Teachley Financial Conflict of Interest Policy
In an effort to promote objectivity in research and reasonable expectation that the design, conduct, and reporting of research will be free from bias resulting from Investigator financial conflicts of interest, Teachley (the Institution) has adopted this Financial Conflict of Interest Policy (the Policy).
Definitions can be found in Appendix A.
Who must disclose Financial Interests
All Institution Principal Investigators and employees considered an Investigator on pending or awarded government funded grants must review this Financial Conflict of Interest Policy and complete a Financial Conflict of Interest Disclosure Form (Disclosure Form) annually and as otherwise required by federal grants. New Investigators must complete this form within thirty days of employment and annually thereafter. All covered individuals must update their Disclosure Form anytime their Significant Financial Interest (SFI) has changed significantly (e.g., a previously disclosed SFI has changed and/or there is a new SFI such as through a purchase, marriage, or inheritance) within thirty days. Investigators are also required to update this form whenever they apply for or receive a grant from a Public Health Service (PHS) agency, such as the NIH. Phase I SBIR Program applications are excluded from this requirement.
If the application or awarded grant includes a Subawardee (e.g., subcontractor, consortium member, consultant) then inclusion of the management of Financial Conflict of Interest will be included within a written agreement between the Institution and Subawardee. Subawardees may adopt the Institution’s policy or use their own policy, if it meets or exceeds the requirements of the Code of Federal Regulations Section 42, Part 50, Subpart F.
The Principal Investigator is responsible for identifying all Investigators and Subawardees for PHS-funded projects and ensuring that each provides a disclosure when needed (see Submission of Disclosure).
What must be disclosed
Investigators must disclose all Significant Financial Interests that reasonably relate to the individual’s Institutional Responsibilities. SFIs of the Investigator’s Family (spouse and dependent children) must also be disclosed.
(1) Significant Financial Interests include remuneration and/or equity received from Outside Entities.
(i) For any publicly traded entity: when 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. For purposes of this definition, 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 reference to public prices or other reasonable measures of fair market value;
(ii) For any non-publicly traded entity: when any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator'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.
(2) The occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional 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 as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The Investigator must specify at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
As appropriate, the Institution will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
The term Significant Financial Interest does not include the following types of Financial Interests:
salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;
any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization;
income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
Submission of Disclosure
A completed Disclosure Form must be provided to the Institution’s Managing Member for review. The Managing Member, will review each form to determine whether it requires additional review of a Significant Financial Interest. If so, the remaining company’s executive members will also review each disclosure and evaluate it for potential conflict. Members will be excluded from reviewing their own disclosure form. The reviewer(s) will determine whether the outside interests disclosed “could directly and significantly affect the design, conduct, or reporting of any PHS-funded research”. If the review determines that a conflict does not exist then the Disclosure Form is filed and no further action is required. If it is determined that a conflict may exist, the reviewer(s) will discuss the concern with the Investigator and seek to develop and implement a management plan in an effort to mitigate such conflict within sixty days of original receipt of the Disclosure Form. A management plan shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest. Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to:
(i) Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
(ii) For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
(iii) 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;
(iv) Modification of the research plan;
(v) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
(vi) Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
(vii) Severance of relationships that create financial conflicts.
Disclosure records and public disclosure
Disclosure Forms, reviews, management plans, and any other record regarding financial conflict of interest will be maintained by the Institution for at least three years from the date the final expenditure report is submitted to the PHS or as otherwise required. The Institution will submit FCOI Reports to the PHS annually and/or as otherwise required. Further, the Institution reserves the right to make information available, promptly upon request, to the HHS relating to any Investigator disclosure of financial interests and the Institution's review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution's determination of a financial conflict of interest.
Failure to fully and truthfully disclose potential or actual conflicts of interest or commitment to the Institution or failure to comply with any plan for managing the disclosed conflict could result in inability to pursue and maintain grants. Under federal law, no PHS-funded research may begin and no PHS grant funds may be expended until disclosure is made and a plan to manage any conflicts is put in place. In the event a Disclosure Form has not been timely submitted, the Investigator will make every reasonable effort to complete the Disclosure Form within 30 days of request and if necessary, cooperate with the implementation of a management plan, retrospective review, and/or a mitigation report. Retrospective reviews, if needed, will be conducted no later than 120 days from the date of request and the results will be reported to PHS.
Training on Financial Conflicts of Interest
All Investigators must undergo training on the Investigator’s responsibilities for disclosing significant financial interests, the Company’s policy, and federal regulations regarding financial conflicts of interest prior to engaging in research related to any PHS-funded grant, at least every four years, and immediately when any of the following circumstances apply:
(1) The Institution revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;
(2) An Investigator is new to an Institution; or
(3) An Institution finds that an Investigator is not in compliance with the Institution's financial conflict of interest policy or management plan.
Investigators should complete training on the NIH website here. A copy of a successfully completed training certificate must be emailed to Rachael Labrecque, Managing Member. Review of this Financial Conflict of Interest Policy along with submission of the Disclosure Form and training certificate will fulfill the training requirements.