College of Charleston
Academic Affairs
Faculty and Administration Manual
Financial Interest (Conflict of Interest) Disclosure Policy for Sponsored Projects and Research
0.0 CONTENTS
1.0 Purpose
2.0 Background
3.0 Definitions
4.0 Guidelines
1.0
PURPOSE
These guidelines1 define general College of Charleston policy and procedures regarding conflicts of interest in relationship to sponsored projects involving research, education, and university service. Their purpose is to protect the credibility and integrity of the College's faculty and staff so that public trust and confidence in the College's sponsored activities is ensured.
In accordance with Federal regulations, the College of Charleston has a responsibility to manage, reduce, or eliminate any actual or potential conflicts of interest that may be presented by a financial interest of a faculty or staff member who is involved in the design, conduct, and/or reporting of a sponsored project or research involving human subjects. Thus, the College requires that these faculty and staff members disclose any significant financial interests that would reasonably appear to be affected by sponsored program activity or human subjects research.
2.0
BACKGROUND
Effective interaction between universities conducting research and industry is essential to ensure the rapid application of scientific discoveries to the needs of the Nation and to maintain the international competitiveness of domestic industry. Nonetheless, prudent stewardship of public funds includes protecting sponsored or human subjects research from being compromised by the conflicting financial interests of any investigator responsible for the design, conduct, or reporting of research.
Numerous statutes and programs demonstrate Federal interest in the promotion of interactions among government, academia, and industry. For example, the Stevenson-Wydler Technology Innovation Act of 1980 (Public Law [P.L.] 96-480) encourages technology transfer, particularly through industrial-academic collaborations. The Patent and Trademark Act Amendments of 1980
(P.L. 96-517) allows universities and other funding recipients to apply for patents developed with Federal funding, and expressly promotes collaboration between commercial concerns and nonprofit organizations.
The Economic Recovery Tax Act of 1981 (P.L. 97-34) is aimed at fostering research and development by small companies and associated university partners. The Federal Technology Transfer Act of 1986 (P.L. 99-502), which amended P.L. 96-480, and Executive Order 12592 provide similar patent and licensing authority to Federal laboratories, and encourage them to participate in cooperative research and development agreements with the private sector and nonprofit organizations, including universities.
These legal authorities facilitate the movement of intellectual capital between the Federal government, academic institutions, and the private sector. This kind of cross-fertilization is critical to the development of U.S. industry. However, these and other inducements for collaboration have created a climate in which the stewardship of public funding for research is increasingly complex and challenging.
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, to give the College the ability to identify and manage financial interests that may bias the research, and to minimize reporting and other burdens on the investigators.
3.0
DEFINITIONS
3.1
A potential conflict of interestoccurs when there is a divergence between an individual's private interests and his or her professional obligations to the College 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 interest depends on the situation and not on the character or actions of the individual. For purposes of this policy, a conflict of interest
exists when the College, through procedures described herein, reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of sponsored projects or research involving human subjects.
3.2
Investigator means the principal investigator/project director, co-principal investigator(s), and/or any other person who is responsible for the design, conduct, or reporting of research, educational, or service activities funded, or proposed for funding, by an external sponsor or research involving human subjects. In the context of this policy, the term "investigator" includes the investigator's spouse and dependent children and the spouse and dependent children of others involved in the design, conduct, and/or reporting of sponsored projects.
3.3
Significant financial interest means anything of monetary value,
including, but not limited to:
3.3.1
Salary or other payments for services (e.g., consulting fees or honoraria);
3.3.2
Equity interests (e.g., stocks, stock options, or other ownership interests);
and
3.3.3
Intellectual property rights (e.g., patents, copyrights, and royalties
from such rights).
3.4
The term significant financial interest does not include:
3.4.1
Salary, royalties, or other remuneration from the College;
3.4.2
Income from seminars, lectures, or teaching engagements sponsored by public
or nonprofit entities;
3.4.3
Income from service on advisory committees or review panels for public
or nonprofit entities; or
3.4.4
An equity interest that, when aggregated for the investigator and the investigator's
spouse and dependent children, meets both of the following tests:
3.4.4.1
Does not exceed $10,000 in value as determined through reference to public
prices or other reasonable measures of fair market value, and
3.4.4.2
Does not represent more than a five percent ownership interest in any single
entity; or
3.4.5
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 $10,000.
4.0
GUIDELINES
4.1
Each investigator is required to disclose the following significant financial
interests:
4.1.1
Any significant financial interest of the investigator that would reasonably appear to be affected by the research, educational, or service activities funded, or proposed for funding, by an external sponsor; or
4.1.2
Any significant financial interest of the investigator in an entity whose financial interest would reasonably appear to be affected by the research, educational, or service activities funded, or proposed for funding, by an external sponsor.
4.2
Regardless of the above minimum requirements, a faculty or staff member, in his or her own best interest, may choose to disclose any other financial or related interest that could present an actual conflict of interest or be perceived to present a conflict of interest. Disclosure is a key factor in protecting one's reputation and career from potentially embarrassing or harmful allegations of misconduct.
4.3
Each investigator who has significant financial interests requiring disclosure shall complete a Significant Financial Interests Disclosure Form and attach all required supporting documentation. For sponsored research the completed disclosure form must be submitted with the proposal and Pre-Award Routing Sheet to the Office of Research and Grants Administration according to routine College proposal processing procedures. For research involving human subjects, the disclosure must be submitted to the IRB along with the Human Research Review Application. 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 routing sheet.
4.4
As required by Federal regulation, all significant financial interests must be disclosed prior to the submission of a project proposal or Human Research Review Application. Investigators must update financial disclosures during the period of the award as new reportable significant financial interests are obtained.
4.5
The Provost, or his or her official designee, shall conduct an initial review of all Financial Interest Disclosure Forms. If the initial determination is made that there may be a potential for conflict of interest covered by this policy, then the disclosure packet will be referred to the College Conflict of Interest Review Committee (CIRC). CIRC members are appointed by the Provost. The CIRC shall include, at a minimum, three faculty members representing a cross section of academic disciplines and a research administrator. A conflict of interest exists when the CIRC reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of the proposed sponsored project. The CIRC shall then determine what conditions or restrictions, if any, the institution should impose to manage actual or potential conflicts of interest that arise from disclosed significant financial interests.
4.6
Prior to consideration by the CIRC, the investigator, in cooperation with his or her academic department/unit director and dean/cognizant vice president, shall develop and present to the CIRC a Conflict of Interest Resolution Plan that details proposed steps that will be taken to manage, reduce, or eliminate any actual or potential conflict of interest presented by a significant financial interest. (To assist faculty and staff in this process, the College has developed "Guidelines for the Development of a Conflict of Interest Resolution Plan and the Preparation of a Memorandum of Understanding.") At a minimum the resolution plan shall address such issues as:
4.6.1
Public disclosure of significant financial interests;
4.6.2
Review of the research protocol by independent reviewers; and
4.6.3
Monitoring of the research by independent reviewers.
4.7
Where it deems appropriate, the CIRC shall review the resolution plan, modify it or add conditions or restrictions as necessary, and approve or disapprove it. Modifications, conditions, and restrictions that the CIRC may consider include, but are not limited to, the following:
4.7.1
Modification of the research/project plan;
4.7.2
Disqualification of the investigator from participation in all or a portion
of the project;
4.7.3
Divestiture of the investigator's significant financial interests; and
4.7.4
Severance of relationships that create actual or potential conflicts of
interest.
4.8
If the CIRC determines that imposing the above referenced conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the CIRC may recommend that, to the extent permitted by Federal regulations (U.S. Public Health Service [PHS] policy, for instance, does not permit such an action), the research go forward without imposing such conditions or restrictions. In these cases, the Provost shall make the final decision regarding resolution.
4.9
The approved resolution plan shall be incorporated into a Memorandum of Understanding between the College of Charleston and the investigator that details the conditions or restrictions imposed upon him or her in the conduct of the project or research in the relationship with the sponsor. The Memorandum of Understanding shall be signed by the investigator, the department chair/unit director, the dean/cognizant vice president, and, on behalf of the College, the Provost. Actual or potential conflicts of interests will be satisfactorily managed, reduced, or eliminated in accordance with these Guidelines and all required reports regarding the conflict of interest submitted to the sponsor prior to expenditure of any funds under an award. (For example, PHS requires the College to report to the PHS Awarding Component the existence of a conflicting interest [but not the nature of the interest or other details] found by the College and to assure that the interest has been managed, reduced, or eliminated. The National Science Foundation [NSF] only requires the College to report conflicts that cannot be satisfactorily managed, reduced, or eliminated.)
4.10
Records of investigator financial disclosures and of actions taken to manage actual or potential conflicts of interest shall be retained by the Office of Research and Grants Administration 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.
4.11
When an investigator violates this policy or the terms of the Memorandum of Understanding, the CIRC shall recommend sanctions that may include disciplinary action ranging from a public letter of reprimand to dismissal and termination of employment. If the violation results in a collateral proceeding under College policies regarding misconduct in research and scholarship, then the CIRC shall defer a decision on sanctions until the misconduct in research and scholarship process is completed. The CIRCs recommendations on sanctions shall be presented to the investigator's dean/cognizant vice president who, in consultation with the Provost, shall enforce any disciplinary action. In addition, the College shall follow Federal regulations regarding the notification of the sponsoring agency in the event an investigator fails to comply with this policy. The sponsor may take its own action as it deems appropriate, including the suspension of funding for the investigator until the matter is resolved.
4.12
Collaborators/subrecipients/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. Subcontractors from commercial firms need not make a certification, except when the prime award is from the U.S. Public Health Service. The PHS requires a certification from any subcontractor, including commercial firms, stating that it is in compliance with Federal policies regarding investigator significant financial interest disclosure and that its portion of the project is in compliance with company policies.
1These guidelines comply with final regulations promulgated by the U.S. Public Health Service (PHS) published in the July 11, 1995, issue of the Federal Register, and by the National Science Foundation (NSF) published in the June 28, 1994, Federal Register as modified in the July 11, 1995, Federal Register.
Revised: July 15, 1998
Revised: June 6, 2005
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