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Conflict of Interest Policy - Research and Sponsored Projects
[ Objective/Purpose
| General Discussion | Policy
| Definitions | Procedures
]
This Conflict of Interest Policy for Research and Sponsored Projects at Clarion University of Pennsylvania was developed pursuant to and in accordance with applicable federal requirements of (1) the National Science Foundation, "Investigator Financial Disclosure Policy," published at 60 Federal Register 35820-35823, July 11, 1995, and (2) the Public Health Service of the Department of Health and Human Services, published at 60 Federal Register 35810-25819, July 11, 1995.
The purposes of these guidelines are to: (1) ensure the credibility and integrity of Clarion University's faculty and staff so that public trust and confidence in the University's research and sponsored activities is also ensured; and (2) preserve the faculty's freedom to participate in these activities while ensuring that faculty and staff exercise substantial responsibility to avoid conflicts of interest. In accordance with Federal regulations, Clarion University has a responsibility to manage, reduce, or eliminate any actual or potential conflicts of interest that may be presented by a financial interest of an investigator. The opportunity for investigators to receive financial or other personal rewards for their endeavors is not intrinsically unacceptable, as long as it does not adversely influence the objectivity, integrity, or professional commitment of an investigator. [42 C.F.R. Section 50.601] Thus, the university requires that investigators disclose any significant financial interest that may present an actual or potential conflict of interest with a sponsored project. [42 C.F.R. Section 50.602]
Interaction between university faculty and external organizations has grown in magnitude and complexity in recent years. In order to fulfill its teaching/research/community service orientated mission, Clarion University encourages its faculty to participate in appropriate relationships with governmental, industrial, and private partners, to obtain public and private support of research and innovative educational programs, through grants and contracts. Similarly, the University recognizes the value of faculty members serving as consultants for the academic and non-academic community. Such partnerships - grants, contracts, consultations - are established for mutually beneficial reasons and typically produce knowledge and/or technology that will help to meet societal and educational needs.
Potential conflicts of interest or the appearance of conflicts of interest may be complex and may involve many different considerations. These conflicts include ethical and financial considerations; priorities in distribution to time and effort; guidance of students' research; guidance of contractual research; consulting; contractual obligations to research sponsors, both governmental and private; and access to privileged information. Federal and state regulations also address the role of the spouse and of dependent children as potential sources of conflicts of interest. Even when behavior itself is exemplary, the appearance of conflict of interest should be avoided.
A conflict of interest is a conflict of interest even if no wrongdoing actually occurs, and even those examples where no wrongdoing is intended should be avoided to preclude the perception of wrongdoing and to protect the reputation of the individual and the university. Generally, the State Adverse Interest Law, 71 P.S. Section 775.1 et seq., prohibits university employees (including faculty) from entering into contracts with the university, other than their contracts of employment, with some very narrow exceptions. It also prohibits them from being a stockholder, partner, member, agent, representative or employee of a corporate entity which enters into contracts with the university. The State Ethics Act, 65 P.S. Section 401 et seq., generally exempts teaching faculty from its application. However, faculty who administer or monitor grants or subsidies are subject to the provisions of this Act. The Ethics Act prohibits a subject employee from using his employment or an confidential information received through his employment for the private pecuniary benefit of himself, a member of his immediate family or a business with which he or a member of his immediate family is associated. The Ethics Act also prohibits subject employees from accepting an honorarium, which is defined as "payment made in recognition of published works, appearances, speeches and presentations and which is not intended as consideration for the value of such services which are non public occupational or professional in nature."
In accordance with Federal regulations, the university has a responsibility to manage, reduce, or eliminate any actual or potential conflicts of interest that may be presented by a financial interest of an investigator. Thus, Clarion requires that investigators disclose any significant financial interest that may present an actual or potential conflict of interest with a sponsored project.
Conflicts of commitment usually involve issues of time allocation. The many diverse demands on an employee's time necessitate setting priorities. The specific responsibilities and professional activities that constitute an appropriate and primary commitment will differ across colleges and departments, but they should be based on a general understanding between faculty members and their respective department chairs and/or deans.
Clarion University encourages and supports university faculty and staff in undertaking research, community service and other scholarly activities in the interest of the public. The University further supports the development of collaborative relationships with business entities for the benefit of the public and of the economic development of the State and the Nation.
In this collaborative environment, the University must ensure that both the occurrence and/or the appearance of conflict of interest is addressed. The integrity or objectivity of university personnel performing research and scholarly activity should not be influenced or affected as a result of any personal financial interest held by investigators, or their immediate family, in the business entities which are external sponsors, in full or in part, for the investigator's sponsored research, scholarly activity, or community service. Disclosure of financial interest is a key factor in protecting the University as well as the investigator's reputation and career from potentially embarrassing or harmful allegations of conflicts of interest.
The university requires that all investigators submitting applications for external funding of sponsored research or scholarly activity disclose to the University any personal financial interests which the investigator or the investigator's immediate family hold, if these holdings could reasonably give the appearance of or actually involve a conflict of interest between the investigator and the external sponsor of the research. In the event that a significant financial interest is held by the spouse or dependent children of the investigator, the investigator is responsible for ensuring that disclosure of this interest is made to the university.
Disputes on matters regarding conflict of interest, including the interpretation of this policy, will be referred to the University President, or the Presidents' designee, for resolution.
All financial disclosure information will be kept confidential, except to the extent required by law, and except to the extent necessary to review, consider, and resolve any conflicts.
This conflict of interest policy applies to all investigators, and their immediate family, who are in a position to affect the design, conduct, or reporting of externally funded research or scholarly activity.
For purposes of this policy the following definitions will be in effect and observed.
Business Entity -
any person or entity or organization, or any combination of one of more
of them. A business entity includes, but is not limited to, a sole
proprietorship, partnership, association, joint venture, corporation, firm,
trust, foundation or other organization or entity used in carrying on a
business, including parent organizations of such entities or any other
arrangement in which an entity operates through a subsidiary.
Conflicts of Interest - (A) Potential 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. (B) 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 University, through procedures described herein, reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of research or sponsored projects [42 C.F.R. Section 50.605(a)]. (C) Conflict of commitment usually involves issues of time allocation. Clarion University acknowledges that while identifying commitments and in setting priorities the employee's first responsibility is to the university and its educational mission.
Immediate Family - spouse, dependent children, and independent children of the investigator.
Intellectual Property - any patentable invention, any copyrightable subject matter or trade secret. It also includes publications, compositions, discoveries, works of art and creations that might normally be developed on a proprietary basis.
Investigator - the principal investigator/project director, co-principal investigators, and 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.
Resolution Plan - a Memorandum of Understanding (MOU), agreed to by the University and the investigator, outlining the steps that must be taken by the investigator and/or the university to manage a potential conflict of interest situation.
Significant Financial Interest - 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).
The phrase does not include:
- salary, royalties,
or other remuneration from the University;
- income from seminars,
lectures, or teaching engagements sponsored by public or nonprofit entities;
- income from service
on advisory committees or review panels for public or nonprofit entities.
- an equity interest
that, when aggregated from the investigator and the investigator's spouse
and dependent children, meets both the following tests: does not
exceed $10,000 in value as determined through reference to public prices
or other reasonable measures of fair market value; and represents less
than or equal to a five percent ownership interest in any single entity;
- salary, royalties,
or other payments that, when aggregated for the investigator and the investigator's
spouse and dependent children over the children over the academic year,
are not expected to exceed $10,000 [42 C.F.R. Section 50.603]
Sponsor - any non-university entity providing partial or full support of research or scholarly activity performed by university members utilizing university resources.
The Clarion University Proposal Transmittal Form for Grants and Contracts for all public and private sponsors will have a check box for the investigator to use in order to indicate whether a potential or actual conflict of interest exists involving the grant proposal that is being submitted. The definitions above should guide the investigator in this determination. A faculty or staff member, in his or her own best interests, may choose to disclose any 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. If the investigator identifies a potential or actual conflict of interest, the following procedure must be followed.
I. Each investigator is required to disclose the following significant financial interests:
2. Any significant
financial interest of the investigator in a business entity whose financial
interest would reasonably appear to be affected by the research or educational
activities funded, or proposed for funding, by and external sponsor.
III. As required by federal regulation, all Significant Financial Interests must be disclosed during the time a proposal is being submitted for university review. All financial disclosures must be updated by investigators during the period of the award as new reportable significant financial interests are obtained.
IV. The Director of Faculty Research Development (Grants Officer) will conduct an initial review of any financial disclosure. 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 University Conflict of Interest Review Board (CIRB).
V. The CIRB will be composed of six faculty members representing a cross section of academic disciplines and an administrator. The faculty members will be recommended by the Senate and the Union. All appointments to the Board will be made by the President. Faculty members on the Board will serve 2 year rotating terms. Initial faculty appointments to the board would be 3 members with one year terms and 3 members with full 2 year terms.
VI. The CIRB will
determine whether a significant financial interest exists that could directly
and significantly affect the design, conduct, or reporting of the proposed
project, thus creating a conflict of interest.
If a review indicates
a potential conflict of interest, the Review Board will then determine
what conditions or restrictions, if any, should be imposed by Clarion on
the investigator to manage actual or potential conflicts of interest arising
from disclosed significant financial interests; or the investigator will
be notified and asked to develop and present to the CIRB 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 significant financial interests. [42 C.F.R. Section 50.604]
At a minimum the resolution plan will address such issues as:
If the CIRB 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 CIRB may recommend that the research or sponsored project go forward without imposing such conditions or restrictions, to the extent permitted by federal regulations (PHS policy, for instance, does not permit such an action). In these cases, the President or designee will make the final decision regarding resolution.
VII. The approved resolution plan will be incorporated into a Memorandum of Understanding (MOU) between Clarion University and the faculty member 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 MOU will be signed by the investigator and the Provost. Actual or potential conflicts in interest 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.
VIII. Records of investigator financial disclosures and of actions taken to manage actual or potential conflicts of interest will be retained by the Office of Faculty Research Development until three years after the termination or completion of the award to which they relate, or the resolution of any governmental action involving those records, whichever is later.
IX. If the University Grants Officer see indications that this policy or the terms of the Memorandum of Understanding may have been violated, the Grants Officer will seek review of the matter with the CIRB. If the CIRB determines there has been a violation, the Grants Officer will notify the President or designee so that appropriate action may be taken. All actions taken will be in accordance with appropriate collective bargaining provisions. Additionally, the University will follow federal regulations regarding the notification of the sponsoring agency in the event an investigator has failed 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.
X. Collaborators/subrecipients/subcontracts 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.
XI. The disclosure of significant financial interests that are held by an author of a publication (journal article, presentation, poster session, etc.) is required to alert all readers of the potential for bias in the research or sponsored project results, even if such bias is unconscious and unintended. Disclosure in all presentations or publications is required whenever disseminating the results of scholarly activities.
XII. Where research or a project at the university that is sponsored by a company which has a financial affiliation with an Investigator/Employee, a clear potential exists for the Investigator/Employee to bias the research or project to promote the business plan or product of the company. Even in the event no such bias exists, the very relationship subjects the employee, the company, and the university to potential criticism from third parties regarding the potential bias. This is particularly true with pharmaceutical or medical related technology, but also applies to other groups.
XIII. To avoid the appearance of Conflict of Interest, if employees intend to use university equipment, facilities or staff (including clerical or other support staff) for their company, for projects not sponsored by the university, they must obtain the prior written approval of the Provost in the form of a letter of agreement. Often, this will require the creation of equipment usage charges which are similar to those the university charges to other non-university companies or entrepreneurs. Similarly, the employee or company must not receive preferential or unusual access to the facilities or equipment involved. Finally, it is important to list the physical location of the equipment for purposes of determining whether the facility in which the equipment is located, or the equipment itself, was financed by the university with tax exempt bonds. In that event, use by a for-profit company will probably be prohibited.
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