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Please Note: The
Addendum to Investigator's Statement of Economic Interests is required
when a Principal Investigator (PI), Co-Principal Investigator, or Key
Personnel have disclosed a financial interest on the 700-U form or the
9510 form. |
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What
is the 9510 form?
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The 9510 form is the...
Please Note: The 9510 disclosure
is different from the State of California 700-U form, which requires Principal
Investigators and Co-Investigators to disclose any financial interest
in non-governmental sponsors of research and gifts administered by the
University. |
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When
is the 9510 form required?
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The 9510
form is required for contract and grant proposals being submitted to...
National Institutes
of Health (NIH): which include these types of proposals/disclosures; New Renewal/Competing Continuation Resubmission Continuation Competitive Supplement Change of Principal Investigator Add Researcher to the Project Subcontract SBIR - Small Business Innovation Research STTR - Small Business Technology Transfer
For detailed information on NIH policy regarding Conflict of Interest,
click here.
AHRQ - Agency for Healthcare Research and Quality ATSDR - Agency for Toxic Substances and Disease
Registry CDC - Centers for Disease Control and Prevention FDA - Food and Drug Administration HRSA - Health Resources and Services Administration IHS - Indian Health Service NIH - National Institutes of Health SAMHSA - Substance Abuse and Mental Health Services
Administration
National Science
Foundation (NSF): which include these types of proposals/disclosures; New Resubmission Change of Principal Investigator Add Researcher to the Project
For detailed information on NSF policy regarding Conflict of Interest,
click here.
American Cancer
Society (ACS): For Research Scholars; which includes these types
of proposals/disclosures; New Resubmission Change of Principal Investigator Add Researcher to the Project
For further information regarding Conflict of Interest for ACS, click
here.
American Heart
Association (AHA): Western and National; which includes these types
of proposals/disclosures; New Resubmission Change of Principal Investigator Add Researcher to the Project
For further information regarding Conflict of Interest for AHA, click
here.
California Institute
for Regenerative Medicine (CIRM): which include these types of
proposals/disclosures: New Resubmission Change of Principal Investigator Add Researcher to the Project
For further information regarding Conflict of Interest for ACS, click
here.
UC Discovery Grant
Program: MICRO, bio, com, dig, ele,
itls; which include these types of proposals/disclosures:
UC Programs: Breast Cancer Research Program (BCRP), California
HIV/AIDS Research Program (CHRP), or Tobacco-Related Disease Research
Program (TRDRP); which include these types of proposals/disclosures:
Subaward: 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. When
the University is the prime contractor and subawards a portion of the
research with another entity. Please Note:
The receiving entity is required to supply assurances that will allow
the University to comply with NIH, NSF, some DHHS agencies, AHA, UC Discovery
Grant Program, and UC Programs BCRP, TRDRP, and UARP regulations.
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When
is the 9510 form not required?
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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
Check with your proposal analyst for other
specific agencies not listed above.
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Why is the 9510 form
required?
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The 9510 form is required...
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Who
is required to submit a 9510 form?
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Individuals required to submit the 9510 form
include...
Principal Investigators (PI) - A UCSD employee,
normally an academic appointee, who has primary responsibility for the
scientific and technical conduct, reporting, fiscal, and programmatic
administration of a sponsored project. Any individuals responsible for the design, conduct,
or reporting of research results for a sponsored project; such as: Co-Principal Investigators Other Investigators Key Personnel |
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What
financial interests need to be disclosed on the 9510 form?
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Disclosure of "significant" financial
interest are those...
That would reasonably appear to be affected by
the funded research or educational activities, or In an entity (a company, non-federal or state
sponsor, corporation, etc.) whose financial interests would reasonably
appear to be affected by such activities, or Entities owned by Investigator, Investigator's
spouse or dependent child(ren).
Financial interests include...
Income of $10,000 or more from a single business,
public, or Non Profit entity including: salary, consulting payments, honoraria,
reimbursement of expenses, royalty payments, dividends, loans from the
entity, or any other payments or consideration with value, including payments
made to the University Medical Compensation Plan, during the prior twelve
months or anticipated in the next twelve months; Equity in the form of stock, stock options, real
estate, loans to the entity, or any other investment or ownership interest
of $10,000 or more (current market
value if publicly traded; otherwise, amount of investment) or a 5% ownership
interest, for any one enterprise; A management position, such as board member, director,
officer, partner, or trustee, held in any business entity by the investigator;
or Intellectual property interest on a patent, a
patent application or a copyright of software assigned or licensed to
a party other than The Regents.
Examples of financial interests "related"
to a sponsored project...
The results of the project would be relevant to
the development, manufacturing, commercializing or improvement of any
drug, device, procedure, or other products or services of the business
Entity in which an Investigator has a financial interest. Consulting income from an Investigator's professional
field that is $10,000 or more
during the prior 12 months, is considered "related" and must
be disclosed. The sponsored project will subaward a portion
of the work, or lease property, or make purchases from an Entity in which
an Investigator has a financial interest. The sponsored project will involve referral of
participants to organizations in which an Investigator has a financial
interest, or includes collaboration or participation in a consortium with
other institutions and/or entities in which an Investigator has a financial
interest.
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What
financial interests do not need to be disclosed on the 9510 form?
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Financial interests that do not need
to be disclosed include...
A financial interest does not include payments
made by The Regents, including salary, stipends, royalty payments, honoraria,
reimbursement of expenses, or any other remuneration from the University.
A financial interest does not include 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. In addition, Investigators would normally not
need to disclose 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?
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The Form 9510 must be submitted...
At the time of submission for any proposal to
NIH, NSF, some DHHS agencies, AHA, UC Discovery Grant Program, and UC
Programs BCRP, TRDRP, and UARP. 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. Please
Note: The receiving entity is required to supply assurances that
will allow the University to comply with NIH, NSF, some DHHS agencies,
AHA, UC Discovery Grant Program, and UC Programs BCRP, TRDRP, and UARP
regulations.
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Where
do I submit the 9510 form?
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All required
disclosure forms must be completed and submitted with the funding proposal
to the appropriate reviewing office...
OCGA - Office of Contract and Grant Administration,
for Research Agreements and Material Transfer Agreements for the General
Campus and Health Sciences, excluding NIH Grant Proposals. SIO - Scripps Institution of Oceanography, Contract
& Grant Office for research agreements at SIO. HSSPPO - Health Sciences Sponsored Projects Pre-Award
Office, for NIH Grant Proposals only.
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?
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After the 9510 form is submitted...
The form is sent to the appropriate proposal
review office. The proposal reviewing office sends the 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 COI Office informs the proposal
review office to hold funds until the disclosure is reviewed by the
Independent Review
Committee (IRC) on Conflict of Interest. The COI Office requests the PI and Co-PI complete
the Addendum to Investigator's Statement of Economic
Interests form. Additional information may be required from the
PI and/or Co-PI to be sent to the COI Office. For example; a
copy of the Consulting Agreement must be provided.
Please Note: NIH
must be notified if a Conflict of Interest exists.
Keep in mind that 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?
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The
IRC review process includes the following actions...
Reviews disclosure
forms on a monthly basis. May request PI/Co-PI
to make changes in their financial relationship with company or donor.
For further detail information regarding the IRC, click
here. 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?
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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?
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The University states...
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. |
