Financial Interest Reporting Requirements

Non-Federal

Federal

Research Involving Human Subjects

• Principal Investigator (PI)

• Principal Investigator (PI)

• All other Individuals who have the responsibility for the design, conduct, or reporting of research results.

• All Individuals on the list of research personnel.

Non-Federal

Federal

Research Involving Human Subjects

A financial interest "in" the sponsor:

Positions:

• Founder, Partner, Director, Manager, Officer, Consultant, Employee or any position of management

Investments:

• Stocks, Bonds, Stock Options, etc.  >$2,000 held during the prior 12 months, as well as any future or anticipated ownership interests in the next 12 months

Income:

• Salaries, or any other payment
  for services > $500 including Consulting Fees, Honoraria, or Dividends  including 
  payments made to the University of California Health Sciences Compensation Plans. 
  This applies to income
  received 12 months prior to the
  time of financial disclosure, as well as future or anticipated
  income in the next 12 months

Gifts:

• Gift, Promise of a Gift, or Multiple Gifts > $50

Loans:

• Loans received or outstanding > $500

Travel Reimbursements:

• Per Diem, Transportation outside California, Travel Advances, Lodging and Meals

Travel Payments:

• Advances and reimbursements for travel and related expenses, including lodging and meals.  Please see 700U Instructions for additional reporting requirements

Please Note: Financial interests must be reported for the PI and their spouse or registered domestic partner, and dependent children.

A related significant financial interest in an entity "other" than the Federal sponsor:

Positions:

• Founder, Partner, Director, Manager, Officer, Consultant, Employee or any position of management

Investments:

• Stocks, Bonds, Stock Options, etc.  >$10,000 market value or 5% ownership interest held during the prior 12 months, as well as any future or anticipated ownership interests in the next 12 months

Income:

• Salaries, or any other payment
  for services > $10,000 including Consulting Fees, Honoraria, Dividends, or  travel reimbursement, including 
  payments made to the University of California Health Sciences Compensation Plans. 
  This applies to income
  received 12 months prior to the
  time of financial disclosure, as well as future or anticipated
  income in the next 12 months

Intellectual Property:

• Intellectual property interest on a patent, patent application, or copyright assigned or licensed to a party other than The Regents of the University of California. This applies to current as well as anticipated intellectual property interests in the next 12 months.

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

A financial interest "in" the sponsor or "in" another entity that would reasonably appear to be affected by the research, such as a Contract Research Organization or the manufacturer of the test article.

Positions:

• Founder, Partner, Director, Manager, Officer, Consultant, Employee or any position of management

Investments:

• Stocks, Bonds, Stock Options, etc.  >$2,000 held during the prior 12 months, as well as any future or anticipated ownership interests in the next 12 months

Income:

• Salaries, or any other payment for services > $500 including Consulting Fees, Honoraria, Dividends, or travel reimbursement, including payments made to the University of California Health Sciences Compensation Plans. Income also includes royalty or other income on a patent, patent application or
  copyright that is related to the proposed study.  This applies to income received 12 months prior to the time of financial disclosure, as well as future or anticipated income in the next 12 months

Gifts:

• Gift, Promise of a Gift, or Multiple Gifts > $50

Loans:

• Loans received or outstanding > $500

Intellectual Property:

• Intellectual property interest on a patent, patent application, or copyright assigned or licensed to any party including The Regents of the University of California. This applies to current as well as anticipated intellectual property interests in the next 12 months.

Please Note: Financial interests must be reported for the PI and their spouse or registered domestic partner, and dependent children.

Non-Federal

Federal

Research Involving Human Subjects

• With the initial proposal

• With additional funding

• With any change with the PI's financial interest(s)

Please Note: All positive disclosures must be reviewed and approved prior to acceptance of the award or additional funding.

• With the initial proposal

• With Continuation proposals

• With Renewal proposals

• With Supplemental proposals

• When new personnel are added

• With any change with the PI's financial interest(s)

Please Note: All positive disclosures must be reviewed and approved prior to acceptance of the award or additional funding.

• With the initial proposal

• With any continuing IRB application

• With any modification request that changes the Lead Researcher or adds Co-Researchers or other research personnel

Please Note: All positive disclosures must be reviewed and approved prior to IRB approval of the protocol and informed consent.

Non-Federal

Federal

Research Involving Human Subjects

• 700-U

• Addendum (positive disclosures)

• 9510

• Addendum (positive disclosures)

• IRB Facesheet–Section 3

• Addendum (positive disclosures)