Appendix C – Additional Provisions Applicable to U.S. Public Health Service (PHS) Funded Research

Research funded by or proposed for funding by the U.S. Public Health Service (PHS), including the National Institutes of Health, is subject to certain requirements imposed by PHS regulations, as amended from time to time (see http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf). Such research is also subject to the Policy and this Appendix C. To the extent of any conflict between a provision of the Policy and a provision of this Appendix C, the provision of this Appendix C shall govern.

The University has implemented the PHS requirements as follows.

Significant Financial Interest

For Investigators who conduct research covered by this Appendix C, 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:
1. 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 in the entity held by the investigator or family member 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;
2. 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);
3. 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 C 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 PHS, each investigator who is planning to participate in the PHS 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.

In addition, investigator engaged in PHS funded research also must disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilites, unless the travel 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 disclosure must include, at a minimum, the purpose of the trip, the identity of the sponsor/organization, the destination, and the duration. Sponsored travel means travel that is paid on behalf of the investigator and not reimbursed to the investigator (so that the exact monetary amount may not be readily determined).
Determination of Financial Conflicts of Interest

Upon receipt of a disclosure of a significant financial interest of an investigator engaged in PHS-funded research, 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 PHS-funded 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 PHS-funded research when the Conflict of Interest Officer reasonably determines that the significant financial interest could be affected by the PHS-funded 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 PHS-funded research.

If during the course of an ongoing PHS-funded project a significant financial interest is disclosed by a new investigator or an existing investigator discloses a significant financial interest not previously reported, or it comes to the attention of University officials that a significant financial interest related to the PHS-funded research was not disclosed in a timely manner by an investigator, the interest shall be reviewed pursuant to Section D of the Policy and this Appendix C within 60 days and a decision shall be made as to whether the significant financial interest constitutes a Financial Conflict of Interest. If the Conflict of Interest Officer determines that a Financial Conflict of Interest exists, the Conflict of Interest Officer shall implement, on at least an interim basis, a management plan that shall specify the actions that have been, or will be taken, to manage the Financial Conflict of Interest.
Management Plans

If a Financial Conflict of Interest is identified pursuant to Section 3 of this Appendix C, 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:
1. Public disclosure of the Financial Conflict of Interest (e.g., when presenting or publishing the research);
2. For research projects involving human subjects, disclosure of Financial Conflicts of Interest directly to participants;
3. 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;
4. Modification of the research plan;
5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
6. Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
7. 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.
Retrospective Review

Whenever a Financial Conflict of Interest involving PHS-funded research is not identified in a timely manner, including failure by the investigator to disclose a significant financial interest that is determined by the Conflict of Interest Officer to constitute a Financial Conflict of Interest, failure by the Conflict of Interest Officer to review or by the University to manage such a Financial Conflict of Interest, or failure by the investigator to comply with a management plan, the University Conflict of Interest Committee shall appoint a person or committee to conduct a retrospective review of the PHS-funded research to determine whether any PHS-funded research, or portion thereof, conducted during the time period of noncompliance was biased in design, conduct, or reporting of such research. Such retrospective review shall be completed within 120 days of the determination of noncompliance.

The respective review will be documented by the individual or committee appointed by the University Conflict of Interest Committee. Such documentation shall include the following elements: (i) Project/Contract number and title; (ii) principal investigator/project director; (iii) name of the investigator with the Financial Conflict of Interest; (iv) name of entity in which the investigator has a significant financial interest that gives rise to the Financial Conflict of Interest; (v) reason for the retrospective review; (vi) detailed methodology used for the retrospective review; (vii) findings of the review; and (viii) conclusions of the review.
Financial Conflict of Interest Reports to PHS

Prior to the University’s expenditure of any funds under a PHS-funded research project, the University will provide the PHS AWARDING COMPONENT with a Financial Conflict of Interest Report (“Report”) regarding any significant financial interests, including significant financial interests of subrecipient investigators, related to the PHS-funded research that the University finds to be conflicting and, to the extent required by regulation, will ensure that the University has implemented a management plan as set forth in Section 4 of Appendix C the Policy. In addition, during the course of a PHS-funded research project, the University will provide the PHS AWARDING COMPONENT with a Report within 60 days of identifying any significant financial interest that the University identifies as conflicting subsequent to its initial Report.

The Report will contain all elements required by regulation, which may include: (i) Project/Contract number; (ii) principal investigator/project director; (iii) name of the investigator with the Financial Conflict of Interest; (iv) name of entity in which the investigator has a significant financial interest that gives rise to the Financial Conflict of Interest; (v) nature of the financial interest; (vi) value of the financial interest, within dollar ranges, or if the value cannot be readily determined through reference to public prices or other reasonable measures, a statement to that effect; (vii) a description of how the financial interest relates to the PHS-funded research and the basis for the University’s determination that the financial interest conflicts with such research; and (viii) a description of the key elements of the management plan, including (a) the role and principal duties of the conflicted investigator in the research project, (b) conditions of the management plan, (c) how the management plan is designed to safeguard objectivity in the research project, (d) confirmation of the investigator’s agreement to the management plan, (e) how the management plan will be monitored to ensure investigator compliance, and (f) other information as needed.

If a retrospective review is performed as provided for in Section 5 of this Appendix C, previously submitted Reports affected by the review will be updated to specify the actions taken to manage the Financial Conflict of Interest going forward. If the retrospective review finds that the PHS-funded research was biased, the University will promptly notify the PHS awarding component and submit a mitigation report, which shall include: (i) the key elements documented in the retrospective review; (ii) a description of the impact of the bias on the research project; and (iii) the University’s plan of action or actions taken to eliminate or mitigate the effect of the bias.

The University will submit updated Reports annually to PHS, addressing the status of previously identified Financial Conflicts of Interest and any changes to management plans, including whether the Financial Conflict of Interest is still being managed or, if it no longer exists, an explanation as to why it no longer exists. Reports will be submitted for the duration of the PHS-funded project period.
Subawardees and Collaborators

If the University carries out PHS-funded research through a subrecipient (e.g., subgrantees, contractors, or collaborators), the University will include in its written agreement with the subrecipient a statement as to whether the financial conflicts of interest policy of the University or that of the subrecipient applies to the subrecipient’s investigators.

If the subrecipient’s financial conflicts of interest policy applies to subrecipient investigators , the subrecipient shall certify as part of the agreement that its policy complies with the PHS regulations. If the subrecipient cannot make such a certification, the University’s policy and this Appendix C as applied to University investigators will apply to subrecipient investigators.

If the subrecipient’s financial conflict of interest policy applies, the University will include in the subrecipient agreement time periods for the subrecipient to report all identified financial conflicts of interests to the University. Such time periods must provide the University with sufficient time to review the reports and make timely reports to PHS, as necessary.

If subrecipient investigators are subject to the University’s policy, the subrecipient agreement will specify time periods for the subrecipient investigators to submit investigator disclosures of significant financial interests to the University so that the University has sufficient time to review the disclosures and comply timely with its review, management, and reporting obligations under this Policy.
Public Disclosure of Information

The University shall make this Financial Conflicts of Interest Policy available via a publicly accessible website. In addition, prior to the expenditure of any funds under a PHS-funded research project, the University will make available, either via a publicly accessible website or by responding within five (5) days to any written request, information concerning any significant financial interest determined by the University to be a Financial Conflict of Interest held by a principal investigator or project director or any other individual who has been identified by the University as key personnel on the PHS-funded project.

In situations where the Department of Health and Human Services determines that a PHS-funded project of clinical research 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 Conflict of Interest that was not managed or reported by the University as required by this Policy, the University will require that the investigator disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.
Notification to PHS

The University will promptly notify the PHS awarding component if failure of an investigator to comply with this Policy or a management plan provided for hereunder has biased the design, conduct or reporting of PHS-funded research.
Training

Prior to engaging in PHS-funded research, investigators will be required to complete training regarding the requirements set forth in this Policy. Training shall be updated every four (4) years, and immediately when any of the following circumstances apply: (i) the University revises its policy in a manner that affects the requirements for investigators with regard to financial interests; (ii) an investigator is new to the University; or (iii) the University finds that an investigator is not in compliance with the Policy on Financial Conflicts of Interest or management plan implemented thereunder.
Record Retention

Records relating to all investigator disclosures of financial interests related to PHS-funded research and the University’s review of, and response to, such disclosures will be maintained for at least three years from the date of submission of the final expenditures report under the PHS-funded research or, where applicable, for such longer periods as specified in 45 CFR 74.53(b).