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Conflict of Interest in Sponsored Activities (A-11.5)

Original Implementation: January 30, 1996
Last Revision: October 30, 2007

 

I. Policy Statement Relating to Conflict of Interest

  1. These guidelines define general university policy and procedures regarding conflicts of interest in relationship to sponsored activities involving research, education, and university service. Their purpose is to protect the credibility and integrity of Stephen F. Austin State University's faculty and staff so that public trust and confidence in the university's sponsored activities is ensured.
  2. 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 or related interest of an investigator. Thus, the university requires that investigators disclose any significant financial or related interest that would reasonably appear to be affected by sponsored activities.
  3. 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. An actual conflict of interest depends on the situation and not on the character or actions of the individual.
  4. 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 sponsored activities.
  5. 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 research from being compromised by the conflicting financial interests of any investigator responsible for the design, conduct, or reporting of sponsored activities.
  6. 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 investigator.
  7. The university will take all necessary steps to assure that any identified conflicts of interests will be managed, reduced, or eliminated prior to the university's expenditure of any funds under an award and certify to the funding agency that this has been done. Conflicts which cannot be satisfactorily managed, reduced, or eliminated must be disclosed to the funding agency. In some cases, it also might be appropriate to voluntarily report apparent conflicts of interest and the steps taken by SFA to mitigate them (such as relationships between grant and university personnel).

 

II. Definitions

  1. Conflict of interest exists if the reviewer(s) of disclosures determines that a significant financial or related interest could directly and significantly affect the design, conduct, or reporting of sponsored activities.
  2. The term investigator, as used in this policy, means the principal investigator project director, co-principal investigator(s), 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. In this context, the term investigator also includes the investigator's spouse and dependent children.
  3. Sponsored activities include research, education, service, or training activities funded by an external sponsor.
  4. Significant financial interest means anything of monetary value, included, but not limited to:
    1. Salary or other payments for services (e.g., consulting fees or honoraria)
    2. Equity interests (e.g., stocks, stock options, or other ownership interests)
    3. Intellectual property rights (e.g., patents, copyrights, and royalties from such rights)

The term does not include:

 

III. Guidelines

  1. Each investigator is required to disclose the following significant financial interests:

    1. 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
    2. Any significant financial interest of the investigator in an entity whose financial interest would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor.
  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.
  3. Each investigator who has significant financial interest requiring disclosure shall complete a Significant Financial Interests Disclosure Form and attach all required supporting documentation. The completed disclosure form must be submitted with the proposal and Proposal Clearance Form (PCF) to the Office of Research and Sponsored Programs 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 PCF.
  4. 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 period of the award as new reportable significant financial interests are obtained. New reportable significant financial interests includes financial interests that become reportable due to an increase in value that meets the reporting threshold, as well as the acquisition of new interests that are reportable.
  5. The director of research and sponsored programs, or official designee, shall conduct an initial review of all financial disclosures. 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 an investigating committee. Committee members are appointed by the provost and vice president for academic affairs after consultation with the associate vice president for graduate studies and research, with this person serving as chair. A conflict of interest exists when the investigating committee reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of the proposed sponsored activities. The committee shall then determine what conditions or restrictions, if any, should be imposed by the institution to manage actual or potential conflicts of interest arising from disclosed significant financial interests.
  6. 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 Public Health Service (PHS). 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 activity is in compliance with those policies.

 

IV. Finding of Presence of Conflict of Interest

  1. Resolution
    1. Resolution of any potential or actual conflicts of interest will not be required until after funding has been approved and prior to any expenditure of funds under the award.
    2. The investigating committee, along with the investigator, will proceed to resolve any actual or potential problems revealed by the initial review of financial disclosures. In order for the conflict to be managed, reduced, or eliminated, the committee may recommend:
      1. Public disclosure of significant financial or related interests;
      2. Monitoring of sponsored activities by independent reviewers;
      3. Modification of the sponsored activity plan;
      4. Disqualification from participation in all or a portion of the activity funded that would be affected by the significant financial interests;
      5. Divestiture of significant financial interests; or
      6. Severance of relationships that create actual or potential conflicts of interest.
    3. If the investigating committee determines that imposing the above referenced conditions or restrictions would either be 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 committee may recommend that, to the extent permitted by federal regulations, the sponsored activity go forward without imposing such conditions or restrictions. In these cases, the provost and vice president for academic affairs and the associate vice president for graduate studies and research shall make the final decision regarding resolution.
    4. The approved resolution plan shall be documented in writing detailing the conditions or restrictions imposed upon the investigator in the conduct of the sponsored activity or in the relationship with the business enterprise or entity.
    5. Actual or potential conflicts of interest will be satisfactorily managed, reduced, or eliminated in accordance with these guidelines and all required reports regarding conflicts of interest submitted to the sponsor prior to the expenditure of any funds under an award.
  2. 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 Sponsored Programs until three (3) 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.

 

V. Enforcement

  1. The provost and vice president for academic affairs shall be responsible for determining and implementing sanctions on investigators who have violated this policy in terms of a conflict of interest resolution. The investigator shall be notified in writing of the recommended sanctions within twenty (20) days. If the sanctions involve a recommendation for termination of employment, the university academic termination procedures will be invoked. The university must take action appropriate for the seriousness of the violation, including, but not limited to, one or more of the following, subject to existing university policies for institutional disciplinary action:
    1. Termination
    2. Removal from particular activity
    3. Special monitoring of future work
    4. Letter of reprimand
    5. Probation for specified period with conditions specified
  2. The university shall 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.
  3. Individuals may appeal the judgment and/or the sanction. A written statement of the grounds for the appeal must be submitted to the president within thirty (30) days of written notification of the sanctions. Grounds for appeal include, but are not limited to, previously unconsidered material evidence, sanctions not commensurate with the finding, and failure to follow the prescribed process. Upon receipt of a written appeal, the president will evaluate the evidence and make a determination. The president will open an investigation if the previously unconsidered material evidence so warrants and may open an investigation if circumstances so dictate. The president's decision will be conveyed to all involved in a timely fashion, but must be conveyed within thirty (30) working days. In the case of termination, the appropriate university policies on termination for cause shall be followed.

 

VI. Other Policies

This policy has been developed in response to federal guidelines for sponsored activities. State ethics laws regarding employee conduct may also apply to situations involving potential conflicts of interest. Employees are encouraged to cross reference the policies listed below and to alert their supervisor(s) of any situation that may be perceived as a potential conflict of interest.

 

Cross Reference: 42 CFR Part 50, Subpart F, 45 CFR Part 94, Faculty Handbook; E-15, Employee Conduct; E-56, Ethics Policy Statements

Responsible for Implementation: Provost and Vice President for Academic Affairs

Contact for Revision: Associate Vice President for Graduate Studies and Research

Forms: Significant Financial Interest Disclosure Form