Review and Management
The UC Berkeley faculty Conflict of Interest (COI) Committee reviews all positive financial disclosures and takes the necessary steps to manage, reduce, or eliminate any conflicts of interest before approval is granted. Approval of the financial disclosure by the COI Committee is required before any awards are set up by the Sponsored Projects Office. Below is an overview of the review process for positive disclosures and what happens when the committee finds a conflict of interest.
- Positive disclosure received
- COI Coordinator reviews disclosure to determine if expedited or full review is needed
- COI Committee review
- Expedited review (1-2 weeks)
- Full review (monthly)
- Results emailed to Investigators and staff (5-10 business days after review)
A positive disclosure is a Significant Financial Interest (SFI), i.e. a disclosable financial interest.
- For PHS, a Financial Conflict of Interest (FCOI) is defined under the regulation as an SFI that is related to the PHS-funded research activity and that could directly and significantly affect the design, conduct or reporting of that activity.
- For NSF and other federal non-PHS agencies, a Related Financial Interest is an SFI that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by NSF; or in entities whose financial interests would reasonably appear to be affected by such activities.
- For State disclosures, a positive disclosure signals the existence of a potential conflict of interest, a situation in which financial or other personal considerations may bias, or have the appearance of biasing, an investigator's professional judgment in conducting or reporting research funded by the non-governmental agency.
The campus Conflict of Interest Committee is a panel of faculty members from disciplines across the campus. They review positive disclosures of financial interests to determine whether these interests constitute significant conflicts of interest that must be eliminated, reduced or managed before research support can be accepted. If they determine that the research support may be accepted, the Committee then also determines an appropriate strategy for management of any significant conflict before approval is granted.
Approval of the COI Committee is required before any awards are set up by the Sponsored Projects Office or Industry Alliances Office, or before any gift funds can be released by the University Development and Alumni Relations office.
The Conflict of Interest Committee reviews each financial disclosure in accordance with the University of California Guidelines for Disclosure and Review of Principal Investigator’s Financial Interest in Private Sponsors of Research (Academic Personnel Manual Section 028-10, Disclosure of Financial Interests and Management of Conflicts of Interest, National Science Foundation Awards (NSF), or Disclosure of Financial Interests & Management of Conflicts of Interest, Public Health Service Research Awards (PHS)).
Conflict of Interest Committee Determination
In general, the Committee asks: are the research interests and the private interests kept separate; is the research appropriate to the University; is the teaching and research environment open; is there freedom to publish; have licensing agreements been appropriately reviewed; and are University facilities used appropriately.
The Committee then determines whether the financial interest represents a real or perceived conflict of interest, and if so, whether any action should be undertaken to eliminate, reduce, or otherwise manage the conflict. The Committee applies standards that have evolved over time, based on their prior experience, the appearance of new types of conflicts, and input from the local and national research community.
Managing Related Significant Financial Interest
If the Committee determines that the disclosed financial interests constitute a real or perceived conflict of interest, they will recommend actions designed to eliminate, reduce, or manage the conflict. In some instances, the Committee may simply recommend disclosing the interest in all publications and presentations. Depending on the facts, the Committee may also recommend other measures such as divestiture of all equity interest in the sponsor or elimination of any consulting arrangement with the sponsor. Management or elimination of conflicts of interest may include but are not limited to:
- Withdrawal of proposal
- Non-acceptance of the gift or grant
- Notice to students and other project personnel of Investigator’s conflicting interests
- Appointment of additional, non-conflicted student advisors
- Public disclosure of the related financial interest
- Monitoring of the project by independent reviewers
- Modification of the research or project plan
- Disqualification from participation in all or a portion of the project
- Divestiture of the related financial interest(s)
- Severance of relationships that create actual or potential conflicts
Additional measures may include the appointment of an ad hoc faculty oversight committee, with the express responsibility to safeguard the interests of students working on the project. See Department Management for guidance on the faculty oversight committee.
The details of personal financial interests reported to the campus are treated sensitively and shared only on a need to know basis within the University. The decision of the Conflict of Interest Committee may be shared with University officials as deemed necessary. In cases relating to projects involving human subjects, the recommendation will be shared with the IRB. It may also be shared with the research sponsor if requested. Other than these mandated disclosures or limited internal disclosures, the information is treated as confidential. However, under California law and PHS regulations, information disclosed to the University must be made available to the public upon request.
Public Access to Information
The institution must make certain FCOI information for senior/key personnel available within five business days of the request. The response must be postmarked or dated (if replying by electronic means) within five days of receipt of a written request. All written requests must be sent to email@example.com.
All information provided as a result of such requests will be current as of the date of the correspondence to the requester and will be updated at least annually and within 60 days of any subsequent request. Any information in such requests which falls outside of the 2011 regulations will be responded to in accordance with the requirements of the California Public Records Act.
Institutional Reporting to NIH
The institution must determine if any disclosed SFI is related to the PHS-funded research and, if so, whether that SFI rises to the level of a Financial Conflict of Interest (FCOI). If such a determination is made, the institution must report the FCOI to NIH, along with details about the SFI and its management. The regulation also now requires that the public be provided, upon request, certain details of the SFI as reported to NIH.
In cases of non-compliance, a retrospective review is required for later determined financial conflicts of interest. The review is not required to be submitted to the PHS Awarding Component unless bias is found.