9510 Form

Form at a Glance:

• What is the 9510 form?

• When is the 9510 form required?

• When is the 9510 form not required?

• Why is the 9510 form required?

• Who is required to submit a 9510 form?

• What financial interests need to be disclosed on the 9510 form?

• What financial interests do not need to be disclosed on the 9510 form?

• When must I submit the 9510 form?

• Where do I submit the 9510 form?

• What happens after the 9510 form is submitted?

• What is the Independent Review Committee's (IRC) review process?

• Is there an appeal process to the IRC's recommendations?

• What happens if I am required to submit the 9510 form and do not?

• University of California Policies

• Contact Information

Want to learn more? Take the Conflict of Interest for Researchers narrated online class.

 

What is the 9510 form?

• The UCSD created 9510 disclosure form is the Disclosure of Financial Interests Related to Federal and Other Sponsored Projects Adopting the Federal Requirements, and is used for the disclosure of significant financial interests when projects are being funded by specific federal sponsors.

• PDF

• Excel

• Addendum

Please Note: The Addendum to Investigator's Statement of Economic Interests is required when the Principal Investigator (PI) and all other individuals, who have responsibility for the design, conduct, or reporting of research results for the sponsored project, have disclosed a financial interest on the 9510 form.

 

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When is the 9510 form required?

The 9510 form is required for contract and grant proposals being submitted to:

• National Institutes of Health (NIH)

• Department of Health and Human Services (DHHS):

1. AHRQ - Agency for Healthcare Research and Quality

2. ATSDR - Agency for Toxic Substances and Disease Registry

3. CDC - Centers for Disease Control and Prevention

4. FDA - Food and Drug Administration

5. HRSA - Health Resources and Services Administration

6. IHS - Indian Health Service

7. NIH - National Institutes of Health

8. SAMHSA - Substance Abuse and Mental Health Services Administration

• National Science Foundation (NSF)

• American Cancer Society (ACS)

• American Heart Association (AHA)

• California Institute for Regenerative Medicine (CIRM)

• UC Discovery Grant Program:

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• UC Programs:

• Breast Cancer Research Program (BCRP)

• California HIV/AIDS Research Program (CHRP)

• Tobacco-Related Disease Research Program (TRDRP)

• Subawards:

• Applies to entities with funds originating from all agencies mentioned above; NIH, the 8 DHHS agencies, NSF, AHA, UC Discovery Grant Program and UC Programs; BCRP, CHRP, and TRDRP. The receiving entity is required to supply assurances that will allow the University to comply with NIH, NSF, some DHHS agencies, AHA, CIRM UC Discovery Grant Program, and UC Programs BCRP, TRDRP, and UARP regulations.

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When is the 9510 form not required?

The 9510 form is not required for:

• Training Grants

• Other Federal Agencies:

• NASA

• Air Force

• Army

• Department of Energy (DOE)

• Office of Naval Research (ONR)

• UC Discovery Opportunity Awards

• UC Programs other than BCRP, TRDRP, and UARP

Be sure to check with your proposal analyst for other specific agencies not listed above.

 

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Why is the 9510 form required?

• Beginning in 1995, federal regulations, as well as the University of California policy's on disclosure of financial interests and the management of conflicts of interests related to sponsored projects, began requiring researchers at UCSD, who receive funding from a particular federal sponsor, to disclose certain significant financial interests. Significant refers to specific financial thresholds, as well as the researcher's financial interests or the financial interests of the entity, that could reasonably appear to be affected by the federal sponsored research.

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Who is required to submit a 9510 form?

• Principal Investigator

• All other individuals who have responsibility for the design, conduct, or reporting of research results for the sponsored project must also disclose their financial interests as well. These individuals can include:

• Co-Principal Investigators

• Other Investigators

• Other individuals participating in the project

Please Note: Financial interests must be reported for the disclosing individual(s) and their spouse and dependent children.

 

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What financial interests need to be disclosed on the 9510 form?

The significant financial interests that must be disclosed for Federal sponsored research include:

• Income from the entity:

• Income of $10,000 or more from a single for-profit company or non-profit foundation, for services that can include; salaries, consulting income, honoraria from speeches or other services that were performed, royalty payments, and stock dividends and/or interest earned, or the proceeds from any stock sales. In addition, income also includes compensation received by the University of California Health Sciences Compensation Plans.

• Investments in the entity:

• Investments in the entity can include stocks, bonds, warrants, stock options, including margin or brokerage accounts, loans, or any other investments or ownership interest exceeding either $10,000 market value if publicly traded; otherwise the amount of the investment, or 5% ownership interest in the entity.

• Positions with the entity:

• Positions as founder, partner, director, manager, officer, trustee, employee, or any other position of management with the entity.

• Intellectual property:

• Any invention, discovery, or work of authorship, in a patent, patent application, or a copyright assigned or licensed to a party other than The Regents of the University of California.

The 4 financial interest categories above, each use a 12 month threshold for financial disclosure, but it is applied in different ways. For example:

• Income uses the 12 month threshold in 2-ways; for activities that took place 12 months prior to the time of financial disclosure, as well as for 12 months of future or anticipated financial interest.

• investments, Positions, and Intellectual property applies only to current, as well as for 12 months of future or anticipated financial interest.

Please Note: Financial interests must be reported for the disclosing individual(s) and their spouse and dependent children.

 

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What financial interests do not need to be disclosed on the 9510 form?

• Payments made by The Regents of the University of California, including salary, stipends, royalty payments, honoraria, reimbursement of expenses, or any other remuneration from the University.

• Income from seminars, lectures, teaching engagements, or service on advisory committees or review panels of public and non-profit Entities.

• Financial interests not related to the sponsored project. For example, a computer scientist conducting research on computer-aided drug design does not need to disclose financial interests (stock in companies such as IBM or Xerox) if these companies are not conducting research or manufacturing in the field of computer-aided drug design.

• Financial interests unrelated to their field of research, such as Wal-Mart stock or real estate investments.

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When must I submit the 9510 form?

With:

• Initial proposal

• Continuation proposals

• Renewal proposals

• Supplemental proposals

• Any change with the PI's financial interest(s)

When:

• New personnel are added

At the time of submission for any proposal being submitted to:

• National Institutes of Health (NIH)

• Department of Health and Human Services (DHHS):

1. AHRQ - Agency for Healthcare Research and Quality

2. ATSDR - Agency for Toxic Substances and Disease Registry

3. CDC - Centers for Disease Control and Prevention

4. FDA - Food and Drug Administration

5. HRSA - Health Resources and Services Administration

6. IHS - Indian Health Service

7. NIH - National Institutes of Health

8. SAMHSA - Substance Abuse and Mental Health Services Administration

• National Science Foundation (NSF)

• American Cancer Society (ACS)
• American Heart Association (AHA)

• California Institute for Regenerative Medicine (CIRM)

• UC Discovery Grant Program:

• MICRO

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• UC Programs:

• Breast Cancer Research Program (BCRP)

• California HIV/AIDS Research Program (CHRP)

• Tobacco-Related Disease Research Program (TRDRP)

• Whenever there is a change in reported financial interests occurring prior to or during the period of an award.

• Whenever a new Investigator who has responsibility for design, conduct or reporting is added to the project.

• Whenever a continuing proposal is one million dollars or more.

• When a project is awarded through a subaward and the awarding agency is NIH, NSF, some DHHS agencies, AHA, UC Discovery Grant Program, and UC Programs BCRP, TRDRP, and UARP.

• When the University is the prime contractor and subawards a portion of the research with another entity. The receiving entity is required to supply assurances that will allow the University to comply with NIH, NSF, some DHHS agencies, AHA, CIRM, UC Discovery Grant Program, and UC Programs BCRP, TRDRP, and UARP regulations.

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Where do I submit the 9510 form?

Submit the 9510 form with the funding proposal to:

• For General Campus and Health Sciences proposals:

• Research Contracts and Grants

• Investigator-Initiated Protocols

• Office of Contract and Grant Administration (OCGA)

• For Scripps Institution of Oceanography proposals:

• Research Contract and Grants

• Industry Service Agreements

• Purchase Orders

• SIO Contract and Grant Office

• For NIH Grant Proposals only:

• Health Sciences Sponsored Projects Pre-Award Office (HSSPPO)

Please Note: An original signature is always preferred, however faxed signatures will be accepted.

 

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What happens after the 9510 form is submitted?

• The proposal review office sends the 9510 form to the Conflict of Interest (COI) Office.

• If no financial interest exists, then 9510 form is approved. This is referred to as a Negative Disclosure. The COI Office informs the proposal review office to release funds upon receipt of the award.

• If a financial interest exists, this is referred to as a Positive Disclosure:

• The 9510 form and the Addendum are forwarded to the Independent Review Committee (IRC) for further review

• The IRC recommends a conflict of interest management strategy to the chancellor

• Chancellor either endorses or disagrees with the recommended strategy

• Memo is issued by the Conflict of Interest Office advising the researcher of the Chancellor's decision

Please Note:   Once the disclosure of financial interests forms have been submitted, they can be made available, upon request, to the public, under the California Public Records Act.

 

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What is the Independent Review Committee's review process?

• Reviews disclosure forms on a monthly basis.

• May request PI/Co-PI to make changes in their financial relationship with company or donor.

• Makes written recommendations to the Chancellor to manage, eliminate and/or reduce conflict of interest.

• Chancellor executes a letter after this review and concurrence with IRC’s recommendations.

• The COI Office sends copies of Chancellor’s concurrence letter to PI, Department Chair and others, as appropriate.

• COI Office informs the reviewing office that the award may be accepted, as appropriate.

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Is there an appeal process to the IRC's recommendations?

If the Investigator does not agree with the IRC’s recommendations:

• The Investigator will contact the IRC.

• The investigator will also be asked to discuss this matter with their Dean and/or Vice Chancellor to implement the IRC’s requests recommendations or to suggest an acceptable alternative to manage the conflict of interest.

• The IRC will meet with the Dean and/or Vice Chancellor to discuss the matter.

• If all attempts to mediate the conflict of interest situation have not been successful, and the PI or Researcher is still not in agreement with the recommendations made by the IRC, the IRC will then recommend that funding for the project not be accepted and forward this recommendation to the Chancellor for concurrence.

• If the PI does not concur with the IRC's recommended management strategies even after this process, the PI can appeal the decision to the Chancellor for review.

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What happens if I am required to submit the 9510 form and do not?

• Failure to file or update economic interests forms or to comply with any conditions or restrictions imposed on the conduct of the project will be grounds for discipline under the University Policy on Faculty Conduct and the Administration of Discipline and/or other applicable employee discipline policies. Furthermore, federal sponsors may suspend or terminate the award and/or debar an investigator from receiving future awards.

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University of California Policies:

• It is the policy of the University of California that any Investigator responsible for the design, conduct or reporting of a sponsored project at the UCSD must disclose significant personal financial interests related to that project, when proposed to be funded by NIH, NSF or other sponsoring agencies around the United States who have adapted the federal disclosure requirements. When UCSD determines that such an interest might reasonably appear to be directly and significantly affected by the sponsored project, UCSD will take steps either to manage or to eliminate the conflict, pursuant to rules and policies promulgated by several jurisdictions; the Federal and State governments, the UC Office of the President, the Academic Senates of both the University of California system and UCSD campus. Access the following links below for further detailed assistance.

• PHS Objectivity in Research

• NSF Investigator Financial Disclosure Policy

• FAQ's Concerning the DHHS and NSF Regulations

• University of California Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Sponsored Projects, (revised 02/02/09)

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Contact Information:

 

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