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Procedures for Federal Financial Disclosures

Investigators are required by Federal regulations of both the Public Health Service (PHS), the National Science Foundation (NSF), and UC policy to positively disclose a private financial interest in an entity if their interest (a) meets certain pre-defined financial thresholds and (b) the work to be performed under the sponsored project and the results of the undertaking would reasonably appear to affect the Investigator's or the entity's financial interests (and is consequently considered "Related.") Following an Investigator's disclosure of an interest, the information is reviewed within the institution to determine if the interest poses a direct and significant impact on the research that could compromise the objectivity by which the sponsored project is designed, conducted or reported - a "conflict of interest."

First Step: Streamlined Disclosure on the Administrative Approval Form

When applying to PHS or NSF with a new or renewal proposal, the Principal Investigator is responsible for indicating on the Administrative Approval (AA) form whether he/she has a significant financial interest that could be related to the sponsored project and if such interests are held by any of the co-Investigators.

Due to the short time period between application and award required by the UC Industry-University Cooperative Research Programs (BioSTAR, DiMI, SMART, LSI, CoRe), a financial disclosure form should accompany the AA form, signed by all Investigators on the project (see Second Step).

Second Step: Disclosure Preparation by Principal Investigator

When a new grant or renewal is about to be awarded, and annually thereafter for the life of the award, a Disclosure of Financial Interests form (also called the Project Cover Sheet) should be signed by the project Investigators and forwarded to the Office of Sponsored Projects Administration. Investigators are defined as those individuals who are responsible for the design, conduct, or reporting of the results of work performed or to be performed under the sponsored project.

If the Investigator does not have a financial interest that is significant and related, as defined above, he/she will file a negative disclosure, answering "no" on the Project Cover Sheet.

If, on the other hand, the Investigator has a significant and related interest, as defined above, he/she will file a positive disclosure: answer "yes" on the Project Cover Sheet, complete a Investigator's Disclosure of Economic Interests Addendum1 , and forward both to the Office of Sponsored Projects Administration. The information will be reviewed by the Conflict of Interest Oversight Committee (COIOC), a faculty committee which is advisory to the Vice Chancellor for Research.

Third Step: Negative Disclosure Review

The COIOC Administrator reviews negative disclosures, noting if they are complete and consistent with other information available. If so, the disclosure is filed. If, however, administrative staff believe previously-disclosed interests could be related, a letter is sent to the Investigator asking for clarification of a negative disclosure.

If the Investigator continues to believe the interests are unrelated, he/she is asked to provide a brief explanation of his/her position, referencing both the entity's interests and the proposed activities. The information is then forwarded to the COIOC Chair for review and recommendation to the Vice Chancellor for Research to either (1) accept the Investigator's explanation and determination of "no relatedness"; or (2) find the explanation insufficient to justify a "no relatedness" decision and require a positive disclosure. The Vice Chancellor for Research (VCR), as the designated Institutional Reviewer, will make the final determination regarding the necessity to file a positive disclosure. If the VCR believes a positive disclosure is necessary, the Investigator will be notified. If none is required, the Investigator's memo of response simply will be retained in his/her file.

Fourth Step: Positive Disclosure Review by COIOC

The COIOC Administrator forwards positive disclosures to the COIOC. As required by PHS and NSF, all positive disclosures must be reviewed and approved prior to the expenditure of grant award monies. The COIOC reviews positive disclosures to determine if the financial interest poses a "direct and significant impact" on the research and thus a "conflict of interest." If the COIOC finds that the interest presents a real or apparent conflict, it will recommend options to the Vice Chancellor for Research to reduce, manage or eliminate the conflict.

If a conflict has been identified and is being reduced, managed or eliminated by the institution, the Vice Chancellor will ask the COIOC Administrator, upon award notification, to notify PHS or UC (if the award is from either of them). NSF policy does not require notification unless the institution determines the conflict can not be managed, reduced or eliminated.

Administrative Actions (if necessary)

If the COIOC determines there is a difference between the PI's disclosure and the apparent facts of the situation, they will be unable to confirm whether or not there is a harmful conflict of interest. In that event, the Committee, in fulfilling its responsibilities to the institution, will make one of two recommendations to the Vice Chancellor. The recommendations are based on Federal regulations, which require reports to the Federal sponsor of any violations of University policy. The recommendation will either be to send a letter to the Agency (PHS or NSF) indicating that:

Under the regulations, "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 interest related to Federally-sponsored projects.