Conflict of Interests Disclosure for Sponsored Programs
Date of Current Revision: November, 2003
Responsible Officer: Provost and Vice President of Academic Affairs
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PURPOSE
These guidelines define general University policy and procedure regarding conflict of interests in relationship to research or educational sponsored projects. Their purpose is to protect the credibility and integrity of the University's faculty and staff so that public trust and confidence in the University's sponsored research and educational activities is ensured. The value of the results of sponsored research to the health and the economy of the nation must not be compromised by any financial interest that will, or may be reasonably expected to, bias the design, conduct or reporting of the research. This policy seeks to maintain a reasonable balance between these competing interests, give the University the ability to identify and manage financial interests that may bias the research, and minimize reporting and other burdens on the investigators. -
AUTHORITY
In accordance with federal regulations, the University has a responsibility to manage, reduce, or eliminate any actual or potential conflict of interests that may be presented by a financial interest of an investigator. The Board of Visitors is charged with the authority to establish policy for the university, and that authority is delegated to the President where the board has not exercised its authority.
The Virginia State and Local Government Conflict of Interests Act (Code of Virginia, Section 2.1-639.1-.24) defines several prohibited conflict of interests for state employees. James Madison University has promulgated a University Conflict of Interests Policy (1106) that supplements the statutes of the Commonwealth of Virginia. The University Conflict of Interests Policy also requires disclosure of a potential conflict of interests and specifies penalties for willful violation of the policy. This policy is unrelated to, and in no way supersedes, the Virginia State and Local Government Conflict of Interests Act or the University Conflict of Interests Policy. -
DEFINITIONS
Conflict of Interests:
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. An actual conflict of interests depends on the situation and not on the character or actions of the individual.
Conflict of Interests Review Committee (CIRC):
A committee constituted for the purpose of determining what conditions or restrictions, if any, should be imposed by the institution to manage actual or potential conflict of interests arising from disclosed Significant Financial Interests.
Investigator:
The principal investigator/project director, co-principal investigators, and/or any other person at the University who is responsible for the design, conduct, or reporting of research or educational activities funded, or proposed for funding, by an external sponsor. In this context only for determining Significant Financial Interests, the term "Investigator" includes the investigator's spouse and dependent children.
Significant Financial Interests:
Anything of monetary value, including, but not limited to:- Salary or other payments for services (e.g., consulting fees or honoraria)
- Equity interests (e.g., stocks, stock options or other ownership interests)
- Intellectual property rights (e.g., patents, copyrights and royalties from such rights).
- Salary, royalties, or other remuneration from the University;
- Income from seminars, lecturers, or teaching engagements sponsored by public or nonprofit entities;
- Income from service or advisory committees or review panels for public or nonprofit entities; or
- An equity interest that when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests: does not exceed $5,000 (or $5,000 per annum if salary, fees or other continuing payments) or represent more than a 5% ownership interest for any one enterprise or entity; or
- Salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected to exceed $5,000.
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APPLICABILITY
This policy applies to all JMU employees and all research and sponsored projects at JMU.
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POLICY
The university requires that investigators disclose any significant financial interest that may present an actual or potential conflict of interests in relationship with research or a sponsored project requiring such disclosure.
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PROCEDURES
6.1 Required Disclosure. Each Investigator is required to disclose the following Significant Financial Interests:
- Any Significant Financial Interest of the Investigator that would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor; or
- Any significant interest of the Investigator in an entity whose financial interest would reasonably appear to be directly and significantly affected by the research or educational activities funded, or proposed by funding, by an external sponsor.
6.3 SFID Form. The method of disclosing a potential conflict of interests is the Significant Financial Interests Disclosure Form, attached to this policy as Appendix A.
- 6.3.1. If the investigator deems in good faith there is no Significant Financial Interest in the project, a Significant Financial Interests Disclosure Form (SFID) will not be required.
- 6.3.2. If the investigator deems there is possible conflict of interests, each Investigator shall complete an SFID and attach all required supporting documentation. The completed Disclosure Form must be submitted with the proposal and University Proposal Internal Approval Form (PIAF) to the Sponsored Programs Office using normal University procedures. Supporting documentation that identifies the business enterprise or entity involved and the nature and amount of the interest should be submitted in a sealed envelope marked confidential and accompany the Disclosure Form and the PIAF.
- 6.3.3. As required by Federal regulation, all Significant Financial Interests must be disclosed prior to the time a proposal is submitted. All financial disclosures must be updated by Investigators during the pendency of the award, either on an annual basis or as changes are made to previously reported Significant Financial Interests. If a new reportable Significant Financial Interest arises at any time during the period after the submission of the proposal through the entire period of any resulting award, the filing of a Disclosure Form is also required.
6.5 Determination of Conflict. If a potential conflict of interests is determined by the Sponsored Programs Office and an appropriate resolution cannot be achieved, the Investigator, in cooperation with the academic unit, shall develop a Conflict of Interests Resolution Plan that details proposed steps that will be taken to manage, reduce, or eliminate any actual or potential conflict of interests presented by a Significant Financial Interest. At a minimum the Resolution Plan shall address such issues as:
- Public disclosure of significant financial interests;
- Review of research protocol by independent reviewers; and
- Monitoring of research by independent reviewers.
- Modification of the research plan;
- Disqualification from participation in all or a portion of the research funded;
- Divestiture of Significant Financial Interests; or
- Severance of relationships that create actual or potential conflict of interests.
6.7 Appeal of Decision. Should a faculty member wish to appeal a decision made by the CIRC, he or she may present the appeal to the Provost and Vice President for Academic Affairs, who will consider the case in consultation with the CIRC.
6.8 Memorandum of Understanding. The approved Resolution Plan shall be incorporated into a Memorandum of Understanding that details the conditions or restrictions imposed upon the investigator in the conduct of the project or in the relationship with the business enterprise or entity. The Memorandum of Understanding shall be signed by the Investigator and the Investigator's supervising University official (usually a Department Head, Director, or Dean). Actual or potential conflict of interests will be satisfactorily managed, reduced, or eliminated in accordance with these Guidelines prior to accepting any award, or they will be disclosed to the sponsoring agency for action.
6.9 Records. Records of Investigator financial disclosures and of actions taken to manage actual or potential conflict of interests, shall be retained by the Sponsored Programs Office until three years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.
6.10 Violations of Policy. Whenever an Investigator has violated this policy or the terms of the Memorandum of Understanding, the CIRC shall recommend sanctions. If the violation results in a collateral proceeding under University policies regarding misconduct in science, then the CIRC shall defer a decision on sanctions until the misconduct in science process is completed. The CIRC's recommendations on sanctions shall be presented to the Investigator's supervising University official who, in consultation with the Provost and Vice President for Academic Affairs, shall enforce any disciplinary action.
6.11 Non-JMU Faculty and Staff. Collaborators from other institutions must either comply with this policy or provide a certification that their institutions 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.
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RESPONSIBILITIES
Investigators have the responsibility to disclose any potential conflict of interests in any research or sponsored project on which they work.
The Office of Sponsored Programs has the responsibility to conduct an initial review of all financial disclosures to determine whether a conflict of interests exists.
Academic Unit Heads have the responsibility to sign off on the approved Resolution Plan that is incorporated into a Memorandum of Understanding that details the conditions or restrictions imposed upon the investigator in the conduct of the project or in the relationship with the business enterprise or entity.
Deans have the responsibility to review any such Memoranda of Understanding in their colleges.
The Provost and Vice President for Academic Affairs has the responsibility to appoint members of the CIRC, and to hear any appeals from that committee’s findings.
The University Conflict of Interests Review Committee (CIRC) has the responsibility to determine what conditions or restrictions, if any, should be imposed by the institution to manage actual or potential conflict of interests arising from disclosed Significant Financial Interests.
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SANCTIONS
Sanctions for violation of this policy may include disciplinary action ranging from a public letter of reprimand to dismissal and termination of employment.
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Exclusions
None.
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Interpretation
The authority to interpret this policy rests with the president and is generally delegated to the provost and Vice president for academic affairs.
Approved
November, 2003
Dr. Linwood H. Rose, President
Appendix A - Significant Financial Interests Disclosure Form
Index Terms:
Conflict of Interests
Research
Financial Disclosure