Research Policy

Conflict of Interest and Financial Conflict of Interest

I. Purpose
This policy governing conflicts of interest applies to all Investigators of the University. Tennessee State University expects all Investigators will conduct their affairs so as to avoid, mitigate, or minimize conflicts of interest, and they must respond appropriately when conflicts of interest arise in accordance with this policy and with Policy 01.07 Conflict of Interest. To that end, this policy informs faculty about situations that generate conflicts of interest related to research; provides mechanisms for Investigators and Tennessee State University (TSU or University) to manage those conflicts of interest; and describes situations that are prohibited. Every Investigator has an obligation to become familiar with, and abide by, the provisions of this policy. If a situation raising questions of conflict of interest arises, an Investigator should discuss the situation with the The Sponsored Project Conflict of Interest Review Committee (Review Committee).

The Review Committee is responsible for ensuring implementation of this policy and may suspend all relevant activities until the conflict of interest is resolved or other action deemed appropriate by the Review Committee is implemented. Violation of any part of this policy may also constitute cause for disciplinary or other administrative action pursuant to University policy.

In addition to this policy, the National Science Foundation (NSF) and the U.S. Public Health Service (PHS) have promulgated additional regulations related to conflicts of interest that affect institutions applying for research funding. The NSF and PHS require each institution to maintain an appropriate policy to ensure that the financial interests of the employees of the institution do not compromise the objectivity of research supported with public funds. In order to comply with federal mandates and to be consistent in application, this policy shall apply to all externally funded projects.

II. Definitions
A. Clinical Trial. Any research study that involves interaction with human subjects and the concurrent investigative use of drugs, biologics, devices, or medical or other clinical procedures, such as surgery.

B. Conflict of Interest. Conflicts of interest include situations in which employees may have the opportunity to influence the University's business decisions in ways that could lead to personal gain or give improper advantage to members of their families or to associates, as well as, situations of conflicts of commitment in which employees' external activities interfere or appear to interfere with their paramount obligations to students, colleagues, and the University.

C. Family Member. With regard to the Investigator, their spouse, and dependent children or stepchildren.

D. Financial Conflict of Interest. A significant financial interest (or, where the Review Committee requires disclosure of other financial interests, a financial interest) that the University reasonably determines could directly and significantly affect the design, conduct, or reporting of institutional research.

E. Financial Interest. Anything of current or potential monetary value received or held by an Investigator or an Investigator's family member, whether or not the value is readily ascertainable, including, but not limited to, salary or other payments for services (i.e., consulting fees, honoraria, or paid authorships for other than scholarly works); any equity interests (i.e., stocks, stock options, or other ownership interests); or intellectual property rights and interests (i.e., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests. Financial interest also includes any reimbursed or sponsored travel undertaken by the Investigator and related to their institutional responsibilities. This includes travel that is paid on behalf of the Investigator rather than reimbursed, even if the exact monetary value is not readily available. It excludes travel reimbursed or sponsored by U.S. federal, state, or local governmental agencies, U.S. institutions of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers. Financial interest does not include:

1. salary, royalties, or other remuneration from the University;

2. income from the authorship of academic or scholarly works;

3. income from seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for U.S. federal, state, or local governmental agencies; U.S. institutions of higher education; U.S. research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or

4. equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles.

F. Significant Financial Interest (SFI). A financial interest that reasonably appears to be related to the Investigator's institutional responsibilities:

1. if with a publicly traded entity, the aggregate value of any salary or other payments for services received during the twelve (12)-month period preceding the disclosure, and the value of any equity interest during the twelve (12)-month period preceding or as of the date of disclosure, exceeds five thousand dollars ($5,000.00); or

2. if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the twelve (12)-month period preceding the disclosure exceeds five thousand dollars ($5,000.00); or

3. if with a non-publicly-traded company, is an equity interest of any value during the twelve (12)-month period preceding or as of the date of disclosure; or 3

4. is income related to intellectual property rights and interests not reimbursed through the institution.

G. Review Committee. The committee within the University that is responsible for the solicitation and review of disclosures of significant financial interests, including those of the Investigator's family member(s) related to the Investigator's institutional responsibilities. For the purposes of this policy, the Review Committee is designated as the Associate Vice President for Research and Sponsored Projects and Director of Research and Sponsored Programs.

H. Institutional Responsibilities. The Investigator's responsibilities associated with their institutional appointment or position, such as research, teaching, clinical activities, administration, and institutional, internal, and external professional committee service.

I. Investigator. Any individual who is responsible for the design, conduct, or reporting of PHS and other sponsored research, or proposals for such funding. This definition is not limited to those titled or budgeted as Principal Investigator or co-Investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students. The definition may also include collaborators or consultants, as appropriate.

J. Public Health Service (PHS). The Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the Administration for Children and Families, Administration on Aging, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and Substance Abuse and Mental Health Services Administration

K. Research. A systematic investigation, study, or experiment designed to contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research (i.e., a published article, book, or book chapter) and product development (i.e., a diagnostic test or drug).

L. Research Misconduct. Misconduct in research or scholarly activity (misconduct) includes, but is not limited to: fabrication; falsification; misrepresentation; plagiarism; failure to provide periodic reporting; failure to promote, or to sustain, collegial collaboration; failure to monitor and/or manage student researchers and graduate assistants; intentional bypass of academic or scientific research procedures; self-dealing; financial conflict of interests (whether current or potential monetary value); or other practices that significantly deviate from those that are commonly accepted within the academic community for proposing, conducting, reviewing, or reporting research or other scholarly accomplishments. This does not include honest errors or honest differences in interpretations or judgments of data.

III. Disclosure of Conflicts of Interest
All Investigators are required to disclose in writing the conflicts of interest of the Investigator and their family members (as defined above), to include any outside financial interests, to the University on an annual and on an ad hoc basis, as described below. The Review Committee is responsible for the distribution, receipt, processing, review, and retention of disclosure forms. Regardless of the disclosure requirements, the Investigator and the Investigator’s family members, in their own best interest, are encouraged 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.

  • Annual Disclosures. All Investigators must disclose the significant financial interests of the Investigator and their family members to the University, through the Review Committee, on an annual basis. All forms should be submitted to the Review Committee or designee by May 31 for the previous calendar year.

 

  • Ad hoc Disclosures. In addition to annual disclosure, certain situations require ad hoc disclosure. All Investigators must disclose their significant financial interests to the University, through the Review Committee, within thirty (30) days of their initial appointment or employment.
    • In addition, all Investigators must submit to the Review Committee an ad hoc disclosure of any significant financial interest they acquire during the course of the year within thirty (30) days of discovering or acquiring the significant financial interest.

 

  • Prior to the time of application for sponsored projects, whether or not the Investigator has a significant financial interest, the Investigator must submit to the Review Committee an ad hoc updated disclosure form.

 

  • Travel Disclosure. Investigators must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined above in the definition of financial interest. Such disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value. The Review Committee will determine if additional information is needed (i.e., the monetary value if not already disclosed) to determine whether the travel constitutes a financial conflict of interest with the Investigator's research.

 

IV. Review and Decision of the Review Committee
Disclosure forms will be reviewed by the Review Committee prior to expenditure of funds related to funded research. If the disclosure form reveals a significant financial interest related to the research, the Review Committee, in collaboration with the Interim Provost and Vice President for Academic Affairs, will determine whether a conflict of interest exists. A conflict of interest exists when the Review Committee determines that the reported interest could directly and significantly affect the design, conduct, or reporting of PHS-supported research, as well as any other externally funded research. If a conflict of  interest exists, the Review Committee will take action within sixty (60) days to eliminate, reduce, mitigate, or manage the conflict, as appropriate.

Examples of conditions or restrictions that might be imposed to manage conflicts of interest include, but are not limited to: (1) Public disclosure of significant financial interests; (2) Monitoring of research by independent reviewers; (3) Modification of the research plan; (4) Disqualification from participation in all or a portion of the funded research; (5) Divestiture of significant financial interests; or (6) Severance of relationships that create actual or potential conflicts

If the Review Committee determines that there is a conflict of interest that can be managed or mitigated, a written management plan must be agreed upon before any related research goes forward. The affected Investigator may assist the Review Committee in developing the management plan. The management plan will detail the conditions of the management plan, the role and principal duties of the Investigator, and any actions that have been, and will be, taken to manage the conflict of interest going forward. The management plan will be designed to safeguard objectivity in the affected research project and will detail how the Review Committee will monitor the Investigator’s compliance with the management plan. The status of the management plan (i.e. whether the conflict no longer exists or is still being managed) must be documented in the Investigator’s annual or updated Disclosure Form. Investigator compliance with the management plan will be monitored by the Review Committee until completion of the impacted project.

V. Notification to Funding Agency of Financial Conflict of Interest
The Director of Research and Sponsored Programs will promptly notify the funding agency of the existence of a conflict of interest and the action taken to manage, mitigate, reduce, or eliminate the conflict under the following circumstances: 

  • Prior to the expenditure of funds;
  • Within sixty (60) days of identification for an Investigator who is newly participating in the project;
  • Within sixty (60) days for new, or newly identified, conflicts of interest for existing Investigators;
  • At least annually (at the same time as when the University is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension) to provide the status of the financial conflict of interest and any changes to the management plan, if applicable, until the completion of the project; or
  • Following a retrospective review to update a previously submitted report, if appropriate.

The Director of Research and Sponsored Programs will promptly notify NIH if an Investigator fails to comply with this policy, and/or bias is found with the design, conduct or reporting of PHS/NIH-funded research. The Review Committee will submit a Mitigation Report that explains the actions that have been, and will be, taken to mitigate the effects of the identified bias. The actions will be in compliance with applicable federal regulations. TSU will make available to the funding agency, upon request, all conflicting interests identified and how those interests were managed, reduced, or eliminated.

VI. Financial Conflict of Interest (FCOI) Training
All Public Health Services (PHS) supported Investigators must complete FCOI training prior to engaging in NIH-funded research, and at least every four (4) years thereafter. Investigators must also complete the training immediately if this policy is substantially amended in a manner that affects the requirements of the Investigator, if an Investigator is new to the university, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities.

Investigators submitting proposals to other federal agencies are also required to take the FCOI training. In addition, if the Review Committee determines that an Investigator has a financial conflict of interest that has not been disclosed, the Investigator will be required to complete the FCOI training.

University FCOI Training is provided via CITI. Investigators must retain training completion certificates and document the latest completion date on their disclosure form.

VII. Subrecipients, Contractors, and Collaborators
Subrecipients, contractors, or collaborators who are working under sub-agreements from TSU that are funded by the federal government, must comply with federal regulations (42 CFR Part 50, Subpart F, Grants and 45 CFR Part 94, Contracts).

If these subrecipient's, contractor’s, or collaborator’s Investigators must comply with the subrecipient's, contractor’s, or collaborator’s financial conflict of interest policy, the subrecipient, contractor, or collaborator shall certify as part of a written agreement that its policy complies with federal regulation (42 CFR Part 50, Subpart F). If the subrecipient, contractor, or collaborator cannot provide such certification, the written agreement will state that subrecipient, contractor, or collaborator Investigators are subject to TSU's financial conflict of interest policy for disclosing significant financial interests that are directly related to the subrecipient's, contractor’s, or collaborator’s work for TSU. The written agreement will include a requirement that TSU is permitted to solicit and review subrecipient, contractor, or collaborator Investigator disclosures. The written agreement will specify time period(s) for the subrecipient, contractor, or collaborator to report all identified financial conflicts of interest to the Review Committee. Such time period(s) shall be sufficient to enable TSU to comply in a timely manner with its review, management, and reporting obligations.

VIII. Investigation of Non-Compliance
In compliance with NSF and PHS, as well as in compliance with research funding from the National Institutes of Health (NIH), the University will comply with its written policies and procedures (Policies 520.00, 520.05 and 520.10) for investigating and responding to allegations of research misconduct and will carry out such investigation and responses with extra care in maintaining the confidentiality of any research subjects, as well as respondents and complainants. The University will protect the scientific integrity of the sponsored research project during any investigation of research misconduct, including the protection of human participants, live vertebrate animals, and the environment, to the extent possible, and will provide reports to the Department of Health and Human Services Office or Research Integrity (ORI), when applicable.

IX. Investigator Non-Compliance
A. Institutional Response to Non-compliance.
In the event of an Investigator's failure to comply with this policy, the Review Committee may suspend all relevant activities until the matter is resolved or other action deemed appropriate by the Review Committee is implemented. The Investigator may also be subject to disciplinary action due to non-compliance. The disciplinary action include, but are not limited to:

  • Removal from the project
  • Letter of reprimand and special monitoring of future work
  • Probation
  • Salary reduction
  • Suspension
  • Rank reduction
  • Barred from University sponsored leaves
  • Termination of Employment
  • Ineligibility for University Awards
  • Termination of Research/ Training Incentive Pay
  • Travel Restrictions

Barred from Conducting Future Research Projects at TSU Consideration in the process will also be given to the formal notification of other concerned parties, such as: 

  • Funding Sources
  • Co-authors, Co-investigators, and Collaborators
  • Editors of Journals in which Fraudulent Research was Published
  • State Professional Licensing Boards
  • Professional Societies
  • Criminal Authorities where Appropriate
  • Other Colleges , Universities, and Corporations

The action(s) taken by the Review Committee will be described in a written explanation of the decision and provided to the Investigator, the Interim Provost, and the Investigator’s Dean and Department Chair, and, where applicable, the Institutional Review Board (IRB), and will notify the Investigator of the right to appeal the decision. The Investigator may appeal the decision by submitting, in writing, a request to appeal, listing the reasons for an appeal, within thirty (30) days of receipt of the Review Committee’s decision. If appealed, the Review Committee will convene an ad hoc Appeals Committee consisting of the respective Dean and Department Chair, one (1) other faculty member from a department other than the Investigator’s, and the IRB chair, if the project is research involving human subjects. The Appeals Committee will review the appeal and respond within thirty (30) days of the receipt of the appeal. The decision will be sent to the Investigator, the Review Committee, the Interim Provost, and the applicable Dean and the Department Chair. The Interim Provost may determine that disciplinary action is appropriate and, if so, will notify the Review Committee of the disciplinary steps being taken.

The Review Committees shall notify the funding agency of any disciplinary steps being taken within one hundred twenty (120) days of the decision to take disciplinary action.

B. Retrospective Review.
In addition, if the Review Committee determines that a financial conflict of interest was not identified or managed in a timely manner, including, but not limited to, an Investigator's failure to disclose a significant financial interest that is determined to be a financial conflict of interest, or failure by an Investigator to materially comply with a management plan for a financial conflict of interest, the Review Committee, with the assistance of the Investigator’s respective Dean and Department Chair, will complete a retrospective review of the Investigator's activities and the research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct, or reporting of the research.

Documentation of the retrospective review shall include the project number, project title, PI, name of Investigator with the financial conflict of interest, name of the entity with which the Investigator has the financial conflict of interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review. Such review shall be completed within one hundred twenty (120) days of the Review Committee's determination of noncompliance.

The Review Committee will update any previously submitted report to the funding agency relating to the research, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, the report will include a mitigation report in accordance with the PHS regulations, including a description of the impact of the bias on the research project, and the plan of action to eliminate or mitigate the effect of the bias.

C. Clinical Research Involving Drugs, Medical Devices, or Treatments.
If the Department of Health and Human Services determines that a PHS-funded clinical research project, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an Investigator with a financial 9 conflict of interest that was not managed or reported by the University as required by the regulations, the Review Committee will require the Investigator involved to:

  1. Disclose the financial conflict of interest in each presentation of the results of the research, or
  2. Require an addendum to previously published presentations.

The Investigator shall submit documentation to the Review Committee confirming that the disclosure of the financial conflict of interest has been made in each presentation of the results. The Director of Research and Sponsored Programs will forward the documentation to PHS in an updated report.

X. Maintenance of Records
The University will maintain records of all disclosures and of all actions taken to resolve conflicts of interest for three (3) years from the date the final expenditure report is submitted (or as otherwise specified in 45 CFR 74.53(b) or 45 CFR 92.42(b)), or until the resolution of any action taken by the funding agency involving those records, whichever is longer.

XI. Confidentiality and Public Accessibility
A. Confidentiality.
To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, the University may make such information available to an agency funding research of the faculty member; to a requestor of information concerning a financial conflict of interest related to PHS external funding; to the ORI for any NIH related research grant or funding; or to the primary entity who made the funding available to the institution, if requested or required. If the University is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure.

B. Public Accessibility.
Prior to the expenditure of funds, the University will publish on a publicly-accessible website, information concerning any conflict of interests determined by the Review Committee to represent a significant financial interest held by an Investigator. The management plan will also be included in the publicly available information. XIII. Regulatory Authority This policy implements the regulatory requirements of 42 CFR 50. Where there are substantive differences between this policy and the requirements, the regulatory requirements shall take precedence.