Administrative Regulation:  EWC Sponsored Research Activities

Regulation Number:  3.10.6

_____________________________________________________________________________________

Employees involved in sponsored research activities that are sanctioned by Eastern Wyoming College have additional requirements to identify and address conflicts of interest and commitment that are potential, actual, or apparent that arise during the conduct of research activities. It is critical that outside activities or outside financial interests do not interfere with objectivity in research. This Administrative Regulation: 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 Administrative Regulation is designed to observe 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 college compliance (45 CFR Part 94; 42 CFR Part 50 Subpart F).

Eastern Wyoming College (“EWC” or “College”) is committed to ensuring that the procedures included herein are carried out properly and consistently, in accordance with the EWC Employee Code of Ethics Policy.

Categories of Conflicts in Research

Conflicts of Interest

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 research activities.  Generally, conflicts of interest can arise naturally from an individual’s engagement with the world outside the College, 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.

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 financial interest consisting of one or more of the following interests of the researcher1 (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 College:

  1. 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.
  2. 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).
  3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
    • (Researcher means the principal investigator/project director, co-principal investigators, and any other person at the College who is responsible for the design, conduct, or reporting of  research or educational activities funded, or proposed to be funded, by an external sponsor. In this context, the term researcher includes the researcher’s spouse and dependent children).
  4. 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 College 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. EWC Administrative Services 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.
  5. The term significant financial interest does not include the following types of financial interest:
    1. salary, royalties, or other remuneration paid by the College to the researcher if the researcher is currently employed or otherwise appointed by the College, including intellectual property rights assigned to the College and agreement to share in royalties related to such rights;
    2. 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;
    3. 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
    4. 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.

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 college 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 protection of human research subjects, and the treatment of students and faculty colleagues.

Conflicts of Commitment

See EWC Administrative Regulation 3.10.5.

  1. Training, Conflict Identification, Disclosure, Management Plan, and Monitoring
  2. Preface: This Administrative Regulation: 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 Eastern Wyoming College and its employees while preserving the integrity of the College’s relationship with the public.
  3. The College shall adhere to federal regulations mandated by National Science Foundation, Public Health Service, and/or other federal entities for conflicts of interest and/or commitment and pursuant to the guidelines established in this Administrative Regulation. Implementation of this Administrative Regulation is the responsibility of EWC Administrative Services, working directly with sponsored researchers, in consultation with legal Administrative Services and college administration will be responsible for reviewing and revising this Administrative Regulation 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.

Training for Researchers

Eastern Wyoming College researchers, both faculty and staff, who are engaging in research related to any Public Health Service-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.

Conflict of Interest in Research Procedure

  1. On an ad hoc basis, the Vice President for Administrative Services shall appoint a Committee on Conflict of Interest in Research that shall consist of the Vice President or Vice President of Student and Academic Services and two 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 Administrative Regulation.
  2. Eastern Wyoming College 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 Eastern Wyoming College’s Significant Financial Interest Disclosure Form, which may be found on the Business Office public shared drive.
    • When a disclosure is received, the Committee on Conflict of Interest in Research 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 Form 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 Administrative Services. The Vice President for Administrative Services shall make the decisions regarding the conflict and its management.
  3. 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:
    1. Refraining from engaging in the proposed activity.
    2. Seeking permission from the College 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 college responsibilities.
    3. Seeking approval of the activity conditioned upon the implementation of a procedure to monitor the situation.
    4. 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.
  4. 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 President. The President’s decision is final and there is no further appeal allowed to the Board of Trustees.
  5. Implementation of a Conflict Management Plan
    1. Eastern Wyoming College Administrative Services 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.
    2. This process will be reviewed and validated on a regular basis.
    3. Eastern Wyoming College Administrative Services will establish adequate enforcement mechanisms and provide for sanctions where appropriate.
    4. Disclosures will be reviewed and centrally inventoried.
    5. The disclosure process will be published and reported to appropriate administrators and project sponsors.
    6. If the research is Public Health Service funded, Eastern Wyoming College Administrative Services will provide a report to the Public Health Service Awarding Component or pass- through entity 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 College that is determined to be a financial conflict of interest.
    7. Eastern Wyoming College Administrative Services will monitor the researcher’s compliance with any management plan on an ongoing basis until the completion of the research project.

Retrospective Review

For researchers engaging in research related to any Public Health Service-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 in Research 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 Administrative Services will notify Public Health Service or the pass- through entity 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 College’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.

Sanctions

The initiative and responsibility for reporting potential or actual conflicts rests upon the individual employee. Any employee who fails to make timely reports of potential conflicts or otherwise violates this Administrative Regulation 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 in Research will review allegations of violations and will make recommendations regarding the imposition of sanctions to the Vice President for Administrative Services.

 

Original Adoption Date: 8/31/15

Revision Date(s): 4/4/16, 6/30/17

Date reviewed, no change: