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Policy on Conflicts of Interest and Commitment in Research


Updated August 23, 2012

 

I. Introduction

The University of Wyoming is a community of scholars, learners and leaders committed to exploring, creating and sharing knowledge to advance the intellectual and ethical capacities of its students and employees. Consistent with this vision and with the requirements of state and federal agencies, the University of Wyoming Office of Research and Economic Development has adopted the following policy to identify and address conflicts of interest and commitment that are potential, actual, or apparent that arise during the conduct of research activities. Each member of the University of Wyoming community, as well as the university as a legal entity, has a duty to act in the best interest of the university and in furtherance of the university's mission. Outside activities or outside financial interests must not interfere with these obligations. This policy is intended to increase awareness of the potential for conflicts of interest and commitment that arise during the conduct of research and to establish procedures whereby such conflicts may be avoided or properly managed. This policy enhances public trust in the university through transparency in interactions between the university and outside activities and entities.

This policy observes the proper stewardship of federal funds under the Department of Health and Human Services, the Public Health Service, and the National Institutes of Health directives.  Federal codes of regulation (CFR) exist for conflict of financial interest requiring university compliance (45 CFR Part 94; 42 CFR Part 50 Subpart F).

The University of Wyoming Office of Research and Economic Development is committed to ensuring that the policies and procedures included herein are carried out properly and consistently, in accordance with the university's ethical code of conduct. The principles of excellence, integrity, respect and responsibility are fundamental to the responsible management of the university's business and its stature as a national model of leadership for a civil society.

II. Categories of Conflicts in Research

A.    Conflicts of Interest

1.      Definition. A conflict of interest exists when an individual has an external interest that affects or provides an incentive to affect the individual's conduct of her or his university research activities.

2.      Generally. Conflicts of interest can arise naturally from an individual's engagement with the world outside the university, and the existence of a conflict of interest does not necessarily imply wrongdoing on anyone's part. When conflicts of interest do arise, however, they must be recognized, disclosed, and either properly managed or eliminated.

The appearance of a conflict may be as serious and potentially damaging as an actual distortion of research processes or outcomes. Reports of conflicts based on appearances can undermine public trust in ways that may not be adequately restored even when the mitigating facts of a situation are brought to light. Apparent conflicts, therefore, should be disclosed and evaluated, managed, or eliminated with the same vigor as actual conflicts.

3.      Financial Conflicts of Interest in Research. Regarding sponsored research, a potential conflict exists when there is a possibility that an individual's outside financial interests could directly and significantly affect the design, conduct, or reporting of the research. A significant financial interest is defined as the following:

(a) A financial interest consisting of one or more of the following interests of the researcher (and those of the researcher’s spouse and dependent children) that reasonably appears to be related to the researcher’s responsibilities as an employee of the University:

(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. 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 the 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 researcher (or the researcher’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.

(b) Researchers also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the researcher and not reimbursed to the researcher so that the exact monetary value may not be readily available, related to their University 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, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.  The researcher must disclose the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.  The Office of Research and Economic Development will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a financial conflict of interest.

(c) The term significant financial interest does not include the following types of financial interest:

(i) salary, royalties, or other remuneration paid by the University to the researcher if the researcher is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreement to share in royalties related to such rights;

(ii) income from investment vehicles, such as mutual funds and retirement accounts, as long as the researcher does not directly control the investment decision made in these vehicles;

(iii) income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or

(iv) income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

4.      Non-financial Conflicts of Interest in Research. Conflicts may also exist with respect to matters with non-financial implications, such as decisions about the use of university equipment and facilities and the negotiation of research agreements and license agreements. Conflicts may also exist with respect to the particular conduct of research, the care of patients, the protection of human research subjects, and the treatment of students and faculty colleagues.


B.     Conflicts of Commitment


1.      Definition. A conflict of commitment exists when a member of the university community renders professional service that is not part of his/her duties to the university and in so doing interferes with his/her primary obligations to the university.

2.      Generally. A conflict of commitment arises when activities contracted outside the university, such as consultations, or outside business activities, of a University of Wyoming researcher interfere with the paramount obligations to students, colleagues and the primary missions and policies of the university. Conflicts of commitment primarily involve questions of obligation and effort, but are often tied to financial remuneration or other inducements and, in such cases, may also constitute conflicts of interest.

All those associated with the University of Wyoming owe their primary professional allegiance to the university. In particular, academic personnel have a principal commitment of time and intellectual energies to the university's education, research, and service missions. Efforts of university employees to balance university responsibilities with non-university activities can result in conflicts regarding allocation of time and energies. This regulation provides standards for the disclosure, evaluation and management of conflicts of commitment to insure compliance with federal regulations for the conduct of sponsored research.

III.      Training, Conflict Identification, Disclosure, Management Plan, and Monitoring

A.    Preface              

This policy provides procedures for identifying potential and actual conflicts of interest in research through immediate and/or annual disclosure and through consistent review of such disclosures. Full disclosure and the creation of a public record will benefit both the University of Wyoming and its employees while preserving the integrity of the university's relationship with the public.


The university shall adhere to federal regulations mandated by NSF, PHS, and/or other federal entities for conflicts of interest and/or commitment and pursuant to the guidelines established in this policy. Implementation of this policy is the responsibility of the Office of Research and Economic Development, working with the University Office of General Counsel. The Office of Research and Economic Development and Office of General Counsel will be responsible for reviewing and revising this policy as needed.  Once a conflict has been disclosed, it must be evaluated, and if identified as an actual or apparent conflict, a conflict management plan will be implemented.

B.        Training for researchers engaging in research related to any PHS-funded grant or contract

University of Wyoming researchers, both faculty and staff, who are engaging in research related to any PHS-funded grant or contract, must complete the Collaborative Institutional Training Initiative (CITI) course on Conflict of Interest (see https://www.citiprogram.org/) prior to engaging in the research.  This training must be completed at least every four years. 

C.     Conflict of Interest in Research Procedure

1.      Committee. On an ad hoc basis, the Vice President of Research and Economic Development shall appoint a Committee on Conflict of Interest and Conflict of Commitment that shall consist of one administrator from the Office of Research and Economic Development and two senior faculty members. Conflict of interest and conflict of commitment issues may be referred to this committee, which will serve in an advisory capacity in the evaluation and management of such conflicts as further delineated within this policy.

2.      Disclosure. University of Wyoming researchers, both faculty and staff must, in a timely manner, make full disclosure of relevant information on potential conflicts of commitment and/or interest prior to the submission of a research proposal for funding using the University of Wyoming Significant Financial Interest Disclosure Form.  

When a disclosure is received, the Committee on Conflict of Interest and Conflict of Commitment will review the disclosure and make a recommendation regarding the existence of a conflict or apparent conflict. Further, if a conflict or apparent conflict is identified, the committee will make, working with the individual and his/her supervisor (if appropriate), a recommendation on procedures to avoid or manage a conflict appropriately.  If a conflict is identified, the researcher must submit an updated disclosure annually and within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest. 

All recommendations will be made to the Vice President for Research and Economic Development.  The Vice President for Research and Economic Development shall make the final decision regarding the conflict and its management.


a.    Management. If the potential conflict of interest and/or commitment is identified as an actual or apparent conflict, options for management may include, but are not limited to:

i.      refraining from engaging in the proposed activity;

ii.      seeking permission from the university  to engage in the activity if the conflict necessarily can be reduced or restructured to be compatible with the required standard for the employee to properly perform her or his university responsibilities; and/or,

iii.      seeking approval of the activity conditioned upon the implementation of a procedure to monitor the situation.

iv.      Where research is involved, management of conflicts may include, but is not limited to: public disclosure of significant financial interests (e.g., when presenting or publishing the research); for research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants; appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest; modification of the research plan; change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research; reduction or elimination of the financial interests (e.g., sale of an equity interest); or severance of relationships that create financial conflicts.

b.     Appeals Procedure. Affected individuals who disagree with a decision regarding a request to manage a potential conflict of interest and/or commitment may file a written appeal within fifteen (15) days of that decision to the Provost.   The decision of the Provost shall be final and not appealable.

c.     Implementation of This Conflict Management Plan

i.      The University of Wyoming Office of Research and Economic Development will provide training and advice to faculty, staff and student researchers about conflict of interest and commitment issues, including required disclosures and the proper disclosure process.

ii.      The University of Wyoming Office of Research and Economic Development's process will be reviewed and validated on a regular basis.

iii.      The University of Wyoming Office of Research and Economic Development will make available publicly its implementation procedures for this policy.

iv.      The University of Wyoming Office of Research and Economic Development will establish adequate enforcement mechanisms and provide for sanctions where appropriate.

v.      Disclosures will be reviewed and centrally inventoried.

vi.      The disclosure process will be published and reported to the appropriate administrators.

vii.       If the research is PHS funded, the University of Wyoming Office of Research and Economic Development will provide a report to the PHS Awarding Component and will provide a written response to any requestor within five business days of a request concerning any researcher’s significant financial interest disclosed to the University that is determined to be a financial conflict of interest. 

viii.      The University of Wyoming Office of Research and Economic Development will monitor the researcher’s compliance with any management plan on an ongoing basis until the completion of the research project.  

IV.       Retrospective Review

For researchers engaging in research related to any PHS-funded grant or contract, if a financial conflict of interest is not identified in a timely manner by the researcher, the Committee on Conflict of Interest and Conflict of Commitment will complete a retrospective review of the researcher’s activities to determine whether research conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.  If bias is found, the Vice President for Research and Economic Development will notify PHS promptly and submit a mitigation report.   

The mitigation report will include the following: the key elements documented in the retrospective review; a description of the impact of the bias on the research projects; and the University’s plan of action or actions taken to eliminate or mitigate the effect of the bias, including impact on the research project, extent of harm done, and analysis of whether the research project is salvageable.

V.      Sanctions

The initiative and responsibility for reporting potential or actual conflicts rests upon the individual. Any employee who fails to make timely reports of potential conflicts or otherwise violates this policy may be subject to disciplinary action up to termination of employment or to other employment requirements, including but not limited to divestiture of significant financial interests that create conflict. The Committee on Conflicts of Interest and Conflicts of Commitment will review allegations of violations and will make recommendations regarding the imposition of sanctions to the Vice President Research and Economic Development.


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