Responsibilities & Procedures: 100-35

Responsibilities and Procedures for Campus Administrative Policy 100-35 Disclosure of Financial Interests & Management of Conflicts of Interest, Non-Public Health Service (Non-PHS) Research Awards

 

  1.  Disclosures

    1. Investigators
      1. Investigators must disclose all Significant Financial Interests that reasonably appear related to the sponsored project before the application for funding can be submitted to NSF or other agency.
      2. UCSF Investigators have an ongoing responsibility to update the disclosure forms throughout the period of award support. Investigators must update the disclosure forms:
        1. At least annually, and
        2. If at any time during the term of an ongoing award an Investigator has a change in a Significant Financial Interest that is related to the sponsored project or acquires a new Significant Financial Interest that is related to the sponsored project that was not reported on the original disclosure form the investigator must disclose this information as a new interest is obtained.
        3. Each time a request for new funds is submitted to NSF or another federal agency following the NSF regulations, Investigators must disclose Significant Financial Interests that are related to the sponsored project;
        4. Each time a request for support is submitted to another research sponsor or program that requires review under federal regulations Investigators must disclose Significant Financial Interests that are related to the sponsored project;
        5. If a new Investigator is added to the project, he/she must disclose all Significant Financial Interests that are related to the sponsored project as soon as possible.
    2. Collaborators & Consultants
      1. Collaborators from other institutions who share responsibility for the design, conduct or reporting of research results, and who will be conducting research under a sub-grant or subcontract from UCSF are expected to comply with the policies and procedures for disclosure and review of any Significant Financial Interest at the institution at which they are employed. Those institutions are responsible for reviewing those disclosures and, if conflicts are identified, for sending UCSF assurances of their ability to manage, reduce or eliminate the conflicts.
      2. Collaborators who share responsibility for the design, conduct, and reporting of research results, and who will participate in research under an independent consulting agreement issued by UCSF should be identified as Investigators by the UCSF PI and should complete the UCSF disclosure forms.  If, upon review, UCSF determines that these financial interests could directly and significantly affect the design, conduct, or reporting of the research to be performed under the agreement, consultants will be expected to adhere to the plans put in place to eliminate, reduce or manage the identified conflicts of interest.
  2. Review of Disclosures
    1.  With each non-PHS proposal, progress report, incremental funding or extension, and when an Investigator reports a new Significant Financial Interest, Investigators’ Significant Financial Interests disclosures will be reviewed by the Designated Official (or designee) to determine whether there are any Significant Financial Interest that reasonably appear to be related to non-PHS-funded research activity in which the Investigator is engaged.
    2. In the event that an Investigator’s Significant Financial Interest reasonably appears related to the non-PHS-funded research, the Disclosure and appropriate documentation shall be forwarded to the COIAC for review.
    3. The COIAC will review the documentation and the Disclosure to determine whether the Significant Financial Interest related to the non-PHS-funded research appears to directly and significantly affect the design, conduct, or reporting of the non-PHS Activity and thereby constitutes a Financial Conflict of Interest (FCOI) that may need to be eliminated, reduced or managed.
    4. When the COIAC determines that there is a FCOI, the COIAC shall make a final recommendation to the Executive Vice Chancellor and Provost to eliminate or manage the FCOI before support can be accepted.
    5. The recommendations are to be implemented prior to expenditure of non-PHS funds awarded for the research project, and shall specify the actions that are required to manage the FCOI.
  3. Reporting Financial Conflicts of Interest
    1. If a Financial Conflict of Interest is found, UCSF will report to the federal sponsor the existence of a conflicting interest found by the institution and assure that the interest has been managed, reduced, or eliminated prior to the expenditure of any funds under the award.
    2. For any interest that UCSF identifies as conflicting subsequent to the initial report under the award, the report will be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty (60) days of that identification.
    3. UCSF agrees to make information available upon request to the agency regarding all conflicting interests identified by UCSF and how those interests have been managed, reduced, or eliminated to protect the research from bias.
  4.  Record Retention
    1.  Records of financial disclosures, Designated Official’s determination, COIAC recommendations, and University action regarding management of a conflict of interest will be retained in the Sponsor Projects Office and the Conflict of Interest Office for at least three years beyond the termination or completion of an award (at least three years from the date of submission of the final expenditures report, or, for awards that are renewed quarterly or annually, from the date of the submission of the quarterly or annual financial report, or until the resolution of any action by the sponsor involving the records, whichever is longer.) 
    2. Records relating to unfunded projects need not be retained.
  5. Access to Statements and Disclosure of Information
    1. The information provided in disclosure forms may be released or transmitted to the sponsor upon request.  
    2. Under the California Public Records Act, this information may be made available to the public upon request.
  6. Sanctions
    1.  Failure to file a complete Disclosure of Financial Interest or Update or to comply with any conditions or restrictions imposed on the conduct of the project under this Policy will be grounds for discipline pursuant to the University Policy on Faculty Conduct and the Administration of Discipline or other applicable employee disciplinary policies. 
    2. In addition, federal regulations may require reports to the federal sponsor of any information which may show a violation of University policy. Sponsors may suspend or terminate the award and/or debar an Investigator from receiving future awards in the event of failure to comply with applicable federal regulations on disclosure, review, and management of significant financial interests related to federally sponsored projects.