Conflict of Interest: Funds Awarded by the National Science Foundation and the Public Health Service

1. Purpose
   On October 1, 1995, the National Science Foundation (NSF) and the Public Health Service (PHS), US Department of Health and Human Services adopted parallel polices on Investigator Financial Disclosure that are relatively consistent. Under these rules the grantee institution (Sonoma State University) must:
   • develop, enforce and certify to Public Health Service (PHS) and National Science Foundation (NSF) a policy to ensure that PHS- or NSF-funded research is not biased by investigators' conflict of interests;
   • inform potential investigators of the policy and their responsibilities under the policy;
   • designate institutional officials to solicit and review financial disclosure statements from each investigator planning to participate in NSF- or PHS-funded research;
   • provide designated officials with guidelines for identifying conflicts of interest and take action to manage, reduce, or eliminate the conflict; and,
   • maintain records for at least three years (from the date the final grant expenditures report is submitted) of all financial disclosures and all actions taken by the institution.
   Additionally, the grantee institution must update all financial disclosures during the period of the award either on an annual basis or as new reportable conflicts of interest are discovered.
   The CSU has had a conflict of interest policy relating to non-governmental funding sources in effect since 1985. This policy, as specified in FSR 85-08 and 86-05, addresses only certain activities funded by non-governmental funding agencies. While the CSU does not have a Conflict of Interest policy specifically related to research funded by federal sources, Executive Order 890 requires that:
   Each campus shall maintain a policy that complies with conflict of interest requirements of the law and applicable CSU, Sponsored Program Administrator and Grantor policies and shall alert Principal Investigators to these requirements
2. Investigator Disclosure
   Investigators must disclose significant financial interests at the time of proposal submission and update this information annually or as new interests are obtained during the life of the award.
   1. Investigator 
      Investigator is defined as principal investigator, co-principal investigator, and any other person who is responsible for the design, conduct, or reporting of the sponsored project or of any related agreement. In addition, disclosure must be made for each investigator's spouse and dependent children.
   2. Significant Financial Interest 
      The term "significant financial interest" means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include:
      1. salary, royalties or other remuneration from the applicant institution;
      2. any ownership interests in the institution, if the institution is an applicant under the Small Business Innovation Research Program or Small Business Technology Transfer Program;
      3. income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
      4. income from service on advisory committees or review panels for public or nonprofit entities;
      5. an equity interest that, when aggregated for the investigator and the investigator's spouse and dependent children, meets both or the following tests: does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity; or
      6. salary, royalties or other payments that when aggregated or the investigator and the investigator's spouse and dependent children, are not expected to exceed $10,000 during the next funded twelve-month period.
3. Institutional Certification
   Certification will be performed by the Associate Vice President of Research and Sponsored Programs (AVPRSP), or his/her designee, and will be based on information provided by the Investigator on the Conflict of Interest Disclosure Form for each entity that may be involved (enclosed). The AVPRSP, or his/her designee, will review disclosures, assess their potential for conflicts of interest, and develop resolution strategies with the investigator to manage, reduce or eliminate such conflicts.
   1. Resolution Plan 
      If the designated official determines a conflict of interest exists¹, a Resolution Plan must be developed with the Principal Investigator and implemented prior to award. The Resolution Plan must be in writing and approved by the AVPRSP, the Dean (or equivalent) of the Principal Investigator’s school/unit, and the Provost.
      Resolution Options may include but are not limited to:
      • public disclosure of significant financial interests
      • monitoring of research by independent reviewers
      • modification of the research plan
      • disqualification from participation in the portion of the project that is affected by the significant financial interest
      • divestiture of significant financial interests
      • severance of relationships that create actual or potential conflicts.
   2. Enforcement Mechanisms and Sactions 
      Potential violations of the Conflict of Interest Resolution Plan shall be handled by the Conflict of Interest Resolution Committee made up of the Campus Conflict of Interest Officer, the Internal Auditor, the Dean (or equivalent) from the affected Principal Investigator's school/unit. This committee will establish and enforce appropriate sanctions based on the specific conduct of an investigator failing to follow the agreed upon Resolution Plan.
   3. Reporting 
      The Associate Vice President for Research and Sponsored Programs will inform the National Science Foundation's Office of the General Counsel if Sonoma State University is unable to satisfactorily manage a conflict of interest. In the case of the Public Health Service (PHS), the Associate Vice President for Research and Sponsored Programs will notify the PHS Awarding Component of the corrective action taken or to be taken if the failure of an Investigator to comply with the policy of Sonoma State University has biased the design, conduct, or reporting of the PHS-funded research.
4. Documentation and Record Maintenance
   The Division of Administration and Finance will maintain records of all financial disclosures associated with governmental sponsors and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any federal action involving those records, whichever is longer. The Division of Administration and Finance will retain custody of all records according to the following priority scheme:
   1. Individual granting agency’s specific requirements
   2. CSU Records management requirements (refer to State University Administrative Manual), and
   3. California Department of General Services General Retention Schedules (refer to Procurement Division)

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      ¹ Section 510 of the National Science Foundations (NSF) Grant Policy Manual and Section 50.605 of the National Institute of Health’s GUIDE, Volume 24, Number 25, July 14, 1995 state that “A conflict of interest exists when the reviewer(s) reasonably determines that a significant financial interest could directly and significantly affect the design, conduct or reporting of (NSF-) (NIH-) funded research or educational activities.”

Addendum to the SSU Conflict of Interest Policy

U.S. Public Health Services proposals and awards

Purpose

This policy promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest and ensures compliance with ICSUAM Policy 11000.010.002.

Policy 

SSU is required to assist investigators, students, and research staff in determining whether and to what extent outside financial relationships and interest may conflict their primary research and academic activities or other institutional activities.

SSU is required to maintain procedures for managing and resolving individual financial conflicts of interest and complying with the regulations applicable to grants and contracts received from the U.S. Public Health Service (PHS).

Scope

This policy and related procedures apply to the University, specifically, externally sponsored programs.

This policy applies specifically to proposals and awards related to the PHS including the National Institutes of Health (NIH) and the Health Resources and Services Administration (HRSA).

Responsibilities

Chief Academic Officer

The Chief Academic Officer's responsibility is to ensure that SSU has procedures to comply with conflicts of interest regulations applicable to proposals submitted to PHS Awarding Components.

Associate Vice President for Research & Sponsored Programs/Chief Research Officer

The AVPRSP's responsibility is to ensure that appropriate processes and procedures are in place to ensure that SSU complies with PHS conflict of interest regulations for proposals submitted to PHS Awarding Components. The AVPRSP has overall responsibility for reviewing and evaluating initial and subsequent disclosures, developing and implementing plans to address financial conflicts of interest, reporting financial conflicts of interest to the PHS Awarding Component, and taking necessary corrective actions to address research that is determined to be biased based on a conflicts of interest.

Office of Research & Sponsored Programs (ORSP)

The Office of Research & Sponsored Programs' responsibility is, under the direction of the AVP Research & Sponsored Programs, to implement SSU's processes and procedures established to ensure that SSU complies with PHS conflict of interest regulations for proposals submitted to PHS Awarding Components.

Investigator

The Investigator's responsibility is to disclose significant financial interests and comply with SSU policies and procedures required for SSU to remain in compliance with PHS conflict of interest regulations.

Chief Financial Officer

The Chief Financial Officer's responsibility is to ensure that SSU has procedures to comply with PHS conflict of interest regulations for awards issued by PHS Awarding Components to SSU.

Associate Vice President for Administration & Finance

The AVP's responsibility is to ensure that appropriate processes and procedures are in place to ensure that SSU complies with PHS conflicts of interest regulations for awards issued by PHS Awarding Components to SSU.

Sponsored Programs Administration

Sponsored Programs Administration's responsibility is, under the direction of the AVP Administration & Finance, to implement SSU's processes and procedures established to ensure that SSU complies with PHS conflict of interest regulations for awards issued by PHS Awarding Components to SSU.

Definitions

Designated institutional official means the SSU official with responsibility for ensuring compliance with PHS conflict of interest regulations for PHS-funded proposals and awards.

Disclosure of significant financial interests means an Investigator's disclosure of significant financial interests to an Institution.

Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

FCOI report means an Institution's report of a financial conflict of interest to a PHS Awarding Component.

Financial interest means anything of monetary value, whether or not the value is readily ascertainable.

HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.

Institutional responsibilities means an Investigator's professional responsibilities on behalf of SSU which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

PD/PI means a project director or principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this subpart.

PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).

PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this subpart.

Research means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this policy, the term includes any such activity for which research funding is available from a PHS Awarding Component.

Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by SSU in the grant application, progress report, or any other report submitted to the PHS by SSU under PHS conflict of interest regulations.

Significant financial interest means:

1. A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:

   1. With regard to any publicly traded entity, a significant financial interest exists if the value of 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;

   2. With regard to any non-publicly traded entity, a significant financial interest exists if the value of 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

   3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

2. Investigators also must disclose 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 disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration; additional disclosure, including the monetary value of the travel may be required by SSU's designated official to determine if the travel constitutes an FCOI with the PHS-funded award.

3. The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by SSU to the Investigator if the Investigator is currently employed or otherwise appointed by SSU, including intellectual property rights assigned to SSU and agreements to share in royalties related to such rights; 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; or 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.

Requirements

1. Institutional Requirements

   1. SSU shall maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with PHS regulations and make such policy available via a publicly accessible web site.

   2. SSU shall inform each Investigator of the SSU's policy on financial conflicts of interest, the Investigator's responsibilities regarding disclosure of significant financial interests, and of PHS regulations, and require each Investigator to complete training regarding the same prior to engaging in research related to any PHS-funded award and at least every four years, and immediately when any of the following circumstances apply:

      1. SSU revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;

      2. An Investigator is new to SSU; or

      3. SSU finds that an Investigator is not in compliance with SSU's financial conflict of interest policy or management plan.

   3. If SSU administers PHS-funded awards through a subrecipient (e.g., subcontractors or consortium members), SSU, as the prime awardee, shall take reasonable steps to ensure that any subrecipient Investigator complies with PHS regulations by:

      1. Incorporating as part of subrecipient agreement terms that establish whether SSU's financial conflict of interest policy or that of the subrecipient will apply to the subrecipient's Investigators.

         1. If the subrecipient's Investigators must comply with the subrecipient's financial conflict of interest policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with PHS regulations. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to SSU's financial conflict of interest policy for disclosing significant financial interests that are directly related to the subrecipient's work for SSU;

         2. Additionally, if the subrecipient's Investigators must comply with the subrecipient's financial conflict of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to SSU. Such time period(s) shall be sufficient to enable SSU to provide timely FCOI reports, as necessary, to the PHS as required by PHS regulations;

         3. Alternatively, if the subrecipient's Investigators must comply with SSU's financial conflicts of interest policy, the subrecipient agreement specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to SSU Such time period(s) shall be sufficient to enable SSU to comply timely with its review, management, and reporting obligations under PHS regulations.

      2. Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators consistent with PHS regulations (i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI).

   4. SSU shall designate an institutional official to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, PHS-funded awards.

   5. SSU shall require that each Investigator who is planning to participate in the PHS-funded research disclose to SSU's designated official(s) the Investigator's significant financial interests (and those of the Investigator's spouse and dependent children) no later than the time of application for PHS-funded award.

   6. SSU shall require each Investigator who is participating in the PHS-funded award to submit an updated disclosure of significant financial interests at least annually during the period of the award. Such disclosure shall include any information that was not disclosed initially or in a subsequent disclosure of significant financial interests (e.g., any financial conflict of interest identified on a PHS-funded project that was transferred from another Institution), and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).

   7. SSU shall require each Investigator who is participating in a PHS-funded award to submit an updated disclosure of significant financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.

   8. The following guidelines shall apply to assist the designated institutional official to determine whether an Investigator's significant financial interest is related to a PHS-funded award and, if so related, whether the significant financial interest is a financial conflict of interest as follows:

      • An Investigator's significant financial interest is related to a PHS-funded award when SSU, through its designated official, reasonably determines that the significant financial interest: could be affected by the PHS-funded award; or is in an entity whose financial interest could be affected by the award.

      • SSU may involve the Investigator in the designated official's determination of whether a significant financial interest is related to a PHS-funded award.

      • A financial conflict of interest exists when SSU, through its designated official, reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded award.

   9. SSU shall take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a subrecipient Investigator. Management of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective review and mitigation report.

   10. SSU shall provide initial and ongoing FCOI reports to the PHS Awarding Component as required by PHS regulations.

   11. SSU shall maintain records relating to all Investigator disclosures of financial interests and SSU's review of, and response to, such disclosures (whether or not a disclosure resulted SSU's determination of a financial conflict of interest) and all actions under SSU's policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the PHS Awarding Component or, where applicable, other record retention requirements.

   12. SSU shall establish adequate enforcement mechanisms to ensure Investigator compliance as appropriate.

   13. SSU shall certify, in each application for PHS funding that SSU:

       1. Has in effect, up-to-date, written, and enforced administrative process to identify and manage financial conflicts of interest with respect to all research projects for which funding is sought or received from the PHS;

       2. Shall promote and enforce Investigator compliance with PHS regulations including those pertaining to disclosure of significant financial interests;

       3. Shall manage financial conflicts of interest and provide initial and ongoing FCOI reports to the PHS Awarding Component consistent with PHS regulations;

       4. Agrees to make information available, promptly upon request, to the HHS relating to any Investigator disclosure of financial interests and SSU's review of, and response to, such disclosure, whether or not the disclosure resulted in the SSU's determination of a financial conflict of interest; and

       5. Shall fully comply with the requirements of PHS's conflict of interest regulations.

2. Management and Reporting of Financial Conflicts of Interest for PHS-funded Proposals and Awards

   1. Management of financial conflicts of interest

      1. Prior to the SSU's expenditure of any funds under a PHS-funded award, SSU's designated official shall, consistent with PSF regulations: review all Investigator disclosures of significant financial interests; determine whether any significant financial interests relate to a PHS-funded award; determine whether a financial conflict of interest exists; and, if so, develop and implement a management plan that 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:

         1. Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);

         2. For research projects involving human subjects research, 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 relationships that create financial conflicts.

      2. Whenever, in the course of an ongoing PHS-funded award, an Investigator who is new to participating in the research project discloses a significant financial interest or an existing Investigator discloses a new significant financial interest, SSU's designated official shall, within sixty days: review the disclosure of the significant financial interest; determine whether it is related to a PHS-funded award; determine whether a financial conflict of interest exists; and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest. 
         Depending on the nature of the significant financial interest, SSU may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded award between the date of disclosure and the completion of the review.

      3. Whenever SSU identifies a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by SSU during an ongoing PHS-funded award (e.g., was not timely reviewed or reported by a subrecipient), the designated official shall, within sixty days: review the significant financial interest; determine whether it is related to a PHS-funded award; determine whether a financial conflict of interest exists; and, if so:

         1. Implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward;

         2. In addition, whenever a financial conflict of interest is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by SSU to constitute a financial conflict of interest; failure by SSU to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, SSU shall, within 120 days of the Institution's determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded award to determine whether the PHS-funded award, or any portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. 
            SSU is required to document the retrospective review; such documentation shall include all of the following key elements:

            1. Project number;

            2. Project title;

            3. PD/PI or contact PD/PI if a multiple PD/PI model is used;

            4. Name of the Investigator with the FCOI;

            5. Name of the entity with which the Investigator has a financial conflict of interest;

            6. Reason(s) for the retrospective review;

            7. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);

            8. Findings of the review; and

            9. Conclusions of the review.

         3. Based on the results of the retrospective review, if appropriate, SSU shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. 
            If bias is found, SSU shall notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the award and SSU's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). 
            Thereafter, SSU will submit FCOI reports annually. Depending on the nature of the financial conflict of interest, SSU may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded award between the date that the financial conflict of interest or the Investigator's noncompliance is determined and the completion of SSU's retrospective review.

      4. Whenever SSU implements a management plan pursuant to PHS regulations, SSU shall monitor Investigator compliance with the management plan on an ongoing basis until the completion of the PHS-funded award.

      5. Prior to SSU's expenditure of any funds under a PHS-funded award, SSU shall ensure public accessibility, via written response to any requestor within five business days of a request, of information concerning any significant financial interest disclosed to SSU that meets the following three criteria:

         • The significant financial interest was disclosed and is still held by the senior/key personnel as defined by this subpart;

         • SSU determines that the significant financial interest is related to a PHS-funded award; and

         • SSU determines that the significant financial interest is a financial conflict of interest.

         The information that SSU shall make publicly available, at a minimum, include the following: the Investigator's name; the Investigator's title and role with respect to the award; the name of the entity in which the significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value range of the significant financial interest, or a statement that the financial interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
         SSU shall note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within 60 days of the identification of a new financial conflict of interest, which should be requested subsequently by the requestor.
         Information concerning the significant financial interests of an individual subject to public accessibility shall remain available, for responses to written requests for at least three years from the date that the information was most recently updated.

   2. Reporting of financial conflicts of interest

      1. Prior to SSU's expenditure of any funds under a PHS-funded award, SSU shall provide to the PHS Awarding Component an FCOI report regarding any Investigator's significant financial interest found by SSU to be conflicting and ensure that SSU has implemented a management plan in accordance with PHS regulations.
         In cases in which SSU identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS-awarded funds, SSU shall not submit an FCOI report to the PHS Awarding Component.

      2. For any significant financial interest that the Institution identifies as conflicting subsequent to the SSU's initial FCOI report during an ongoing PHS-funded award (e.g., upon the participation of an Investigator who is new to the research project), SSU shall provide to the PHS Awarding Component, within sixty days, an FCOI report regarding the financial conflict of interest and ensure that SSU has implemented a management plan in accordance with PHS regulations. 
         Where such FCOI report involves a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed or managed by SSU (e.g., was not timely reviewed or reported by a subrecipient), SSU also is required to complete a retrospective review to determine whether any PHS-funded award, or any portion thereof, conducted prior to the identification and management of the financial conflict of interest was biased in the design, conduct, or reporting of such research. 
         If bias is found, SSU is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.

      3. FCOI reports required by PHS shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of SSU's management plan. Elements of the FCOI report shall include, but are not necessarily limited to the following:

         1. Project number;

         2. PD/PI or Contact PD/PI if a multiple PD/PI model is used;

         3. Name of the Investigator with the financial conflict of interest;

         4. Name of the entity with which the Investigator has a financial conflict of interest;

         5. Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);

         6. Value of the financial interest (dollar ranges are permissible: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value;

         7. A description of how the financial interest relates to the PHS-funded award and the basis for SSU's determination that the financial interest conflicts with the PHS-funded award; and

         8. A description of the key elements of SSU's management plan, including:

            1. Role and principal duties of the conflicted Investigator in the research project;

            2. Conditions of the management plan;

            3. How the management plan is designed to safeguard objectivity in the research project;

            4. Confirmation of the Investigator's agreement to the management plan;

            5. How the management plan will be monitored to ensure Investigator compliance; and

            6. Other information as needed.

      4. For any financial conflict of interest previously reported by SSU with regard to an ongoing PHS-funded award, SSU shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded award. 
         The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. SSU shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.

3. Other Obligations to PHS

   1. If the failure of an Investigator to comply with an SSU's financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of a PHS-funded award, SSU shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken.

   2. SSU shall submit, or permit on site review of, all records pertinent to compliance with this PHS's conflict of interest regulations.

Procedures

Office of Research & Sponsored Programs

• Develop Statement of Economic Interests for Principal Investigators on Proposals to PHS Agencies Form (Disclosure Form) which is consistent with the disclosure requirements of PHS;

• Ensure Disclosure Form is completed in conjunction with Proposal Endorsement Form;

• Communicate disclosed items to AVP Research & Sponsored Programs;

• Provide adequate training and resources for Principal Investigators and other staff regarding conflicts of interest;

• Ensure publication of policy on web site.

AVP Research & Sponsored Programs/Chief Research Officer (Designated Official)

• Primary Endorsement Official for the Disclosure Form;

• Review disclosures, assess their potential for conflicts of interest, and develop resolution strategies to manage, reduce or eliminate such conflicts;

• When appropriate, convene the Campus Conflict of Interest Committee consisting of the AVP Research & Sponsored Programs, the Internal Auditor, the Dean (or equivalent of the Principal Investigator's school), and the Campus Conflict of Interest Officer;

• Overall responsibility for financial conflict of interest reporting to PHS awarding agencies (pre award and post award);

• Respond to written request regarding FCOI disclosures subject to this policy.

Sponsored Programs Administration

• Ensure that any FCOI disclosures have been properly addressed prior to expenditure of any award funds;

• Initiate and review annual disclosure process;

• In collaboration with Procurement Office, ensure that subrecipient agreements comply with PHS regulations;

• In collaboration with ORSP, ensure conflict of interest training is provided to appropriate individuals as required by PHS regulations;

• Notify AVP Research & Sponsored Programs of any disclosures subsequent to award that require reporting to PHS awarding agency;

• Ensure proper reporting PHS awarding agencies has been completed;

• Maintain conflict of interest Disclosure Form(s), management plans, and other applicable documentation within award files in compliance with PHS regulations and CSU record retention standards.

Related Documents

• 42 Code of Federal Regulations Subpart F (Grants and Cooperative Agreements)

• 45 Code of Federal Regulations Part 94 (Contracts)

Updated May 10, 2012 by SSU.policies@sonoma.edu