Appendix B – Additional Provisions Applicable to Research and Educational Activities Sponsored By an External Sponsor Other than the U.S. Public Health Service (PHS)
Research and educational activities funded by or proposed for funding by an external sponsor other than the U.S. Public Health Service (PHS) are subject to the requirements set forth in the Policy and this Appendix B. To the extent of any conflict between a provision of the Policy and a provision of this Appendix B, the provision of this Appendix B shall govern. Requirements related to research and other activities sponsored by PHS are addressed in Appendix C.
- Significant Financial Interest
For investigators who conduct research covered by this Appendix B, a “significant financial interest” includes, in addition to the interests described in section 11(a)-(d) of Appendix A, a financial interest consisting of one or more of the following interests of the investigator or a member of the investigator’s family that reasonably appears to be related to the investigator’s university responsibilities:
- With regard to any publicly traded entity, a significant financial interest exists if the value of (i) any remuneration received from the entity by the investigator or family member in the twelve-month period immediately prior to the disclosure, plus (ii) any remuneration expected from the entity by the investigator or family member in the twelve-month period immediately following the disclosure, plus (iii) any equity interest held by the investigator or family member in the entity as of the date of disclosure, when aggregated, exceeds $5,000, or the equity interest in the entity represents more than five percent (5%) ownership. 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. This definition does not include any interest owned solely by reason of investment in an entity by a mutual fund, pension fund, or other institutional investment fund over which the investigator or family member exercises no control;
- With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity by the investigator or family member in the twelve-month period immediately prior to the disclosure, plus the value of any remuneration expected from the entity by the investigator or family member in the twelve-month period immediately following the disclosure exceeds $5,000, or the investigator (or family member) holds any equity interest (e.g., stock, stock option, or other ownership interest);
- Any intellectual property rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to such rights.
The term significant financial interest as defined in this Appendix B does not include the following types of financial interests: (i) salary, royalties, or other remuneration paid by the University to the Investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights; (ii) 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; (iii) 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.
“University responsibilities” include professional responsibilities on behalf of the University, including, but not limited to, teaching, research, research consultation, professional practice, institutional committee membership, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
- Disclosure of Significant Financial Interests
In addition to the disclosure obligations set forth in Section C of the Policy, prior to the submission of a proposal to an external sponsor each investigator who is planning to participate in the funded research or activity must have on file a current disclosure form that reports his/her significant financial interests and such other information as may be requested by the Conflict of Interest Officer. Disclosures must be updated at least annually during the period of the sponsored activity to reflect any information not disclosed initially or updates to any previously-disclosed significant financial interests (e.g., the updated value of previously disclosed equity interests). In addition, investigators are required to report new significant financial interests within 30 days of discovering or acquiring the interest.
- Determination of Financial Conflicts of Interest
Upon receipt of a disclosure of a significant financial interest of an investigator, the Conflict of Interest Officer will determine under the procedures in Section D of the Policy (a) whether the significant financial interest is related to the externally sponsored research and, if so related, (b) whether the significant financial interest is a Financial Conflict of Interest. An investigator’s significant financial interest is related to the externally sponsored research when the Conflict of Interest Officer reasonably determines that the significant financial interest could be affected by the externally sponsored research or is in an entity whose financial interest could be affected by the research. A Financial Conflict of Interest exists when the University reasonably determines that the significant financial interest could directly and significantly affect the design, conduct or reporting of the externally sponsored research.
- Management Plans
If a Financial Conflict of Interest is identified pursuant to Section 3 of this Appendix B, prior to the expenditure of award funds the Conflict of Interest Officer, as designated in Section D of the Policy, will develop and implement a management plan specifying the actions that have been or will be taken to manage, reduce or eliminate the 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:
- Public disclosure of the Financial Conflict of Interest (e.g., when presenting or publishing the research);
- For research projects involving human subjects, 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 interest (e.g., sale of an equity interest); or
- Severance of the relationships that create actual or potential financial conflicts.
Determination of the existence of a Financial Conflict of Interest and the means identified for eliminating or managing the conflict will be communicated in writing to the affected investigator and other appropriate personnel. When applicable, the appropriate manager responsible for grant and contract administration will also be notified of pertinent facts needed for grant administration and regulatory compliance.
The Conflict of Interest Officer may monitor investigator compliance with any management plan implemented pursuant to this section on an ongoing basis until completion of the sponsored research project.
- Subawardees and Collaborators
If the University carries out externally sponsored research or other activities through a subrecipient (e.g., subgrantees, contractors, or collaborators), the University will take reasonable steps to ensure that:
- The entity has its own policies in place that meet any conflict of interest requirements of the sponsor; or
- Investigators working for such entities follow this Policy and this Appendix B as applied to University investigators.
- Notification to External Sponsors
The University will make reports to appropriate external sponsors to the extent required by and in accordance with its funding agreement with the sponsor and applicable law and regulation. For NSF funded research and educational activities, the University will keep NSF’s Office of General Counsel appropriately informed if the University finds that it is unable to satisfactorily manage a conflict of interest.
- Record Retention
Records relating to all investigator disclosures of financial interests related to externally sponsored research and activities and the University’s review of, and response to, such disclosures will be maintained for at least three years from the termination or completion of the external research or activity or for such longer periods as prescribed in the external agreement or applicable regulations. Upon authorized request of a sponsoring agency, disclosure documents and related records pertaining to the specific sponsored project will be made available to appropriate officials.