disclosure (Word form)
A conflict of interest occurs when there is a divergence between an individual’s private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations of personal gain, financial or otherwise. This policy is not intended to eliminate external activities or to preclude financial interests of researchers, rather its intent is to limit and control conflicts of interest that might compromise the objectivity of scientific research. The policy places responsibility, and therefore, an obligation, on the part of the researcher to discern and to make known the existence of significant financial interests that would reasonably appear to be affected by the activities proposed for funding by the PHS or NSF.
This policy does not supplant nor obviate any provisions of the University’s policy on Conflict of Interest as presented in the Faculty Manual, but instead addresses specific additional requirements for participants in PHS and/or NSF projects. As always, faculty members are expected to conduct their affairs in a manner consistent with the teaching, research, and service missions of the University.
This policy shall apply to any individual at Northwestern Health Sciences University who is responsible for the design, conduct, or reporting of research proposed for funding by the PHS or NSF. Such individuals must report the existence of any significant financial interest that would reasonably appear to be affected by that research activity. Collaborators, subrecipients, and subcontractors from other academic or not-for-profit institutions must either comply with this policy or provide a certification from their institutions that they are in compliance with Federal policies regarding investigator significant financial interest disclosure and that their portion of the project is in compliance with their institutional policies. The PHS requires certification from any subcontractor, including commercial firms, stating that it is in compliance with Federal Policies regarding investigator significant financial interest disclosure.
2. Applicable definitions
The U. S. Public Health Service (PHS) regulations in 42 CFR Part 50 subpart F, and 45 CFR Part 94, under the heading of Promoting Objectivity in Research became effective October 1, 1995, and carry the weight of federal regulation. The federal policies stipulate requirements for:
- annual financial disclosures on the part of ALL research investigators covered by this policy;
- institutional certification that all proposed and ongoing PHS and /or NSF sponsored research is either free of conflicts of interest, or that such conflicts are adequately managed;
- implementation of an institutional mechanism for managing conflicts of interest in research;
- sponsoring agency notification if Northwestern Health Sciences University is unable to satisfactorily manage actual or potential conflicts of interest;
- sanctions where appropriate; and,
- Maintenance of records relating to this policy, for at least three years following the termination of a given project.
Business: any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes.
Financial conflict of interest: a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
Immediate family: an Investigator’s spouse, minor children, and any other persons living in the same household.
Investigator: the Principal Investigator and any other person at Northwestern Health Sciences University, who is responsible for the design, conduct or reporting of research, and the investigator’s immediate family. This shall include faculty, students, and research staff. This may also include consultants or collaborators.
Participate: to be part of the described activity in any capacity, including but not limited to serving as the Principal Investigator, Co-Investigator, research collaborator, or provider of direct patient care. The term is not intended to apply to individuals who provide primarily technical support or who are purely advisory, with no direct access to the data (e.g., control over its collection or analysis) or, in the case of clinical research, to the trial participants, unless they are in a position to influence the study’s results or have privileged information as to the outcome.
Significant financial interest:
(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
(i) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel ( i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that 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), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The Institution’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
Research: a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research, and product development.
Technology: any compound, drug, device, diagnostic, medical, dental or surgical procedure intended for use in health care or healthcare delivery.
4. Key elements of the policy
This policy is designed to identify actual or potential sources of financial conflicts of interest in research; and to either eliminate, reduce or manage such conflicts. As such, the following subsections outline the procedures that will be followed to assure compliance with this policy and all applicable federal regulations related to conflicts of interest.
4.1 Notification of investigators
Upon adoption and revisions of this policy, a URL link will be sent to all investigators (as defined in Section 3 above). This will be the responsibility of Research Services. Subsequent to the initial notification of this policy, a URL link to this policy shall be provided to all new and visiting investigators.
4.2 Financial disclosure procedures
Research Services shall annually distribute and collect the Northwestern Health Sciences University Financial Conflict of Interest (FCOI) Disclosure form. The form will be sent to all investigators engaged in federally-funded research. For investigators who may join research efforts between annual distributions of the FCOI Disclosure form, Research Services will ensure that the form is completed and reviewed prior to the initiation of research by those investigators. Investigators and department heads are responsible for ensuring that an updated FCOI Disclosure form is completed and filed at any time during a year when an investigator’s significant financial interests change.
The Chief Financial Officer is the designated official whose responsibility will be to review FCOI Disclosure forms to determine if a conflict of interest exists with respect to the conduct of research of any investigator. If a conflict of interest is noted, an ad-hoc Financial Conflict of Interest Management Committee will be formed to determine a management plan.
4.3 Review of disclosure forms and certification of financial conflict of interest status
Upon review of the FCOI Disclosure form, the Director of Research Services is responsible for notifying the department head of the conflict of interest status of all investigators within that department. Certification that investigators have complied with the requirement to complete the FCOI Disclosure form, and that NO financial conflict of interest exists, will be accomplished as the Authorized Official signs off on the proposal face page, each time an investigator submits a proposal for federal funding.
In the event a conflict of interest has been identified, the Chief Financial Officer shall notify the department head that such a conflict has been identified, and the steps have been initiated to eliminate or manage the conflict of interest, as outlined in Section 4.5 below. During the period of resolution, no proposals for extramural support (that are the subject of the conflict of interest) for the investigator(s) shall be approved. Once a resolution of the conflict has been achieved, the Chief Financial Officer will notify the department head of the terms of the resolution, and authority to process all proposals will be reinstated.
In the event that the conflict is not resolved within 45 days of discovery, the Chief Financial Officer shall notify the department head of this, and the facts surrounding that case. In the event that notification of research sponsors is required, the Chief Financial Officer will be responsible for effecting this notification.
4.4 Resolution and/or management of financial conflicts of interest
If a financial conflict of interest has been identified as a result of the procedures outlined in Section 4.3 above, department heads are responsible for taking the appropriate following action(s):
- Notify the investigator(s) that as a result of the financial disclosure process, a conflict of interest has been discovered in relation to research in which the investigator(s) are involved
- Refer the matter to the Financial Conflict of Interest Management Committee
4.5 Financial Conflict of Interest Management Committee
The Chief Financial Officer shall appoint a Financial Conflict of Interest Management Committee composed of three to five faculty members, one of whom will be appointed as chair.
The committee will be responsible for reviewing cases referred to it and determine whether the financial interest identified in the disclosure process could affect the design, conduct, or reporting of the research of the affected investigator(s), and determine what conditions or restrictions, if any, should be imposed to manage such conflicts; or it may decide that the probability that the financial interest would affect the design, conduct or reporting of the research is too remote to warrant any specific conditions or restrictions. The committee will be authorized to request any other information that it deems necessary to assist it in this determination. Examples of conditions or restrictions that might be imposed to manage actual or potential conflicts of interest include:
- public disclosure of significant financial interests;
- monitoring of the research by independent reviewers;
- modification of the research plan;
- disqualification from participation in all or a portion of the research subject to the conflict of interest;
- divestiture of the financial interests; or,
- severance of relationships that create actual or potential conflicts.
This committee’s operating guidelines will be developed subsequent to the adoption of this policy. Every effort will be made to maintain the privacy of information gathered in the committee’s deliberations, within the limits imposed by applicable laws and regulations.
4.6 Maintenance of records
All records related to the implementation of this policy, e.g., FCOI Disclosure forms, minutes of meetings called to resolve or manage conflicts, minutes of the meetings of the Financial Conflict of Interest Management Committee, notifications to funding agencies, etc., shall be maintained in the Office of Research Services. These records shall be maintained, with an appropriate degree of security, for a period of at least three years following the termination of the given project. Financial conflict of interest records shall be subject to periodic review for compliance with this policy by the Administration, or by any sponsoring agency, per the regulations cited in Section 2 above.
4.7 Notification of research sponsors
The Chief Financial Officer shall be responsible for timely notification of research sponsors, as may be required by the sponsors’ policies or agreements between Northwestern Health Sciences University and the sponsors, of any actual or potential conflicts of interest; including any measures taken to reduce, manage, or eliminate such conflicts.
In situations where the investigator(s) dispute the decision of the Financial Conflict of Interest Management Committee, the matter will be referred to the Faculty Review Board, whose decision regarding the management of conflicts of interest shall be final.
6. Prohibited activities
Consistent with the regulations outlined in Section 2, it is the policy of Northwestern Health Sciences University that financial conflicts of interest in research may be allowable, provided that an acceptable plan of management, as outlined in Section 4 above, can be developed and implemented in situations where such conflicts arise, as long as such management plans are not in conflict with applicable federal regulations.
Section 7. Sanctions
Sanctions and penalties for those who knowingly and willfully disregard this policy, or refuse to comply with its terms, will be determined by the Chief Financial Officer with advice from the investigator(s) department head. Sanctions include, but are not restricted to:
- Letter of reprimand
- Notification to professional and/or scientific societies, funding agencies and/or professional journals
- Reassignment of duties
- Termination of grant support
- Adjustment of research space allocation
- Adjustment of salary
8. Examples of activities which are not a financial conflict of interest
The term significant financial interest does not include the following types of financial interests:
- Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights
- Any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization
- Income from 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, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education
- Income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.