October 6, 1997
SENIOR VICE PRESIDENT-BUSINESS AND FINANCE
VICE PRESIDENT-AGRICULTURE AND NATURAL RESOURCES
University of California Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Sponsored Projects
The enclosed University of California Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Sponsored Projects is effective October 15, 1997. It replaces the Interim Policy and Procedures on Disclosure of Financial Interests Related to Sponsored Projects which became effective October 1, 1995. It responds to requirements promulgated by the National Science Foundation and the U.S. Public Health Service, including the National Institutes of Health, that institutions responsible for the conduct of research sponsored by those agencies provide for the disclosure and review of interests of investigators that are related to the research.
The Policy will apply automatically only to NSF and PHS sponsored research projects. The University may elect to apply the disclosure requirements of this Policy to certain University-managed programs, if those programs so request, and if their requests are subsequently granted by the Vice Provost for Research. However, application of this Policy will be expanded to other extramural sponsors only if necessary to comply with official requirements subsequently imposed by those sponsors.
This Policy supplements, but does not supplant, the University Policy on Disclosure of Financial Interest in Private Sponsors of Research (issued April 26, 1984) and the Guidelines for Disclosure and Review of Principal Investigator's Financial Interest in Private Sponsors of Research (issued April 27, 1984).
This Policy was developed by the Office of the President in conjunction with the Council on Research and the Council of Vice Chancellors for Research. It has been reviewed by each of the campuses and the three DOE laboratories, relevant committees of the Academic Senate, relevant parties within the Office of the President, including the Office of General Counsel, and by the Directors of University-managed research programs.
This Policy, in and of itself, does not require any immediate changes in the procedures campuses and Laboratories have been following since implementation of the Interim Policy in October 1995.
However, there are a few significant differences between this Policy and the interim policy which it replaces aimed at increasing administrative flexibility and easing the overall regulatory burden on research at the University. Campuses and Laboratories now have the discretion to alter their forms and procedures based on these changes:
1. Scope. With respect to extramural sponsors, its provisions apply only to research proposals submitted to the National Science Foundation and the U.S. Public Health Service, including the National Institutes of Health. It will be extended to other extramural sponsors only if those sponsors officially require it.
2. Negative Disclosures. Consistent with federal regulations, the University will continue to require Investigators to fill out written disclosure forms when there are significant and related financial interests to report under the provisions of this Policy. However, when an Investigator does not have a significant and related financial interest, a simple negative statement, in some documented form, may be substituted for the full written disclosure. This reporting responsibility is separate from an Investigator's ongoing duty to update financial disclosures either annually or as new significant and related financial interests are obtained throughout the period of the award. Each campus and Laboratory may design its own forms as long as they meet minimum requirements established in this Policy. Campuses and Laboratories retain the option of requiring a single, annual Disclosure from an Investigator in lieu of a separate Disclosure with each award, provided that a designated University Reviewing Official and, if necessary, an Independent Substantive Review Committee (ISRC), can assure that each specific sponsored project and the related financial interests were examined in the scope of the annual review.
3. Level of Financial Detail to be Reported. To determine the "significance" of a financial interest, Investigators will be asked simply whether their income from or investments in a single entity exceeded $10,000 during the prior twelve months. (Federal regulations require institutions to ensure that their Investigators make their best reasonable estimates of expectedincome, from a single entity, over the next twelve months. It is the policy of the University of California that the best reasonable estimate of expected income from an entity over the nexttwelve months is the amount of income the Investigator received from the entity, exceeding $10,000, during the previous twelve months). A campus or Laboratory reviewing official or review committee may request more detailed financial information at a later point in the review process if they deem such detail necessary to assess and manage a potential conflict of interest.
4. Comprehensiveness and Consistency. Strong concerns were raised in comments by some campuses about the need for a more comprehensive conflict of interest policy, concerns that have been difficult to balance with equally strongly-voiced concerns about not exceeding current federal disclosure requirements. This Policy balances those concerns by creating a mechanism which allows the Vice Provost for Research to extend the specific disclosure requirements of this Policy to certain University-managed programs, upon the request of those programs. A new mechanism for voluntary disclosure is also provided, should an Investigator wish to have a personal interest reviewed by the University whose review is not otherwise required by this Policy. (As required by state law, Principal Investigators must also continue to file University Form 730-U whenever research proposed for funding to PHS or NSF [or a University-managed program subsequently covered by this Policy] will also be sponsored in part by a non- governmental entity. In such cases, campuses and laboratories are encouraged to alert Principal Investigators to the separate reporting thresholds for 730-U purposes and the need to also file a 730-U form).
5. Relatedness of Consulting Income to Proposed Research. The Policy provides campuses and Laboratories with more flexibility in deciding how to assess whether an Investigator's consulting interests are related to a proposed research project. Investigators are still required to report consulting income from a single entity that exceeded $10,000 during the prior twelve months, when the financial interests of that entity, or the Investigator's financial interests related to consulting for that entity, would reasonably appear to be affected by the research.
However, the assessment of which, if any, of the Investigator's financial interests related to consulting (or which, if any, of the financial interests of the entity to which the Investigator consults) would "reasonably appear to be affected by the [proposed] research" may now be made by the Investigator based on his or her academic expertise in his or her professional field; those interests are to be reported if they exceed the reporting threshold of $10,000 from a single entity during the prior twelve months. Investigators who are members of the faculty are reminded of their separate obligation, pursuant to the University Policy on Outside Professional Activities of Faculty Members, published as Academic Personnel Manual Policy 025, to provide descriptive information, through annual reports to department chairpersons or equivalent unit heads, regarding time and effort devoted to all outside professional activities related to their academic specialty.
Alternatively, campuses and Laboratories may still elect to require Investigators to report allconsulting income in the Investigator's professional field (provided it exceeds $10,000 from a single entity during the previous twelve months) to a University Reviewing Official, the ISRC, or to a panel of experts in the Investigator's academic specialty, for an independent assessment as to whether any of that entity's financial interests, or the Investigator's financial interests related to consulting for that entity, would reasonably appear to be affected by the proposed research.
Thank you for your advice and cooperation in developing this Policy.
Richard C. Atkinson
cc: Members, President's Cabinet
Vice Chancellors for Research
Members, Council on Research
Special Assistant Gardner
Principal Officers of The Regents