Responsibilities & Procedures: 100-34

Disclosure of Financial Interests & Management of Conflicts of Interest, Public Health Service (PHS) Research Awards

  1. Disclosure
    1. Investigators
      1. Investigators must disclose all Significant Financial Interests related to their Institutional Responsibilities, no later than at the time of application for PHS funding.
      2. UCSF Investigators who are engaged in PHS Activities have an ongoing responsibility to update their disclosures throughout the period of PHS support: 
        1. Within thirty (30) days of acquiring or discovering any new SFI (with the exception of travel disclosures explained below, see  section IV. A.1.d.); and 
        2. At least annually throughout the period of the award.
      3. New Investigators must complete a disclosure of SFI before joining an ongoing PHS Activity.
      4. Sponsored or reimbursed travel may be disclosed:
        1. Prospectively listing all anticipated travel (including information about the purpose of the trip, the identity of the sponsor/organizer, the destination and the duration of the trip, as well as any other relevant information as defined by the COIAC) for the 12 month period following the filling of the Investigator's annual disclosure form; and/or
        2. Within 30 days of the occurrence of travel that either was not listed on the prospective annual travel report pursuant to paragraph i) or that significantly varied in the threshold reporting details from what was listed in the prospective report.
    2. Principal Investigators (PIs)
      1. PIs must identify all Investigators on the award (that is, all individuals who will have responsibility for designing, conducting, or reporting the research to be funded by PHS) who are required to disclose Significant Financial Interests. 
    3. Collaborators/ Subrecipients
      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 subaward from UCSF are expected to comply with the policies and procedures of the organization at which they are employed. Subawards issued by the University will ask the subrecipient institution to certify that its policy is in compliance with Department of Health and Human Services (HHS) conflict of interest regulations, and unless the subrecipient does not have a HHS-compliant policy, will indicate that the recipient < organization is responsible for reviewing the disclosures submitted by its Investigators and, if a Financial Conflict of Interest is identified, for sending prompt notification to UCSF of the conflict and of the subrecipient institution&rsquo;s plan to manage, reduce or eliminate the identified conflicts, so that UCSF can report identified FCOIs to the NIH as required by the regulation.
        1. if the subrecipient institution does not have a conflict of interest policy that complies with the HHS regulations, collaborators must comply with UCSF's policies and procedures for disclosure and review of a Significant Financial Interests related to PHS sponsored awards.
      2. Collaborators who share responsibility for the design, conduct, and reporting of research results, and who&nbsp;will participate in research under an <em>independent consulting agreement</em> issued by UCSF should be identified as Investigators by the UCSF PI and must complete the UCSF disclosure forms. If, upon review, UCSF determines that these SFI could directly and significantly affect the design, conduct, or reporting of the research to be performed under the agreement, these collaborators will be expected to adhere to the mitigation plans put in place to eliminate, reduce or manage the identified conflicts of interest.
  2. Training/Education  

      1. Investigators must complete NIH-compliant training/education program on Financial Conflicts of Interest, the responsibilities to disclose and the PHS regulations:
        1. Before engaging in PHS Activities and at least every four years thereafter while receiving PHS funding, and
        2. Immediately when
          1. An Investigator is not in compliance with this Policy or has failed to comply with a plan put in place to manage or mitigate a Financial Conflict of Interest; or
          2. UCSF revises its FCOI policy and the revision affects requirements of Investigators; or
          3. An Investigator is new to UCSF; or
          4. At any other time as may be required by the University in accordance with HHS regulations.
  3. Review of Disclosures; Management Plan
      1. With each PHS proposal, progress report, incremental funding or extension, when a new Investigator participates in the PHS Activity, and when an Investigator reports a new Significant Financial Interest, Investigators's 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 PHS Activity in which the Investigator is engaged.
      2. In the event that the Designated Official (or designee) concludes that an Investigator's Significant Financial Interest reasonably appears related to the PHS Activity, 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 SFI related to the PHS Activity appears to directly and significantly affect the design, conduct, or reporting of the PHS Activity and thereby constitutes a FCOI that may need to be eliminated, reduced or managed.
      4. When the COIAC determines that there is a Financial Conflict of Interest, 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 ("management plan.")
      5. The management plan is to be implemented prior to expenditure of PHS funds awarded for the project, and shall specify the actions that are required to manage the FCOI, and may include:
        1. The role and principal duties of the conflicted Investigator;
        2. Conditions of the management plan;
        3. How the plan will safeguard objectivity in the research activity; 
        4. Confirmation of the investigators agreement to the plan; and
        5. How the plan will be monitored.
  4. Reporting to PHS
      1. Initial Reports
        1. Prior to expenditure of any funds provided under a PHS award, the Designated Official (or designee) must provide to the PHS funding agency an initial report regarding Investigator Financial Conflict of Interest. If Financial Conflicts of Interest are eliminated before research funds are expended, UCSF is not required to submit a report to the PHS funding agency.
      2. Additional FCOI reports must be submitted to PHS under the following circumstances:
        1. Within sixty (60) days of determining that a FCOI exists based on disclosure of a newly acquired or newly discovered SFI by an Investigator during the course of an ongoing PHS Research Activity;
        2. Within sixty (60) days of determining that a FCOI exists for an Investigator who joins an&nbsp;ongoing PHS Research Activity; 
        3. Throughout the lifetime of an award when progress reports are submitted, or at the time that an award is extended (either through extension notification or an NIH prior approval request) to provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project. When during the course of an ongoing PHS Activity a FCOI ceases to exist, updated information about the status of that FCOI should be provided with the subsequent progress report; 
        4. In any case which the Department of Health and Human Services (HHS) determines that a PHS-sponsored 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 UCSF as required by this policy and Federal regulation, UCSF may require the Investigator to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.
      3. Retrospective Review
        1. When during the course of an ongoing PHS Research Activity, UCSF identifies an SFI that was not&nbsp;disclosed in a timely manner by an Investigator, or which was not previously reviewed, the Designated&nbsp;Official will review the SFI within sixty (60) days to determine whether it is related to PHS Activities and whether a FCOI exists. If a FCOI is identified after such a review, a management plan&nbsp;must be implemented, at least on an interim basis. 

          In addition, whenever a FCOI is not identified or managed in a timely manner, regardless of whether the Investigator;did not disclose a SFI that was later determined to be a FCOI, or UCSF's failure to review or manage the FCOI, or because the Investigator failed to comply with a previously implemented management plan,&nbsp;UCSF must within one hundred twenty (120) days of the determination of non-compliance complete a retrospective review of the Investigator's activities and the PHS Activities. The purpose of this&nbsp;retrospective review is to determine if the ongoing PHS Activity was biased in its design, conduct or reporting.

          1. Based on the results of the retrospective review, the previously submitted FCOI report must be&nbsp;updated to specify the actions that UCSF will take to manage the identified FCOI going forward.  
          2. If bias was found during the retrospective review, UCSF will promptly notify the PHS funding agency and will draft&nbsp;a mitigation report that at a minimum documents the key elements of the retrospective review, describes the impact of the bias on the research, and outlines UCSF&rsquo;s plans to eliminate or&nbsp;mitigate the effect of the bias.
        2. UCSF will document the retrospective review; such documentation will include the project number; project title; name of Investigator with the FCOI; name of entity with which the Investigator has a FCOI; the reasons for the retrospective review; detailed methodology used for the retrospective review; findings and conclusions.
  5. Monitoring
      1. Management plans put in place by UCSF will specify how the Investigator's compliance with the management will be monitored on an ongoing basis until completion of the PHS-funded project.  
  6. Public Access to Information
      1. UCSF is required to respond within five (5) business days to any request for information about FCOIs of senior/key personnel for research grants and cooperative agreements and key personnel for research contracts. The 5-day response shall start from the date the request for information is received at the campus designated email address (coiac@ucsf.edu).
  7. Record Retention
      1. Records of financial disclosures, Designated Official's determinations, COIAC recommendations, and University action regarding management of a conflict of interest will be retained for at least three (3) years beyond the date of submission of the award's final expenditure report, or until the resolution of any actions by PHS involving the records, whichever is longer. Records relating to unfunded projects need not be retained.  See  45 CFR 74.53(b), 92.42(b).
  8. Sanctions
      1. Failure by an individual to file a complete and truthful financial disclosure for pending proposals, or when a new interest is obtained, or failure to comply with any conditions or restrictions directed or imposed, including failure to cooperate with appointed project monitoring bodies, will be grounds for discipline pursuant to the University Policy on Faculty Conduct and the Administration of Discipline (Academic Personnel Manual, APM-016) and/or other applicable employee or student disciplinary policies. Agreements with consultants who either fail to file a complete disclosure or fail to comply with any conditions or restrictions imposed may be terminated for cause. Similarly, agreements with subrecipient organizations may be terminated for cause if that organization fails to comply with its obligations under the PHS regulations. In addition, federal regulations may require reports to the federal sponsor of any violations of federal regulations and University policy.