420.030 Conflict with the Interests of Federal Grant Agencies

Executive Order 39, previously issued as Executive Guideline 32, 9-18-95, Amended 8-24-12.

1. Purpose – This Executive Order is intended to comply with the requirement of the National Science Foundation (NSF) and the Public Health Service of the Department of Health and Human Services (PHS), that grantee institutions maintain an appropriate written and enforced policy on conflict of interest consistent with provisions in the NSF Grant Policy Manual and 42 CFR Part 50 and 45 CFR Part 94.  This policy pertaining to conflicts with the interests of federal grant agencies is applicable to investigators, as defined below, involved in proposed or funded research by NSF or PHS (including NIH).  All University employees are also subject to CRR 330.015, pertaining to conflicts with the interests of the University.  Researchers on Human Subjects and certain University officials are also subject to CRR 410.020 pertaining to Institutional Conflicts in Human Subjects Research.
2. Definitions – For the purposes of this Executive Order, the following terms have the meanings stated:
   
   1. The term “investigator” means the project director, principal investigator, co-principal investigators, collaborators or consultants and any other person who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by NSF or PHS.
   2. The term ‘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 (salary, consulting fees, honoraria, paid authorship or other payment for services) received from the entity in the twelve months preceding the disclosure and the value of any equity interests (stock, stock option, or other ownership interest and determined through reference to public prices or other reasonable measures of fair market value) in the entity as of the date of disclosure, when aggregated, exceeds $5,000 for PHS-funded purposes and $10,000 for NSF-funded purposes. 
         (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. PHS-funded Investigators must also 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 by 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 University will determine if a determination or disclosure of monetary value is required in order to determine whether the travel constitutes a conflict of interest with PHS-funded research.
      3. The term does not include:
         

         (1) salary, royalties or other remuneration from the University, including intellectual property rights assigned to the institution and agreements to share in royalties related to such rights;
         (2) 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;
         (3) 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;
         (4) 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;
         (5) public or nonprofit entities.

   3. For the purpose of this Executive Order, a “Financial Conflict of Interest” means a significant financial interest that could directly and significantly affect the design, conduct or reporting of NSF- or PHS-funded research.
3. Investigator’s Duty – Training.  Each investigator involved in any PHS- or NSF- funded grant or contract shall complete training prior to engaging in research related to such grant or contract; shall complete training at least every four years; and shall complete training immediately if (a) there is a change in this policy that affects investigator requirements, (b) the investigator is new to the University, or (c) the University finds the investigator noncompliant with this policy or management plan created pursuant to this policy.
4. Investigator’s Duty – Disclosure.  Each investigator shall disclose to the designated Institutional Official(s) all significant financial interests of the investigator (including those of the investigator’s spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities.
   This information must be disclosed:
   1. at the time the application is submitted;
   2. on an annual basis during the period of the award; and
   3. within 30 days of discovering or acquiring a new significant financial interest.

   For PHS proposals and awards, subgrantees, contractors and collaborators shall have the same duty to disclose as investigators.

5. Institutional Duties
   
   1. Institutional Duties – The Chancellor of each campus shall designate one or more persons (Reviewer) to
      
      1. provide training for investigators;
      2. solicit and review financial disclosures;
      3. determine whether a financial conflict of interest with the interests of NSF or PHS exists;
      4. determine what conditions or restrictions, if any, should be imposed by the University to manage, reduce or eliminate such conflict of interest and resolve actual or potential problems revealed;
      5. conduct a retrospective review in cases of noncompliance and make any reports required by the appropriate regulations to the granting agency or the public;
      6. incorporate in a written agreement with any subrecipient terms that establish whether the conflict of interest policy of the University or that of the subrecipient will apply to the subrecipient’s Investigators, and otherwise comply with the requirements of 42 U.S.C. Section 50.604; and
      7. develop and publish campus guidelines and procedures to comply with NSF and PHS requirements for the identification, management and reporting of financial conflicts of interest with respect to all research projects for which funding is sought or received from NSF or PHS, and for any reporting or records maintenance requirements of those agencies.
   2. Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate actual or potential conflicts of interest include, but are not limited to:
      
      1. public disclosure of significant 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. monitoring of research by independent reviewers 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 from participation in the portion of the NSF-funded research that would be affected by the significant financial interests;
      6. reduction or elimination of the financial interest (e.g. sale of an equity interest); or
      7. severance of relationships that create financial conflicts.

   If the University is unable to satisfactorily manage an actual or potential conflict of interest, the Reviewer shall keep the NSF or PHS appropriately informed.

   PHS shall be informed of all conflicts with its interests and mechanisms for managing them.

6. Enforcement
   
   1. Allegations of undisclosed conflicts with the interests of NSF or PHS or of failures to comply with conditions or restrictions imposed to manage, reduce or eliminate such conflicts shall be investigated by the University, and appropriate notifications to NSF, PHS and the public shall be made.
   2. Conduct by an employee that violates this policy shall constitute a breach of the employment contract and may lead to disciplinary action up to and including termination.
   3. Conduct by subgrantees, contractors or collaborators that violates this policy shall constitute a breach of contract and may lead to appropriate action, up to and including termination of the contractual agreement.
7. Records – The University will retain records of investigator financial disclosures and of actions taken to manage conflicts of interest for (for NSF) three years after the later of the termination or completion of the award to which they relate or the resolution of any government action involving those records; or (for PHS) for three years after final payment or, where applicable, for the other time periods specified in 45 CFR 74.53(b), 45 CFR 92.42(b), and 48 CFR Part 4, subpart 4.7.